Feedback y EMPP R Cochrane2011

Feedback or biofeedback to augment pelvic floor muscle
training for urinary incontinence in women (Review)
Herderschee R, Hay-Smith EJC, Herbison GP, Roovers JP, Heineman MJ
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2011, Issue 7
http://www.thecochranelibrary.com
Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women (Review)
Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Analysis 1.2. Comparison 1 PFMT + BF versus PFMT alone, Outcome 2 Women’s perception of change in incontinence -
not cured or improved. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Analysis 1.3. Comparison 1 PFMT + BF versus PFMT alone, Outcome 3 Women’s perception of change in incontinence -
not cured. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Analysis 1.4. Comparison 1 PFMT + BF versus PFMT alone, Outcome 4 Women’s satisfaction with progress - not
satisfied. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Analysis 1.5. Comparison 1 PFMT + BF versus PFMT alone, Outcome 5 Leakage episodes in 24 hours. . . . . . 81
Analysis 2.2. Comparison 2 PFMT + F versus PFMT alone, Outcome 2 Women’s perception of change in incontinence -
not cured or improved. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Analysis 2.3. Comparison 2 PFMT + F versus PFMT alone, Outcome 3 Women’s satisfaction with progress - not satisfied. 95
Analysis 2.4. Comparison 2 PFMT + F versus PFMT alone, Outcome 4 Leakage episodes in 24 hours. . . . . . 96
Analysis 3.3. Comparison 3 PFMT + F + BF versus PFMT alone, Outcome 3 Leakage episodes in 24 hours. . . . 98
Analysis 4.2. Comparison 4 PFMT + BF vs PFMT + F, Outcome 2 Women’s perception of change in incontinence - not
cured or improved. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Analysis 4.3. Comparison 4 PFMT + BF vs PFMT + F, Outcome 3 Women’s perception of change in incontinence - not
cured. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Analysis 4.4. Comparison 4 PFMT + BF vs PFMT + F, Outcome 4 Women’s satisfaction with progress - not satisfied. 103
Analysis 4.5. Comparison 4 PFMT + BF vs PFMT + F, Outcome 5 Leakage episodes in 24 hours. . . . . . . . 104
Analysis 5.2. Comparison 5 PFMT + BF versus PFMT + BF, Outcome 2 Leakage episodes in 24 hours. . . . . . 109
Analysis 6.1. Comparison 6 Subgroup assessment, Outcome 1 Women’s perception of change in incontinence - not cured
or improved (type of BF)). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Analysis 6.2. Comparison 6 Subgroup assessment, Outcome 2 Leakage episodes in 24 hours (type of BF). . . . . 113
or improved (type of UI). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Analysis 6.4. Comparison 6 Subgroup assessment, Outcome 4 Leakage episodes in 24 hours (type of UI). . . . . 115
or improved (times (B)F given). . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Analysis 6.6. Comparison 6 Subgroup assessment, Outcome 6 Leakage episodes in 24 hours (times (B)F given). . . 117
Analysis 6.7. Comparison 6 Subgroup assessment, Outcome 7 Women’s perception of incontinence - not cured or improved
(concealment of allocation). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Analysis 6.8. Comparison 6 Subgroup assessment, Outcome 8 Leakage episodes in 24 hours (concealment of allocation). 119
or improved (difference in PFMT). . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Analysis 6.10. Comparison 6 Subgroup assessment, Outcome 10 Leakage episodes in 24 hours (difference in PFMT). 121
ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women (Review) i
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . . 145
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women (Review) ii
[Intervention Review]
Feedback or biofeedback to augment pelvic floor muscle

training for urinary incontinence in women
Roselien Herderschee1 , E. Jean C. Hay-Smith2 , G Peter Herbison3 , Jan Paul Roovers1 , Maas Jan Heineman1
1 Department of Obstetrics & Gynaecology Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.
2 RehabilitationTeaching and Research Unit, Department of Medicine, University of Otago, Wellington, New Zealand. 3 Department
of Preventive & Social Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
Contact address: Roselien Herderschee, Department of Obstetrics & Gynaecology Academic Medical Centre, University of Amsterdam,
Kerkstraat 379b, Amsterdam, 1017 HW, Netherlands. roselien.herderschee@gmail.com.
Editorial group: Cochrane Incontinence Group.

Publication status and date: New, published in Issue 7, 2011.
Review content assessed as up-to-date: 22 July 2010.
Citation: Herderschee R, Hay-Smith EJC, Herbison GP, Roovers JP, Heineman MJ. Feedback or biofeedback to augment pelvic floor
muscle training for urinary incontinence in women. Cochrane Database of Systematic Reviews 2011, Issue 7. Art. No.: CD009252. DOI:
10.1002/14651858.CD009252.
ABSTRACT
Background
Pelvic floor muscle training (PFMT) is an effective treatment for stress urinary incontinence in women. Whilst most of the PFMT
trials have been done in women with stress urinary incontinence, there is also some trial evidence that PFMT is effective for urgency
urinary incontinence and mixed urinary incontinence. Feedback or biofeedback are common adjuncts used along with PFMT to help
teach a voluntary pelvic floor muscle contraction or to improve training performance.
Objectives
To determine whether feedback or biofeedback adds further benefit to PFMT for women with urinary incontinence.
To compare the effectiveness of different forms of feedback or biofeedback.
Search methods
We searched the Cochrane Incontinence Group Specialised Trials Register (searched 13 May 2010) and the reference lists of relevant
articles.
Selection criteria
Randomised or quasi-randomised trials in women with stress, urgency or mixed urinary incontinence (based on symptoms, signs or
urodynamics). At least two arms of the trials included PFMT. In addition, at least one arm included verbal feedback or device-mediated
biofeedback.
Data collection and analysis
Trials were independently assessed for eligibility and risk of bias. Data were extracted by two reviewers and cross-checked. Disagreements
were resolved by discussion or the opinion of a third reviewer. Data analysis was conducted in accordance with the Cochrane Handbook
for Systematic Reviews of Intervention (version 5.1.0). Analysis within subgroups was based on whether there was a difference in PFMT
between the two arms that had been compared.
Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women (Review) 1
Main results
Twenty four trials involving 1583 women met the inclusion criteria; 17 trials contributed data to analysis for one of the primary
outcomes. All trials contributed data to one or more of the secondary outcomes. Women who received biofeedback were significantly
more likely to report that their urinary incontinence was cured or improved compared to those who received PFMT alone (risk ratio
0.75 , 95% confidence interval 0.66 to 0.86). However, it was common for women in the biofeedback arms to have more contact with
the health professional than those in the non-biofeedback arms. Many trials were at moderate to high risk of bias, based on trial reports.
There was much variety in the regimens proposed for adding feedback or biofeedback to PFMT alone, and it was often not clear what
the actual intervention comprised or what the purpose of the intervention was.
Authors’ conclusions
Feedback or biofeedback may provide benefit in addition to pelvic floor muscle training in women with urinary incontinence. However,
further research is needed to differentiate whether it is the feedback or biofeedback that causes the beneficial effect or some other
difference between the trial arms (such as more contact with health professionals).
PLAIN LANGUAGE SUMMARY
Feedback or biofeedback in addition pelvic floor muscle training for urinary incontinence in women
Women of all ages are affected by urinary incontinence. A common treatment is pelvic floor muscle exercises (also called pelvic floor
muscle training) where the pelvic floor muscles are squeezed and lifted then relaxed several times in a row, up to three times a day. The
exercises can help strengthen the muscles, improve muscle endurance (so the muscle tires less easily), and improve coordination (so the
muscle squeezes hardest when the risk of leaking is greatest, e.g. with a cough or sneeze).
Contracting the right muscles, and doing enough of the exercises are important for successful treatment. Feedback or biofeedback are
used as ways to teach women to contract the correct muscles, learn when and how to contract the muscle to prevent leakage, assess
whether the muscle contraction is improving over time, and can be used as a ’trainer’ for repetitive exercising. A common method of
feedback is for the health professional to feel the pelvic floor muscles during a vaginal examination and describe how well the muscles
squeeze and lift when the woman contracts them. Biofeedback uses a vaginal or anal device to measure the muscle squeeze pressure or
the electrical activity in the muscle. The device gives this information back to the woman using the device as a sound (for example, the
sound gets louder as the squeeze increases) or a visual display (for example, more lights meaning a stronger squeeze).
Contracting the right muscles at the right time, and doing enough of the exercises, are important for successful treatment. There was
some evidence that adding biofeedback was beneficial. However, it was not clear whether this was the effect of the biofeedback device
itself. It is possible that the benefit came from spending more time in clinic with the doctor, nurse or physiotherapist.
BACKGROUND
’ever’, ’any’ or ’at least once in the past 12 months’ (Milsom 2009).
Urinary incontinence (UI) is a common problem affecting many UI can be a debilitating condition with a large negative impact on
women, and is increasingly common with age (Milsom 2009). For quality of life (Bartoli 2010).
a variety of reasons (such as difference in study populations, def-
initions of UI and ways of measuring UI) estimates of UI preva- Economic costs of urinary incontinence are considerable. In 1995
lence differ widely. Van der Vaart et al reported a prevalence rate the estimated annual direct costs of all types of UI in the USA were
of UI higher than 50% (Van der Vaart 2007). According to a re- reported to be over 16 billion American dollars (Wilson 2001).
view including 36 general population studies included in the 4th More recently, Ganz et al (2010) estimated the total (direct and
International Consultation on Incontinence, most studies report indirect) economic costs of overactive bladder (including urgency
a prevalence of ‘any’ UI in the range of 25% to 45%; this estimate urinary incontinence) in the ever aging population of the USA
comes from studies in which symptoms of UI were reported as to be over 65 billion dollars annually, and predicted these costs
would keep rising over the next decade (Ganz 2010). Given the Urgency urinary incontinence (UUI)
latest estimate was for only one type of incontinence rather than all Urgency urinary incontinence (UUI) is the term used when the
types, that new interventions are likely to add yet more cost, and woman describes the involuntary loss of urine associated with ur-
these estimates were confined to just one developed country, these gency; urgency is a “sudden, compelling desire to pass urine which
estimated costs must be a significant underestimate of worldwide is difficult to defer” (Haylen 2010). It is thought that the urgency
economic impact. occurs when the detrusor (or bladder) muscle involuntarily con-
First line therapy for many people with urinary incontinence tracts and/or the urethra ‘relaxes’ (Dietz 2009). If such involun-
includes conservative management, defined as non-surgical and tary detrusor muscle contractions are seen on urodynamic testing,
non-pharmaceutical therapies (Dumoulin 2010). Among the most during the filling phase (whether the person feels urgency or not),
common of these is pelvic floor muscle training. Buckley 2010 this is called detrusor overactivity (Haylen 2010). Often there is
recently reported the development of a methodology (using the no known cause (idiopathic detrusor overactivity) but sometimes
James Lind process), and the outcomes of this, in which patients there is evidence of a relevant neurological disorder (neurogenic
and clinicians worked together to identify and prioritise important detrusor overactivity) (Haylen 2010).
UI research questions through consensus (Buckley 2010). Among Commonly, women with urgency and UUI report other symp-
the most important outcomes was the need to identify an optimal toms as well. Among these are urinary frequency (going to the
protocol for pelvic floor muscle training. In clinical practice, pelvic toilet more often than the woman considers as normal) and noc-
floor muscle training is often combined with some type of feed- turia (interrupted sleep because of the need to get up and go to
back (often biofeedback) to help the woman learn how to contract the toilet). The group of symptoms comprising urgency, usually
the muscles or to modulate the contraction or encourage training with frequency and nocturia, is described as overactive bladder
performance. However it is not clear if the inclusion of feedback syndrome (OAB). Women with OAB may experience leakage as-
(or biofeedback) is part of an optimal PFMT programme or if sociated with urgency (i.e. they have UUI) but some women may
adjunctive biofeedback adds to the cost of treatment. Therefore, have urgency without any involuntary urinary leakage.
not only would it be useful to know if feedback (or biofeedback) In contrast to SUI, there is still not much known about the aetiol-
makes pelvic floor muscle training more effective, but also whether ogy and pathophysiology of UUI (Dietz 2009). However the in-
this is a cost-effective addition to treatment. continence is “usually the result of an involuntary increase in blad-
der pressure due to contraction of the detrusor muscle” (Dumoulin
2010). UUI is normally treated with bladder training (Wallace
Description of the condition 2009) or anticholinergic drugs (Nabi 2009) or both.
Definitions jointly recommended by the International Inconti-

nence Society (ICS) and the International Urogynecological As- Mixed urinary incontinence (MUI)
sociation are used, except where specifically noted (Haylen 2010). Mixed urinary incontinence (MUI) is the combination of both
Urinary incontinence (UI) is the “complaint of involuntary loss stress and urgency urinary incontinence, whether reported as a
of urine” (Haylen 2010). The three most prevalent types of UI in symptom or sign.
women are stress urinary incontinence, urgency urinary inconti-
nence, and mixed urinary incontinence.
Treatment of stress, urgency and mixed urinary
incontinence with pelvic floor muscle training (PFMT)
Stress urinary incontinence (SUI) The pelvic floor muscles are the only muscle group in the body
Women who describe stress urinary incontinence (SUI) are most able to give structural support to the pelvic organs (urethra, vagina
likely to complain of involuntary leakage with activities that in- and rectum) (Bø 2004), and they also contribute to urethral
volve physical exertion (such as running, or jumping, or lifting) or closure pressure (DeLancey 1994). In addition, it seems that a
with coughing or sneezing (Haylen 2010). During a urodynamic PFM contraction can help to inhibit detrusor muscle contraction
assessment, if the involuntary loss of urine is observed with increas- (Berghmans 2002). For a variety of reasons, the PFM may be
ing intra- abdominal pressure but is not associated with detrusor weakened or damaged. Rehabilitation of the pelvic floor muscles,
muscle contractions (Haylen 2010) this condition is referred to as specifically pelvic floor muscle training (PFMT), might therefore
urodynamic stress incontinence (USI). reduce or cure UI symptoms through:
The continence system is a multifaceted system, including struc- • strengthening the pelvic floor muscles to improve urethral
tures of different origins such as the muscles, nerves and connective closure pressure;
tissues of the pelvic floor (DeLancey 1997). SUI is likely “to be due • strengthening the pelvic floor muscles to improve the
to anatomical defects in structures that support the bladder and position of the pelvic organs;
urethra , resulting in lost control of urethral pressure” (Dumoulin • making use of a learned voluntary pelvic floor muscle
2010). contraction to increase urethral closure pressure to counter a rise
in intra-abdominal pressure (for example, with a cough) (called timing of the information, which can be given during (concur-
‘The Knack’ by Miller et al. (Miller 1998)); rent) or after muscle contraction (terminal). Further, some aug-
• making use of a learned voluntary pelvic floor muscle mented feedback is called, more specifically, biofeedback. We de-
contraction to control urgency arising from a detrusor fined biofeedback (BF) as being augmented, concurrent or termi-
contraction, and/or urethral ‘relaxation’. nal feedback of biological signals that enables a person to identify
and modify a bodily function of which they are usually unaware.
Readers are referred to the Cochrane review ’Pelvic floor muscle (Beatty 1977; Olton 1980; Sandweiss 1985).
training versus no treatment, or inactive control treatments, for For the purposes of this review, feedback studies were those which
urinary incontinence in women’ for a more comprehensive review used a clinician mediated method of giving information about
of the common types of UI in women, and the rationale for treat- a voluntary pelvic floor muscle contraction back to the woman
ment of UI with PFMT (Dumoulin 2010). performing the contraction. In practice, this meant verbal feedback
In clinical practice, PFMT is often combined with some type of from observation or palpation of the perineum, vagina or anus
feedback or biofeedback. during a contraction.
In contrast, biofeedback (BF) studies were those that used an in-
strument or device to record the biological signals (e.g. squeeze
Description of the intervention pressure, electrical activity) during a voluntary pelvic floor mus-
cle contraction and present this information back to the woman
in auditory or visual form (for example, a louder sound with a
stronger squeeze or an increasing number of lights on a visual dis-
Pelvic floor muscle training (PFMT) play as the strength of the squeeze increased). Use of devices may
For the purpose of this review the definition of pelvic floor muscle add to the costs of treatment.
training (PFMT) is adapted from that described by Dumoulin and BF devices vary considerably. They can be inserted into the rec-
Hay-Smith (2010), that is PFMT is “a programme of repeated vol- tum or vagina or placed on the perineum. Many of the BF devices
untary pelvic floor muscle contractions taught and supervised by used in the included studies of this review were air or water filled
a health care professional” (Dumoulin 2010). In clinical practice, balloons inserted into the rectum or vagina to measure pressure.
PFMT is often combined with some type of feedback or biofeed- Depending on the number and placement of the balloon catheters
back to help the woman: it was possible to measure vaginal, anal and intra-abdominal pres-
(1) to learn how to contract the muscles; sure (e.g. Burgio 2002a; Aksac 2003). The other main group of
(2) to improve the effectiveness of the contraction through mod- BF devices used in the included studies measured electrical ac-
ulating the performance of the learned contraction; tivity (that is, electromyography) via surface metal electrodes on
(3) to encourage further exercising. vaginal or anal probes (e.g. Berghmans 1996; Burns 1993). An-
Dumoulin and Hay-Smith (2010) also included trials that used “a other BF option is to show movement, such as lifting the bladder
single episode of biofeedback for the purposes of teaching a pelvic neck, which is possible with real time images from ultrasound (e.g.
floor muscle contraction” in their definition of PFMT alone. We Tisseverasinghe 2006). BF typically gives the user an auditory or
chose to redefine such studies as ’PFMT plus biofeedback’ because visual record of the contraction or both. Some devices can only be
our objective was to determine whether feedback or biofeedback used in clinic settings because they require a health professional to
added benefit to PFMT compared to PFMT alone. Thus, when set up and use the equipment (e.g. Tisseverasinghe 2006) whereas
we screened studies for this review, all trials where feedback or some are very simple and portable and are designed for home use
biofeedback was used (even if used only once) were classified as (e.g. Laycock 2001a).
’PFMT plus feedback or biofeedback’. However, there are some devices used with PFMT that are not
BF devices (by our definition). For example, women may use a
balloon catheter placed in the vagina to squeeze against and ’resist’
Feedback, including biofeedback (BF) the muscle contraction, using resistance training to strengthen
muscle. These are called intra-vaginal resistance devices (IVRD).
Feedback is the return of a fraction of the outcome from a system
If the device does not give the user a visual or auditory record of
to its input (Oxford Dictionary 1989). Rather than giving “pre-
the muscle contraction then we did not class it as a BF device.
practice information about what to do, feedback provides infor-
If the intra-vaginal resistance device also gives auditory or visual
mation about what was done” (Schmidt 1999). The bodily sensa-
feedback on the contraction then it is both a resistance device and
tions felt by the woman performing the contraction give inherent
a BF device.
feedback about the movement. When supplementary information
In addition to how the feedback is delivered (from a BF device
is given (e.g. verbal feedback from a clinician who is palpating
or from the clinician or both), treatment can also vary in other
or observing the contraction), this is called augmented feedback
ways. For example: the purpose of feedback (see below); how the
(Schmidt 1999). Augmented feedback can be characterised by the
health professional explains what the feedback means; how the review included all studies in women with UI regardless of cause or
health professional encourages the woman to improve her con- presence of other significant co-morbidities (for example, women
traction performance; the amount of time in a clinic visit that with neurological conditions); it is possible that women who have
feedback is used; and so on. These variations are best understood more ‘complex’ presentations of UI might be the very group that
by reading the table describing the included studies in the review benefit from the extra information that feedback gives them.
(Characteristics of included studies) and the Additional Tables
which describe the interventions in each trial in detail (Table 1;
Table 2; Table 3; Table 4; Table 5; Table 6).
OBJECTIVES
To determine whether feedback (including BF) provides additional
How the intervention might work benefit to PFMT in women with UI (stress, urgency or mixed),
Much research suggests that feedback is the single most important regardless of cause.
variable for motor learning (Schmidt 1999). Essentially, feedback
Our tested comparisons were:
works because it helps people learn how to do a movement (such
as a pelvic floor muscle contraction), or how to do it better. In the 1. PFMT plus Biofeedback versus PFMT alone;
context of this review, feedback (or BF) might be used to: 2. PFMT plus Feedback versus PFMT alone;
• teach a correct voluntary pelvic floor muscle contraction;
that is, how to do it, which we have called ‘teaching’. 3. PFMT plus Feedback plus Biofeedback versus PFMT alone;
• change or adjust the learned contraction; that is, how to do 4. PFMT plus Biofeedback versus PFMT plus Feedback;
it better (such as increase strength or timing of contractions), 5. PFMT plus one type of Biofeedback versus PFMT plus another
which we have called ‘modulating’. type of Biofeedback;
• inspire confidence about training performance and improve 6. Subgroup assessment.
training adherence (for example, increase motivation to exercise),
which we have called ‘encouraging’.
METHODS
Why it is important to do this review

The current number one priority in UI research is, according to Criteria for considering studies for this review
Buckley and colleagues, to develop an optimal PFMT protocol
for the treatment of different types of UI (Buckley 2010). Because
feedback (such as verbal instruction with vaginal palpation) and Types of studies
BF are used widely in clinical practice as part of PFMT protocols, Randomised controlled trials and quasi-randomised (e.g. alterna-
investigating the additional effect of adding any form of feedback tion, date of birth) trials were included.
to teach, modulate or encourage PFMT might be an important
part of identifying the optimal PFMT protocol.
Types of participants
In a previous Cochrane systematic review, Dumoulin and Hay- Women of all ages with SUI, UUI or MUI, diagnosed by symp-
Smith found that PFMT was better than no treatment, placebo toms (as reported by the woman), signs (as reported or observed by
drug, or inactive control treatments for women with stress, ur- the health care professional) or urodynamics, regardless of cause.
gency, or mixed incontinence (Dumoulin 2010). In the current Women whose ability to identify and train the pelvic floor muscles
review the focus is on the added effect of feedback (or BF) when might be impaired by trauma (e.g. operative vaginal delivery) or
combined with PFMT for the management of UI. Another review disease (e.g. neurological, cognitive or psychological disorders, or
addresses other potential elements of an optimal PFMT protocol significant medical co-morbidities) were included. It was assumed
(such as the effects of different exercise parameters, the addition that the trialists included only women who had the potential to
of adherence strategies, more versus less supervision of training). benefit from the intervention.
The current review was expected to add to what is already known
by taking a more inclusive approach to the topic than any of the Some studies used urodynamic diagnosis of detrusor overactivity
previous reviews. First, all forms of feedback including BF were as an inclusion criterion. These studies might have included par-
included. Second, all uses of feedback regardless of purpose (that is ticipants who had urgency but no UUI. We included these trials
teaching, modulating or encouraging) were included. Third, this as long as two thirds or more of the study participants had UUI.
Studies of women with hypertonic pelvic floor muscles were ex- or visual form (for example, the sound gets louder or more lights
cluded. Feedback (or BF) are used in this group to help teach pelvic show on a visual display as the strength of the squeeze increases).
floor muscle relaxation (rather than pelvic floor muscle contrac- Based on these definitions, vaginal cones were specifically excluded
tion). Further, UI is seldom the primary problem for women with from the review.
hypertonic pelvic floor muscles. These women are likely to have Studies where the trialists described the use of an intra-vaginal
other treatment objectives (such as improved sexual function, re- resistance device, which did not give auditory or visual feedback
duced pelvic pain), which we did not include as outcomes in this on the pelvic floor muscle contraction, were excluded. However,
review. intra-vaginal resistance devices that resisted the muscle contraction
but also gave biofeedback were eligible for inclusion.
Types of interventions
Types of outcome measures
To be eligible for inclusion, the trial must have made use of a PFMT
Treatment outcomes for women with UI can be divided into
programme in two or more arms of the study, to treat UI. Studies
five categories: woman’s observations; quantification of symptoms;
where PFMT was used to prevent UI were excluded. Moreover, at
clinician’s observations; quality of life; and socioeconomic mea-
least one PFMT arm had to include a form of feedback (or BF) to
sures (Lose 1998). With regard to these domains we considered
teach, modulate or encourage pelvic floor muscle contractions.
the following outcomes of interest:
For the purpose of this review the definition of pelvic floor mus-
cle training (PFMT) is adapted from that described by Dumoulin
and Hay-Smith, that is PFMT is “a programme of repeated volun- Primary outcomes
tary pelvic floor muscle contractions taught by a health care pro-
The primary outcomes of interest were:
fessional” (Dumoulin 2010). We included trials regardless of the
1. Quality of life, both generic and condition specific, as that is
purpose of the PFMT; this could be for strengthening, fatigue re-
considered the most important outcome by patients (Herbison
sistance or using a contraction to counter a rise in intra-abdominal
2009).
pressure (’The Knack’ Miller 1998) or counter urgency (through
2. Symptomatic cure or improvement, as reported by the women.
suppressing a detrusor muscle contraction). Dumoulin and Hay-
Note: in the course of the review it was found that some included
Smith (Dumoulin 2010) also included studies that used “a sin-
studies reported only ’cure’ or ’improvement;’ (but not both) and
gle episode of biofeedback for the purposes of teaching a pelvic
yet others combined cure and improvement data. Therefore, two
floor muscle contraction” in their definition of PFMT alone. We
separate outcomes (’cure’ only, and ’cure or improvement’) were
chose to reclassify such studies as ’PFMT plus biofeedback’ because
made to maximise use of the data.
our objective was to determine whether feedback (or biofeedback)
added benefit to PFMT compared to PFMT alone. Thus, when
we screened studies for this review, all trials where feedback or Secondary outcomes
biofeedback was used (even if used only once) were classified as
’PFMT plus feedback or biofeedback’. The secondary outcomes of interest were:
Interventions that gave advice on strategies for symptoms of urge 1. Women’s observations
and/or frequency (including bladder training and scheduled void- • Satisfaction with treatment outcome;
ing regimes) or other lifestyles advice (such as reduction of caffeine) • Desire for further treatment.
were eligible for inclusion provided the same advice was given to 2. Quantification of symptoms (e.g. from urinary diaries)
both study arms being compared. We did exclude studies where • Leakage (incontinence) episodes;
PFMT was combined with any other physical therapy (such as • Frequency of micturition, and nocturia;
vaginal cones or electrical stimulation) that might influence pelvic • Number of women using pads.
floor muscle performance or drug therapy that might influence
urethral closure pressure or detrusor contraction. 3. Clinician’s observations
For this review, feedback studies are those which use a clinician • Measures of pelvic floor muscle function.
mediated method of giving information about a voluntary pelvic
4. Symptom distress.
floor muscle contraction back to the woman performing the con-
5. Socioeconomic measures
traction. In practice, this means verbal feedback from observation
• Costs of interventions;
or palpation of the perineum, vagina or anus during a contraction.
• Cost-effectiveness of interventions.
In contrast, biofeedback (BF) studies use an instrument or device
to record the biological signals (e.g. squeeze pressure, electrical ac- 6. Adverse events: any event that is plausibly related to feedback,
tivity, movement) during a voluntary pelvic floor muscle contrac- BF, or PFMT such as pelvic pain, vaginal or anal bleeding, skin
tion and present this information back to the woman in auditory reaction to probes or gel, muscle discomfort.
7. Non-prespecified outcomes judged important when performing
the review.
Note: Because of difficulties with interpretation of data from the
variety of pad and paper towel tests available, this outcome was not
pre-specified as an outcome of interest. However, while performing
the review it was decided to report pad test data because this was
one of the most commonly reported outcomes in the review as a
whole. There was too much heterogeneity in the tests to combine
the data in a forest plot, so the data are presented in Other Data
tables.
Search methods for identification of studies

See Figure 1.
Figure 1. PRISMA study flow diagram.
Electronic searches
RH and JHS independently screened the list of titles and abstracts
This review drew on the search strategy developed for the that were retrieved by the Trials Search Coordinator. Studies that
Cochrane Incontinence Group. Relevant trials were identified appeared to be irrelevant were immediately excluded after cross
from the Cochrane Incontinence Group Specialised Trials Reg- checking. The full texts of the remaining studies were retrieved.
ister (For more details of the search methods used to build the The full text articles were independently assessed for eligibility for
Specialised Register please see the ‘Specialized Register’ section inclusion in the review by RH and JHS, using the inclusion and
of the Group’s module in The Cochrane Library.). The register exclusion criteria described above.
contains trials identified from the Cochrane Central Register
of Controlled Trials (CENTRAL), MEDLINE, CINAHL, and
handsearching of journals and conference proceedings. The trials Data extraction and management
in the Cochrane Incontinence Group’s Specialised Register are also RH and JHS designed and tested a data extraction form which was
contained in CENTRAL. The date of the last search was: 13 May used to identify characteristics and extract the data from included
2010. trials . Data extraction was independently undertaken by two peo-
The terms used to search the Incontinence Group Specialised Reg- ple (RH and JHS) and the results were cross checked. Any differ-
ister are given below: ences in opinion with regard to the data were resolved by discus-
(({DESIGN.CCT*} sion. If available, the full paper was used for initial assessment and
OR {DESIGN.RCT*}) AND ({INTVENT.PHYS.PFMT*} OR any additional data from other publications arising from the same
{INTVENT.PHYS.BIOFEED*})) trial were added. In order to access data that were not reported,
(All searches were of the keyword field of Reference Manager 12, or reported in a way that could not be used in the comparisons,
Thomson Reuters). the trialists were contacted. Twelve trialists responded with further
We did not impose any restrictions, such as language or publication information or to confirm that the data were no longer retrievable.
status, on the searches. If additional data were provided, this was stated in the additional
data tables. Data entry was carried out by RH and cross checked
by JHS.
Searching other resources
We also searched for other possible relevant trials listed in the
reference lists of retrieved articles. Assessment of risk of bias in included studies
The risk of bias for the included studies was assessed using the
Cochrane Risk of Bias Assessment Tool. This included: sequence
Data collection and analysis
generation, allocation concealment, blinding of participants, ther-
Data collection and analysis was conducted in accordance with apists and outcome assessors, completeness of outcome data, se-
the Cochrane Handbook for Systematic Reviews of Intervention lective outcome reporting and other potential sources of bias. RH
(version 5.1.0) (Higgins 2009). and JHS/MJH assessed these domains, whereby any disagreement
was resolved by consensus or discussion with PH. The findings are
summarised in the Risk of Bias table and Figures (Figure 2; Figure
Selection of studies 3).
Figure 2. Risk of bias graph: review authors’ judgements about each risk of bias item presented as
percentages across all included studies.
Figure 3. Risk of bias summary: review authors’ judgements about each risk of bias item for each included
study.
Subgroup analysis and investigation of heterogeneity
Measures of treatment effect
A priori, we thought that one or more of the following subgroup
For dichotomous data, such as number of women cured or im-
analysis might be possible and useful:
proved, the numbers reporting an outcome to the numbers at risk
• Type of feedback or BF;
in each group were related to derive a risk ratio, with 95% confi-
• Purpose of feedback or BF;
dence intervals For continuous outcome data, such as quality of
• Type of incontinence, that is four subgroups comprising: 1)
life scores, results from each study are expressed as a difference in
stress urinary incontinence; 2) urgency urinary incontinence; 3)
means with 95% confidence intervals. If similar outcomes were re-
mixed urinary incontinence; 4) a range of diagnosis or the type
ported on different scales the standardised mean difference (SMD)
of urinary incontinence not specified.
was calculated. Ninety five persent confidence intervals were pre-
sented for all outcomes.
When performing the analysis we chose two of the most commonly
reported outcomes (women’s perception of cure or improvement,
Unit of analysis issues and leakage episodes in 24 hours) for subgroup analysis.
The primary analyses were per women randomised.
Sensitivity analysis
Dealing with missing data
Sensitivity analysis with respect to risk of bias was planned as there
The data analysis was done on an intention-to-treat basis as far is evidence that this may have an impact on the findings of meta-
as possible. Attempts were made to obtain missing data from the analysis (Pildal 2007; Moher 1998). There were insufficient trials
trialists. If additional data were provided, this was made clear in to do a sensitivity analysis in any of the comparisons. The influence
additional data tables. of allocation of concealment was investigated in one comparison
(PFMT + BF versus PFMT alone) with a reasonable number of
trials.
Assessment of heterogeneity
Statistical heterogeneity was assessed in three ways; visual exam-
ination of the forest plots; Chi2 test (p<0.10) for heterogeneity
and I2 statistics. An I2 statistic measurement greater than 50% was
taken to indicate substantial heterogeneity. RESULTS
Assessment of reporting biases Description of studies

Because of the difficulty in detecting and correcting for publication See: Characteristics of included studies; Characteristics of
bias and other reporting biases, the reviewers aimed to minimise excluded studies; Characteristics of studies awaiting classification;
their potential impact by ensuring a comprehensive search for Characteristics of ongoing studies.
eligible studies and by being alert for duplication of data. See: Characteristics of included studies; Characteristics of excluded
studies.
Data synthesis
The data from primary studies were displayed using fixed effect
Results of the search
models in stated comparisons.
The search of the Specialised Register produced 518 records to
If there were enough studies, results were combined for meta- screen of which 36 relevant trials were identified. One is ongoing
analysis. The direction of benefit is clearly labelled on the forest (Ruff 2004). One study was classified as awaiting assessment; there
plots. were no data in the abstract (Sam 2004) and as yet there has been
If it was determined that outcome measurements were reported no reply from the trialists. Ten studies were excluded (see: Excluded
in such a way that data could not be combined (e.g. data reported studies). Twenty four trials were included. Please see the PRISMA
as mean without a measure of dispersion), Other Data tables were flow chart (Figure 1) for the flow of literature through the search
used to present results. process.
Included studies Age
Ten of the 24 trials had more three or more treatment arms. In None of the included studies set an age limit to deliberately ex-
nine of these only two arms were relevant to this review and only clude post menopausal women, although some set upper age limits
the two relevant treatment arms were described in the Table of that excluded older women (Laycock 2001a, 64 years; Berghmans
Included Studies (Aksac 2003; Burns 1993; Goode 2003; Laycock 1996 and Aukee 2002, 70 years; Wang 2004, 75 years). Two tri-
2001a; McClurg 2006; Schmidt 2009; Wang 2004; Williams als deliberately recruited postmenopausal, older women ((Burgio
2006; Wilson 1987). In one trial all three treatment arms were 2002a; Burgio 2002b; Burgio 2002c; Burns 1993), 55 years and
eligible for inclusion in this review resulting in each comparison older; Tisseverasinghe 2006, 60 to 85 years).
being described separately in the Table of Included Studies and
entered separately in the data analyses (Burgio 2002a; Burgio
Severity and duration of UI
2002b; Burgio 2002c).
These characteristics varied across the studies. Four studies
specifically included only women with “mild to moderate UI”
(Berghmans 1996; Pages 2001; Smidt 1997; Tsai 2009). Eleven
Sample characteristics trials reported duration of UI as a baseline characteristic but none
For a complete description of the characteristics of each study see used this as an inclusion criterion. When reported, the mean or
Characteristics of included studies and Table 1; Table 2; Table 3; median duration of symptoms was usually at least six years or
Table 4; Table 5. longer.
Other characteristics
Diagnosis of UI Two trials recruited noticeably different sample populations of
women with UI when compared to the other included studies.
• Thirteen of the 24 trials diagnosed the type of UI based on
Only one trial recruited women with a neurologic diagnosis (mul-
urodynamics (Aksac 2003; Aukee 2002; Burgio 2002a; Burgio
tiple sclerosis) (McClurg 2006) and one trial recruited “female ac-
2002b; Burgio 2002c; Burns 1993; Goode 2003; Schmidt 2009;
tive duty soldiers” who were likely to be younger and fitter than
Shepherd 1983; Tejero 2008; Tisseverasinghe 2006; Tsai 2002;
the women in other study samples (Sherman 1997).
Williams 2006; Wilson 1987; Wong 2001).
Across the included studies, common reasons for excluding partic-
• In six trials diagnosis was based on urodynamics or
ipants were neurological conditions, cognitive impairment, preg-
symptom questionnaire, or both (Berghmans 1996; McClurg
nancy or being within a certain period after childbirth, untreated
2006; Morkved 2002; Pages 2001; Sherman 1997; Smidt 1997).
urinary tract infection, (symptoms of ) genital prolapse, and post
• One trial based confirmation of SUI on more than 2 g
void residual volume exceeding a specified amount.
leakage on a one hour pad test (Glavind 1996).
• In three trials the diagnosis of UI was symptomatic
(Laycock 2001a; Tsai 2009; Wang 2004). Interventions
• In one trial it was not stated how UI was diagnosed
(Johnson 2000).
Pelvic floor muscle training (PFMT)
For a detailed description of the PFMT programmes see Table
1; Table 2; Table 3; Table 4; Table 5. Because, in this review, we
Types of UI
were interested in the additional effect of feedback or BF when
The trials recruited samples of women with: combined with PFMT we were particularly interested in any dif-
• SUI only: 14 trials (Aksac 2003; Aukee 2002; Berghmans ferences between the PFMT in the feedback (or BF) and non-
1996; Glavind 1996; Goode 2003; Laycock 2001a; Morkved feedback (or BF) arms of the included studies. There were two
2002; Pages 2001; Shepherd 1983; Smidt 1997; Tejero 2008; main differences, the amount of PFMT supervision (and health
Tsai 2009; Wilson 1987; Wong 2001); professional contact) and the PFMT parameters.
• SUI and MUI: five trials (Burns 1993; Schmidt 2009; Seventeen trials stated that the amount of supervision was equal in
Sherman 1997; Williams 2006; Tisseverasinghe 2006) both groups (Aksac 2003; Aukee 2002; Berghmans 1996; Burgio
• SUI, MUI and UUI: two trials (Johnson 2000; Tsai 2002) 2002c; Burns 1993; Johnson 2000; Laycock 2001a; McClurg
• UUI and MUI: one trial (Burgio 2002a; Burgio 2002b; 2006; Morkved 2002; Schmidt 2009; Shepherd 1983; Sherman
Burgio 2002c) 1997; Smidt 1997; Tisseverasinghe 2006; Tsai 2002; Williams
• UUI: two trials (McClurg 2006, neurogenic DO; Wang 2006; Wong 2001). One study reported a small difference in ac-
2004, OAB) tual treatment time between both groups but, as the number of
treatment sessions and PFMT programme was otherwise the same 2002c; Goode 2003; Laycock 2001a; Morkved 2002; Pages
in both arms, this difference was considered to be negligible (Burns 2001; Schmidt 2009; Shepherd 1983; Williams 2006; Wilson
1993). 1987), and
Seven trials reported different amounts of supervision between • movement with ultrasound (Tisseverasinghe 2006).
the groups (Burgio 2002a; Burgio 2002b; Glavind 1996; Goode
2003; Pages 2001; Tejero 2008; Tsai 2009; Wilson 1987). In one
trial it was not clear if the amount of supervision was equal, but Setting
it seemed that the BF group had more clinic check-ups than the
non-BF group (Wang 2004). Pages compared group PFMT ver- In some studies BF was used only in the clinic setting (Berghmans
sus individual PFMT plus BF; both group and individual PFMT 1996; Burgio 2002b; Burgio 2002c; Burns 1993; Glavind 1996;
groups had 20 treatment sessions over two weeks but the group Goode 2003; Pages 2001; Tisseverasinghe 2006; Wang 2004;
sessions were one hour long and the individual sessions were 15 Williams 2006; Wilson 1987) or only at home (Shepherd 1983).
minutes each (Pages 2001). In five remaining trials the difference Other studies provided BF devices that were used in the clinic and
in supervision was because the PFMT group (no BF) had only at home (Aukee 2002; Laycock 2001a; McClurg 2006; Morkved
one appointment and received an instruction sheet on PFMT 2002; Sherman 1997; Smidt 1997).
(Burgio 2002a; Burgio 2002b; Goode 2003; Tejero 2008; Tsai
2009; Wilson 1987) whereas the BF groups had more than one
contact with health professionals. Excluded studies
Five trials described a difference in exercise programme across the
Ten trials were excluded (see Characteristics of excluded studies).
comparison groups (e.g. different types or number of exercises)
Three of these studies (Delgado 2010; Ferguson 1990; Klingler
(Aksac 2003; Burns 1993; Pages 2001; Wang 2004; Williams
1995) described the use of an intra-vaginal resistance device and
2006).
were excluded because it was not clear whether the device did or
In terms of the preparation for PFMT, in four trials the PERFECT
did not give visual or auditory biofeedback in addition to resisting
scheme (Laycock 2001b) was used to confirm a correct voluntary
muscle contraction.
pelvic floor muscle contraction at baseline or to design an individu-
alized training program (Berghmans 1996; McClurg 2006; Wang
2004; Tisseverasinghe 2006). Three further trials stated that a cor-
rect voluntary pelvic floor muscle contraction was confirmed prior
Risk of bias in included studies
to training by use of digital vaginal palpation (Laycock 2001a;
Morkved 2002; Pages 2001). Risk of Bias characteristics are summarised in Figure 2 and Figure
3.
Feedback and Biofeedback (BF)

For detailed descriptions of the feedback and BF interventions Allocation
(such details of BF devices) see Table 1 Table 2; Table 3; Table 4; Seven trials provided enough details about the methods used to
Table 5. We found that the trialists seldom explicitly stated the be sure of adequate sequence generation and allocation of con-
purpose of their feedback or BF intervention. See Table 6 for a cealment (Berghmans 1996; Burgio 2002a; Burgio 2002b; Burgio
description of purpose(s), as stated by the trialists. 2002c; Goode 2003; Morkved 2002; Wang 2004; Tisseverasinghe
The most common approach to feedback was verbal feedback from 2006; Williams 2006).
the health professional during or after digital vaginal palpation of Fifteen trials reported solely that allocation was ’at random’ or gave
a voluntary pelvic floor muscle contraction (Aksac 2003; Burgio some more details about the sequence generation (e.g. ’randomi-
2002a; Burgio 2002c; Tisseverasinghe 2006; Tsai 2009; Williams sation done by randomisation table’) but did not give enough in-
2006). One of these studies also described clinician feedback based formation to be sure whether allocation of concealment was ad-
on observation of the perineum (Tisseverasinghe 2006). Because equate or not (Aksac 2003; Aukee 2002; Burns 1993; Glavind
of the clinician-dependent nature of feedback, this was given only 1996; Johnson 2000; Laycock 2001a; McClurg 2006; Pages 2001;
in the clinic setting. Schmidt 2009; Sherman 1997; Smidt 1997; Tejero 2008; Tsai
BF was more commonly used than feedback. BF devices recorded: 2002; Tsai 2009; Wong 2001). One trial did not provide any de-
• electrical activity using electromyography (Aksac 2003; tails about allocation methods (Shepherd 1983).
Aukee 2002; Berghmans 1996; Burns 1993; Johnson 2000; Another trial (Wilson 1987) used a quasi-random technique:
McClurg 2006; Sherman 1997; Smidt 1997; Wang 2004; Wong women were consecutively assigned to one of four treatment
2001); groups. Sequence generation and concealment allocation were
• vaginal and/or anal squeeze pressure (Burgio 2002b; Burgio therefore assessed as inadequate in this study (Wilson 1987).
Blinding • Ten trialists stated the analysis was by ITT but it was not
It was assumed, given the nature of PFMT, feedback and BF, that clear if this meant one or both of the above criteria were met
blinding of the women and therapists was not feasible. (Aukee 2002; Berghmans 1996; Burgio 2002a; Burgio 2002b;
Six trials stated that the outcome assessors were blinded ( Burgio 2002c; Goode 2003; Morkved 2002; Pages 2001; Smidt
Berghmans 1996; Burgio 2002a; Burgio 2002b; Burgio 2002c; 1997; Tsai 2002; Williams 2006; Wilson 1987).
Burns 1993; McClurg 2006; Morkved 2002; Tisseverasinghe • A further three trials stated that ITT analysis did not alter
2006) and two trials stated that the outcome assessor was blinded the findings of the per protocol analysis (Burgio 2002b; Goode
for some, but not all, outcome assessments (Aukee 2002; Schmidt 2003; Smidt 1997).
2009). • Nine studies did not appear to have any losses to follow up
Sixteen trials did not provide enough or any information about (but this was inferred rather than explicitly stated) which made it
blinding of outcome assessment (Aksac 2003; Glavind 1996; hard to assess whether the second criterion was met (Aukee
Goode 2003; Johnson 2000; Laycock 2001a; Pages 2001; 2002; Berghmans 1996; Tisseverasinghe 2006; Wong 2001;
Shepherd 1983; Sherman 1997; Smidt 1997; Tejero 2008; Tsai Aksac 2003; Johnson 2000; Schmidt 2009; Wilson 1987).
2002; Tsai 2009; Wang 2004; Williams 2006; Wilson 1987; Wong
2001).
Overall risk of bias assessment
Incomplete outcome data When we consider the reported adequacy of concealment al-
location, blinding of outcome assessor and reporting of drop
outs (Figure 3), one trial appeared to be at lower risk of bias
Reporting of dropout and withdrawal (Tisseverasinghe 2006), ten were in the middle (Berghmans 1996,
Burgio 2002a; Burgio 2002b; Burgio 2002c; Burns 1993; Goode
There were no dropouts or losses to follow up in four trials (Aukee
2003; McClurg 2006; Morkved 2002; Smidt 1997; Tsai 2009;
2002; Berghmans 1996; Tisseverasinghe 2006; Wong 2001), and
Williams 2006; Wong 2001) and twelve were at higher risk (Aksac
in four more it appeared there were no dropouts, but this was not
2003; Aukee 2002; Glavind 1996; Johnson 2000; Pages 2001;
clearly stated (Aksac 2003; Johnson 2000; Schmidt 2009; Wilson
Schmidt 2009; Shepherd 1983; Sherman 1997; Tejero 2008; Tsai
1987).
2009; Wang 2004; Wilson 1987).
In the remaining studies the proportion was:
• less than 10% (Burns 1993; Glavind 1996; McClurg 2006;
Morkved 2002; Smidt 1997; Tsai 2009; Williams 2006);
• between 10% and 20% (Burgio 2002a; Burgio 2002b; Selective reporting
Burgio 2002c; Sherman 1997; Wang 2004), and Five trials did not report data for all outcomes collected (Laycock
• more than 20% (Goode 2003; Laycock 2001a; Pages 2001; 2001a; Pages 2001; Shepherd 1983; Tejero 2008; Tsai 2009).
Shepherd 1983; Tejero 2008; Tsai 2002).
In one trial 11 of the 24 participants (in the BF group) were ex-
cluded directly after randomisation because they met pre-specified Other potential sources of bias
exclusion criteria (Pages 2001).
In two studies the proportion of withdrawals or losses to follow up
was higher in the control group (Goode 2003; Tsai 2002). Laycock
Size of trials
et al (Laycock 2001a) reported a higher proportion of withdrawal
in the BF group. In common with previous reviews of PFMT none of the included
studies were very large. In fact five were very small with fewer than
15 women per arm (Johnson 2000; McClurg 2006; Schmidt 2009;
Analysis by intention-to-treat (ITT) principle Shepherd 1983; Tisseverasinghe 2006). Ten trials were small with
For a study to be analysed according to the full intention to treat 15 to 25 women per arm (Aksac 2003; Aukee 2002; Berghmans
principle, two criteria were used. 1996; Glavind 1996; Laycock 2001a; Pages 2001; Sherman 1997;
1. Participants were analysed in the group to which they were Smidt 1997; Wilson 1987; Wong 2001). Six were of moderate
originally assigned. size (25 to 50 women per arm) (Burns 1993; Morkved 2002;
2. If there are any missing data, the effect of this must be assessed Tejero 2008; Tsai 2002; Tsai 2009; Wang 2004) and three trials
in a reasonable way, such as ’multiple imputation’ (Lane 2008). allocated more than 50 women per arm (Burgio 2002a; Burgio
2002b; Burgio 2002c; Goode 2003; Williams 2006). One trial
None of the included studies clearly met both the criteria for a full allocated women using a 2:1 ratio, with more women allocated to
intention-to-treat analysis: the BF group (Laycock 2001a).
Power calculation Comparison 1. PFMT + BF versus PFMT alone
Nine studies reported an a priori power calculation (Burgio 2002a; Sixteen trials made this comparison and nine of them had the same
Burgio 2002b; Burgio 2002c; Goode 2003; Laycock 2001a; PFMT programme/regimen in both groups (Berghmans 1996;
Morkved 2002; Schmidt 2009; Tsai 2002; Tsai 2009; Wang 2004; Burns 1993; Laycock 2001a; McClurg 2006; Morkved 2002;
Williams 2006). Smidt 1997; Shepherd 1983; Sherman 1997; Schmidt 2009).
Seven trials had a different PFMT regimens in the two randomised
groups. In six of these it was a difference in the amount of PFMT
Funding or financial assistance
supervision (Burgio 2002b; Glavind 1996; Goode 2003; Tejero
Eleven trials reported details of financial or other assistance. Eight 2008; Wang 2004; Wilson 1987). The remaining trial used two
trials had received funding (Burgio 2002a; Burgio 2002b; Burgio different approaches to supervision (individual PFMT + BF versus
2002c; Burns 1993; Goode 2003; Laycock 2001a; Morkved 2002; group PFMT) (Pages 2001).
Schmidt 2009; Wang 2004; Williams 2006). One trial had been
supported by the Multiple Sclerosis Society but the type of support
was not stated (McClurg 2006). Four trials clearly said no funding Primary outcome measures
or financial assistance was received (Tejero 2008; Tisseverasinghe
2006; Tsai 2009; Wong 2001).
General and incontinence specific quality of life (Analysis
1.1)
Conflict of interest
Three different robust validated measures (in concordance with
Three trials reported ’none’ under the heading conflict of interest
Staskin 2009) were used to assess incontinence specific quality of
(Schmidt 2009; Tsai 2009; Williams 2006).
life in nine trials (Berghmans 1996; Burgio 2002b; Goode 2003;
Laycock 2001a; McClurg 2006; Schmidt 2009; Smidt 1997;
Tejero 2008; Wang 2004). However, only four trials reported data
Effects of interventions from which an effect estimate could be calculated, and two trials
The 24 trials addressed the following comparisons: reported a ’total score’ for the King’s Health Questionnaire (which
1. PFMT + BF versus PFMT alone: 16 trials (Berghmans 1996; has domain scores but not a total score). Two of these trials also
Burgio 2002b; Burns 1993; Glavind 1996; Goode 2003; Laycock used a validated health status measure, the Short Form 36 (SF-36)
2001a; McClurg 2006; Morkved 2002; Schmidt 2009; Shepherd (Burgio 2002b; Goode 2003). Because a variety of instruments
1983; Sherman 1997; Smidt 1997; Pages 2001; Tejero 2008; Wang were used, and there was reason to doubt the veracity of a ’total
2004; Wilson 1987). score’ for the King’s Health questionnaire, we did not pool the
2. PFMT + F versus PFMT alone: two trials (Burgio 2002a; Tsai data and they are presented in Other Data tables (Analysis 1.1).
2009). The overall pattern, on the basis of data reported, was one of no
3. PFMT + F + BF versus PFMT alone: one trial (Williams difference.
2006).
4. PFMT + BF versus PFMT + F: five trials (Aksac 2003; Burgio
2002c; Johnson 2000; Tisseverasinghe 2006; Tsai 2002). Women’s perception of change in incontinence (Analysis 1.2
5. PFMT + BF versus PFMT + BF: two trials (Aukee 2002; Wong and Analysis 1.3)
2001). The patient’s perception of change in incontinence symptoms was
Of these 24 trials, 17 reported at least one of the pre-specified measured in a variety of ways. Trialists often reported data in the
primary outcomes and all 24 reported one or more of the pre- ’positive’ sense, that is the number of participants who were better
specified secondary outcomes of interest. or cured. As long as we could categorise the data into ’cured’ or
Data on socioeconomics, adverse events, adherence to treatment, ’improved’ we calculated the inverse (i.e. not cured, not improved)
and longer term follow up were seldom reported. The few data are and entered these data into the meta-analysis, regardless of what
summarised as a whole (rather than by comparison) at the end of instrument was used.
the results. Nine trials reported ’cure’ or ’improvement’. In two of these
Readers should note that when referring to the graphs (forest plots) (Shepherd 1983; Tejero 2008) it was not clear if this was patient
for three of the four outcomes (patients’ perception of cure or reported data or this was clinician perception, based on a urinary
improvement, patients’ perception of cure and patients’ satisfac- diary, pad test, or some other measure so neither of these were
tion with progress) the right hand of the side of the plot favours included in the analysis. In the remaining seven studies (Burgio
the experimental group on the left. For one of the four outcomes 2002b; Burns 1993; Goode 2003; Morkved 2002; Pages 2001;
(leakage episodes in 24 hours), the left hand of the plot favours Wang 2004; Wilson 1987) several different scales were used to
the experimental group on the left. measure patients’ perception of outcome of treatment (e.g. Likert
scale and percent reduction in symptoms). Whatever the scale,
data were included in the formal comparisons when the trialists
stated the number of women who perceived that they were cured
or improved after treatment. When more than one level of im-
provement was reported (for example a bit improved and much
improved) the higher degree of improvement was entered in the
comparison. The trials reported the patient’s perception of cure
and improvement as follows:
Trial Measurement Trialists definition Our categorisation
Burgio 2002b Self reported progress, 4 point scale “much better” improved
(much better to worse)
Burns 1993 “Absence of urine loss compared to “absence of urine loss” cured
start”
Goode 2003 Self reported progress, 4 point scale “much better” improved
(much better to worse)
Morkved 2002 Self report of severity, 5 point scale “unproblematic” cured

(unproblematic to very problematic)
Pages 2001 “Subjective improvement” “no incontinence episodes” cured
Sherman 1997 Subject’s rating of severity of problem “non existing” cured

as “non existing”
Wang 2004 Subjective improvement, 3 “resolved” cured

point scale (resolved, modified, un-
changed)
Wilson 1987 Subjective improvement, 3 point “much improved” improved

scale (much improved, improved, no
better)
Not cured or improved (Analysis 1.2)

Pooled data from two trials (Burns 1993; Morkved 2002) without a the meta-analysis).
difference in PFMT regimen did not show a statistically significant Not cured (Analysis 1.3)
difference between the two groups (RR 0.87, 95% CI 0.72 to Six trials reported the patients’ perception of ’cure’, but one (
1.05, Analysis 1.2.1), whereas the summary statistic from the five Schmidt 2009) did not contribute data to analysis because the data
trials with a difference in PFMT regimen (Burgio 2002b; Goode were reported for the group as a whole which made it impossible to
2003; Pages 2001; Wang 2004; Wilson 1987) was in favour of calculate a risk ratio. Neither summary statistic from the trials with
PFMT with BF (RR 0.69, 95% CI 0.58 to 0.83, Analysis 1.2.2). (Pages 2001; Wang 2004) or without (Burns 1993; Morkved 2002;
Overall, the summary statistic was statistically significant in favour Sherman 1997) a difference in PFMT was statistically significant.
of PFMT with BF (RR 0.75 , 95% CI 0.66 to 0.86, Analysis 1.2) The overall summary statistic did not favour PFMT with or with
but this finding might be confounded by the difference in the BF (RR 0.92, 95% CI 0.81 to 1.05, Analysis 1.3).
PFMT programmes (because these studies carried more weight in
Secondary outcome measures Laycock 2001a; Morkved 2002; Schmidt 2009; Shepherd 1983;
Tejero 2008; Wang 2004; Wilson 1987); and a score based on dig-
ital vaginal palpation (Laycock 2001a; Pages 2001). Three stud-
Women’s satisfaction with progress or outcome (Analysis 1.4) ies did not contribute data to the analysis because data were not
As long as we could categorise the data into ’satisfied’ we calculated reported (Wang 2004), incomplete (Tejero 2008) or presented in
the inverse (i.e. not satisfied) and entered these data into the meta- such a way that no usable effect estimate could be calculated (Pages
analysis. 2001; Shepherd 1983). Data from the remaining trials were not
Three trials collected data on ’women’s satisfaction with progress’. combined as the comparability of the findings from the differ-
The pooled data were congruent with the data for ’women’s per- ent measures of pelvic floor muscle function is not known. While
ception of cure or improvement’. That is, the overall summary some studies (that had more than one measure of pelvic floor mus-
statistic favoured PFMT with BF (RR 0.65, 95% CI 0.46 to 0.90, cle function) found a statistically significant difference in one of
Analysis 1.4), but data from one trial (Morkved 2002) without several measures within same study, the overall pattern was one of
a difference in PFMT did not show a statistically significant dif- no difference (Analysis 1.7).
ference between the two groups (RR 0.74, 95% CI 0.36 to 1.51,
Analysis 1.4.1), whereas the summary statistic from the two tri-
Symptom distress (Analysis 1.8)
als with a difference in PFMT (Burgio 2002b; Goode 2003) was
in favour of PFMT with BF (RR 0.62, 95% CI 0.43 to 0.90, ’Symptom distress’ was assessed by four trials using the: Social
Analysis 1.4.2). The latter two trials carried more weight in the Activity Index (Morkved 2002); Hopkins symptom checklist (
overall summary statistic because there were more participants (in Burgio 2002b; Goode 2003); and Urogenital Distress Inventory
total) in this subgroup numbers. (McClurg 2006). Because different measures were used the data
could not be not pooled. None of the trials found a difference
between the groups (Analysis 1.8).
Number of leakage episodes in 24 hours (Analysis 1.5)
Nine trials used urinary diaries to collect data on leakage episodes,
Other pre-specified secondary outcomes (Analysis 1.9,
and one did not contribute to the analysis (Wang 2004, no data
Analysis 1.10, Analysis 1.11)
in the study report because of the large number of incomplete
records). Some trials reported data on leakage episodes per week ’Frequency of micturition’, ’pad use’ and ’desire for further treat-
but in this review, data were presented as number of leakage ment’ were pre-specified as outcomes of interest but not enough
episodes per 24 hours to make comparison between trials possible. trials measured and reported these outcomes to make meta-anal-
One study reported data as change from baseline (Smidt 1997). ysis of the results useful.
While almost all the trials reported fewer leakage episodes in the
PFMT + BF groups (compared to PFMT alone), this only reached
marginal statistical significance when the six trials with similar Other outcomes of interest, not pre-specified: Pad and paper
PFMT regimens in both arms were combined with the two with towel tests (Analysis 1.14)
different regimens (MD -0.12 95% CI -0.22 to -0.01, Analysis Five trials collected data on ’pad and paper towel tests’: a 1-hour
1.5). This result was heavily weighted by data from one trial with pad test (Glavind 1996); a 24 hour pad test (McClurg 2006; Smidt
very precise estimates of treatment effect (Berghmans 1996). In 1997); and a 48 hour pad test (Berghmans 1996; Morkved 2002).
real terms, the mean difference between the groups was equivalent Regardless of whether the data were reported as a continuous (in
to about one fewer leak every eight days. grams) or dichotomous (cured or not) variable, none of the cal-
culated effect estimates was statistically significantly in favour of
either comparison group.
Frequency and nocturia (Analysis 1.6)
Four trials collected data on ’nocturia’ (Schmidt 2009; Sherman
1997; Pages 2001; Tejero 2008). The data could not be combined Comparison 2. PFMT + feedback versus PFMT
due to different outcome measures, and some problems with the Two trials investigated the additional effect of verbal feedback
way data were reported. The overall pattern was one of no differ- after digital vaginal palpation, compared to pelvic floor muscle
ence (Analysis 1.6). training alone (Burgio 2002a; Tsai 2009). PFMT was not the same
in both arms in either trial (Table 2). In both trials the PFMT-
only group received a pamphlet with written instructions on pelvic
Pelvic floor muscle function (Analysis 1.7) floor muscle exercises and no face to face contact with a health
Nine trials measured pelvic floor muscle function and reported: professional during treatment. Only one trial contributed data to
electromyography (Burns 1993); vaginal squeeze pressure ( this comparison (Burgio 2002a).
Primary outcome measures Comparison 3. PFMT + feedback + BF versus PFMT
One trial contributed data to this comparison (Williams 2006).
There was a difference in PFMT programme content between the
General and incontinence specific quality of life (Analysis PFMT groups (Table 3) but equal numbers of visits.
2.1)
Burgio 2002a measured both incontinence specific (IIQ) and
generic (SF- 36) quality of life. No differences between the groups Primary outcome measures
were reported.
Women’s perception of change of incontinence (Analysis 2.2) General and incontinence specific quality of life (Analysis
3.1)
Women in the PFMT with feedback group were approximately The Leicester Impact Scale was used to assess quality of life, but
twice as likely to report that they were ’much better’ than women no data were reported.
in the PFMT only group (RR 0.53, 95% CI 0.37 to 0.78, Analysis
2.2).
Women’s perception of change in incontinence (Analysis 3.2)
Not cured or improved
Secondary outcome measures
Data for improvement were not reported.
Not cured (Analysis 3.2)
Williams 2006 reported no difference in cure (“no symptoms”)
Women’s satisfaction with progress or outcome - not satisfied
between the two groups (Odds Ratio 1.59, 95% CI 0.43 to 5.87,
(Analysis 2.3)
Analysis 3.2) but the confidence interval was wide.
Burgio 2002a found that women in the PFMT with feedback
group were approximately one and a half times more likely to re-
port satisfaction with progress than women in the control group
Secondary outcome measures
(RR 0.33, 95% CI 0.16 to 0.66, Analysis 2.3). This was in con-
cordance with the findings of the patient’s perception of change
in incontinence.
Outcomes from a three day urinary diary showed no statistically
significant differences between the groups (Analysis 3.3).
A 14 day urinary diary found a small difference between the groups
(in favour of PFMT with feedback) that was not statistically sig-
nificant. Pelvic floor muscle function (Analysis 3.5)
A number of PFMT measures were taken; the unit of measure-
Symptom distress (Analysis 2.5) ment is not clear for some measures. In general the PFM function
measures were statistically significantly better in the PFMT with
Congruent with the assessment of quality of life, Burgio 2002a
feedback and BF group compared with PFMT alone.
did not find a statistically significant difference between the two
groups.
Other outcomes of interest, not pre-specified: Pad and paper
towel tests (Analysis 2.6) Other pre-specified secondary outcomes (Analysis 3.6,
Although Tsai 2009 used a one hour pad test, and stated a signif- Analysis 3.7, Analysis 3.8)
icant difference between the intervention and control group was ’Frequency of micturition’, ’pad use’ and ’symptom distress’ were
found (favouring the PFMT with feedback group), this could not pre-specified as outcomes of interest and measured by Williams
be verified because the data were presented as means without mea- 2006; no statistically significant differences between the two
sures of dispersion. groups were reported.
Pre-specified outcomes not reported Pre-specified outcomes not reported
Although pre-specified as outcomes of interest for the review, nei- Although pre-specified as outcomes of interest for the review,
ther trial reported data on ‘desire for further treatment’, ‘frequency Williams et al (2006) did not report data on ’satisfaction with
of micturition’, ’nocturia’, ‘pad use’, or ‘PFM function’. progress’, ‘desire for further treatment’, or ’nocturia’.
Comparison 4. PFMT + BF versus PFMT + feedback the overall summary statistic for the three trials finding no differ-
Five trials addressed this comparison; three with no difference.
ences in the PFMT programmes (Burgio 2002c; Johnson 2000;
Tisseverasinghe 2006) and two with differences in the PFMT
Pelvic floor muscle function (Analysis 4.6)
(Aksac 2003; Tsai 2002).
Four trials measured pelvic floor muscle function using
electromyography (Johnson 2000; Tsai 2002), ultrasound (
Primary outcome measures Tisseverasinghe 2006), and both digital vaginal palpation and vagi-
nal squeeze pressure (Aksac 2003). However, Johnson (2000) re-
ported no data and Aksac et al (2003) did not report either of their
General and incontinence specific quality of life (Analysis measures in such a way that it was possible to calculate an effect
4.1) estimate.
Tsai et al (2002) reported two pelvic floor muscle function out-
Two different robust validated measures (in concordance with
comes, both of which statistically significantly favoured the PFMT
Staskin 2009) were used to assess incontinence specific quality
with BF group; there was a difference in PFMT between the two
of life in three trials (Burgio 2002c; Tisseverasinghe 2006; Tsai
groups in this study. In contrast, Tisseverasinghe (2006), in a study
2002). Because a variety of instruments were used, and in one trial
with no differences in the PFMT programmes across the groups,
the data were follow up rather than post treatment data, we did not
found no difference in ultrasound displacement between PFMT
pool the data. The overall pattern, on the basis of data reported,
with BF and PFMT with feedback groups.
was one of no difference.
Symptom Distress (Analysis 4.7)

Women’s perception of change in incontinence (Analysis 4.2
and Analysis 4.3) Congruent with the assessment of quality of life, Burgio et al
(2002) did not find a statistically significant difference between
the two groups.
Two trials collected data on cure or improvement (Burgio 2002c;
Johnson 2000) and neither found a statistically significant differ-
ence between the groups (pooled estimate RR 1.02, 95% CI 0.64 Other pre-specified secondary outcomes (Analysis 4.8)
to 1.63, Analysis 4.2). ’Frequency of micturition’ was measured by one trial (Aksac 2003).
Not cured (Analysis 4.3) It was not possible to calculate an effect estimate although the
Johnson 2000 found no statistically significant difference between frequency was similar in both groups.
the groups for self-reported ’cure’ but the trial was small.
Other outcomes of interest, not pre-specified: Pad and paper

Secondary outcome measures towel tests (Analysis 4.9)
Aksac et al (2003) used a one hour pad test and dichotomised the
data into cured versus not cured (Aksac 2003), and Tisseverasinghe
Patients’ satisfaction with progress or outcome - not satisfied
(2006) reported data on a 24 hour pad test (Tisseverasinghe 2006).
(Analysis 4.4)
Neither found a difference between the groups.
Burgio 2002c reported data on patients’ satisfaction with progress,
but there was no statistically significant difference between the
groups (Analysis 4.4), in line with the lack of difference in percep- Pre-specified data not reported
tion of cure/improvement (Analysis 4.2). Although pre-specified as outcome of interest for the review, none
of the studies reported data on ’pad use’, ’nocturia’, or ’desire for
further treatment’.
Three trials measured leakage episodes using urinary diaries
(Burgio 2002c; Tisseverasinghe 2006; Tsai 2002). Tsai (2002) re- Comparison 5. PFMT + BF versus PFMT + BF
ported a barely statistically significant difference in favour of the Two trials compared the effects of different types of BF. Both trials
PFMT with BF group (MD -0.54, 95% CI -1.08 to 0.00), in a used clinic based BF in both arms, using the same PFMT pro-
trial where there were differences in the PFMT programmes. The grammes. Aukee 2002 investigated the further benefit of adding
pooled data from the other two trials (same PFMT in both arms) home BF in the intervention group, and Wong 2001 the further
found no difference (WMD -0.05, 95% CI -0.38 to 0.27), with benefit of adding abdominal muscle BF.
Primary outcome measures Comparison 6. Further analyses by type of
biofeedback, type of incontinence, frequency of
biofeedback, allocation concealment and different
regimens of PFMT (Analysis 6)
General and incontinence specific quality of life (Analysis
5.1) There were two reasons why grouping by type of feedback or BF,
was not useful. First, there were only two feedback studies and only
One trial used a validated instrument to assess incontinence qual-
one of these contributed data to the analysis. Second, while there
ity of life (Wong 2001). Although the study reported significant
were 16 trials (using four different types of BF) in the comparison
difference in favour of the abdominal BF group, this could not be
of PFMT + BF versus PFMT alone, in general the results either
verified because the means for each group were given without a
significantly favoured BF or tended to favour BF with no apparent
measure of dispersion.
difference by type of BF (Analysis 6.1; Analysis 6.2).
With regard to the second option, purpose of feedback or BF, we
found it impossible to subgroup the trials this way as the purpose
Secondary outcome measures was seldom clearly stated (see Table 6).
Further analysis by type of incontinence was considered because
it is possible that feedback or BF may be more or less effective
depending on the underlying pathology. For example, feedback or
BF to help a woman suppress urgency (through inhibiting a de-
Wong 2001, on the basis of a seven day urinary diary, found no trusor contraction) might differ in effect compared with feedback
statistically significant difference in the number of leakage episodes or BF to strengthen muscle (to increase urethral closure pressure
in 24 hour post treatment between the groups (Analysis 5.2). in women with SUI). When we looked at the results there were
many more studies in women with SUI than in any other type.
While it looked like BF was effective in women with SUI, the pat-
Pelvic floor muscle function (Analysis 5.3) tern of effect was much less consistent in other types of UI. This
may be because there were fewer studies in the other subgroups.
Pelvic floor muscle function was measured using electromyogra- Therefore we did not choose this subgroup analysis as it was not
phy (Aukee 2002) and vaginal squeeze pressure (Wong 2001). clear if this approach overemphasized type of UI when there were
There was no consistent effect noted. too few studies in some subgroups to trust the findings (Analysis
6.3; Analysis 6.4).
When performing the review, two further possibilities for futher
Symptom distress (Analysis 5.4) sensitivity anlayses using different sub groups were evident. The
A different measure was used in each study to investigate ’symptom first of these was to group the studies according to the number
distress’. An effect estimate could not be calculated for one study, of times feedback or BF was given. We thought this might be a
and in the other no statistically significant difference was found. reasonable surrogate for the purpose of feedback or BF; that is,
fewer occasions if the purpose was teaching and more often for
encouraging women to exercise. We did try this, and grouped the
trials as follows: 1) feedback or BF once or twice; 2) feedback or BF
Other outcomes of interest, not pre-specified: Pad and paper three to 12 times; 3) feedback or BF more than 12 times (Analysis
towel tests (Analysis 5.5) 6.5; Analysis 6.6). The analyses suggested that feedback or BF
Aukee et al used a short pad test (one hour) (Aukee 2002) and given a few times was possibly as or more effective as feedback or BF
Wong et al used a 24 hour pad test Wong 2001. Although the given many times. The potential clinical relevance of the number
experimental groups had less urine loss, neither study found a sta- of times feedback or BF is given is discussed later. However, we
tistically significant difference between the groups for pad weight did not choose this subgroup analysis because there were few data
gain (Analysis 5.5). in each subgroup and we were reluctant to overemphasize this
possible difference.
A futher analysis by ’concealment of allocation’ was done to deter-
mine whether there was much likelihood that risk of bias had some
Pre-specified data not reported
influence on the outcomes of the review (Analysis 6.7; Analysis
Although pre-specified as outcome of interest for the review, none 6.8).
of the studies reported data on ’satisfaction with outcome’, ’desire Although women in the BF group were more likely to report
for further treatment’, ’frequency of micturition’, ’nocturia’, or benefit for the outcome ’cure’ (Analysis 6.7) , the outcome ’leakage
’pad use’. episodes’ did not show a difference between the groups.
We did not choose this subgroup analysis because 1) the pattern • Aukee 2002 reported that two women who received both
was not consistent; 2) we could think of other plausible reasons home and clinic BF discontinue the home BF because they
why the data for the outcome ’cure’ was in favour of the BF group found the vaginal probe ’uncomfortable’. Furthermore, three
(it could have been blinding rather than concealment of alloca- women receiving clinic BF and two using clinic and home BF
tion); and 3) It was not possible to make a robust analysis because reported pain while training.
the few data were too spread out over the possible subgroups. • Morkved 2002 reported that one women dropped out
The second option that occurred to us during the critique and de- because she disliked the device and seven other women ’found
scription of included studies was to subgroup the studies according the device unpleasant’.
to whether the PFMT was the same in the two arms being com- • Wang 2004 reported that two women withdrew because of
pared. We noted that a considerable proportion of included tri- an allergic reaction to the lubricant jelly used with the BF device.
als were potentially confounded by differences in amount or type
Thus, all the reported adverse events appeared to be associated
of PFMT between the groups and we wished to draw attention
with a BF device in some way.
to this in analysis (Analysis 6.9; Analysis 6.10). These differences
included: 1) a difference in amount of supervision between two
treatment arms (e.g. face to face instructions versus leaflet instruc-
Adherence to treatment: results for all comparisons
tions); 2) a difference in the actual type of PFMT programme be-
(Analysis 1.12; Analysis 4.10; Analysis 5.8)
tween both groups (e.g. a standard versus a personalised training
programme). This was the subgroup analysis we chose because: Of the twenty four included studies, eleven attempted to mea-
• only two subgroups were used (no difference in PFMT, sure adherence to treatment, using different instruments (e.g.
difference in PFMT) which limited the ’spread’ of the few data bladder diary or questionnaire) (Aukee 2002; Berghmans 1996;
available for analysis. Laycock 2001a; McClurg 2006; Schmidt 2009; Sherman 1997;
• when the pooled estimate for the patients’ perception of Tisseverasinghe 2006; Tsai 2002; Wang 2004; Williams 2006; ).
cure or improvement was considered it was in favour of BF in A further five stated that adherence was measured (and some even
one subgroup (difference in PFMT) but not in the other stated whether it was the same in both groups) without any sup-
subgroup (no difference in PFMT), suggesting the apparent porting data in the study report (Morkved 2002; Smidt 1997;
benefit of BF could be confounded by differences in PFMT. Tejero 2008; Tsai 2009; Wong 2001). Although more than half of
the studies measured adherence, the data could not be combined
(See: Analysis 6.1 to Analysis 6.8) due to variety in measurements and reporting.
’Adherence to treatment’ was addressed in different ways.
• Three trials used clinic attendance as a measure (Berghmans
Socioeconomics: results for all comparisons (Analysis 1996; McClurg 2006; Tsai 2002) and none found a difference
3.11) between the groups.
Only one trial (Williams 2006) reported an estimate of the treat- • Two used a questionnaire to measure adherence to home
ment cost (in pounds sterling) in both arms of their study. The es- training (Sherman 1997; Tisseverasinghe 2006) and neither
timated cost of PFMT with BF and feedback was £338 per person, study reported a difference.
and in the PFMT- only group it was £287 per person. In this study • Exercise diaries were used by six studies to measure home
both groups attended clinic the same number of times, although training (Aukee 2002; Laycock 2001a; Tisseverasinghe 2006;
the PFMT programmes were different. The group with the higher Tsai 2002; Wang 2004; Williams 2006) and overall the pattern
treatment costs had an individualised (rather than generic) PFMT was one of no difference between the groups.
programme and also received feedback and BF at their clinic visits. • Three trials used a ’built in system’ in the BF device to
record home training (Aukee 2002; McClurg 2006; Schmidt
2009), but only one of these used the device in both treatment
Adverse events: results for all comparisons groups (Schmidt 2009) and no difference was found.
Of the 24 included trials, fifteen did not mention anything
about adverse events (Burgio 2002a; Burgio 2002b; Burgio 2002c; Across all the studies that reported adherence data, in a variety of
Burns 1993; Goode 2003; Johnson 2000; Laycock 2001a; Pages ways, the consistent pattern was one of no difference.
2001; Shepherd 1983; Sherman 1997; Smidt 1997; Tejero 2008;
Williams 2006), and two made the assumption that BF does not
Interim and follow up data: results for all comparisons
have any adverse events (Aksac 2003; Glavind 1996).
(Analysis 1.13; Analysis 4.11; Analysis 5.9)
Four trials stated there were no adverse events (Berghmans 1996;
McClurg 2006; Schmidt 2009; Tisseverasinghe 2006), and three
did report some (Aukee 2002; Morkved 2002; Wang 2004).
Interim (within treatment) data
Amongst these three trials:
Four trials took measures during the intervention (Berghmans DISCUSSION
1996; Morkved 2002; Smidt 1997;Tsai 2002). There was no con-
This review considers whether the feedback or BF adds benefit to
sistency in choice of measures. Overall, the consistent pattern was
PFMT; that is, is PFMT with feedback or BF more effective than
one of no difference between the comparison groups for within
PFMT without these adjuncts. The review is part of a series of
treatment measures.
reviews of PFMT for UI in women and should be viewed in that
Three trials (Berghmans 1996; Morkved 2002; Smidt 1997) all
context. Other reviews consider:
compared PFMT with BF versus PFMT, and all used the same
PFMT programmes in both treatment arms.
• Berghmans et al found that after six treatments (half of the • PFMT for prevention and treatment of urinary and faecal
total treatments) women in the PFMT with BF group had incontinence in antenatal and postnatal women (Hay-Smith
essentially achieved their post treatment scores for pad test and 2008);
leakage episodes, whereas the PFMT group had not; at neither • whether PFMT is better than no treatment or inactive
time point was the difference between the groups for either control treatment (Dumoulin 2010);
measure statistically significantly different, however (Berghmans
1996; Analysis 1.13). • whether PFMT is better than other treatments and
• Similarly, Smidt et al (Smidt 1997) measured leakage • whether PFMT adds benefit to other treatments.
episodes and pad test several times during treatment, and their
paper reported that there was no statistical difference between
the groups for either measure at any time point. Summary of main results
• Morkved et al measured pelvic floor muscle strength half
way through treatment and did not find a difference between the
groups, nor was a difference found post treatment (Morkved Does feedback or biofeedback add benefit to pelvic
2002; Analysis 1.13). floor muscle training? Is one approach better than
another?
• Tsai et al (2002), who measured leakage episodes at weeks
two, four and six (all during treatment), reported a gradual
decline in leakage episodes in both groups, and the difference in Additional benefit of BF
leakage episodes barely reached statistical significance by the end
of treatment (eight weeks) in favour of the PFMT with BF group Sixteen trials addressed this comparison but the most that con-
versus the PFMT with feedback group (MD -0.54, 95% CI - tributed to any one meta-analyses was eight trials (for leakage
1.08 to 0.00). There was a difference in the PFMT programmes episodes). There was no statistically significant difference in rates
between the two treatment groups (Tsai 2002; Analysis 4.11). of cure (five trials) reported by women between BF and no BF
groups. However, twice as many women in the BF group reported
cure or improvement (seven trials), and a similar finding was ob-
served for satisfaction with progress. However, the subgroup anal-
Follow up data
ysis (based on whether the PFMT programmes are the same in
Data could not be combined in a pooled analysis because of the both treatment arms or not) showed the effect was not consistent;
variety in: 1) outcome measures and 2) differences in follow up the pooled data from trials where the PFMT programmes were
time. No consistent pattern was observed, and with few exceptions the same in both arms did not find a statistically significant dif-
most reported no differences between treatment arms. ference between BF and no BF. The fact that women tended to
There was no consistency in the choice of outcome measures; these report higher rates of cure/improvement might be confounded by
included pad tests (of different types), quality of life (different a difference in PFMT between the groups.
measures), symptom distress, leakage episodes, cure/improvement For the other pre-specified primary outcome, quality of life, which
(both women’s and clinicians’ observations), exercise adherence, is considered as the most important outcome as reported by the
frequency, nocturia, and pelvic floor muscle function (different women (Herbison 2009), it was not possible to do a pooled anal-
measures). ysis because of differences in measurement instruments and the
Nine trials reported follow up data (Aukee 2002, one year; Burns different ways in which results were reported. Although effect es-
1993, three and six months; Glavind 1996, three months and timates in separate did not show a statistically significant differ-
two to three years; McClurg 2006, four and six months; Morkved ence, the possibility of a summary statistic favouring BF or no BF
2002, one year; Pages 2001, three months; Schmidt 2009, three could not be excluded because data could not be combined, which
months; Tisseverasinghe 2006, three months; Wilson 1987, six made it hard to determine robust changes in quality of life. Similar
months), although in most cases this was still within a short period patterns of outcome (and also similar problems with combining
after the end of treatment (e.g. within three months). data) were observed for symptom distress.
Effect also varied in the more objective measures. The overall unpooled data, and the pooled data, suggested no difference across
summary statistic showed fewer leakage episodes (eight trials) in a range of outcomes including quality of life, cure/improvement,
women receiving BF although this difference comprised around leakage episodes, symptom distress and pad test.
one fewer leakage episodes every eight days, which questions the Overall, the potential benefit of feedback or BF when added to
clinical relevance of this outcome. There was a consistent pattern PFMT (for the patients’ perception of cure/improvement and sat-
of no difference in pelvic floor muscle function measures and pad isfaction with progress in the two comparisons above) was not
tests. evident here. Although based on few data, no pattern favouring
There was also a single trial that combined BF and feedback with feedback over BF or vice versa, could be detected. However, tri-
PFMT and did not find any differences, between this group and als in this comparison compared two active feedback arms so any
the comparison group (PFMT only), for measures of perceived difference might be small and difficult to establish.
cure, leakage episodes, urinary frequency or symptom distress al-
though the feedback/BF group had better pelvic floor muscle func-
tion measures post treatment. Other considerations
Subgroup analysis
Additional benefit of feedback
It was interesting to see that women may benefit from the addi-
In contrast to BF, there were only two trials making this compar-
tion of feedback or BF, but a considerable number of trials that
ison (both giving verbal feedback with digital vaginal and/or anal
showed this effect were potentially confounded by some difference
palpation) and only one contributed data to the analysis. There was
in PFMT regimen between both groups; the difference was usually
no statistically significant difference between the feedback and no
a greater amount of contact with a health professional. A difference
feedback groups for either incontinence specific or general quality
in PFMT between treatment arms appeared to be at least as influ-
of life. However, with regard to the women’s perceptions cure or
ential as the addition of feedback or BF. Women who had more
improvement women in the feedback group were twice as likely
contact with a health professional during the treatment period, did
to perceive that they were ’much better’ post treatment. The data
better on outcomes such as patients’ satisfaction with progress and
for satisfaction with progress were very similar. With regard to sec-
patients’ perception of cure or improvement, throughout all com-
ondary outcomes of interest, there was no statistically significant
parisons. Other outcomes, such as leakage episodes in 24 hours,
difference in leakage episodes in 24 hours between the groups.
showed a less consistent pattern. It remained unclear whether the
One caution in interpreting these data is that the feedback group
patient reported benefit was due to the addition of feedback or BF
had four clinic visits over the eight weeks of treatment whereas the
or the higher amount of contact with a health professional in the
no feedback group had none.
feedback or BF groups.
Readers should note that it is sometimes difficult to differentiate
(based on the study report) verbal feedback after digital palpation
and palpation used only as means to assess the PFM function. For Adverse events
the purposes of this review, muscle assessment by palpation was not
It was somewhat surprising that 14 trials did not report whether
considered to be verbal feedback unless it was clearly stated that they had measured adverse events or not, because both BF and
verbal feedback of the muscle function was given to the woman feedback usually involved some vaginal or anal procedure. Some
with the express purpose of teaching, modulating or encouraging women might consider these invasive or intrusive. Of the trials
pelvic floor muscle exercise performance.
that did report data on adverse events these were all associated with
BF and none were reported for feedback. The adverse events with
regard to BF were generally minor and none of them were serious.
One approach versus another
Only few women dropped out because of adverse events. Although
If the addition of feedback or BF increases the effectiveness of serious adverse events are unlikely to occur during conservative
PFMT for women with UI, a comparison of different forms of treatment, trialists should be careful in making assumptions that
feedback or biofeedback could determine which approach is bet- BF does not have adverse events.
ter. There were no trials that compared two different approaches
to feedback, and only two studies that compared two different ap-
proached to BF. In the latter comparison, because the approaches Adherence to treatment
being compared were different and there were so few data, it was Across the 15 studies that reported adherence data, in a variety of
not possible to draw any conclusion about whether one approach ways, the consistent pattern was one of no difference. Although
was better than another. adherence is probably necessary for successful treatment with an
There were more trials (five) that compared feedback with BF, but intervention such as exercise, this outcome seemed to be hard to
very few data in the pooled analyses. The consistent patterns in measure, based on trialists’ statements and the variety in reported
data. There is neither consensus on what should be recommended The contribution of data to the pooled analyses was limited; of
as instruments to measure adherence nor what should exactly be the many reported outcomes there was only enough data for four
measured. outcomes to make meta-analyses worthwhile. The fact that there
Some trials reported data on adherence to home training, some on were so many different outcomes measured, in combination with
adherence to clinic treatment sessions and some on both. Exercise the fact that there are numerous instruments for every outcome,
diaries were widely used, but difficulties in motivating women to means it is was hard to gather sufficient data for a pooled analysis.
keep the diaries up to date means these are often poorly com- This was further complicated by the variety of ways in which
pleted. The efficiency of exercise diaries and other measurements trialists decided to report data (for example, post treatment data,
for adherence may need some reflection. It may be that measuring change from baseline, dichotomising continuous variables and so
adherence is not necessary or helpful unless one of the aims of on). There were a few older trials in the review and although it
adding feedback or BF is to improve exercise adherence. could be expected that the quality of reporting (and consensus
Two trials used brief questionnaires at the end of treatment to in- about what to report) would have improved with the years this
vestigate treatment adherence. It is possible that a brief question- did not appear to be the case. One of the most recent trials only
naire, or questions from the health professional about how often reported data for one outcome measure and did not give a measure
the exercises were done, could be as useful as a training diary as of dispersion for this single outcome.
there is no evidence to assume that answering a few simple ques-
tions will be less reliable than data that is obtained from a diary.
Finally, adherence rates do not indicate why women stopped train- Quality of life
ing. A lack of adherence could be for opposite reasons, such as Although the overall effect on quality of life across the different
they got better and decided that further training was not necessary comparisons did not seem to favour one group or the other, it
or because training did not help and they did not see a point in remained hard to tell because of the variety of instruments used
continuing. Reasons for non-adherence may be more profitably to assess the impact of urinary incontinence on quality of life
be investigated by qualitative studies. and the variety in the ways of reporting data for the same quality
of life measure. It was encouraging that many trialists had made
an attempt to assess this highly relevant outcome. However, data
Interim and follow up data
reported on the King’s Health Questionnaire (KHQ) were hard to
The fact that four trials collected data during the treatment phase, interpret because only two trials did report data for each domain
indicated that early effects of the addition of feedback or biofeed- separately. Other trials reported a total score on KHQ but it was
back were considered possible by a few trialists. Some trials based unclear how this score was derived, as the KHQ does not have a
their rationale for collecting interim data on the encouraging dif- total score.
ference that an early trial by Berghmans et al (1996) found during The only trial that attempted to determine the effect of BF in
treatment. Hwever, the use of different outcome measures across a population of women with a neurological condition (multiple
the studies suggested that there was no agreement about what these sclerosis) was unable to use a psychometrically robust question-
differences would be. Overall, the consistent pattern was one of no naire to assess the effect on quality of life because no question-
difference between the comparison groups for within treatment naires were tested to be valid in this specific population when the
measures. trial was conducted. The IIQ and KHQ were used and while a
As with the interim data, no consistent pattern was observed in the significant difference was found in the total score of the IIQ, the
longer term follow up data, and with few exceptions most reported fact that the IIQ was not tested as a validated, reliable and respon-
no differences between treatment arms. It was notable that most sive condition specific quality of life instrument in this population
of the follow up data was quite short term (often within three made this finding difficult to assess. Especially in a population of
months), and there was no consistency in the choice of follow women who can potentially benefit from the addition of feedback
up measures. The one trial that reported a statistically significant or BF, establishing a validated incontinence specific quality of life
difference two to three years post treatment, measured an essential questionnaire is imperative.
outcome; that is how many women were still performing exercises.
Socioeconomics
Overall completeness and applicability of Many studies mentioned aspects of reducing the financial and so-
evidence cial burden of incontinence to the woman in their reports, but only
one study reported any cost data (the cost of treatment). None
of the studies reported a substantive economic analysis, or cost-
Issues with choice and reporting of outcome effectiveness analysis. Although it was acknowledged that different
measures currencies and world wide health care systems make it difficult to
generalise cost information world wide, a cost-effective analysis Some thought needs to be given to the best way to match the pur-
would be useful because this information is fundamental for dis- pose of feedback or BF and the choice of outcome measures. A-
cussion about funding health services. priori we identified three purposes of feedback or BF, which were
teaching, modulating and encouraging. We found that even when
the purpose of feedback or BF was stated, or could be inferred
Pad and paper towel tests
from something in the study report, the purpose was often not
Although not pre-specified, data on pad and paper towel tests were congruent with the intervention protocol as described. For exam-
reported in the review as it was one of the most commonly reported ple, some trials that described BF for the purpose of teaching a
outcome across all trials. We found a wide range of pad tests and contraction gave BF 12 or more times. It seems likely only one
highly variable ways of reporting the data so there was no way to or two instances of BF would be needed to teach and therefore
reasonable combine the data from this commonly used measure. the purpose of 12 occasions of BF is more likely to be improving
We had chosen only leakage episodes in 24 hours to quantify urine the contraction performance (i.e. ’modulating’) or encouraging
loss. Although it was difficult to be sure, it seemed that the pad women to exercise.
test outcomes were not particularly congruent with the data on ’Teaching’ could potentially benefit women who are unaware of
leakage episodes. Although pad tests are recommended as outcome their pelvic floor muscles, even if this is temporary such as after
measure by the International Continence Society (Milsom 2009), childbirth. While a lack of awareness of a voluntary pelvic floor
there appear to be some real problems when comparing data from muscle contraction might be good reason to offer feedback or BF,
different studies. For a more extensive discussion see Dumoulin women who could not perform a contract were sometimes specif-
2010. ically excluded from trials in this review. It would be interesting
to see, when the purpose of BF is teaching, which outcomes are
Relationship between purpose and type of feedback, likely to demonstrate this effect. It seems unlikely that an outcome
type of UI, and frequency of intervention like leakage episodes in 24 hours or pelvic floor muscle strength
would change quickly after one or two episodes of feedback or BF.
Most trials were conducted in women with SUI, of samples of
It may be more appropriate to consider confirmation of a correct
women with SUI or MUI. Therefore the findings of these review
contraction or a measure the patients’ self efficacy for training.
are based on more data from these groups, and fewer data from
When ’modulating’ is the stated purpose, more occasions of feed-
women with other forms of UI. Only one trial included women
back or BF might be needed to improved training performance.It
with UI due to a neurological condition, one trial included women
is possible that measures such as pelvic floor muscle function could
with OAB and other populations were also not represented, e.g.
demonstrate improved contraction performance or training self-
antenatal or postanal women. However, the findings of the trials
efficacy. Finally, using feedback or BF to ’encourage’ training could
(regardless of type of UI) appeared consistent and there was no
also be a valid purpose and might be measured by outcomes such
reason to suppose the findings did not apply to all types of UI that
as adherence to treatment, self efficacy and patient’s satisfaction
were included in the review. The fact that one of the most robust
with progress.
trials (Burgio et al 2002) was conducted in women with UUI and
MUI and showed favourable results for both feedback and BF (for
A variety of types of BF were identified. Subgroup analysis accord-
women’s perception of cure/improvement) suggested that further
ing to type of BF did not seem to make a difference in outcome. If
research in women with other types of UI (other than SUI) is
the different types of feedback and/or BF have a similar effect, then
imperative. Further, there was nothing to suggest that type of UI
the women’s perception of the different types (e.g. intrusiveness)
should be a reason to include or exclude women from receiving
and the clinical availability of different types is an important clin-
feedback or BF in clinical practice.
ical consideration. Miska et al (Miska 2000) compared women’s
We assumed that the purpose of feedback or BF would be related
preferences for perineal ultrasound, verbal feedback from digital
to the type of UI in the research population, because the purpose of
vaginal palpation, electromyography and vaginal squeeze pressure.
adding feedback or BF could be different for different populations
Perineal ultrasound was the preferred form of feedback for im-
of women suffering UI. For example, the rationale for feedback
proving awareness of pelvic floor anatomy. Overall, electromyog-
and BF in women with SUI is probably to improve the timing
raphy, vaginal squeeze pressure and ultrasound were all preferred
of a pelvic floor muscle contraction relative to a change in the
to verbal feedback after digital vaginal palpation with regard to:
intra abdominal pressure and to improve training performance in
1) understanding the anatomic location of the pelvic floor mus-
order to build pelvic floor muscle strength of the PFM. On the
cles; 2) understanding the function of the pelvic floor muscles for
other hand, for women with UUI the focus is more directed to the
urethral closure; and 3) understanding the aims of physiotherapy.
timing of a voluntary pelvic floor muscle contraction to suppress
Only one of the included trials in the review investigated ultra-
urgency via the reflex pathway. With the limited reporting of the
sound as a form of BF. Although results were encouraging, the
purpose of feedback or BF in the included studies it was difficult
trial was small. More trials of ultrasound BF are needed to draw
to tell if our assumptions were substantiated.
conclusions about its effectiveness. Although the costs are con- treatment period. In one trial (Pages 2001) 11 women in the BF
siderable, ultrasound equipment is becoming more accessible and group where excluded directly after randomisation, before treat-
portable. If ultrasound as BF is appreciated by women, this poten- ment, because they did not meet the inclusion criteria. Pages et
tially less intrusive/invasive form of BF creates new opportunities. al introduced heterogeneity in any meta-analysis to which it con-
In contrast, digital vaginal palpation is the most accessible of the tributed; one plausible explanation is that the groups were poten-
feedback methods although a skilled health professional is needed tially unbalanced.
to do it, and it is potentially seen as a more intrusive or invasive
procedure than an alternative such as ultrasound. Analysis according to the ITT principle was reported by nine trials
but it was difficult to be sure what the trialists meant by ITT. When
With regard to costs and effectiveness, frequency of intervention we appraised the studies it was difficult to assess if full ITT had
is important. Some intervention protocols were likely based on been used. Two criteria add up to full ITT analysis: 1) Participants
the assumption that the more times feedback or BF was given are analysed in the group to which they were originally assigned;
the better the outcome would be. When investigating potential and 2) If there are any missing data, the effect of this must be
subgroup analyses according to the number of times feedback or assessed in a reasonable way. It seemed that what some trialists
BF was given, it seemed that fewer occasions were as effective or meant by ITT, was that participants were analysed in group to
possibly even more effective than giving feedback or BF more than which they were assigned, but this is not a full ITT analysis. If
twelve times. It may be that any of the benefits of feedback or there were missing data, most trialists seem to deal with this using
BF could be established with few treatments. Clinicians weighing last value carried forward. However, last value carried forward is
costs (in terms of both economic costs and indirect costs such known to give biased results. It is better to asses the effect of
as the invasiveness of the BF device) should take these findings this in a more reasonable way, such as multiple imputation (Lane
into account when the addition of feedback or BF to PFMT is 2008). We strongly recommend that both components of ITT are
considered. explicitly reported in the methods of trials.
Full sensitivity analysis on the basis of trial quality was not consid-
ered appropriate based on the small numbers of trials contributing
Quality of the evidence to each comparison. It is not known to what extent the variable
quality of the trials has affected the findings of the review but
Methodological quality was evaluated from the trial reports.
there did not seem to be a pattern of trials at greatest risk of bias
Therefore, the quality of reporting might have affected the judge-
reporting the most favourable outcomes for one intervention or
ment of methodological quality. Although all included trials were
another.
full papers (or theses) many did not include key information that
was needed to asses risk of bias and often the data were incom-
plete or reported in ways that it was not useful or could not be
extracted. While it was expected that there would be some less Potential biases in the review process
well reported trials (because some of the included trials pre-dated We were not blinded to the authorship of the papers being screened
reporting guidelines such as CONSORT) our expectation that for eligibility, during risk of bias assessment or data extraction.
reporting would have improved over the years was not what we Between the review authors we already knew many of the included
found when the trials were critically appraised. Two thirds of the studies and it was not possible to blind them effectively. None of
included trials did not sufficiently describe the randomisation pro- the review authors were authors of a paper that was included in
cedure so that the we could be sure there was adequate conceal- the review.
ment; we were unable to assess concealment in the four most re-
cent published studies. The difficulties with blinding of partici-
pants and therapists were acknowledged, but blinding of outcome
assessor should be possible to reduce the risk of bias. Blinding for
Agreements and disagreements with other
all outcome assessments was done in five trials and blinding for
studies or reviews
some outcome assessment in two trials. The most recent, substantive, and rigorous systematic review of
Proportion of dropout and withdrawals varied widely between the randomised trials investigating the added effect of feedback or
trials. It was interesting that, except for two trials (Glavind 1996; BF with PFMT was the National Health Technology Assessment
Wilson 1987), all the studies with a difference in PFMT between (NHTA) report titled ’Systematic review and economic modelling
the comparison groups had higher proportions of dropouts and of the effectiveness and cost-effectiveness of non-surgical treat-
withdrawals (11 to 20% and more than 20%). This might reflect ments for women with stress urinary incontinence’ (Imamura
the PFMT regimen in the non-feedback or non-BF groups, which 2010). The NICE report stated that “There is clear evidence that
was usually PFMT consisting of instructions provided by a leaflet PFMT plus BF was effective ” (page xi). Our own conclusions are
without face to face contact with a health professional during the more cautious than this, and we contend that the apparent addi-
tional effect of feedback or BF may be confounded by underlying Implications for practice
differences in the PFMT programmes in the two treatment arms
Based on the data available:
(that is the feedback/BFand non-feedback/BF arms). We think
this apparent difference of interpretation of a similar body of evi- • Feedback or BF, as an addition to PFMT, may benefit in
dence arose because: women with SUI, MUI or UUI. This recommendation could
• Although different forms of BF (e.g. different probes), not be made stronger because of the range of other plausible
different ways of providing BF (visual/audio) and different explanations for the difference between the two treatment
settings (home versus clinic BF) were considered in the NHTA groups. It is possible that around twice as many women receiving
report, differences in PFMT between the comparison groups feedback or BF will consider themselves cured or improved with
were not taken into account as being a possible confounder. We this addition to treatment, although the difference in leakage
think this is the most plausible explanation of the differences in episodes between feedback and non-feedback groups was only
the findings of our review and the NHTA report. about one fewer leak every eight days.
• The two reviews defined the term ’cure’ differently. In the
NHTA report ’cure’ was any form of cure. It could be patients’ • When feedback or BF are considered as an adjunct to
perception or some measure such as no leakage episodes in a PFMT, the preference of women and therapist are important in
urinary diary or ’cure’ on pad test. In our review we defined the decision about which form to use. Availability, cost-
’cure’ as the women’s perception of cure; we were less interested effectiveness and the woman’s perception of the invasiveness of
in whether other ways of quantifying symptoms (such as leakage the procedure are important factors that may influence this
episodes or pad tests) suggested a cure because we thought it was decision.
the women’s perception of change in symptoms that was most • Therapists would do well to consider the purpose of adding
likely to determine whether further treatment was sought, feedback and BF, and on this basis consider how often feedback
quality of life, symptom distress and so on. or BF is given; it seems a few (one or two) occasions may well be
• The NHTA report and our review defined PFMT as or more effective than many.
differently. We categorised any trial in which feedback or BF was
used (even if only once to assist the teaching of a voluntary pelvic
floor muscle contraction) as a feedback or BF intervention. The Implications for research
NHTA report included these as PFMT studies; only studies that Adequate reporting of trials is imperative to be able to combine
used repeated occasions of feedback or BF were classified as data for analyses in a Cochrane systematic review. Consistency in
feedback or BF studies. Thus, our review is potentially more chosen outcome measures and improvements in the reporting of
’sensitive’ to the additional effect of feedback or BF to PFMT. methods could lead to more robust findings in the future. In plan-
ning research, trialists are encouraged to consider the following:
Other plausible explanations for the difference, that we think are
less likely are: • The choice of primary outcome should be condition
• The NHTA report only included women with SUI. While specific QoL because this is what women value most.
the majority of studies in our review we in women with SUI, we
also included women with other incontinence diagnoses. • Ideally, all trials would use the same core condition specific
However, we did not see any inconsistency in the effects of QoL measure, the ICIQ-SF. This measure is psychometrically
feedback/F between the trials in women with SUI and the trials robust and is short.
in other sample populations in our review. • If further detail about which components of QoL have
• Only one form of feedback, that is BF, was considered in the changed with treatment is needed, then in addition to the ICIQ-
NHTA report. No distinction was made between verbal feedback SF trialists might also use another measure, validated for the
and BF. We find it difficult to be sure what difference this made. population (e.g. IIQ, KHQ, BFLUTS).
Note: There are a number of other less recent although rigorous, • Cost data and formal economic analyses are needed.
comprehensive reviews (in terms of inclusion of other types of
• Pad tests, at least until there is agreement about which to
UI than the NHTA report) on this topic. Readers may wish to
use and how to report the findings consistently, are not a useful
compare the findings of this review with others such as the NIH
measure and should certainly not be used as a primary outcome
publications on UI (Shamliyan 2008) or Hay-Smith 2009.
measure.
• It may not be useful to measure adherence. We recognise
that adherence to PFMT is an key contributor to treatment
effect, but it could be supposed that adherence is the same in
AUTHORS’ CONCLUSIONS both treatment arms of a feedback/BF trial unless there are
differences in the PFMT in both arms, or the purpose of ACKNOWLEDGEMENTS
feedback/BF is to enhance adherence.
The authors of this review are grateful acknowledging the follow-
• Rather than adherence it may be useful to measure other ing authors for clarifying uncertainties and/or providing additional
constructs such as self efficacy for exercise, satisfaction on data: P Aukee, B Berghmans, D Delgado, M Drake, P Goode, M
progress etc, depending on the purpose of feedback and/or BF. Isikoglu, T Janssen, A Lucio, D McClurg, S Tisseverasinge, C Tsai
and A Wang.
• It might be useful to measure change during treatment if it
is thought that the effect of feedback and/or BF is seen early in The considerable contribution of Rebecca George, Chantale Du-
treatment with less difference being expected over time. moulin and Ros Herbison was acknowledged with regard to data
extraction, and of Sheila Wallace for performing the search.
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Sherman 1997 {published data only} and mixed incontinence. BJU International 2006;98(5):
Sherman RA, Davis GD, Wong MF. Behavioral treatment 1043–50.
of exercise-induced urinary incontinence among female
Wilson 1987 {published data only}
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Smidt 1997 {published data only} AD. An objective assessment of physiotherapy for female
Smidt N, te Giffel MA, Gerards-Last TM, de Vet HC. genuine stress incontinence. British Journal of Obstetrics &
Effectiveness of myofeedback for women with stress Gynaecology 1987;94(6):575–82.
incontinence. Nederlands Tijdschrift Fysiotherapie 1997;107 Wilson PD, Al Samarrai T, Deakin M, Kolbe E, Brown
(5):121–7. ADG. The value of physiotherapy in female genuine stress
Tejero 2008 {published data only} incontinence [abstract]. Proceedings of the International
Tejero M, Marco E, Boza R, Selva F, Piqueras M, Guillen Continence Society (ICS), 14th Annual Meeting, 1984 Sep
A, et al.[Stress urinary incontinence and pelvic floor muscle 13-15, Innsbruck, Austria 1984:156–8.
exercises: effectiveness of two different intensive training Wong 2001 {published data only}
versus home instructions]. Trauma 2008;19(3):171–7. Wong KS, Fung BKY, Fung ESM, Fung LCW, Tang LCH.
Tisseverasinghe 2006 {published and unpublished data} Randomized prospective study of the effectiveness of pelvic
Galea M, Tisseverasinghe S, Sherburn M, Phillips B. Motor floor training using biofeedback in the treatment of genuine
skill training of the pelvic floor muscles using visual versus stress urinary incontinence in Chinese population [abstract].
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Tsai C, Engberg S. Is biofeedback-assisted pelvic floor Bernier F. Pelvic floor muscle retraining: quantitative,
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Tsai YC, Liu CH. The effectiveness of pelvic floor exercises, Castleden 1984 {published data only}
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Association between urogenital symptoms and depression in ∗
Indicates the major publication for the study
CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Aksac 2003
Methods 3-arm RCT, parallel design.

A priori power calculation: not stated.
Participants 50 women with USI, from a single centre in Turkey.

No further inclusion or exclusion criteria stated.
Age: median in years (SD): PFMT + F 52.5 (7.9), PFMT + BF 51.6 (5.8).
Body weight: median in kg (SD): PFMT + F 59.4 (6.1), PFMT + BF 57.5 (5.8).
Parity: median n (SD): PFMT + F 2.8 (0.5), PFMT + BF 3.5 (1.1)
Interventions Details of PFMT, F and BF in Table 4

1. PFMT + F (n=20): taught vPFMC using verbal F.
2. PFMT + BF (n=20): unclear whether BF home or clinic.
3. Control (n=10): this arm not considered in this review
Outcomes Primary endpoint: 8 weeks.

Primary outcome measure: not stated.
Outcome measures: pad test cure (weight gain of 1g or less), pad test improvement (50%
or greater reduction in pad weight), PFM performance (vaginal squeeze pressure, digital
palpation score), incontinence frequency (four point ordinal scale), Social Activity Index
(based on a Visual Analogue Scale; scaled and evaluated between 0 and 10 point; 0=
cannot make any social activity, 10=does not have any problem)
Notes Dropouts: nothing stated
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection Unclear risk Only stated that women were allocated “at
bias) random”.
Allocation concealment (selection bias) Unclear risk Patients drew sealed envelope on first visit.
Unclear if envelopes were opaque sealed or
numbered
Blinding (performance bias and detection Unclear risk Unclear if outcome assessor was blinded.
bias)
All outcomes
Incomplete outcome data (attrition bias) Unclear risk No dropouts reported.

All outcomes ITTA:
1. participants analysed in group to which
assigned? Probably, but not stated.
2. authors stated analysis by intention to
Aksac 2003 (Continued)
treat? No.
3. full intention to treat used? No.
Other bias Unclear risk Funding or financial assistance: unclear.

Ethical approval: unclear.
Conflict of interest: unclear.
Aukee 2002
Methods 2- arm RCT, parallel design

A priori power calculation: no, pilot study.
Participants 35 women with USI, from a single centre in Finland.

Inclusion criteria: Women with SUI and an abdominal leak point pressure greater than
90 cm H2O, no previous incontinence operation, age 21-70.
Exclusion criteria: Genital protrusion beyond hymen, inability to understand home
training instructions, pregnancy, any severe disease such as malignancy, multiple sclerose
or insulin dependent diabetes.
Age: mean in years (SD): PFMT + clinic BF 49.4 (9.5), PFMT + clinic BF + home BF
51.4 (6.1)
Duration of symptoms: mean in years (SD): PFMT + clinical BF 6.6 (3.9), PFMT +
clinical BF + home BF 8.5 (8.6).
Means symptom severity (24 hour pad test) in grams, (SD): PFMT + clinical BF 47.1
(34.6), PFMT + clinical BF + home BF 28.1 (29.4)
Interventions Details of PFMT, clinic BF and home BF in Table 5

1. PFMT + clinic BF (n=19).
2. PFMT + clinic and home BF (n=16).

Primary outcome measure: 24 hour pad test, EMG measure (microV) of PFM activity,
Leakage Index (Bo 1994).
Secondary outcomes measures (2004): PFM activity, the need for surgical intervention,
after conservative treatment and the patient’s subjective evaluation of PFMT.
Other outcome measures: none reported.
Notes 2 patients in the clinic + home BF group stopped training with the device and continued
PFMT alone.
Follow up after primary endpoint: 1 year.
Risk of bias
Random sequence generation (selection Unclear risk Randomisation was done by a randomisa-
bias) tion table, in blocks of 4
Aukee 2002 (Continued)
Allocation concealment (selection bias) Unclear risk Randomisation was done by a randomisa-
tion table, in blocks of 4
Blinding (performance bias and detection Low risk A blinded urogynecological nurse con-
bias) ducted pad test and Leakage Indes
All outcomes
Incomplete outcome data (attrition bias) Unclear risk Dropouts: 2/16 in the clinic + home BF
All outcomes group.
ITTA:
assigned? Yes. Analysed in group to which
assigned, baseline values carried forward for
missing data.
treat? Yes.
3. full intention to treat used? Unclear.
Selective reporting (reporting bias) Low risk All measured outcomes are reported.
Other bias Unclear risk Funding or financial assistance: not stated.

Ethical approval: yes.
Conflict of interest: not stated.
Berghmans 1996
Methods 2- arm RCT, parallel design.

Stratified by incontinence severity and source of referral.
Participants 40 women with USI or symptomatic indications of SUI, from a single centre in the
Netherlands.
Inclusion criteria: age 18 to 70 years, mild to moderate SUI (grade 1 or 2), able to fill
out forms, willingness to participate.
Exclusion criteria: Medicine for LUT dysfunction, obvious pudendal nerve dysfunction
on clinical neurological exam, UTI, non-compliance in diagnostic phase, neurogenic
bladder dysfunction, urological or gynaecological surgery, within 6 weeks postnatal, other
forms of treatment for SUI, psychological disorders, vaginitis, pacemaker, hip prosthesis,
not able to speak Dutch.
Age: mean in years (SD): PFMT 50.35 (10.50), PFMT + BF 46.40 (12.12)
Symptom duration: 75% of each group had been symptomatic for more than 24 months.
Symptom severity mean (symptom score; higher score worse), (SD): PFMT 23.78 (6.89)
, PFMT + BF 22.12 (4.64)
Interventions Details of PFMT and BF in Table 1

1. PFMT (n=20).
2. PFMT+ clinic BF (n=20): BF in clinic sessions.
Berghmans 1996 (Continued)

Primary outcome measures: 48 hours pad test.
Other outcome measures: symptom questionnaire (minimum 5, maximum 10),
urinary diary, and combined measure of effect (all three measures with same weighting
for each element, to give % change)
Notes
Risk of bias
Random sequence generation (selection Low risk Randomisation done in blocks of four
bias) within the strata. Sealed envelopes, con-
taining a note with ’PFMT’ or ’BF’ were
used
Allocation concealment (selection bias) Low risk Randomisation done in blocks of four
within the strata. Sealed envelopes, con-
taining a note with ’PFMT’ or ’BF’ were
used
Blinding (performance bias and detection Low risk The observer was blinded for allocation of
bias) treatment. Effect measurements and data
All outcomes analysis were blinded
Incomplete outcome data (attrition bias) Low risk 100% compliance during trial; no drop-
All outcomes outs.
ITTA:
assigned? Yes.
treat? Yes.
3. full intention to treat used? Yes.

Ethical approval: not stated.
Burgio 2002a

Stratified by race, type of incontinence and severity of incontinence.
A priori power calculation: yes.
Participants 222 women with urodynamic evidence of detrusor overactivity from a single centre in
the USA.
Inclusion criteria: Age 55 years or older, ambulatory, community dwelling, non de-
Burgio 2002a (Continued)
mented, average 2 or more urge incontinence episodes/week, urge predominant pattern

(more urge than stress or other leakage episodes), urge symptoms for at least 3 months.
Exclusion criteria: Continual leakage, post-void residual volume >150 ml, severe uterine
prolapse past the vaginal introitus, decompensated congestive heart failure, impaired
mental status. Those with UTI, faecal impaction, severe atrophic vaginitis or metabolic
problems were considered for study if they had received treatment for these conditions
but incontinence persisted.
Age: mean in years, (SD): PFMT written instruction 65.8 (8.5), PFMT + verbal F 65.8
(7.6), PFMT + BF 64.8 (7.1).
Mean symptom duration in years, (SD): PFMT written instructions 6.6 (8.7), PFMT
+ verbal F 6.6 (7.7), PFMT + BF 7.1 (7.8).
Symptom severity: moderate to severe, PFMT written instructions 78.7%, PFMT +
verbal F 81.1%, PFMT + BF 80.8%
Interventions Details of PFMT, F in Table 2

1. PFMT standardised written instructions (n=75): Received written instructions on
PFMT, no professional contact for 8 weeks.
2. PFMT + verbal F (n=74): Taught vPFMC using verbal F.
Urge suppression strategies in both groups.
Outcomes Primary endpoint: 8 weeks

Primary outcome measures: frequency of incontinence episodes (from 2 week bladder
diary).
Other outcome measures: % reduction in leakage episodes, Hopkins Symptom checklist
(SCL-90-R for psychological distress), IIQ, SF 36, bladder capacity, patient satisfaction
Notes
Risk of bias
Random sequence generation (selection Unclear risk Patients were randomised to behavioural
bias) treatment with biofeedback, behavioural
treatment without biofeedback, or a con-
trol condition
Allocation concealment (selection bias) Unclear risk Patients were randomised to behavioural
treatment with biofeedback, behavioural
treatment without biofeedback, or a con-
trol condition
Blinding (performance bias and detection Low risk Outcome assessor was blinded.
bias)
All outcomes
Incomplete outcome data (attrition bias) Low risk Dropouts: 27/222; 7/75 PFMT written in-
All outcomes struction. 9/74 PFMT + verbal F
ITTA:
Burgio 2002a (Continued)

assigned? Yes.
treat? Yes; when the patient did not com-
plete treatment, the most recent bladder di-
aries were used to calculate outcome.
Selective reporting (reporting bias) Low risk
Other bias Low risk Funding or financial assistance: yes, source

of funding stated.
Ethical approval: yes.
Burgio 2002b
Methods See Burgio (a) 2002.
Participants See Burgio (a) 2002.

1. PFMT written instructions (n=75): Received written instructions on PFMT, no pro-
fessional contact for 8 weeks.
2. PFMT + BF (n=73): Taught vPFMC using anorectal BF.
Outcomes See Burgio (a) 2002.
Notes
Risk of bias
Random sequence generation (selection Unclear risk See Burgio (a) 2002
bias)
Allocation concealment (selection bias) Unclear risk See Burgio (a) 2002
bias)
All outcomes
Incomplete outcome data (attrition bias) Low risk Dropouts: 27/222; 7/75 PFMT written instruction. 11/73
All outcomes PFMT + BF.
See Burgio (a) 2002
Burgio 2002b (Continued)
Selective reporting (reporting bias) Low risk See Burgio (a) 2002
Other bias Low risk See Burgio (a) 2002
Burgio 2002c
Methods See Burgio (a) 2002.
Participants See Burgio (a) 2002.
Interventions Details of PFMT, verbal F and BF in Table 4

1. PFMT + verbal F (n=74): Taught vPFMC with vaginal palpation.
2. PFMT + BF (n=73): Taught vPFMC using anorectal BF, more BF provided if little
improvement after 6 weeks
Outcomes See Burgio (a) 2002.
Notes
Risk of bias
Random sequence generation (selection Unclear risk See Burgio (a) 2002
bias)
Allocation concealment (selection bias) Unclear risk See Burgio (a) 2002
bias)
All outcomes
Incomplete outcome data (attrition bias) Low risk Dropouts: 27/222; 9/74 PFMT + verbal F, 11/73 PFMT + BF.
All outcomes See Burgio (a) 2002
Selective reporting (reporting bias) Low risk See Burgio (a) 2002
Other bias Low risk See Burgio (a) 2002
Burns 1993

A priori power calculation: no.
Participants 135 women with urodynamic SUI or MUI, from a single centre in the USA.
Inclusion criteria: female volunteers aged 55 years and older, at least 3 losses per week,
absence of glycosuria or pyruria, residual volume < 50 cc, MMSE score >23, peak urine
flow rate of >15 ml/sec.
Exclusion criteria: not further stated.
Age: mean in years (SD): PFMT: 63 (6), PFMT + BF: 63 (6)
Mixed incontinence: 12/123.

1. PFMT (n=43, after drop outs)
2. PFMT + BF (n=40, after drop outs)
3. Control, no rx (n=40, after drop outs) (this arm not considered in this review)

Primary outcome measures: episodes of urine loss, 14 day voiding diary.
Other outcome measures: incontinence severity, average of five EMG measures (peak
contraction, sustained contraction score), MUCP and FUL
Notes
Risk of bias
Random sequence generation (selection Low risk Random allocation; participants were ran-
bias) domised in blocks of 12
Allocation concealment (selection bias) Unclear risk Random allocation; participants were ran-
domised in blocks of 12
Blinding (performance bias and detection Unclear risk Stated that the principal investigator was
bias) the only person who knew the group assign-
All outcomes ments. Remaining clinical trial personnel
performed procedures and collected out-
come measures
Incomplete outcome data (attrition bias) Unclear risk Data only reported for 123 participants.
All outcomes 12/135 dropped out.
ITTA:
treat? No.
Burns 1993 (Continued)
Other bias Low risk Funding or financial assistance: yes, public

funding stated.
Ethical approval: not stated. Individual in-
formed consent was obtained prior to pro-
curement of study data.
Glavind 1996
Methods 2- arm RCT, parallel design

Participants 40 women with USI from a single centre in Denmark.

Inclusion criteria: Leakage while coughing or jumping, confirmed USI, >2g leakage on
one hour pad test. VPFMC was checked but also women with weak or no contraction
were randomised.
Exclusion criteria: DO, previous incontinence surgery.
Median age in years: 45.
Median pad test weight in grams (95% CI): PFMT 12.8 (9 to 14), PFMT + BF 9 (5 to
22)

1. PFMT (n=20).
2. PFMT+BF (n=20): 4 x extra weekly clinic visits with BF.
Outcomes Primary endpoint: 1 month post-treatment. Longer term follow-up: 3 months post-
treatment.
Primary outcome measures: not reported.
Other outcome measures: 1 hour pad test, self reported improvement
Notes
Risk of bias
bias)
All outcomes
Incomplete outcome data (attrition bias) Unclear risk Dropouts 6/40; 5/20 PFMT, 1/20 PFMT
All outcomes + BF
ITTA:
treat? No.
Glavind 1996 (Continued)

Ethical approval: yes, by the local ethical
committee.
Goode 2003

Stratified by type of incontinence (SUI, MUI), severity of incontinence and race
(coloured or white; self identified by the patient).
Participants 200 women with USI from a single centre in the USA.
Inclusion criteria: age >40 years, UI for at least 3 months, average 2 or more incontinence
episodes/week in baseline diary, predominantly SUI.
Exclusion criteria: continual leakage, post-void residual volume >150 ml, severe uterine
prolapse past vaginal introitus, decompensated congestive heart failure, haemoglobin A
>/= 9, impaired mental status. UTI, faecal impaction, severe atrophic vaginitis, uncon-
trolled diabetes.
Age: mean in years (SD): PFMT written instructions 55.9 (10.1), PFMT + BF 57.7
(10.0)
Duration of symptoms: mean in years (SD): PFMT written instructions 10.3 (11.7),
PFMT + BF 6.9 (8.3)
Moderate to severe symptoms: PFMT written instructions 74.7%, PFMT + BF 80.3%
Type of incontinence: PFMT written instructions SUI 28.8% MUI 71.2%, PFMT +
BF SUI 37.3% MUI 62.7%

1. PFMT written instructions (n=67): Received self-help booklet detailing isolation of
PFM and progression of PFMT programme.
2. PFMT + BF (n=66): Taught VPFMC with BF and received instruction for progressive
PFMT regimen.
3. PFMT + BF + ES (n=67): This arm not considered in this review

Primary outcome measures: % reduction in leakage episodes.
Other outcome measures: leakage episodes, Hopkins Symptom checklist (SCL-90-R for
psychological distress), IIQ, SF 36, urodynamics, patient satisfaction
Notes
Risk of bias
Random sequence generation (selection Low risk Patients were randomised within each stra-
bias) tum using a block size of 6. The randomi-
sation schedule was computer generated
Goode 2003 (Continued)
by the biostatistician and implemented by

nurse practitioners
Allocation concealment (selection bias) Low risk Patients were randomised within each stra-
tum using a block size of 6. The randomi-
sation schedule was computer generated
by the biostatistician and implemented by
nurse practitioners
bias)
All outcomes
Incomplete outcome data (attrition bias) Unclear risk Dropouts 45/200; 25/67 PFMT; written
All outcomes instructions, 12/66 PFMT + BF, 8/67
PFMT + BF/ES
ITTA:
assigned? Yes.
treat? Yes; last value carried forward from
bladder diary.
Other bias Unclear risk Funding or financial assistance: source of

public funding stated.
Johnson 2000
Methods 2- arm quasi-RCT, parallel design.

Participants 20 women with SUI, MUI or UUI, from a single centre in the USA.
Inclusion: SUI, MUI, or UUI for more than a year.
Exclusion: pregnancy, more than 1 prior bladder surgery, systemic illness.
Age range in years: PFMT + F 45 to 69; PFMT + BF 36 to 80.
Range of symptom duration, years: PFMT + F 1 to 20; PFMT + BF 1 to 20.
Type of incontinence: PFMT + F SUI 3, MUI 5, UUI 2; PFMT + BF SUI 3, MUI 5
and UUI 2

1. PFMT + F (n=10)
2. PFMT + clinic BF (n=10): Surface EMG BF at clinic.
Johnson 2000 (Continued)

Primary outcome measures: investigator-defined cure or improvement.
Other outcome measures: leakage episodes/week from 7 day diary, pads used per week,
surface EMG (highest of 10 one second contractions for maximal muscle recruitment,
average of 10 ten second contractions with 10 second rest for endurance)
Notes Outcome measurements during intervention: 4 weeks.
Risk of bias
Random sequence generation (selection High risk Participants were allocated to group by al-
bias) ternate assignment
Allocation concealment (selection bias) High risk Participants were allocated to group by al-
ternate assignment
bias)
All outcomes
Incomplete outcome data (attrition bias) Unclear risk Dropouts not reported.
All outcomes
ITTA:
assigned? Apparently.
treat? No.

Laycock 2001a

Participants 101 women with symptoms of SUI, from multiple centres in Australia, New Zealand,
Ireland, and the UK.
Inclusion criteria: age 20 to 64, able and willing to comply with trial procedures and to
give informed consent to do so, no other clinically significant abnormalities.
Exclusion criteria: Pregnant or planning pregnancy, on medication for bladder symp-
tomology or medication likely to affect the lower urinary tract, HRT for less than 3
months, neurological conditions, moderate/severe urge incontinence, present/previous
participation in incontinence research, moderate/severe genital prolapse, UTI.
Laycock 2001a (Continued)
Age: range in years 20 to 64.

Mean symptom severity in leakage episodes/day: PFMT 1.71, PFMT + BF 2.04

1. VC (n=41): This arm not considered in this review.
2. PFMT (n=20).
3. PFMT+ home BF (n=40).
Outcomes Primary endpoint: 3 months.

Primary outcome measures: reduction in leakage episodes (urinary diary), subjective
assessment using VAS.
Other outcome measures: maximal contraction measured with an electronic perineome-
ter, KHQ, pad usage
Notes
Risk of bias
Random sequence generation (selection Low risk Randomization done using prepared ran-
bias) dom number tables, in the ratio 2:2:1
Allocation concealment (selection bias) Unclear risk Randomization done using prepared ran-
dom number tables, in the ratio 2:2:1
bias)
All outcomes
Incomplete outcome data (attrition bias) Unclear risk Dropouts 33/101; 11/41 VC, 4/20 PFMT,
All outcomes 18/ 40 PFMT+BF.
ITTA:
treat? No.
Other bias Unclear risk Funding or financial assistance: yes, source

stated.
Ethical approval: unclear
Conflict of interest: not stated
McClurg 2006

Participants 30 women with neurogenic DO, due to multiple sclerosis (MS), from 2 hospital sites in
the Republic of Ireland.
Inclusion criteria: women with clinically definite or laboratory supported diagnosis of
MS with disease stabilized for the previous 3 months; age >18, Expanded Disability Status
Scale (EDSS) score <7.5 and sufficient dexterity- enabling completion of assessments and
treatment protocol, any involuntary leakage of urine and voiding frequency >8 per 24 hr
[Stohrer 2003], nocturia [Abrams 2002], and/or voiding dysfunction such as hesitancy,
straining, poor stream and incomplete emptying.
Exclusion criteria: symptomatic prolapse, UTI, current or recent diagnosis of serious
medical condition (other than MS), severe cognitive impairment, and any contraindi-
cations to electrical stimulation [Laycock and Vodusek 2002].
Age: years in mean (SD): PFMT 49.5 (8.7), PFMT + BF 52.1 (11.5)
EDSS: score in mean (SD): PFMT 5.4 (1.3), PFMT + BF 5.9 (1.3)
Years since diagnosis of MS in mean (SD): PFMT 6.0 (0.1), PFMT + BF 10.2 (1.0)

1. PFMT (n=10)
2. PFMT + EMG BF (n=10)
3. PFMT + EMG BF + NMES (n=10) This arm not considered in this review

Primary outcome measure: leakage episodes per 24 hours.
Other outcome measures: 24 hour pad test, voiding frequency, nocturia, voided volumes
and fluid intake, uroflowmetry, digital vaginal assessment of PFM, EMG BF contrac-
tion/relaxation (only group 2), KHQ, IIQ and UDI, Multiple Sclerosis Quality of Life
(MSQoL-54)
Notes
Risk of bias
Random sequence generation (selection Low risk Computer generated randomisation list
bias) was used.
Allocation concealment (selection bias) Unclear risk Computer generated randomisation list
was used.
Blinding (performance bias and detection Low risk The data assessor was blinded for all out-
bias) comes.
All outcomes
Incomplete outcome data (attrition bias) Low risk Dropouts 2/30; 1/10 PFMT, 1/10 PFMT +
All outcomes BF + ES. 2 patients withdrew due relapsing
of MS. Stated that data were taken into
McClurg 2006 (Continued)
account in final analysis, but unclear how.

assigned? Yes.
treat? No.
Selective reporting (reporting bias) Low risk All outcomes listed are reported.
Other bias Low risk Funding or financial assistance: ’support’ by

MS Society of Great Britain and Northern
Ireland.
Ethical approval: not stated
Morkved 2002
Methods 2 arm RCT, parallel design.

Stratified by pad test result (</=20g, >20g).
Participants 103 women with USI, from a single centre in Norway.

Inclusion criteria: SUI, more than 2g leakage on pad test.
Exclusion criteria: DO, abnormal bladder activity (residual volume >50 ml), previous
surgery for SUI, neurologic or psychiatric disease, UTI, other diseases that could inter-
fere with participation, pregnancy, use of concomitant treatments during trial period,
inability to understand instructions in Norwegian.
Age: mean in years (SD): PFMT 45.4 (8.1), PFMT + BF 47.8 (8.2).
Duration of symptoms: mean in years, (SD): PFMT 10.5 (6.6), PFMT + BF 8.8 (6.2).
48 hour pad test result: mean in grams (SD): PFMT 39.8 (36.6), PFMT + BF 44.6
(33.9)

1. PFMT (n=50).
2. PFMT+ home and clinic BF (n=53).

Primary outcome measures: pad test with standardised bladder volume, subjective as-
sessment of severity (4 point Likert, unproblematic to very problematic).
Other outcome measures: 48 hours pad test, Leakage Index, Social Activity Index, PFM
function by vaginal squeeze pressure
Notes 1-year follow up data presented in International Continence Society abstract 2003. 70
out of 94 women agreed on having urodynamic assessments and the standardised pad
test.
7 women in the PFMT + BF group found the BF apparatus unpleasant
Morkved 2002 (Continued)
Risk of bias
Random sequence generation (selection Low risk Centralized randomisation procedure, but
bias) not computerized.
Allocation concealment (selection bias) Low risk Opaque sealed envelopes were used. Each
participant drew an envelope after the en-
velopes were mixed and stored in a bigger
envelope
Blinding (performance bias and detection Low risk The main investigator was not involved in
bias) any intervention or outcome assessment.
All outcomes The nurses and gynaecologists doing the
outcome assessments were blinded to group
allocation
Incomplete outcome data (attrition bias) Unclear risk Dropouts 9/103; 4/50 PFMT and 5/53
All outcomes PFMT + BF. 1 woman disliked the BF
equipment
ITTA:
assigned? Yes.
treat? Yes; last value carried forward, but
primary analysis only on those who com-
pleted treatment.
Other bias Low risk Funding or financial assistance: yes, source

stated.
Ethical approval: yes; study was approved
by the local ethics committee.
Pages 2001

Participants 51 women with SUI, from a single centre in Gemany.

Inclusion criteria: SUI grade I or II (Ingelman-Sundberg scale), free of significant coex-
isting medical illness, not taking medication that affects LUT.
Exclusion criteria: neurological illness, evidence of cystitis, genital prolapse, or gynaeco-
logical haemorrhage on physical examination.
Pages 2001 (Continued)
Age: mean in years, (range): 51.1 (27 to 80).

Severity: SUI Grade I 25/40, SUI Grade II 15/40.

1.PFMT (n=27): Group PFMT.
2.PFMT + clinic BF (n=13, after do): Individual PFMT + BF.
Outcomes Primary endpoint: 3 months, assessment also performed at 4 weeks from baseline.
Primary outcome measures: frequency (7 day diary), subjective improvement.
Other outcome measures: PFM function; digital palpation (Fischer scale) and vaginal
squeeze pressure (10 consecutive measures for average contraction pressure, max con-
traction pressure, maximal cough pressure), speculum (amount of introital closure)
Notes
Risk of bias
Random sequence generation (selection Low risk The patients were randomised to one of the
bias) groups, using a randomisation table
Allocation concealment (selection bias) Unclear risk The patients were randomised to one of the
groups, using a randomisation table
Blinding (performance bias and detection Unclear risk Blinding of outcome assessor unclear.
bias)
All outcomes
Incomplete outcome data (attrition bias) High risk Dropouts: 11/51; all from PFMT + BF.
All outcomes Found to be ineligible after randomisation,
because they did not meet the inclusion cri-
teria
ITTA:
assigned? Unclear.
treat? No.

Ethical approval: study was approved by the
ethics committee of the Humboldt Univer-
sity, Berlin, Germany.
Schmidt 2009

A priori calculation: yes.
Participants 32 women with SUI or MUI, from a single centre in Brazil.

Inclusion criteria: >30 years old, no clinical or surgical treatment during the previous 6
months, free of significant genital prolapse (according to ICS guidelines) and no urethral
sphincter involvement.
Exclusion criteria: no additional criteria reported.
Age: mean in years (SD): PFMT 52.09 (13.78), PFMT + BF 54.7 (6.94)
BMI: mean in kg/m2 (SD): PFMT 30.73 (13.78), PFMT + BF 29.8 (6.36)
Type of incontinence: PFMT SUI 4, MUI 7; PFMT + BF SUI 5, MUI 5

1. PFMT (n=11)
2. PFMT + BF (n=10)
3. PFMT + ES (n=11) This arm not considered in this review.
Outcomes Primary endpoint: 12 weeks. Longer term follow up: 3 months.

Primary outcome measure: not stated
Other outcomes measures: changes in KHQ, 3-day bladder diary, urodynamic and per-
ineometric parameters. Subjective assessment of improvement, actual compliance with
treatment and performance
Notes
Risk of bias
Random sequence generation (selection Unclear risk Only stated that participants were ran-
bias) domly allocated to 1 of 3 intervention
groups
Allocation concealment (selection bias) Unclear risk Not described.
Blinding (performance bias and detection Unclear risk Only stated that the examiner who per-
bias) formed perineometry was blinded to the
All outcomes patient groups
Incomplete outcome data (attrition bias) Low risk No drop outs.

All outcomes
ITTA:
treat? No.
3. full intention to treat used? Yes.
Schmidt 2009 (Continued)
Other bias Unclear risk Funding or financial assistance: yes, source

of funding stated.
Ethical approval: yes, approved the research
ethics committee at Hospital de Clinicas de
Porto Allegre.
Conflict of interest: none stated.
Shepherd 1983

Stratified by age and parity.
Participants 22 women with USI, from a single centre in the UK.

Inclusion criteria: USI, stable bladder.
Exclusion criteria: no additional criteria stated.
Age: mean in years (range): PFMT 48.4 (28 to 67), PFMT + BF 48.2 (28 to 67).
Duration of symptoms: mean in years (range): PFMT 11 (6 months to 30 yrs),
PFMT+BF 9 (8 months to 16 yrs).
Mean leakage episodes/week (range): PFMT 5.5 (3 to 12), PFMT + BF 6.5 (1 to 18)

1. PFMT (n=11)
2. PFMT + home BF (n=11)

Other outcome measures: frequency, leakage episodes per week, PFM function; vaginal
squeeze pressure, data on cure/improvement (dry, improved, same)
Notes
Risk of bias
Random sequence generation (selection Unclear risk Not described.

bias)
Allocation concealment (selection bias) Unclear risk Not described.
bias)
All outcomes
Incomplete outcome data (attrition bias) Unclear risk Dropouts: 3/11 withdrew from PFMT af-
All outcomes ter 2 sessions (but still had reported out-
comes for these women)
Shepherd 1983 (Continued)
ITTA:
assigned? Unclear.
treat? No.

Sherman 1997

Stratified by type of incontinence.
A priori calculation: no.
Participants 39 military women with SUI or MUI, from a single centre in the USA.
Inclusion criteria: female active duty soldiers with leakage during exercise, who indicated
desire for further treatment.
Exclusion criteria: no additional criteria stated.
Age mean in years (SD): 32.9 (7.8)
Parity mean (SD): 1.28 (1.05)
Type of incontinence: 30 SUI, 9 MUI
Interventions Details of PFMT, BT and BF in Table 1

1. PFMT + BT (n=16, after drop outs)
2. PFMT + BT + BF (n=23, after drop outs)

Primary outcome: not stated
Other outcomes: amount of urine per void, time between voids, degree of urgency, ability
to stop the stream of urine, activity level, subjects’ rating of severity of problem, size
of defect, how much practice occurred during treatment, days of treatment, number of
treatments, number of leaks per day, number of voids per night, fluid intake per day
Notes A slightly different sample population? Female active duty soldiers are exposed to more
high impact exercise than the normal population and could therefore be more disturbed
by or experience more episodes of urinary incontinence
Risk of bias
Random sequence generation (selection Unclear risk Women were randomised to one of the two
bias) groups.
Sherman 1997 (Continued)
Allocation concealment (selection bias) Unclear risk Women were randomised to one of the two
groups.
bias)
All outcomes
Incomplete outcome data (attrition bias) Unclear risk Dropouts: 4 women, who were originally
All outcomes randomised to PFMT were excluded from
analyses because they had received BF on
PFM relaxation. 1 woman dropped out of
PFMT + BF. 2 women injured their PFM
during duty, underwent surgery and were
excluded from analysis. Unclear to which
group they were originally assigned.
ITTA:
assigned? Yes.
treat? No.

Smidt 1997

Stratification; by severity of incontinence (grade I or II) and by referral (GP or specialist)
.
Both analysed according to intention to treat principle as per-protocol analysis.
a-priori power calculation: unclear.
Participants 33 women with grade I or II SUI, from multiple centres in the Netherlands.
Inclusion criteria: women >18 years with SUI.
Exclusion criteria: SUI grade III or IV, previous or current treatment for symptoms of
SUI, neurological conditions causing SUI, giving birth in the last three months, breast-
feeding at moment of entry, implanted electrical devices (e.g. pacemaker), irritation of
the vagina, lower urinary tract infections, not possible to place an intravaginal electrode,
woman not able to fill in questionnaire.
Age: years in mean (SD): PFMT: 46.33 (9.38), PFMT + BF: 45.33 (8.35)
Parity: number in mean (SD): PFMT: 2.33 (1.18), PFMT + BF: 2 (1.14)
Years since SUI was diagnosed, mean (SD): PFMT: 7.34 (6.90), PFMT + BF: 7.44
(5.34)
Smidt 1997 (Continued)
Diagnosed by urodynamics: PFMT: 9, PFMT + BF: 11

Severity of incontinence: SUI grade I: PFMT: 6, PFMT + BF: 7. SUI grade II: PFMT:
9, PFMT + BF: 11

1. PFMT (n= 15)
2. PFMT + myofeedback (n= 18)
Outcomes Primary endpoint: between 7 and 12 weeks. 12 was maximum.

Primary outcomes: not stated.
Secondary outcomes: 48 hours pad test, PRAFAB, frequency of toilet use, leakage
episodes and liquid intake
Notes
Risk of bias
Random sequence generation (selection Low risk Computer generated randomisation list.
bias)
Allocation concealment (selection bias) Unclear risk Computer generated randomisation list.
Blinding (performance bias and detection Unclear risk Not stated if outcome assessor was blinded.
bias)
All outcomes
Incomplete outcome data (attrition bias) Low risk 7 women were excluded from the per-pro-
All outcomes tocol analysis: PFMT 2/15, PFMT + BF 5/
18; 2 dropped out, 4 had more than 25%
missing data and 1 had SUI grade III
ITTA:
assigned? Yes.
treat? Yes.
3. full intention to treat used? Unlcear.
Other bias Unclear risk Funding or financial assistance: possibly

from the BF company
Ethical approval: yes
Tejero 2008

Participants 62 women with urodynamic SUI, from a single centre in Barcelona, Spain.
Inclusion criteria: >18 years, diagnosed with genuine stress incontinence.
Exclusion criteria: neurological and/or cognitive impairments that would alter ability to
collaborate with treatment, nocturnal enuresis, pregnancy and up to six months postnatal,
urogenital prolapse beyond hiatus.
Age: mean in years (SD): PFMT 55 (11), PFMT + BF 55 (11)
Duration of symptoms in years, n (%): PFMT <1 year: 2 (6.9), 1-5 years: 16 (55.2), 5-
10 years: 6 (20), >10 years: 5 (17). PFMT + BF <1 year: 0 (0), 1-5 years: 12 (44), 5-10
years: 6 (22), >10 years 9 (33)

1. PFMT (n=29, after dropouts)
2. PFMT + BF (n=27, after dropouts)

Primary outcomes measure: not stated.
Other outcomes measures: IIQ, degree of subjective improvement, degree of compliance,
swab test, perineometry, visual analogue scale for discomfort (0=no discomfort, 100=
max. discomfort)
Notes
Risk of bias
Random sequence generation (selection High risk Trialist reports both ’distributed in a ran-
bias) dom manner’ and ’divided’
Allocation concealment (selection bias) High risk Trialist reports both ’distributed in a ran-
dom manner’ and ’divided’
bias)
All outcomes
Incomplete outcome data (attrition bias) High risk 62 women were randomised. 6 apparently
All outcomes dropped out immediately after randomisa-
tion; 2/31 PFMT, 4/31 PFMT + BF.
However the post intervention follow up
only included 18/31 for the PFMT and 16/
31 women for the PFMT + BF group.
Losses to follow up: 55%.
ITTA:
Tejero 2008 (Continued)
assigned? Unclear.
treat? No.
Other bias Unclear risk There was no funding or financial assis-

tance.
Tisseverasinghe 2006

Participants 23 women with SUI and/or UUI, from a single centre in Australia.
Inclusion criteria: age 60 to 85 years, healthy community dwelling women.
Exclusion criteria: no faecal loading, known neurological symptoms, unable to provide
informed consent, currently receiving physiotherapy for their urinary incontinence.
Age: mean in years (SD): PFMT + F 71.4 (6.1), PFMT + BF 75.8 (7.3)
Interventions Details of PFMT, F an BF in Table 4

1. PFMT + F (n=11)
2. PFMT + BF (n=12)
Outcomes Primary endpoint: 10 weeks. Longer term follow up: 3 months

Other outcomes measures: Accident and Exercise diary (type of loss, wet, flood, reason for
leakage, amount of practice), 24 hour pad test, ultrasound assessment of PFM function,
KHQ, visual analogue scale for treatment compliance
Notes No dropouts. 1 extreme outlier was not taken into account for data analysis.
Note: author confirmed that 2 women in the BF group underwent ES in order to make
them aware of their PFM. No further ES was used
Risk of bias
Random sequence generation (selection Low risk A computer-generated random numbers

bias) list was used to randomly assign the par-
ticipants to one of the two groups. Treat-
ment codes were placed in opaque sealed
envelopes were used. Allocation was con-
trolled by a person independent of the re-
cruitment process
Tisseverasinghe 2006 (Continued)
Allocation concealment (selection bias) Low risk A computer-generated random numbers

list was used to randomly assign the par-
ticipants to one of the two groups. Treat-
ment codes were placed om opaque sealed
envelopes were used. Allocation was con-
trolled by a person independent of the re-
cruitment process
Blinding (performance bias and detection Low risk Data collection completed by an indepen-
bias) dent assessor who was blinded to the sub-
All outcomes ject’s group allocation
Incomplete outcome data (attrition bias) Unclear risk No dropouts. 23 women were randomised,
All outcomes 22 were included in the analysis.
ITTA:
assigned? Yes.
treat? No.
Other bias Unclear risk Funding or financial assistance: there was

no funding.
Ethical approval: approval obtained.
Tsai 2002
Methods 2 arm RCT, parallel design.

Randomised with minimisation technique with three stratifying factors (age, type of UI
and severity of UI) at each centre.
Participants 98 women with SUI, UUI, or MUI, from three centres in Taiwan.
Inclusion criteria: Age >40, living in the community, incontinent in previous 3 months
with > 2 UI episodes per-week, MMSE >24 for subjects aged greater than 75.
Exclusion criteria: Grade 3 pelvic prolapse, unable to complete the bladder diary after 2
attempts.
Age: mean in years (SD): PFMT + verbal F 55.6 (10.7), PFMT + BF 53.1 (8.6).
Duration of symptoms: mean in months (SD): PFMT + verbal F 94.2 (97.9), PFMT +
BF 71.5 (64.1).
Type of incontinence: PFMT + verbal F SUI 14, UUI 9 and MUI 26. PFMT + BF SUI
16 , UUI 9 and MUI 24.
Underwent previous uro-gynacological surgery: PMFT + verbal F 15 and PFMT + BF
17
Tsai 2002 (Continued)
Interventions Details of PFMT, F and BF in Table 4

1. PFMT + verbal F (n=49): Taught vPFMC using palpation and verbal F.
2. PFMT + BF (n=49): Taught vPFMC using BF.

Primary outcome measures: Incontinence episodes, PFM activity measured by EMG,
PFMT adherence, IIQ, Pelvic Floor Muscle Self-Efficacy Scale .
Other outcome measures: leakage episodes measured at 2, 4, 6 and 8 weeks
Notes Only presented as an abstract. Additional information from thesis
Risk of bias
Random sequence generation (selection Unclear risk A computer program designed by the in-
bias) vestigator and a data manager were used to
assign subjects on of the two groups
Allocation concealment (selection bias) Unclear risk A computer program designed by the in-
vestigator and a data manager were used to
assign subjects on of the two groups
bias)
All outcomes
Incomplete outcome data (attrition bias) Unclear risk Dropouts 29/98; 23/49 PFMT + verbal F,
All outcomes 6/49 PFMT + BF.
ITTA:
assigned? Yes
treat? Yes. When data was missing, calcu-
lation was based on the most recent data
available.

Tsai 2009

Participants 99 women with self reported symptoms of SUI, from a single centre in Taiwan.
Inclusion criteria: UI not as chief complaint, no transient UI, absence of uterine prolapse
past the vaginal coitus, absence of heart failure. No history of dementia (MMSE > 24),
no prior PFMT prescribed by a health professional.
Exclusion criteria: Transient UI (resulting form delirium, UTI, atrophic vaginitis, psychi-
atric disorder, pharmacological effects, excessive urine output, restricted mobility, stool
impaction etc)
Age: mean in years (SD): PFMT + verbal F 55.50 (9.16), PFMT written instructions
55.20 (10.12)
Severity of incontinence: PMFT + verbal F; 43 mild, 7 moderate. PFMT written in-
structions; 42 mild, 7 moderate.
BMI: mean in kg/m2 (SD): PFMT + verbal F 25.07 (4.85), PFMT written instructions
26.15 (3.51)
Interventions Details of PFMT and F in Table 2.

1. PFMT written instructions (n=49)
2. PFMT + verbal F after digital vaginal palpation (n=50)

Primary outcome measure: 1 hour pad test (Abrams et al. 1998)
Other outcome measures: PFMT diary was kept to record times per day and how many
minutes of exercising, but data not reported
Notes
Risk of bias
Random sequence generation (selection High risk A block size of 2 was used. Participants were
bias) randomly assigned to two groups using the
roll of a dice
Allocation concealment (selection bias) High risk A block size of 2 was used. Participants were
randomly assigned to two groups using the
roll of a dice
bias)
All outcomes
Incomplete outcome data (attrition bias) Unclear risk Dropouts 9/99; PFMT + F 4/50, PFMT
All outcomes written instructions 5/50
ITTA:
Tsai 2009 (Continued)
treat? No.
Selective reporting (reporting bias) Unclear risk Trialist could have reported PFME diary
data, but data not reported

tance.
Ethical approval: no
Conflict of interest: none stated.
Wang 2004

Participants 120 women with symptoms of OAB, from a single centre in Taiwan.
Inclusion criteria: Age 16 to 75, symptoms of OAB for more than 6 months, frequency
>8/day, urge incontinence at least 1/day.
Exclusion criteria: Pregnancy, deafness, neurological disorders, diabetes, pacemaker or
IUD, genital prolapse greater than Stage II of the International Continence Society
grading system, residual urine greater than 100 ml UTI.
Age: mean in years (SD): PFMT 50.1 (15.9), PFMT + BF 52.3 (12.7).
Severity of incontinence: mean leakage episodes/day (SD): PFMT 0.9 (1.8), PFMT +
BF 0.9 (1.8)

1. PFMT (n=40).
2. PFMT + clinic BF (n=38): Intravaginal electromyogram probe used at clinic visits.
3. ES (n=42): This arm was not considered in this review.

Primary outcome measures: KHQ, changes in urinary symptoms (self report of un-
changed/modified/resolved).
Other outcome measures: urodynamics, PFM strength measured (vaginal squeeze pres-
sure)
Notes
Risk of bias
Random sequence generation (selection Low risk Prepared by biostatistical centre in blocks
bias) of 6. Decoding randomisation done by bio-
statistical centre
Wang 2004 (Continued)
Allocation concealment (selection bias) Low risk Opening sequentially numbered sealed en-
velops.
Blinding (performance bias and detection Unclear risk Unclear for PFM activity, yes for others if
bias) outcome assessor was principal investigator
All outcomes
Incomplete outcome data (attrition bias) Unclear risk Dropouts: 17/120; 6/40 PFMT, 4/38
All outcomes PFMT + BF. Dropouts: 7/42 ES. Not in-
cluded in analysis
ITTA:
treat? No.
Other bias Unclear risk Funding or financial assistance: the study

was supported by a grant from the National
Science Council, Taiwan.
Ethical approval: yes, approved by institu-
tional review board.
Williams 2006

A priori power calculation.
Participants 238 women with SUI or MUI, in the UK.

Inclusion criteria: USI or urodynamic mixed UI or DO, age >40.
Exclusion criteria: pregnant, urinary fistula, pelvic malignancy, severe prolapse, receiving
treatment for urinary symptoms (e.g. on a waiting list for continence surgery).
Mean age in years (SD): PFMT 56.7 (10.8), PFMT + F + BF 55.9 (8.5), VC 58.2 (9.4)
.
Symtpom severity, median frequency UI episodes/24 hours (IQ range): PFMT 1.0 (0.3
to 2.8), PFMT + F + BF 1.7 (0.7 to 4.0), VC 1.2 (0.3 to 3.3)
Interventions Details of PFMT in Table 3.

1. PFMT (leaflet + clinic visits) (n= 79).
2. Individualised PFMT (n= 79).
3. VC (n=80): This arm not considered in this review.

Primary outcome measure: incontinence episodes from voiding diary.
Other outcome measures: urine loss in 24 hour and 1 hour pad tests, patients’ perception
Williams 2006 (Continued)
of the severity of their problem (recorded 12 weeks after treatment), PFM function
measured by muscle power and endurance and perineometry, voiding frequency and pad
usage. Home interviews using Leicester Urinary Symptom Questionnaire and Leicester
Impact Scale
Notes
Risk of bias
Random sequence generation (selection Low risk A random allocation sequence was gener-
bias) ated by use of a statistical programme. This
was implemented in sequentially num-
bered sealed envelopes.The patients’ name
was written on the envelope before open-
ing so that once opened and randomisation
was revealed, it could not be exchanged for
a different allocation
Allocation concealment (selection bias) Low risk A random allocation sequence was gener-
ated by use of a statistical programme. This
was implemented in sequentially num-
bered sealed envelopes.The patients’ name
was written on the envelope before open-
ing so that once opened and randomisation
was revealed, it could not be exchanged for
a different allocation
Blinding (performance bias and detection Unclear risk Blinding of outcome assessor for some out-
bias) comes.
All outcomes
Incomplete outcome data (attrition bias) Unclear risk Did not complete final assessment (i.e.
All outcomes primary and secondary outcomes): 7/238;
comprising PFMT 3/79, PFMT + BF + F
3/79, VC 1/80.
Did not complete home interview: 7/238;
comprising PFMT l4/79, PFMT + F + BF
2/79, VC 1/80
ITTA:
assigned? Yes.
treat? Yes.
Williams 2006 (Continued)
Other bias Unclear risk Funding or financial assistance: yes, work

was funded by the medical research council
(UK).
Ethical approval: approval of the Leices-
tershire Ethical Committee, from 1998 to
2001.
Conflict of interest: none declared.
Wilson 1987
Methods 4 arm quasi-RCT, parallel design.

Stratification: not stated.
Participants 60 women with USI, from a single centre in the UK.

Inclusion criteria: USI.
Exclusion criteria: not further stated.
Age: mean in years: 46.8.
Severity of UI: 25 with grade 1 USI, 35 with grade 2 USI.
Interventions Details of PFMT and BF in Wilson 1987

1. PFMT supervised (n=15): 12 physiotherapist visits, including BF.
2. PFMT + ES (faradism) (n=15): This arm not considered in this review.
3. PFMT + ES (interferential) (n=15): This arm not considered in this review.
4. PFMT home (n=15): PFMT home programme only.
Outcomes Primary endpoint: 6 weeks. Longer term follow up: 6 months.

Primary outcome measures: not stated.
Other outcome measures: subjective assessment (much improved, improved, no better)
, 7 day voiding diary, perineometry (mmHg), urodynamics (MUCP)
Notes
Risk of bias
Random sequence generation (selection High risk Alternation; participants were consecu-
bias) tively assigned to one of four therapy
groups
Allocation concealment (selection bias) High risk Alternation; participants were consecu-
tively assigned to one of four therapy
groups
bias)
All outcomes
Wilson 1987 (Continued)
Incomplete outcome data (attrition bias) Unclear risk Dropouts: not reported.
All outcomes ITTA:
treat? No.
Selective reporting (reporting bias) Low risk All measured outcomes are reported.
Other bias Low risk Funding or financial assistance: unclear.

Wong 2001

Participants 38 women with USI, from a single centre in Hong Kong.

Inclusion criteria: No further criteria stated.
Exclusion criteria: Second or third degree uterine prolapse, previous failure of PFMT,
previous continence surgery, neurological pathology, pad test <2g.
Mean age in years (SD): Vaginal BF 47.6 (8.0), vaginal + abdominal BF 44.4 (4.3).
Mean duration of symptoms in months (SD): Vaginal BF 69.2 (57.3), vaginal + abdom-
inal BF 67.3 (53.8).
Mean leakage episodes per week (SD): Vaginal BF 9.1 (14.6), vaginal + abdominal BF
3.5 (5.6)
Interventions Details of PFMT programme in Table 5.

1. PFMT + clinic vaginal BF (n=19).
2. PFMT + clinic vaginal BF + abdominal BF (n=19).
Outcomes Primary endpoint: Unclear

Primary outcome measures: Not stated.
Other outcome measures: Pad test, PFM strength and endurance measured by perineom-
etry, IIQ, UDI, leakage episodes
Notes
Risk of bias
Random sequence generation (selection Low risk Subjects were allocated to two equal groups
bias) by a block randomisation method using
random number table. Blocks of two par-
ticipants were assigned AB for numbers 0-
Wong 2001 (Continued)
4, BA for numbers 5-9
Allocation concealment (selection bias) Unclear risk Subjects were allocated to two equal groups
by a block randomisation method using
random number table. Blocks of two par-
ticipants were assigned AB for numbers 0-
4, BA for numbers 5-9
bias)
All outcomes
Incomplete outcome data (attrition bias) Low risk No losses to follow up.
All outcomes
ITTA:
treat? No.

tance.
BF= biofeedback, BMI = body mass index, BT = bladder training, DO = detrusor overactivity, EMG = electromyography, ES = electrical
stimulation, F = feedback, FUL = functional urethral length, HRT = hormone replacement therapy, IIQ = incontinence impact
questionnaire, ITTA = intention to treat analysis, IVR = intra-vaginal resistance, KHQ = King’s health questionnaire, LUT = lower
urinary tract, MMSE = mini mental state examination, MUCP = maximum urethral closure pressure, OAB = overactive bladder
syndrome, PFM = pelvic floor muscle, PFMT = pelvic floor muscle training, PRAFAB = Protection, amount, frequency, adjustment,
body image questionnaire, RCT = randomised controlled trial, SF-36 = Short Form 36, SD = standard deviation, SUI = stress
urinary incontinence, UDI = urogenital distress inventory, USI = urodynamic stress incontinence, UTI = urinary tract infection,
VC = vaginal cones, vPFMC = voluntary pelvic floor muscle contraction.
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Bernier 2008 3- arm RCT. Before randomisation, women were assessed on the ability to perform a vPFMC. Only women who
were not able to perform a vPFMC were randomised and to one of the following treatments:
1) PFMT + active ES
2) PFMT + non-active ES
(Continued)
3) PFMT + EMG BF
Because both other arms consisted of PFMT + another therapy, it was not possible to determine if the teaching
effect was from the EMG BF or by one of the other therapies
Castleden 1984 2- arm cross over RCT, cross- over design. Data not useable due to expected carry over effect + data were presented
in such a way (no measure of dispersion) that no effect could be calculated
Delgado 2010 2- arm RCT, comparing PFMT vs PFMT + PelvicToner (IVRD). It was not clear if visual or auditory BF was
part of this device so does intervention did not fit the definition of BF used in this review
Ferguson 1990 2-arm RCT, comparing PFMT vs. PFMT + IVRD. See Delgado 2010 for reason why IVRD not considered
Hui 2006 2- arm RCT, comparing a telemedicine continence programme (TCP) versus conventional continence service
(CS). Both groups received the same first clinical visit in which pelvic floor muscle strength was assessed by use of
a BF device + verbal feedback after vaginal palpation. Thus, both groups has the same feedback/BF intervention
and the comparison was TCP versus CS
Hung 2010 2- arm RCT, comparing the Sapsford approach (Sapsford 2004) versus self monitored PFM exercises at home.
The Sapsford method includes five stages:
1) diaphragmatic breathing
2) tonic activation of transversus abdominus muscle (TrA) and PFM
3) muscle strengthening of TrA, PFM and internal obliques
4) functional expiratory patterns like coughing and sneezing
5) impact activities such as running and jumping.
Tactile F on lower abdominal movements (in front of mirror) was provided by the therapist. Both groups underwent
digital vaginal palpation during the first visit (with the aim to learn how to perform a vPFMC). While this means
the comparison was PFMT + F vs PFMT + F + F, in which the F on the lower abdominal movements is the extra
variable, this method of Fcould only be analysed in the context of the whole Sapsford program
Klingler 1995 2-arm RCT, comparing PFMT versus PFMT + endotrainer (intermittent gas filled balloon; IVRD). See Delgado
2010 for reason why IVRD not considered
Lucio 2009 2- arm RCT, comparing PFMT + BF vs. sham PFMT + BF in women with LUT dysfunction, as complication
of multiple sclerosis. The control group did not receive any instructions on PFM exercises and were told that the
BF device would help them resolving their bladder problems but no PFM contraction was required. The study
aim was to determine the effect of the combination of PFMT + BF versus no treatment
O’Donnell 1991 2-arm RCT, comparing PFMT + BF versus no treatment.
Taylor 1986 4- arm RCT of approximately 12 participants, comparing PFMT versus PFMT + home BF versus PFMT + IVRD
+ BF versus PFMT + clinic BF. While this trial met the inclusion criteria for the review, it was excluded for the
following reasons; 1) Participants were randomised to one of four groups but neither the number of participants
for the whole trial, nor per group separately was given; 2) No endpoint was stated; 3) No useable data were
reported
BF= biofeedback, EMG = electromyography, ES = electrical stimulation, F = feedback, IVRD = intra-vaginal resistance device, LUT =
lower urinary tract, PFM = pelvic floor muscle, PFMT = pelvic floor muscle training, RCT = randomised controlled trial, vPFMC
= voluntary pelvic floor muscle contraction.
Characteristics of studies awaiting assessment [ordered by study ID]
Sam 2004

A priori power calculation: no, pilot study.
Participants 50 women with USI or MUI, from a single centre in Austria.

Referred by gynaecologist.
No further inclusion or exclusion criteria stated.
No baseline characteristics of participants reported.
Interventions Details of PFMT and BF in Additional Table

1. PFMT (n=?): 8 weeks supervised training, 4 weeks home PFMT.
2. PFMT + home BF (n=?): 4 weeks supervised training with BF, 8 weeks home PFMT
Outcomes Primary endpoint: 12 weeks, (assessment also performed at 4 weeks form baseline). Longer term follow up: 6 months
and 12 months
Primary outcome measures: PAD test, ICI-Q-SF (quality of life) questionnaire.
Other outcome measures: clinical stress test, questionnaire for motivation (QMOT), perineometry
Notes Abstract. Too few details of methods, and no useful data, for this to be reasonably included in the review. Awaiting
response from authors
BF = biofeedback, MUI = mixed urinary incontinence, PFMT = pelvic floor muscle training, RCT = randomised controlled trial, USI
= urodynamic stress incontinence
Characteristics of ongoing studies [ordered by study ID]
Ruff 2004
Trial name or title Behavioral therapy for UI in African American women
Participants 200 African women aged 50 years or older selected from the Women’s Health Initiative Study
Interventions Women randomised to:

1. verbal taught PFMT
2. BF taught PFMT
3. no treatment
Outcomes Bladder diary, incontinence questionnaire (not specified) and quality of life scale (not specified) at 3, 6, 9 and
12 months
Starting date 2003
Ruff 2004 (Continued)
Contact information Coralease Ruff, Howard University, USA.
Notes Principal investigator advises that recruitment is complete and analysis beginning (Grant number:
5K01NR000153-03)
BF = biofeedback, RCT = randomised controlled trial, UI = urinary incontinence.
DATA AND ANALYSES
Comparison 1. PFMT + BF versus PFMT alone
No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size
1 Generic and condition specific Other data No numeric data

quality of life assessment
1.1 No difference in PFMT Other data No numeric data
1.2 Difference in PFMT Other data No numeric data
2 Women’s perception of change 7 520 Risk Ratio (M-H, Fixed, 95% CI) 0.75 [0.66, 0.86]
in incontinence - not cured or
improved
2.1 No difference in PFMT 2 177 Risk Ratio (M-H, Fixed, 95% CI) 0.87 [0.72, 1.05]
2.2 Difference in PFMT 5 343 Risk Ratio (M-H, Fixed, 95% CI) 0.69 [0.58, 0.83]
in incontinence - not cured
4 Women’s satisfaction with 3 294 Risk Ratio (M-H, Fixed, 95% CI) 0.65 [0.46, 0.90]
progress - not satisfied
5 Leakage episodes in 24 hours 8 532 Mean Difference (IV, Fixed, 95% CI) -0.12 [-0.22, -0.01]
5.1 No difference in PFMT 6 251 Mean Difference (IV, Fixed, 95% CI) -0.10 [-0.21, 0.01]
5.2 Difference in PFMT 2 281 Mean Difference (IV, Fixed, 95% CI) -0.27 [-0.61, 0.07]
6 Nocturia Other data No numeric data
7 PFM function Other data No numeric data
8 Symptom distress Other data No numeric data
9 Frequency of micturition Other data No numeric data
10 Women’s desire for further Other data No numeric data
treatment
11 Pad changes per 24 hours Other data No numeric data
12 Adherence to treatment Other data No numeric data
13 Interim and follow up data Other data No numeric data
14 Pad and paper towel tests Other data No numeric data
Comparison 2. PFMT + F versus PFMT alone
No. of No. of

improved
4 Leakage episodes in 24 hours 1 149 Mean Difference (IV, Fixed, 95% CI) -0.10 [-0.61, 0.41]
4.1 No difference in PFMT 0 0 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
Comparison 3. PFMT + F + BF versus PFMT alone
No. of No. of

2 Women’s perception of change Other data No numeric data
3.1 No difference in PFMT 0 0 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
5 Frequency of micturition Other data No numeric data
7 Pad changes in 24 hours Other data No numeric data
9 Economic costs Other data No numeric data
Comparison 4. PFMT + BF vs PFMT + F
No. of No. of

improved
5.1 No difference in PFMT 2 169 Mean Difference (IV, Fixed, 95% CI) -0.05 [-0.38, 0.27]
8 Frequency of micturation Other data No numeric data
Comparison 5. PFMT + BF versus PFMT + BF
No. of No. of

5 Pad and towel tests Other data No numeric data
Comparison 6. Subgroup assessment
No. of No. of
improved (type of BF))
1.1 Electromyography 4 211 Risk Ratio (M-H, Fixed, 95% CI) 0.91 [0.76, 1.09]
1.2 Vaginal squeeze pressure 3 211 Risk Ratio (M-H, Fixed, 95% CI) 0.71 [0.57, 0.88]
1.3 Ultrasound 0 0 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
1.4 Electromyography and 1 118 Risk Ratio (M-H, Fixed, 95% CI) 2.02 [1.33, 3.08]
anal squeeze pressure
2 Leakage episodes in 24 hours 9 554 Std. Mean Difference (IV, Fixed, 95% CI) -0.23 [-0.40, -0.07]
(type of BF)
2.1 Electromyography 5 213 Std. Mean Difference (IV, Fixed, 95% CI) -0.37 [-0.64, -0.10]
2.2 Vaginal squeeze pressure 2 171 Std. Mean Difference (IV, Fixed, 95% CI) -0.23 [-0.53, 0.07]
2.3 Ultrasound 1 22 Std. Mean Difference (IV, Fixed, 95% CI) -0.20 [-1.04, 0.64]
2.4 Electromyography and 1 148 Std. Mean Difference (IV, Fixed, 95% CI) -0.06 [-0.38, 0.26]
anal squeeze pressure
improved (type of UI)
3.1 Stress urinary incontinence 3 157 Risk Ratio (M-H, Fixed, 95% CI) 0.60 [0.48, 0.75]
3.2 Stress and mixed urinary 2 177 Risk Ratio (M-H, Fixed, 95% CI) 0.87 [0.72, 1.05]
incontinence
3.3 Urgency and mixed 2 186 Risk Ratio (M-H, Fixed, 95% CI) 1.72 [1.24, 2.40]
urinary incontinence
3.4 Stress, mixed and urgency 1 20 Risk Ratio (M-H, Fixed, 95% CI) 1.0 [0.65, 1.55]
(type of UI)
4.1 Stress urinary incontinence 5 281 Std. Mean Difference (IV, Fixed, 95% CI) -0.30 [-0.54, -0.06]
4.2 Stress and mixed urinary 3 143 Std. Mean Difference (IV, Fixed, 95% CI) -0.33 [-0.66, 0.00]
incontinence
4.3 Urgency and mixed 2 168 Std. Mean Difference (IV, Fixed, 95% CI) -0.07 [-0.37, 0.23]
4.4 Stress, mixed and urgency 1 98 Std. Mean Difference (IV, Fixed, 95% CI) -0.39 [-0.79, 0.01]
incontinence
improved (times (B)F given)
5.1 1 or 2 times 2 205 Risk Ratio (M-H, Fixed, 95% CI) 0.50 [0.38, 0.64]
5.2 3 to 12 times 2 50 Risk Ratio (M-H, Fixed, 95% CI) 0.73 [0.46, 1.18]
5.3 more than 12 times 4 285 Risk Ratio (M-H, Fixed, 95% CI) 0.87 [0.75, 1.02]
(times (B)F given)
6.1 1 or 2 times 2 281 Mean Difference (IV, Fixed, 95% CI) -0.27 [-0.61, 0.07]
6.2 3 to 12 times 3 145 Mean Difference (IV, Fixed, 95% CI) -0.10 [-0.21, 0.01]
6.3 more then 12 times 3 96 Mean Difference (IV, Fixed, 95% CI) -0.09 [-0.84, 0.65]
7 Women’s perception of 8 540 Risk Ratio (M-H, Fixed, 95% CI) 0.78 [0.66, 0.90]
incontinence - not cured or
improved (concealment of
allocation)
7.1 Adequate concealment of 4 367 Risk Ratio (M-H, Fixed, 95% CI) 0.65 [0.52, 0.81]
allocation
7.2 Allocation of concealment 3 143 Risk Ratio (M-H, Fixed, 95% CI) 0.95 [0.78, 1.14]
unclear
7.3 No concealment of 1 30 Risk Ratio (M-H, Fixed, 95% CI) 3.0 [0.72, 12.55]
allocation
(concealment of allocation)
8.1 Adequate concealment of 4 343 Mean Difference (IV, Fixed, 95% CI) -0.10 [-0.21, 0.01]
allocation
8.2 Allocation of concealment 7 347 Mean Difference (IV, Fixed, 95% CI) -0.41 [-0.71, -0.11]
unclear
8.3 No concealment of 0 0 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
allocation
or improved (difference in
PFMT)
(difference in PFMT)
10.1 No difference in PFMT 7 273 Std. Mean Difference (IV, Fixed, 95% CI) -0.30 [-0.54, -0.06]
10.2 Difference in PFMT 3 281 Std. Mean Difference (IV, Fixed, 95% CI) -0.18 [-0.41, 0.06]
Analysis 1.1. Comparison 1 PFMT + BF versus PFMT alone, Outcome 1 Generic and condition specific
quality of life assessment.
Generic and condition specific quality of life assessment
Study QoL measure Measure PFMT + BF PFMT Effect estimate

MD [95%- CI]
No difference in PFMT
Berghmans 1996 Protection, Mean score (SD) 11.1 (5.9) 13.1 (8.6) -0.27 [-0.89, 0.36]
Amount, Frequency, n= 20 n= 20
Adjustment,
Body
image (PRAFAB); 5
item questionnaire
to assess treatment ef-
fects for UI in women
(Staskin 2009)
’Short version’
Laycock 2001a King’s Health Ques- Mean score (SD) 6.14 (2.59) 8.13 (4.44) -1.99 [-4.42, 0.44]
tionnaire (KHQ); n= 22 n= 16
to assess the impact
of lower urinary tract
symptoms including
on health related
quality of life
(Staskin 2009)
(Change) ’Total
score’
Data from abstract.
McClurg 2006 King’s Health Ques- Mean score (SD) 1. 27.7 (39.2) 1. 46.3 (37.7) 1. -18.60 [-52.31,
tionnaire 2. 32.1 (36.6) 2. 46.5 (37.3) 15.11]
(KHQ): no data. 3. 30.9 (37.5) 3. 50.4 (35.5) 2. -14.40 [-46.79,
4. 23.7 (40.0) 4. 43.5 (38.2) 17.99]
Inconti- 5. 55.1 (39.5) 5. 96.7 (44.8) 3. -19.50 [-51.51,
nence Impact Ques- n= 10 12.51]
tionnaire (IIQ); n= 10 4. -19.80 [-54.08,
describes the severity 14.48]
of incontinence 5. -41.60 [-78.62, -
and used to assess im- 4.58]
pact
of UI on health re-
lated quality of life
measures (HRQL) (
Staskin 2009)
Generic and condition specific quality of life assessment (Continued)
30 items, four sub-

scales:
1. Physical activity
2. Emotional health
3. Travel
4. Social relation-
ships
5. Total score
Schmidt 2009 King’s Health Ques- Mean score (SD) 44.25 (9.11) 48.7 (22.21) -4.45 [-18.64, 9.74]
tionnaire n= 11 n= 11
(KHQ)
’Total score’
Smidt 1997 Protection, Mean score (SD) 7.94 (10.13) 11.47 (8.62) -0.36 [-1.05, 0.33]
Amount, Frequency, n= 18 n= 15
Adjustment,
Body image
(PRAFAB);
presented as change
compared to base-
line.
Difference in PFMT
Burgio 2002b Inconti- Not estimable

nence Impact Ques-
tionnaire (IIQ) + SF-
36 short form
No data.
Goode 2003 Inconti- Not estimable

nence Impact Ques-
tionnaire (IIQ)
+ SF- 36 short form
No data.
Tejero 2008 Inconti- Not estimable

nence Impact Ques-
tionnaire (IIQ):
no data.
Wang 2004 King’s Health Mean score (SD): 1) 1) 1) -2.56 [-13.27 to

Questionnaire comparison 14.66(24.57) 12.10 (20.28) 8.15]
(KHQ); of changes after rx 2) 6.03(120.82) 2) 2) 31.39 [-11.09 to
1. General health 3) 25.86(26.57) 37.42 (37.11) 73.89]
perception 4) 25.29(26.58) 3) 3) 4.78 [-8.73 to
2. Incontinence im- 5) 17.05(21.20) 30.64 (30.15) 18.29]
pact 6) 2.30 (13.89) 4) 4) 8.04 [-6.43 to

3. Role limitation 7) 19.31(29.86) 33.33 (33.88) 22.51]
4. Physical limita- 8) 18.83(26.18) 5) 5) 5.71 [-6.42 to
tion 9) 14.71(20.27) 22.76 (29.20) 17.84]
5. Social limitation n= 34 6) 6) 8.45 [-1.56 to
6. Personal relation- 10.75 (26.37) 18.47]
ships 7) 7) 2.91 [-10.76 to
7. Emotions 22.22 (27.82) 16.58]
8. Sleep/energy 8) 8) 8.05 [-4.03 to
9. Severity measures 26.88 (24.60) 20.13]
9) 9) 5.94 [-6.56 to
20.65 (31.19) 18.44]
n=34
Analysis 1.2. Comparison 1 PFMT + BF versus PFMT alone, Outcome 2 Women’s perception of change in
incontinence - not cured or improved.
Review: Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women
Comparison: 1 PFMT + BF versus PFMT alone
Outcome: 2 Women’s perception of change in incontinence - not cured or improved
Study or subgroup PFMT + BF PFMT Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
1 No difference in PFMT
Burns 1993 31/40 36/43 18.4 % 0.93 [ 0.75, 1.15 ]
Morkved 2002 27/48 32/46 17.3 % 0.81 [ 0.59, 1.11 ]
Subtotal (95% CI) 88 89 35.7 % 0.87 [ 0.72, 1.05 ]

Total events: 58 (PFMT + BF), 68 (PFMT)
Heterogeneity: Chi2 = 0.54, df = 1 (P = 0.46); I2 =0.0%
Test for overall effect: Z = 1.48 (P = 0.14)
2 Difference in PFMT
Burgio 2002b 20/53 45/65 21.4 % 0.55 [ 0.37, 0.80 ]
Goode 2003 20/47 28/40 16.0 % 0.61 [ 0.41, 0.90 ]
Pages 2001 10/13 21/27 7.2 % 0.99 [ 0.69, 1.42 ]
Wang 2004 21/34 24/34 12.7 % 0.88 [ 0.62, 1.23 ]
Wilson 1987 9/15 13/15 6.9 % 0.69 [ 0.44, 1.09 ]
Subtotal (95% CI) 162 181 64.3 % 0.69 [ 0.58, 0.83 ]
0.1 0.2 0.5 1 2 5 10

Favours PFMT + BF Favours PFMT alone
(Continued . . . )
(. . . Continued)
Heterogeneity: Chi2 = 7.53, df = 4 (P = 0.11); I2 =47%
Total (95% CI) 250 270 100.0 % 0.75 [ 0.66, 0.86 ]
Test for subgroup differences: Chi2 = 3.03, df = 1 (P = 0.08), I2 =67%
0.1 0.2 0.5 1 2 5 10

Favours PFMT + BF Favours PFMT alone
Analysis 1.3. Comparison 1 PFMT + BF versus PFMT alone, Outcome 3 Women’s perception of change in
incontinence - not cured.
Outcome: 3 Women’s perception of change in incontinence - not cured

Burns 1993 31/40 36/43 29.0 % 0.93 [ 0.75, 1.15 ]
Morkved 2002 27/48 32/46 27.4 % 0.81 [ 0.59, 1.11 ]
Sherman 1997 19/20 13/16 12.1 % 1.17 [ 0.91, 1.51 ]
Subtotal (95% CI) 108 105 68.5 % 0.92 [ 0.79, 1.08 ]

Pages 2001 10/13 21/27 11.4 % 0.99 [ 0.69, 1.42 ]
Wang 2004 21/34 24/34 20.1 % 0.88 [ 0.62, 1.23 ]
Subtotal (95% CI) 47 61 31.5 % 0.92 [ 0.71, 1.18 ]

Total (95% CI) 155 166 100.0 % 0.92 [ 0.81, 1.05 ]
0.1 0.2 0.5 1 2 5 10

Favours PFMT + BF Favours PFMT
(Continued . . . )
(. . . Continued)
Test for subgroup differences: Chi2 = 0.00, df = 1 (P = 0.97), I2 =0.0%
0.1 0.2 0.5 1 2 5 10

Analysis 1.4. Comparison 1 PFMT + BF versus PFMT alone, Outcome 4 Women’s satisfaction with progress
- not satisfied.
Outcome: 4 Women’s satisfaction with progress - not satisfied

Morkved 2002 10/48 13/46 22.2 % 0.74 [ 0.36, 1.51 ]
Subtotal (95% CI) 48 46 22.2 % 0.74 [ 0.36, 1.51 ]

Heterogeneity: not applicable
Burgio 2002b 13/52 27/61 41.6 % 0.56 [ 0.33, 0.98 ]
Goode 2003 16/47 20/40 36.2 % 0.68 [ 0.41, 1.13 ]
Subtotal (95% CI) 99 101 77.8 % 0.62 [ 0.43, 0.90 ]

Total (95% CI) 147 147 100.0 % 0.65 [ 0.46, 0.90 ]
0.5 0.7 1 1.5 2

Analysis 1.5. Comparison 1 PFMT + BF versus PFMT alone, Outcome 5 Leakage episodes in 24 hours.
Outcome: 5 Leakage episodes in 24 hours
Study or subgroup PFMT + BF PFMT Mean Difference Weight Mean Difference

N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI
Smidt 1997 17 6.22 (11.43) 15 11.98 (11.29) 0.0 % -5.76 [ -13.64, 2.12 ]
Sherman 1997 22 2.9 (6.53) 16 5.25 (7.24) 0.1 % -2.35 [ -6.83, 2.13 ]
Burns 1993 40 0.71 (0.86) 43 1.14 (1.43) 4.6 % -0.43 [ -0.93, 0.07 ]
McClurg 2006 10 1.1 (1.2) 10 1.4 (2) 0.6 % -0.30 [ -1.75, 1.15 ]
Berghmans 1996 20 0.12 (0.19) 20 0.2 (0.19) 83.3 % -0.08 [ -0.20, 0.04 ]
Laycock 2001a 22 1.2 (1.29) 16 1.13 (1.42) 1.5 % 0.07 [ -0.81, 0.95 ]
Subtotal (95% CI) 131 120 90.0 % -0.10 [ -0.21, 0.01 ]

Goode 2003 66 0.64 (0.87) 67 1.07 (1.73) 5.4 % -0.43 [ -0.89, 0.03 ]
Burgio 2002b 73 0.87 (1.47) 75 0.96 (1.63) 4.6 % -0.09 [ -0.59, 0.41 ]
Subtotal (95% CI) 139 142 10.0 % -0.27 [ -0.61, 0.07 ]

Total (95% CI) 270 262 100.0 % -0.12 [ -0.22, -0.01 ]
-4 -2 0 2 4
Analysis 1.6. Comparison 1 PFMT + BF versus PFMT alone, Outcome 6 Nocturia.

Nocturia
Study Nocturia Measure PFMT + BF PFMT Effect estimate
Schmidt 2009 Number of night- Median (interquar- 1 (1-2) 2 (1-2) Not estimable
time tile range) n= 10 n= 11
micturitions
Sherman 1997 Number of voids Mean score (SD) 0.26 (0.54) 0.25 (0.45) 0.01 [-0.30, 0.32]
per night n= 23 n= 16
Nocturia (Continued)
Difference in PFMT
Pages 2001 Nocturia Mean score (SD) 0.38 (0.4) 0.34 (0.5) MD [95% CI]
n= 13 n= 27 0.04 [-0.25, 0.33]
Tejero 2008 Reported as women Number out of total 2/18 0/14 RR [95% CI]
who [3.95 [0.20, 76.17]
suffered nocturia
Analysis 1.7. Comparison 1 PFMT + BF versus PFMT alone, Outcome 7 PFM function.
PFM function
Study Assessment of PFM Measure Experimental: Control: Estimate effect

function PFMT + BF PFMT MD [95% CI]
Burns 1993 1) Quick contrac- Mean score (SD) 1) 6.0 (5.1) n=40 1) 3.5 (4.4) n=40 1) 3.00 [1.09, 4.91]
tions: electromyo- 2) 4.0 (3.1) 2) 2.0 (1.8) 2) 2.20 [0.97, 3.43]
graph (EMG) mea- n=35 n=34
sures (microV)
2) Sustained contrac-
tions: electromyo-
graph (EMG) mea-
sures (microV)
Laycock 2001a Muscle contractility, Mean score (SD) 11.00 (6.28) 7.13 (4.99) 3.87 [0.28, 7.46]
vaginal squeeze pres- n= 22 n= 16
sure
(cm H2O) (change)
Data from abstract.
Morkved 2002 change Mean score (SD) 25.9 (14.5) 25.4 (14.5) 0.50 [-5.36, 6.36]
in Pelvic Floor Mus- (calculated) n= 48 n = 46
cle Strength; mea-
sured by
vaginal squeeze pres-
sure (cm H2O)
Schmidt 2009 Perineometric assess- 1) Mean score (SD) 1) 37.20 (11.46) 1) 37.06 (12.69) 1) 0.14 [-10.19,
ment; 2) Mean score(SD) 2) 57.93 (26.15) 2) 47.67 (25.26) 10.47]
1) Baseline pressure 3) Mean score (SD) 3) 0.85 3) 0.61 2) 10.26 [11.77,
(pressure at rest with (0.47) (0.25) 32.29]
the patient relaxed) 3) 0.24 [-0.09, 0.57]
in cmH2O.
2) Perineometric In-
tensity (peak pres-
sure
PFM function (Continued)
achieved during con-

traction) in cm
H2O.
3) Time taken
to achieve maximum
intensity (time
taken for the pres-
sure signal to go from
10% to
90% of maximum
intensity) in seconds.
Shepherd 1983 PFM Mean score (range) 19.3 (10-30) 11.2 (5-20) Not estimable
strength, perineome- n= 11 n= 11
try, VSP (mmHg)
Difference in PFMT
Pages 2001 Digital Contraction Median score (SD) 1) 4 (0.8) 1) 3.5 (1.0) Not estimable
Strength Assesment; 2) 4 (0.6) 2) 4 (0.9)
according to Fischer
(Fischer 1995) n=12 n=21
Grade 1 - no contrac-
tion
Grade 2 - slight con-
traction of the PFM
Grade 3 - moder-
ate contraction of the
PFM
Grade 4 - good (more
than 3 sec) contrac-
tion of the PFM
Grade 5 - excellent
contraction of the
PFM.
1) during voluntary
contraction (1-5)
2) during cough (1-
5)
Pages 2001 Manometric Median score (SD) 1) 50 (14) 1) 16 (10) Not estimable
measurements, vagi- 2) 75 (21) 2) 38 (22)
nal squeeze pressure 3) 55 (12) 3) 38 (22)
(cmH2O)
1) average on max. n= 13 n= 27
contraction
2) max. contraction
pressure
3) max. forced cough

pressure
Tejero 2008 Perineometry Mean score (SD) 45.8 (14.2) 35 (22.2) Not estimable
(mmHg) n= ? n= ?
Wilson 1987 PFM Mean (standard de- 15.7 (10.5) 6.9 (7.7) 8.80 [2.13, 15.47]
strength, perineome- viation) n=15 N=14
try, VSP (mmHg).
Analysis 1.8. Comparison 1 PFMT + BF versus PFMT alone, Outcome 8 Symptom distress.
Symptom distress
Study Symtom distress Measure PFMT + BF PFMT Effect estimate

measure MD [95% CI]
McClurg 2006 Urinary Distress In- Mean score (SD) 1. 26.7 (21.0) 1. 42.8 (21.2) 1. -16.10 [-34.59,
ventory (UDI) 2. 32.4 (21.5) 2. 33.9 (28.5) 2.39]
1. Irritative symp- 3. 14.9 (19.9) 3. 35.4 (38.6) 2. -1.50 [-23.63,
toms 4. 81.6 (36.7) 4.113.3 (69.4) 20.63]
2. Obstructive/ 3. -20.50 [-47.42,
discomfort n= 10 n= 10 6.42]
3. Stress symptoms 4. -31.70 [-80.36,
4. Total score 16.96]
Morkved 2002 Leakage index Mean score (SD) 1.9 (0.7) 1.9 (0.7) 0.00 [-0.28, 0.28]
(calculated) n= 48 n= 46
Morkved 2002 Social Activity Index Mean score (SD) 9.5 (0.7) 9.4 (0.7) 0.10 [-0.18, 0.38]
(SAI): (calculated) n= 48 n= 46
Participation
addressed in nine
social situations
Difference in PFMT
Burgio 2002b Hopkins Symp-

tom Checklist 90-R
(SCL-90)
No data.
Goode 2003 Hopkins Symp- Mean (SD) 1. 49.2 (12.0) 1. 53.0 (11.7) 1. -3.80 [-8.79,
tom Checklist 90-R 2. 45.9 (13.2) 2. 47.3 (12.2) 1.19]
(SCL-90) 3. 49.4 (10.2) 3. 49.3 (11.1) 2. -1.40 [-6.74,
4. 45.5 (10.2) 4. 48.5 (9.8) 3.94]
1. Global Severity In- 5. 50.4 (12.1) 5. 52.8 (12.5) 3. 0.10 [-4.44, 4.64]
Symptom distress (Continued)
dex 6. 51.3 (13.1) 6. 54.2 (11.6) 4. -3.00 [-7.21,

2. Anxiety 7. 49.7 (12.4) 7. 55.0 (10.5) 1.21]
3. Interpersonal Sen- 8. 45.1 (7.9) 8. 49.1 (10.5) 5. -2.40 [-7.59,
sivity 9. 45.9 (11.2) 9. 51.1 (11.1) 2.79]
4. Anger-Hostility 10. 50.0 (11.0) 10. 52.0 (11.2) 6. -2.90 [-8.09,
5. Depression n= 40 for 2.29]
6. Obsessive-Com- n= 47 (1,2,4,5,6,8 and 10) 7. -5.30 [-10.14, -
pulsive n= 39 for (3,7 and 9) 0.46]
7. Somaticism 8. -4.00 [-7.96, -
8. Phobic Anxiety 0.04]
9. Paranoid Ideation 9. -5.20 [-9.93, -
10. Psychoticism 0.47]
(Additional data pro- 10. -2.00 [-6.68,
vided by author) 2.68]
Analysis 1.9. Comparison 1 PFMT + BF versus PFMT alone, Outcome 9 Frequency of micturition.
Frequency of micturition
Study Outcome measure Measure PFMT + BF PFMT Effect estimate

MD [95% CI]
Schmidt 2009 Number of daytime Median (interquar- 7 (4-8.25) 7 (5-10) Not estimable
micturitions tile range) n= 10 n= 11
Smidt 1997 Difference in toilet Mean score (SD) 10.73 (13.99) 16.32 (17.19) -5.59 [-16.43, 5.25]
use n =18 n= 15
(compared to base-
line)
Difference in PFMT
Pages 2001 Frequency of mic- Mean score (SD) 5.5 (1) 5.2 (1.3) 0.30 [-0.43, -1.03]
turition n= 13 n= 27
in 24 hours
Wilson 1987 Frequency of mic- Mean score (SD) 7.6 (1.6) 8.2 (2.7) -0.60 [-2.32, 1.12]
turition n= 16 n= 12
in 24 hours
Analysis 1.10. Comparison 1 PFMT + BF versus PFMT alone, Outcome 10 Women’s desire for further
treatment.
Women’s desire for further treatment
Study Desired further Measure PFMT + BF PFMT Effect estimate

treatment
Sherman 1997 Women desired fur- Number out of total 5/23 3/16 RR [95% CI]
ther treatment 1.16 [0.32, 4.18]
Analysis 1.11. Comparison 1 PFMT + BF versus PFMT alone, Outcome 11 Pad changes per 24 hours.
Pad changes per 24 hours
Study Outcome measure Measure PFMT + BF PFMT Effect estimate

MD [95% CI]
Difference in PFMT
Pages 2001 Pad changes in 24 Mean score (SD) 2.27 (1.49) 1.88 (1.15) 0.39 [-0.45, 1.23]
hours n= 22 n= 16
(change)
Data from abstract
Wilson 1987 Pad changes in 24 Mean score (SD) 0.9 (1.5) 2.7 (2.5) -1.80 [-3.28, -0.32]
hours n= 15 n= 15
Analysis 1.12. Comparison 1 PFMT + BF versus PFMT alone, Outcome 12 Adherence to treatment.
Adherence to treatment
Study Adherence to treat- Measure PFMT + BF PFMT Effect estimate

ment
Berghmans 1996 Adherence to clinical Percentage 100% 100%

sessions n= 20
n= 20
Laycock 2001a Adherence to home Percentage 79% 81%

treatment (extracted
from exercise n= 22 n= 16
diary)
McClurg 2006 a) Adherence to clin- Percentage a) 78% a) 78%

ical sessions b) 75%
b) Adherence to to n= 10
home BF use n= 10
Adherence to treatment (Continued)
(measured by de-
vice)
Morkved 2002 Percentage ’exer- Percentage 88.9% 85.3%

cised > 3x a week’
n= 48 n= 46
Schmidt 2009 Compli-

ance with treatment;
’ratio between
numbers of sessions
stored in the mem-
ory
of the device and
the number of treat-
ment
days.’
No data.
Sherman 1997 Adherence to exer- N 0) 0 0) 1 RR [95% CI]

cises (based on a 1) 5 1) 15 0) 0.48 [0.02,
4 point question- 2) 9 2) 6 11.03]
naire) 3) 1 3) 0 1) 0.49 [0.23, 1.06]
0 - rarely 2) 2.20 [0.99, 4.89]
1 - occasionally n= 15 n= 22 3) 4.31 [0.19,
2 - frequently 99.27]
3 - all the time
Smidt 1997 Adherence to exer-

cises with BF device.
’No data analysed’
Difference in PFMT
Glavind 1996 Asked about training Number out of total 17/19 7/14 RR [95% CI]
activity; (percentage) (89%) (50%) 1.79 [1.04, 3.09]
Participants exercis-
ing ’regularly’
Tejero 2008 Unclear what was N 16/16 16/18 RR [95% CI]

measured by 1.12 [0.92, 1.36]
addressing ’compli-
ance’
Wang 2004 a) Adherence to a) Median % a) 0.750 (0.54-1.00) a) 0.833 (0.25-1.00) Not estimable
treatment b) Days (median) b) 14.5 (0-44) b) 8.5 (0-44)
b) Adherence to
home training n= 34
Adherence to treatment (Continued)
n= 34
Wilson 1987 Adherence to clinical

sessions
’no difference stated’
Analysis 1.13. Comparison 1 PFMT + BF versus PFMT alone, Outcome 13 Interim and follow up data.
Study Outcome Measure PFMT + BF PFMT Effect estimate

MD [95% CI]
Berghmans 1996 Interim data at 6 Mean score 12.4 (10.0) 17.4 (17.6) -5.00 [-13.87, 3.87]
treatments (SD) n= 20 n= 20
Pad test (48 hours) g.
Berghmans 1996 Interim data at 6 Mean score (SD) 0.14 (0.23) 0.33 (0.5) -0.48 [-1.11, 0.15]
treatments n= 20 n= 20
Leakage episodes per

24 hours
McClurg 2006 Follow up data at 24 Mean score (SD) 0.89 (1.1) 1.7 (2.1) -0.81 [-2.34, 0.72]
weeks
Leakage episodes in
24 hours.
McClurg 2006 Follow up data at 24 Mean score (SD) 1. 40.0 (18.12) 1. 56.6 (28.8) 1. -16.60 [-38.51,
weeks 2. 23.7 (18.2) 2. 49.1 (36.1) 5.31]
3. 19.9 (23.3) 3. 47.5 (34.7) 2. -25.40 [-51.54,
Urinary distress in- 4. 77.9 (33.5) 4. 139.6 (66.5) 0.74]
ventory (UDI) 3. -27.60 [-54.48, -
1. Irritative symp- n= 10 n= 9 0.72]
toms 4. -61.70 [-109.85, -
2. Obstructive/dis- 13.55]
comfort
3. Stress symptoms
4. Total score
McClurg 2006 Follow up data at 16 Mean score (SD) 58.0 (130.0) 43.7 (59.4) 14.30 [-75.13,
weeks n= 10 n= 9 103.73]
Pad test (24 hour) in
g.
Interim and follow up data (Continued)
McClurg 2006 Follow up data at 16 Mean score (SD) 1.1 (1.4) 1.9 (2.4) -0.80 [-2.52, 0.92]
weeks
Leakage episodes in
24 hours.
McClurg 2006 Follow up data at 24 Mean score 48.0 (117.0) 42.8 (59.2) 5.20 [-76.99, 87.39]
weeks (SD) n= 9
Pad test (24 hour) in n= 10
g.
weeks 2. 28.7 (39.2) 2. 28.7 (26.0) 25.77]
3. 32.9 (37.1) 3. 46.4 (28.0) 2. 0.00 [-29.65,
Inconti- 4. 28.8 (39.3) 4. 14.9 (12.4) 29.65]
nence Impact Ques- 5. 62.5 (44.2) 5. 101.6 (46.1) 3. -13.50 [-42.88,
tionnaire (IIQ) 15.88]
n= 10 n= 9 4. 13.90 [-11.77,
1. Physical activity 39.57]
2. Emotional health 5. -39.10 [-79.81,
3. Travel 1.61]
4. Social relation-
ships
5. Total score
weeks 2. 29.1 (31.7) 2. 48.5 (28.5) 10.45]
3. 19.9 (23.2) 3. 47.5 (38.4) 2. -19.40 [-46.47,
Urinary distress in- 4. 93.5 (50.9) 4. 150.6 (79.7) 7.67]
ventory (UDI) 3. -27.60 [-56.52,
1. Irritative symp- n= 10 n= 9 1.32]
toms 4. -57.10 [-117.98,
2. Obstructive/dis- 3.78]
comfort
3. Stress symptoms
4. Total score
weeks 2. 23.7 (29.0) 2. 33.1 (28.1) 17.42]
Inconti- 3. 27.7 (50.9) 3. 45.6 (29.0) 2. -9.40 [-35.09,
nence Impact Ques- 4. 18.6 (30.1) 4. 45.6 (29.0) 16.29]
tionnaire (IIQ) 5. 67.8 (44.8) 5. 105.6 3. -17.90 [-54.70,
(58.8) 18.90]
1. Physical activity n=10 n= 9 4. -8.80 [-33.99,
2. Emotional health 16.39]
3. Travel 5. -37.80 [-85.20,
4. Social relation- 9.60]
ships
5. Total score
Morkved 2002 Follow up data at 1 Number out of total Only presented for Not estimable
year whole group
<2 g leakage on pad
test (n)
Morkved 2002 Interim data at 3 Mean score (SD) 22.5 (12.4) 22.0 (11.1) 0.50 [-5.36, 6.36]
months (calculated) n= 48 n= 46
Pelvic Floor Muscle

Strength;
measured by vaginal
squeeze pressure
(cm H2O)
Schmidt 2009 Follow up data at 3 Mean score (SD) 41.12 (15.44) 49.3 (24.96) -8.18 [-25.52, 9.16]
months n= 11 n= 11
King’s Health Ques-
tionnaire
(KHQ)
’Total score’
Difference in PFMT
Glavind 1996 Follow up data at 3 a) Median score a) 0.8 (0-4) a) 10 (2-27) a) Not estimable
months (95% CI)
Pad test (1 hour) g.
Glavind 1996 Follow up data at 2-3 Number out of total a) 17/19 b) 7/14 RR [95% CI]
years (based on ques- b) 5/19 b) 0/14 a) 1.79 [1.04, 3.09]
tionnaire) c) 8/19 c) 4/14 b) 8.25 [0.49,
137.94]
a) Women still doing c) 2.39 [0.99, 5.79]
PFM exercises regu-
larly
b) Women still sub-
jective ’cured’
c) Women still sub-
jective ’improved’
Pages 2001 Follow up data at 3 Mean (SD) 5.8 (1.1) 5.4 (1.4) MD [95% CI]
months 0.40 [-0.40, 1.20]
n= 13 n= 27
Daytime frequency
Pages 2001 Follow up data at 3 Number out of total 1) 13 1) 27 1) not estimable

months 2) 8 2) 19 2) 0.87 [0.53, 1.43]
1) Sub- n= 13 n= 27
jective cure and im-

provement (n)
2) Subjective cure
(n)
Pages 2001 Follow up data at 3 Median score (SD) 1) 43 (16) 1) 17 (14) Not estimable
months 2) 73 (20) 2) 36 (25)
3) 48 (21) 3) 37 (25)
PFM activity
Manometric n= 13 n= 27
measurements, vagi-
nal squeeze pressure
(cmH2O)
1) average on max.
contraction
2) max. contraction
pressure
3) max. forced
cough pressure
Pages 2001 Follow up data at 3 Median score (SD) 1) 4 (0.8) 1) 4 (1.0) Not estimable
months 2) 4 (0.3) 2) 4 (0.8)
PFM activity n= 12 n= 21
Digital Contraction
Strength Assesment;
according to Fischer
(Fischer 1995)
Grade 1 - no con-
traction
Grade 2 - slight con-
traction of the PFM
Grade 3 - moderate
contraction of the
PFM
Grade 4 - good
(more than 3 sec)
contraction of the
PFM
Grade 5 - excellent
contraction of the
PFM.
1) during voluntary
contraction (1-5)
2) during cough (1-
5)
Pages 2001 Follow up data at 3 Mean score (SD) 0.2 (0.4) 0.38 (0.4) MD [95% CI]
months -0.18 [-0.44, 0.08]
n=13 n= 27
Nocturia
Wilson 1987 Follow up data at 6 Number out of total 3/14 2/15 RR [95% CI]
months 1.61 [0.31, 8.24]
Symptomatic im-
provement, reported
by the woman
’much better’
Analysis 1.14. Comparison 1 PFMT + BF versus PFMT alone, Outcome 14 Pad and paper towel tests.
Study Pad or towel test Measure PFMT + BF PFMT Effect Estimate
Berghmans 1996 Pad test (48 hours), Mean score (SD) 12.2 (15.4) 12.5 (12.0) MD [95% CI] -0.30
g. [ -8.86, 8.26]
a) 5/20 a) 3/20
a) Pad test cure (n) b) 19/20 b) 17/20 RR [95% CI] a) 1.67
b) Pad test cure and n= 20 n= 20 [0.46, 6.06]
improvement (n) b) 1.12 [0.91, 1.38]
McClurg 2006 Pad test (24 hours), Mean score (SD) 117 (300) 35.3 (53.7) MD [95% CI]
g. n= 10 n= 10 81.70 [-107.19,
(data provided by 270.59]
author)
Morkved 2002 Standardized pad Mean score (SD) 6.1 (10.6) 10.6 (20.9) MD [ 95% CI] -4.50
test, g. (calculated) n=48 n=46 [-11.24, 2.24]
(presented as
change)
Morkved 2002 Pad test (48 hours) , Mean score (SD) 6.5 (14.5) 6.0 (9.3) MD [95% CI] 0.50
g. (calculated) n=48 n=46 [-4.40, 5.40]
(presented as Number out of total 31/48 26/46 RR [95% CI] 1.14
change) [0.82, 1.59]
Pad test cure (less
than 2 g leakage at
pad test)
Pad and paper towel tests (Continued)
Smidt 1997 Towel test (Mulder Mean score (SD) 12.75 (4.71) 5.26 (8.97) MD [95% CI]
1990) n=18 n=15 -0.28 [-0.97, 0.41]
Inco-test in ml.
Difference in PFMT
Glavind 1996 Pad test (1 hour) g. Median score (95% a) 2.5 (1-10) a) 19.0 (0.51) Not estimable
CI)
Glavind 1996 Pad test (1 hour), g. N 1) 11 1) 3 RR [95% CI]

2) 5 2) 2 1) ’cure’ 2.89 [0.98,
1) <2 g. (n) con- 3) 3 3) 9 8.54]
sidered as ’cured’ on 4) 0 4) 1
pad test. n= 19 n= 15
2) 2-10 g. (n)
3) 10-50 g. (n)
4) >50 g. (n)
Analysis 2.1. Comparison 2 PFMT + F versus PFMT alone, Outcome 1 Generic and condition specific
Study QoL measure Measure PFMT + F PFMT Effect estimate
Difference in PFMT
Burgio 2002a Incontinence Impact

Questionnaire (IIQ)
+ SF- 36 short form
No data. Text re-

ported no difference
between groups.
Analysis 2.2. Comparison 2 PFMT + F versus PFMT alone, Outcome 2 Women’s perception of change in
Comparison: 2 PFMT + F versus PFMT alone
Study or subgroup PFMT + F PFMT Risk Ratio Weight Risk Ratio

Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]
Total events: 0 (PFMT + F), 0 (PFMT)
Test for overall effect: not applicable
Burgio 2002a 21/57 45/65 100.0 % 0.53 [ 0.37, 0.78 ]
Subtotal (95% CI) 57 65 100.0 % 0.53 [ 0.37, 0.78 ]

Total (95% CI) 57 65 100.0 % 0.53 [ 0.37, 0.78 ]
Test for subgroup differences: Not applicable
0.5 0.7 1 1.5 2

Favours PFMT + F Favours PFMT
Analysis 2.3. Comparison 2 PFMT + F versus PFMT alone, Outcome 3 Women’s satisfaction with progress -
not satisfied.
Study or subgroup PFMT + F PFMT Risk Ratio Weight Risk Ratio

Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]
Burgio 2002a 8/55 27/61 100.0 % 0.33 [ 0.16, 0.66 ]
Subtotal (95% CI) 55 61 100.0 % 0.33 [ 0.16, 0.66 ]

Total (95% CI) 55 61 100.0 % 0.33 [ 0.16, 0.66 ]
0.5 0.7 1 1.5 2

Analysis 2.4. Comparison 2 PFMT + F versus PFMT alone, Outcome 4 Leakage episodes in 24 hours.
Study or subgroup PFMT + F PFMT Mean Difference Weight Mean Difference

Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]
Burgio 2002a 74 0.86 (1.53) 75 0.96 (1.63) 100.0 % -0.10 [ -0.61, 0.41 ]
Subtotal (95% CI) 74 75 100.0 % -0.10 [ -0.61, 0.41 ]

Total (95% CI) 74 75 100.0 % -0.10 [ -0.61, 0.41 ]
-1 -0.5 0 0.5 1
Analysis 2.5. Comparison 2 PFMT + F versus PFMT alone, Outcome 5 Symptom distress.
Symptom distress
Difference in PFMT
Burgio 2002a Hopkins symptom

checklist
awaiting data from
author
Analysis 2.6. Comparison 2 PFMT + F versus PFMT alone, Outcome 6 Pad and paper towel tests.
Study Test Heading 2 PFMT + F PFMT Effect estimate
Difference in PFMT
Tsai 2009 Pad test (1 hour) g. Mean score 0.20 0.45 Not estimable
n=50 n=49
Analysis 3.1. Comparison 3 PFMT + F + BF versus PFMT alone, Outcome 1 Generic and condition specific
Difference in PFMT
Williams 2006 Leicestershire Impact

Score
No data.
Analysis 3.2. Comparison 3 PFMT + F + BF versus PFMT alone, Outcome 2 Women’s perception of change
in incontinence - not cured.
Women’s perception of change in incontinence - not cured
Study Outcome Measure Face to face vs leaflet
Difference in PFMT
Williams 2006 Women reporting ’no symptoms’ Odds ratio (95% CI) 1.59 (0.43, 5.87)
(= cure)
Analysis 3.3. Comparison 3 PFMT + F + BF versus PFMT alone, Outcome 3 Leakage episodes in 24 hours.
Comparison: 3 PFMT + F + BF versus PFMT alone
Study or subgroup PFMT + F + BF PFMT Mean Difference Weight Mean Difference

Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]
Williams 2006 76 -1.03 (3.1) 76 -0.59 (2) 100.0 % -0.44 [ -1.27, 0.39 ]
Subtotal (95% CI) 76 76 100.0 % -0.44 [ -1.27, 0.39 ]

Total (95% CI) 76 76 100.0 % -0.44 [ -1.27, 0.39 ]
-2 -1 0 1 2
Favours PFMT + F + BF Favours PFMT
Analysis 3.4. Comparison 3 PFMT + F + BF versus PFMT alone, Outcome 4 PFM function.
PFM function
Study Outcome Measure PFMT + F + BF PFMT Effect estimate
Williams 2006 Repetitions Mean (SD) 2.25 (4.0) 1.03 (3.2) 1.22 [0.07, 2.37]
(presented as change) (calculated) n= 76 n= 76
Williams 2006 Endurance (in sec- Mean (SD) 2.49 (3.9) 0.88 (2.5) 1.61 [0.57, 2.65]
onds) (calculated) n= 76 n= 76
(presented as change)
Williams 2006 Perineometry (cm Mean (SD) 1) -0.34 (8.4) 1) 0.79 (7.9) MD [95% CI]
H2O) (calculated) 2) 0.54 (13.6) 2) 0.49 (10.1) 1) -1.13 [-3.72,
(presented as 3) 1.62 (8.7) 3) 0.13 (7.9) 1.46]
change) 4) 1.39 (4.6) 4) -0.15 (4.4) 2) 0.05 [-3.76, 3.86]
1) rest pressure n= 76 n= 76 3) 1.49 [-1.15, 4.13]
2) peak pressure 4) 1.54 [0.11, 2.97]
3) average pressure
4) duration
Williams 2006 Modified Oxford Mean (SD) 0.56 (1.2) 0.23 (0.85) 0.33 [0.00, 0.66]
Scale (calculated) n= 76 n= 76
Williams 2006 Number of fast con- Mean (SD) 1.95 (4.2) 0.73 (3.3) 1.22 [0.02, 2.42]
tractions (calculated) n= 76 n= 76
Analysis 3.5. Comparison 3 PFMT + F + BF versus PFMT alone, Outcome 5 Frequency of micturition.
Frequency of micturition
Study Outcome Measure PFMT experimen- PFMT control: Effect estimate

tal: leaflet
face to face
Williams 2006 Frequency Mean (SD) -0.23 (1.5) -0.27 (1.7) MD [95% CI]
(reported as change) (calculated) n= 76 n= 76 0.04 [-0.47, 0.55]
Analysis 3.6. Comparison 3 PFMT + F + BF versus PFMT alone, Outcome 6 Symptom distress.
Symptom distress
Difference in PFMT
Williams 2006 Number of partici- Number out of total 30/80 34/79 RR 1.15; 95% CI 0.78 to 1.68
pants reporting they
would be “satisfied
with current urinary
symptoms for the rest
of life”
Analysis 3.7. Comparison 3 PFMT + F + BF versus PFMT alone, Outcome 7 Pad changes in 24 hours.
Pad changes in 24 hours
Study Outcome measure Measure PFMT experimen- PFMT control: Effect estimate
tal: control MD [95% CI]
face to face
Williams 2006 Number of pad Mean (SD) 0.05 (1.6) -0.16 (1.0) 0.21 [-0.21, 0.63]
changes (calculated) n= 76 n= 76
Analysis 3.8. Comparison 3 PFMT + F + BF versus PFMT alone, Outcome 8 Adherence to treatment.
Study Measure of adher- Measure PFMT + F + BF PFMT Effect estimate

ence
Difference in PFMT
Williams 2006 Number of exercises percentage 76% 80% RR [95% CI]

daily performed (number out of total 58/76 61/76
recorded in ’exercise calculated) 0.95 [0.80, 1.12]
diary’.
Data reported for
women exercising
’most or all of the
time’.
Analysis 3.9. Comparison 3 PFMT + F + BF versus PFMT alone, Outcome 9 Economic costs.
Economic costs
Study Outcome Measure PFMT + F + BF PFMT Effect estimate
Difference in PFMT
Williams 2006 Cost of intervention GB pounds 338 287 Not estimable

per
patient
Analysis 4.1. Comparison 4 PFMT + BF vs PFMT + F, Outcome 1 Generic and condition specific quality of
life assessment.
Study QoL assessment Measure PFMT + BF PFMT + F Effect estimate
Burgio 2002c Incontinence Impact

Questionnaire (IIQ)
+ SF- 36 short form
No data.
Difference in PFMT
Tsai 2002 Incontinence Impact a) Mean score (SD) a) 6.91 (3.93) a) 7.96 (5.27) MD [95% CI]
Questionnaire n= 43 n= 26
short -1.05 [-3.39, 1.29]
form (IIQ-7) Adress-
ing seven items.
Analysis 4.2. Comparison 4 PFMT + BF vs PFMT + F, Outcome 2 Women’s perception of change in

Comparison: 4 PFMT + BF vs PFMT + F
Study or subgroup PFMT + BF PFMT + F Risk Ratio Weight Risk Ratio

Burgio 2002c 20/53 21/57 91.0 % 1.02 [ 0.63, 1.66 ]
Subtotal (95% CI) 53 57 91.0 % 1.02 [ 0.63, 1.66 ]

Total events: 20 (PFMT + BF), 21 (PFMT + F)
Johnson 2000 2/10 2/10 9.0 % 1.00 [ 0.17, 5.77 ]
Subtotal (95% CI) 10 10 9.0 % 1.00 [ 0.17, 5.77 ]

Total (95% CI) 63 67 100.0 % 1.02 [ 0.64, 1.63 ]
0.5 0.7 1 1.5 2

Favours PFMT + BF Favours PFMT + F
Analysis 4.3. Comparison 4 PFMT + BF vs PFMT + F, Outcome 3 Women’s perception of change in
incontinence - not cured.
Outcome: 3 Women’s perception of change in incontinence - not cured

Johnson 2000 5/10 5/10 100.0 % 1.00 [ 0.42, 2.40 ]
Subtotal (95% CI) 10 10 100.0 % 1.00 [ 0.42, 2.40 ]

Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]
Total (95% CI) 10 10 100.0 % 1.00 [ 0.42, 2.40 ]
0.01 0.1 1 10 100

Favours control Favours experimental
Analysis 4.4. Comparison 4 PFMT + BF vs PFMT + F, Outcome 4 Women’s satisfaction with progress - not
satisfied.

Burgio 2002c 12/52 8/55 100.0 % 1.59 [ 0.71, 3.57 ]
Subtotal (95% CI) 52 55 100.0 % 1.59 [ 0.71, 3.57 ]

Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]
Total (95% CI) 52 55 100.0 % 1.59 [ 0.71, 3.57 ]
0.5 0.7 1 1.5 2

Analysis 4.5. Comparison 4 PFMT + BF vs PFMT + F, Outcome 5 Leakage episodes in 24 hours.
Study or subgroup PFMT + BF PFMT + F Mean Difference Weight Mean Difference

Burgio 2002c 73 0.87 (1.47) 74 0.86 (1.53) 33.6 % 0.01 [ -0.48, 0.50 ]
Tisseverasinghe 2006 11 0.49 (0.54) 11 0.6 (0.53) 39.5 % -0.11 [ -0.56, 0.34 ]
Subtotal (95% CI) 84 85 73.1 % -0.05 [ -0.38, 0.27 ]

Tsai 2002 49 0.39 (0.91) 49 0.93 (1.71) 26.9 % -0.54 [ -1.08, 0.00 ]
Subtotal (95% CI) 49 49 26.9 % -0.54 [ -1.08, 0.00 ]

Total (95% CI) 133 134 100.0 % -0.19 [ -0.47, 0.10 ]
-4 -2 0 2 4
Analysis 4.6. Comparison 4 PFMT + BF vs PFMT + F, Outcome 6 PFM function.

PFM function
Study PFM activity Measure PFMT + BF PFMT + F Effect estimate
Johnson 2000 % of subjects with a) % a) 100% a) 80% RR [95% CI]

increase b) Number out of b) 10/10 b) 8/10 1.24 [0.87, 1.75]
on EMG assessment total n= 10 n= 10
(calculated)
Johnson 2000
Tisseverasinghe UltraSound Mean score (SD) 0.47 (0.82) 0.62 (0.55) MD [95% CI]
2006 Displacement (calculated) n= 11 n= 11 0.15 [-0.73 to 0.43]
(cm)
(Data provided by
the author)
Tisseverasinghe UltraSound Mean score (SD) 0.65 (0.45) 0.70 (0.45) MD [95% CI]
2006 Displacement (calculated) n= 11 n= 11 -0.05 [-0.43 to
(cm) 0.33]
(Data provided by
the author)
Difference in PFMT
Aksac 2003 Pressure perineome- Median score (SD) 50.0 (11.5) 37.5 (8.7) Not estimable
try (cm H2O) n= 20 n= 20
Aksac 2003 Digital vaginal pal- Median score (SD) 4.9 (0.2) 4.8 (0.4) Not estimable
pation n= 20 n= 20
(0= no contraction
till
5= strong contrac-
tion of 9 sec or
longer)
Tsai 2002 Endurance (sec) Mean score (SD) 1) 8.08 (2.06) 1) 5.01 (2.06) 1) 3.07 [2.25 to
1) sitting 2) 7.96 (2.21) 2) 4.64 (2.39) 3.89]
2) standing n= 49 n= 49 2) 3.32 [2.41 to
4.23]
(Data provided by
the author)
Tsai 2002 Amplitude EMG Mean score (SD) 1) 26.56 (11.73) 1) 19.23 (16.87) 1) 7.33 [1.58 to
(microV) 2) 29.58 (13.28) 2) 20.79 (16.55) 13.08]
1) sitting n= 49 n= 49 2) 8.79 [2.58 to
2) standing 14.73]
(Data provided by
the author)
Analysis 4.7. Comparison 4 PFMT + BF vs PFMT + F, Outcome 7 Symptom distress.

Symptom distress
Study Symptom distress Measure PFMT + BF PFMT + F Effect estimate

measure
Burgio 2002c Hopkins Symp-

tom Checklist 90-R
(SCL-90)
No data.
Symptom distress (Continued)
Difference in PFMT
Aksac 2003 The Social Activity Median score (SD) 8.1 (0.8) 7.5 (1.2) Not estimableros
Index (SAI) n= 20 n= 20
Based on Visual Ana-

logue Scale
(VAS) (0= cannot
make any social
activity till 10= does
not have a
problem)
Analysis 4.8. Comparison 4 PFMT + BF vs PFMT + F, Outcome 8 Frequency of micturation.

Frequency of micturation
Study Outcome measure- Measure PFMT + BF PFMT + F Effect estimate

ment
Aksac 2003 Addressed on a four- Median (SD) 3.6 (0.4) 3.5 (0.5) Not estimable
point ordinal scale
(1= urine loss once a
day to
4= urine loss once a
month)
Analysis 4.9. Comparison 4 PFMT + BF vs PFMT + F, Outcome 9 Pad and paper towel tests.
Study Pad or towel test Measure PFMT + BF PFMT + F Effect estimate
MD [95% CI]
Tisseverasinghe Pad test (24 hour) g Mean score (SD) 22.28 (32.58) 15.94 (37.18) 6.34 [-22.87,
2006 (calculated) n= 11 n= 11 35.55]
(data provided by
the author)
Difference in PFMT
Aksac 2003 Pad test (1 hour), g Median score (SD) 1.2 (0.2) 2.1 (0.4) MD [95% CI] Not
1) cured: ’pad test 1 and 2: percentage 1) 80% (n=16) estimable
results of 1 g or less’ (number out of to- 2) 20% (n=4) 1) 75% (n=15)
2) improved: ’50% tal) 2) 25% (n=5) RR [95% CI]
Pad and paper towel tests (Continued)
or more decrease in n= 20 1) 1.07 [0.76 to

wet weight’ n= 20 1.49]
2) 0.80 [0.25 to
2.55]
Analysis 4.10. Comparison 4 PFMT + BF vs PFMT + F, Outcome 10 Adherence to treatment.

Study Adherence to treat- Measure PFMT + BF PFMT + F Effect estimate

ment
Tisseverasinghe Percentage compli- Percentage 76.8% 63.4% Not estimable

2006 ance with n= 10 n= 10
home exer-
cises, based on ques-
tionnaire
(Visual Analogue
Scale)
Difference in PFMT
Tsai 2002 Adherence Mean % score (SD) 88.68 (14.79) 65.53 (24.86) MD [95% CI]
calculated as n= 49 n= 49 23.15 [15.05,
a proportion. 31.25]
Based on bladder di-

aries.
Analysis 4.11. Comparison 4 PFMT + BF vs PFMT + F, Outcome 11 Interim and follow up data.
Study Outcome Measure PFMT + BF PFMT + F Effect estimate

MD [95% CI]
Tisseverasinghe Data at 3 months Mean score (SD) 0.45 (0.39) 0.52 (0.59) -0.07 [-0.49 to
2006 follow up n= 11 n= 11 0.35]
leakage episodes in
24 hours
Tisseverasinghe Data at 3 months Mean score (SD) 3.47 (6.66) 12.65 (30.42) -9.18 [-27.58, 9.22]
2006 follow up (calculated) n= 11 n= 11
Pad test (24 hour) g
(data provided by
the author)
Tisseverasinghe Data at 3 months Median (range) 1) 25.00 1) 25.00 Not estimable

2006 follow up (0.00-50.00) (0.00-0.75)
2) 33.33 2) 33.33
King’s Health Ques- (0.00-100.00) (0.00-66.66)
tionnaire 3) 16.66 3) 0.00
(KHQ) (0.00-50.00) (0.00-33.33)
4) 0.00 4) 0.00
Domain 1 - 9 (0.00-33.33) (0.00-16.66)
5) 0.00 5) 0.00
(data from thesis, (0.00-50.00) (0.00-16.66)
provided by 6) 0.00 6) 0.00
the author) (0.00-16.66) (0.00-33.33)
7) 11.11 7) 0.00
(0.00-100.00) (0.00-33.33)
8) 33.33 8) 33.33
(0.00-66.66) (0.00-83.33)
9) 13.33 9) 20.00
(0.00-53.33) ( 0.00-40.00)
n= 11 n= 11
Tisseverasinghe
2006
Difference in PFMT
Tsai 2002 Data at 2 weeks of Mean score (SD) 1.39 (1.97) 1.19 (1.67) 0.20 [-0.52 to 0.92]
treatment (interim) n= 49 n= 49
leakage episodes in
24 hours
Tsai 2002 Data at 4 weeks of Mean score (SD) 0.97 (1.60) 1.09 (1.79) -0.12 [-0.79 to
treatment (interim) n= 49 n= 49 0.55]
leakage episodes in
24 hours
treatment (interim) n= 49 n= 49 0.22]
leakage episodes in
24 hours
treatment (end) n= 49 n= 49 0.00]
leakage episodes in
24 hours
Analysis 5.1. Comparison 5 PFMT + BF versus PFMT + BF, Outcome 1 Generic and condition specific
Study Tool Data presented Control Experimental Effect estimate
Wong 2001 Incontinence Impact Mean, total score. 14.29 14.29 Not estimable
Questionnaire short No measure of disper- n=19 n=19
form sion.
(IIQ-7). Used to as-
sess the
impact of urinary in-
continence
on HRQL (Milsom
2009)
Analysis 5.2. Comparison 5 PFMT + BF versus PFMT + BF, Outcome 2 Leakage episodes in 24 hours.
Comparison: 5 PFMT + BF versus PFMT + BF
Study or subgroup PFMT + BF PFMT + BF Mean Difference Weight Mean Difference

Wong 2001 19 0.21 (0.43) 19 0.59 (1.53) 100.0 % -0.38 [ -1.09, 0.33 ]
Total (95% CI) 19 19 100.0 % -0.38 [ -1.09, 0.33 ]

-1 -0.5 0 0.5 1
Favours PFMT + BF Favours PFMT + BF
Analysis 5.3. Comparison 5 PFMT + BF versus PFMT + BF, Outcome 3 PFM function.
PFM function
Study Measure Heading 2 PFMT + ’extra BF’ PFMT + BF Effect estimate

MD [95%- CI]
Aukee 2002 PFM activity (EMG, Mean (SD) 25.38 (9.85) 19.26 (7.93) 6.12 [0.12 to 12.12]
microV), n=16 n=19
measured in supine
position.
(data provided by au-

thor)
Wong 2001 PFM activity, max. Mean (SD) 16.8 (8.1) 21.7 (14.0) -4.90 [-12.17 to 2.37]
strength recorded n=19 n=10
when asked to con-
tract as hard as
possible (VSP, peri-
neometer,
cmH2O).
Wong 2001 PFM activity, Mean (SD) 6.3 (2.9) 6.7 (3.0) -0.40 [-2.28 to 1.48]
endurance recorded n=19 n=19
when
asked to contract and
hold the contraction
as long as possible
(seconds).
Analysis 5.4. Comparison 5 PFMT + BF versus PFMT + BF, Outcome 4 Symptom distress.
Symptom distress
Study Tool Data presented PFMT + (extra) BF PFMT + BF Effect estimatate
Aukee 2002 Leakage index Mean (SD) 34.9 (10.4) 38.1 (10.5) MD [95% CI]
n= 15 n= 15 -3.20 [-10.68, 4.28]
Wong 2001 Urogenital Distress Mean, total score. 27.78 16.67 Not estimable
Inventory No measure of disper- n= 19 n=19
short form (UDI-6). sion.
Represents
experience and both-
ering of
incontinence symp-
toms. The lower
the score, the better.
Analysis 5.5. Comparison 5 PFMT + BF versus PFMT + BF, Outcome 5 Pad and towel tests.
Pad and towel tests
Study Measure Heading 2 PFMT + (extra) BF PFMT + BF Effect estimate
Aukee 2002 Pad test (24 hour), g. Mean (SD) 19.0 (19.7) 22.5 (19.6) MD -3.50 [-17.56, 10.56]
n=15 n=15
Pad and towel tests (Continued)
Wong 2001 Pad test (1 hour), Mean (SD) 3.9 (3.6) 23.0 (69.0) MD -19.10 [-50.17, 11.97]
with n=19 n=19
500 ml fluid ingested,
g.
Analysis 5.6. Comparison 5 PFMT + BF versus PFMT + BF, Outcome 6 Adherence to treatment.
Study Adherence to treat- Measure PFMT + (extra) BF PFMT + BF Effect estimate

ment
Aukee 2002 a) Adherence in home a) mean trainings a) 68 (9-130) b) 56.2 (21-87) a) not estimable
BF group (range) n= 19 b) not estimable
(measured by device) b) mean days (range) b) 47.5 (6-93)
n= 16
b) Adherence to treat-
ment
(extracted from di-
ary)
Analysis 5.7. Comparison 5 PFMT + BF versus PFMT + BF, Outcome 7 Interim and follow up data.
Study Follow up data Measure PFMT + (Extra) BF PFMT + BF Effect estimate
Aukee 2002 Data at one year fol- Mean (SD) 22.67 (7.27) 24.63 (7.90) MD -1.96 [-7.30 to
low-up n= 15 n= 16 3.38]
PFM activity (EMG,

microV),
measured in supine
position.
Aukee 2002 Data at one year fol- Mean % 68.8% 52.6% RR [95% CI]
low-up n out of total 11/16 9/19 1.45 [0.81, 2.59]
Number of women
avoiding surgery
(defined by trialist as
cured or improved)
Analysis 6.1. Comparison 6 Subgroup assessment, Outcome 1 Women’s perception of change in
incontinence - not cured or improved (type of BF)).
Comparison: 6 Subgroup assessment
Outcome: 1 Women’s perception of change in incontinence - not cured or improved (type of BF))

1 Electromyography
Burns 1993 31/40 36/43 21.0 % 0.93 [ 0.75, 1.15 ]
Johnson 2000 2/10 2/10 1.2 % 1.00 [ 0.17, 5.77 ]
Pages 2001 10/13 21/27 8.3 % 0.99 [ 0.69, 1.42 ]
Wang 2004 17/34 21/34 12.7 % 0.81 [ 0.53, 1.24 ]
Subtotal (95% CI) 97 114 43.2 % 0.91 [ 0.76, 1.09 ]

2 Vaginal squeeze pressure
Goode 2003 20/47 28/40 18.3 % 0.61 [ 0.41, 0.90 ]
Morkved 2002 27/48 32/46 19.8 % 0.81 [ 0.59, 1.11 ]
Wilson 1987 9/15 13/15 7.9 % 0.69 [ 0.44, 1.09 ]
Subtotal (95% CI) 110 101 46.0 % 0.71 [ 0.57, 0.88 ]

3 Ultrasound
Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]
4 Electromyography and anal squeeze pressure
Burgio 2002b 33/53 20/65 10.9 % 2.02 [ 1.33, 3.08 ]
Subtotal (95% CI) 53 65 10.9 % 2.02 [ 1.33, 3.08 ]

Total (95% CI) 260 280 100.0 % 0.94 [ 0.82, 1.07 ]
0.1 0.2 0.5 1 2 5 10

Analysis 6.2. Comparison 6 Subgroup assessment, Outcome 2 Leakage episodes in 24 hours (type of BF).
Outcome: 2 Leakage episodes in 24 hours (type of BF)
Study or subgroup PFMT + BF PFMT Std. Mean Difference Weight Std. Mean Difference
1 Electromyography
Berghmans 1996 20 0.12 (0.19) 20 0.2 (0.19) 7.2 % -0.41 [ -1.04, 0.21 ]
Burns 1993 40 0.71 (0.86) 43 1.14 (1.43) 14.9 % -0.36 [ -0.79, 0.08 ]
McClurg 2006 10 1.1 (1.2) 10 1.4 (2) 3.6 % -0.17 [ -1.05, 0.70 ]
Sherman 1997 22 2.9 (6.53) 16 5.25 (7.24) 6.7 % -0.34 [ -0.99, 0.31 ]
Smidt 1997 17 6.22 (11.43) 15 11.98 (11.29) 5.6 % -0.49 [ -1.20, 0.21 ]
Subtotal (95% CI) 109 104 38.1 % -0.37 [ -0.64, -0.10 ]

2 Vaginal squeeze pressure
Goode 2003 66 0.64 (0.87) 67 1.07 (1.73) 24.1 % -0.31 [ -0.65, 0.03 ]
Laycock 2001a 22 1.2 (1.29) 16 1.13 (1.42) 6.8 % 0.05 [ -0.59, 0.70 ]
Subtotal (95% CI) 88 83 30.8 % -0.23 [ -0.53, 0.07 ]

3 Ultrasound
Subtotal (95% CI) 11 11 4.0 % -0.20 [ -1.04, 0.64 ]

4 Electromyography and anal squeeze pressure
Burgio 2002b 73 0.87 (1.47) 75 0.96 (1.63) 27.1 % -0.06 [ -0.38, 0.26 ]
Subtotal (95% CI) 73 75 27.1 % -0.06 [ -0.38, 0.26 ]

Total (95% CI) 281 273 100.0 % -0.23 [ -0.40, -0.07 ]
-2 -1 0 1 2
incontinence - not cured or improved (type of UI).
Outcome: 3 Women’s perception of change in incontinence - not cured or improved (type of UI)

1 Stress urinary incontinence

Goode 2003 20/47 38/40 23.6 % 0.45 [ 0.32, 0.63 ]
Pages 2001 10/13 21/27 7.8 % 0.99 [ 0.69, 1.42 ]
Wilson 1987 9/15 13/15 7.5 % 0.69 [ 0.44, 1.09 ]
Subtotal (95% CI) 75 82 38.9 % 0.60 [ 0.48, 0.75 ]

Test for overall effect: Z = 4.47 (P < 0.00001)
2 Stress and mixed urinary incontinence
Burns 1993 31/40 36/43 19.9 % 0.93 [ 0.75, 1.15 ]
Morkved 2002 27/48 32/46 18.8 % 0.81 [ 0.59, 1.11 ]
Subtotal (95% CI) 88 89 38.7 % 0.87 [ 0.72, 1.05 ]

3 Urgency and mixed urinary incontinence
Burgio 2002b 33/53 20/65 10.3 % 2.02 [ 1.33, 3.08 ]
Wang 2004 17/34 13/34 7.5 % 1.31 [ 0.76, 2.25 ]
Subtotal (95% CI) 87 99 17.8 % 1.72 [ 1.24, 2.40 ]

4 Stress, mixed and urgency urinary incontinence
Johnson 2000 8/10 8/10 4.6 % 1.00 [ 0.65, 1.55 ]
Subtotal (95% CI) 10 10 4.6 % 1.00 [ 0.65, 1.55 ]

Total (95% CI) 260 280 100.0 % 0.92 [ 0.81, 1.05 ]
0.01 0.1 1 10 100

Analysis 6.4. Comparison 6 Subgroup assessment, Outcome 4 Leakage episodes in 24 hours (type of UI).
Outcome: 4 Leakage episodes in 24 hours (type of UI)
1 Stress urinary incontinence

Berghmans 1996 20 0.12 (0.19) 20 0.2 (0.19) 5.8 % -0.41 [ -1.04, 0.21 ]
Goode 2003 66 0.64 (0.87) 67 1.07 (1.73) 19.3 % -0.31 [ -0.65, 0.03 ]
Laycock 2001a 22 1.2 (1.29) 16 1.13 (1.42) 5.5 % 0.05 [ -0.59, 0.70 ]
Smidt 1997 17 6.22 (11.43) 15 11.98 (11.29) 4.5 % -0.49 [ -1.20, 0.21 ]
Wong 2001 19 0.21 (0.43) 19 0.59 (1.53) 5.5 % -0.33 [ -0.97, 0.31 ]
Subtotal (95% CI) 144 137 40.6 % -0.30 [ -0.54, -0.06 ]

2 Stress and mixed urinary incontinence
Burns 1993 40 0.71 (0.86) 43 1.14 (1.43) 12.0 % -0.36 [ -0.79, 0.08 ]
Sherman 1997 22 2.9 (6.53) 16 5.25 (7.24) 5.4 % -0.34 [ -0.99, 0.31 ]
Subtotal (95% CI) 73 70 20.6 % -0.33 [ -0.66, 0.00 ]

3 Urgency and mixed urinary incontinence
Burgio 2002b 73 0.87 (1.47) 75 0.96 (1.63) 21.8 % -0.06 [ -0.38, 0.26 ]
McClurg 2006 10 1.1 (1.2) 10 1.4 (2) 2.9 % -0.17 [ -1.05, 0.70 ]
Subtotal (95% CI) 83 85 24.7 % -0.07 [ -0.37, 0.23 ]

4 Stress, mixed and urgency incontinence
Tsai 2002 49 0.39 (0.91) 49 0.93 (1.71) 14.1 % -0.39 [ -0.79, 0.01 ]
Subtotal (95% CI) 49 49 14.1 % -0.39 [ -0.79, 0.01 ]

Total (95% CI) 349 341 100.0 % -0.26 [ -0.41, -0.11 ]
-2 -1 0 1 2
incontinence - not cured or improved (times (B)F given).
Outcome: 5 Women’s perception of change in incontinence - not cured or improved (times (B)F given)

1 1 or 2 times
Burgio 2002b 20/53 45/65 20.4 % 0.55 [ 0.37, 0.80 ]
Goode 2003 20/47 38/40 20.7 % 0.45 [ 0.32, 0.63 ]
Subtotal (95% CI) 100 105 41.0 % 0.50 [ 0.38, 0.64 ]

2 3 to 12 times
Johnson 2000 2/10 2/10 1.0 % 1.00 [ 0.17, 5.77 ]
Wilson 1987 9/15 13/15 6.5 % 0.69 [ 0.44, 1.09 ]
Subtotal (95% CI) 25 25 7.6 % 0.73 [ 0.46, 1.18 ]

3 more than 12 times
Burns 1993 31/40 36/43 17.5 % 0.93 [ 0.75, 1.15 ]
Morkved 2002 27/48 32/46 16.5 % 0.81 [ 0.59, 1.11 ]
Pages 2001 10/13 21/27 6.9 % 0.99 [ 0.69, 1.42 ]
Wang 2004 17/34 21/34 10.6 % 0.81 [ 0.53, 1.24 ]
Subtotal (95% CI) 135 150 51.4 % 0.87 [ 0.75, 1.02 ]

Total (95% CI) 260 280 100.0 % 0.71 [ 0.62, 0.81 ]
0.05 0.2 1 5 20
Analysis 6.6. Comparison 6 Subgroup assessment, Outcome 6 Leakage episodes in 24 hours (times (B)F
given).
Outcome: 6 Leakage episodes in 24 hours (times (B)F given)

1 1 or 2 times
Burgio 2002b 73 0.87 (1.47) 75 0.96 (1.63) 4.4 % -0.09 [ -0.59, 0.41 ]
Goode 2003 66 0.64 (0.87) 67 1.07 (1.73) 5.1 % -0.43 [ -0.89, 0.03 ]
Subtotal (95% CI) 139 142 9.4 % -0.27 [ -0.61, 0.07 ]

2 3 to 12 times
Berghmans 1996 20 0.12 (0.19) 20 0.2 (0.19) 78.8 % -0.08 [ -0.20, 0.04 ]
Burns 1993 40 0.71 (0.86) 43 1.14 (1.43) 4.3 % -0.43 [ -0.93, 0.07 ]
Subtotal (95% CI) 71 74 88.6 % -0.10 [ -0.21, 0.01 ]

3 more then 12 times
Laycock 2001a 22 1.2 (1.29) 16 1.13 (1.42) 1.4 % 0.07 [ -0.81, 0.95 ]
McClurg 2006 10 1.1 (1.2) 10 1.4 (2) 0.5 % -0.30 [ -1.75, 1.15 ]
Sherman 1997 22 2.9 (6.53) 16 5.25 (7.24) 0.1 % -2.35 [ -6.83, 2.13 ]
Subtotal (95% CI) 54 42 2.0 % -0.09 [ -0.84, 0.65 ]

Total (95% CI) 264 258 100.0 % -0.12 [ -0.22, -0.01 ]
-2 -1 0 1 2
Analysis 6.7. Comparison 6 Subgroup assessment, Outcome 7 Women’s perception of incontinence - not
cured or improved (concealment of allocation).
Outcome: 7 Women’s perception of incontinence - not cured or improved (concealment of allocation)

1 Adequate concealment of allocation

Burgio 2002b 20/53 45/65 25.5 % 0.55 [ 0.37, 0.80 ]
Goode 2003 20/47 28/40 19.1 % 0.61 [ 0.41, 0.90 ]
Morkved 2002 12/48 14/46 9.0 % 0.82 [ 0.43, 1.58 ]
Wang 2004 17/34 21/34 13.3 % 0.81 [ 0.53, 1.24 ]
Subtotal (95% CI) 182 185 66.9 % 0.65 [ 0.52, 0.81 ]

2 Allocation of concealment unclear
Burns 1993 31/40 36/43 21.9 % 0.93 [ 0.75, 1.15 ]
Johnson 2000 2/10 2/10 1.3 % 1.00 [ 0.17, 5.77 ]
Pages 2001 10/13 21/27 8.6 % 0.99 [ 0.69, 1.42 ]
Subtotal (95% CI) 63 80 31.8 % 0.95 [ 0.78, 1.14 ]

3 No concealment of allocation
Wilson 1987 6/15 2/15 1.3 % 3.00 [ 0.72, 12.55 ]
Subtotal (95% CI) 15 15 1.3 % 3.00 [ 0.72, 12.55 ]

Total (95% CI) 260 280 100.0 % 0.78 [ 0.66, 0.90 ]
0.1 0.2 0.5 1 2 5 10

Analysis 6.8. Comparison 6 Subgroup assessment, Outcome 8 Leakage episodes in 24 hours (concealment
of allocation).
Outcome: 8 Leakage episodes in 24 hours (concealment of allocation)

1 Adequate concealment of allocation

Berghmans 1996 20 0.12 (0.19) 20 0.2 (0.19) 74.4 % -0.08 [ -0.20, 0.04 ]
Burgio 2002b 73 0.87 (1.47) 75 0.96 (1.63) 4.1 % -0.09 [ -0.59, 0.41 ]
Goode 2003 66 0.64 (0.87) 67 1.07 (1.73) 4.8 % -0.43 [ -0.89, 0.03 ]
Subtotal (95% CI) 170 173 88.5 % -0.10 [ -0.21, 0.01 ]

2 Allocation of concealment unclear
Burns 1993 40 0.71 (0.86) 43 1.14 (1.43) 4.1 % -0.43 [ -0.93, 0.07 ]
Laycock 2001a 22 1.2 (1.29) 16 1.13 (1.42) 1.3 % 0.07 [ -0.81, 0.95 ]
McClurg 2006 10 1.1 (1.2) 10 1.4 (2) 0.5 % -0.30 [ -1.75, 1.15 ]
Sherman 1997 22 2.9 (6.53) 16 5.25 (7.24) 0.1 % -2.35 [ -6.83, 2.13 ]
Smidt 1997 17 6.22 (11.43) 15 11.98 (11.29) 0.0 % -5.76 [ -13.64, 2.12 ]
Tsai 2002 49 0.39 (0.91) 49 0.93 (1.71) 3.5 % -0.54 [ -1.08, 0.00 ]
Wong 2001 19 0.21 (0.43) 19 0.59 (1.53) 2.0 % -0.38 [ -1.09, 0.33 ]
Subtotal (95% CI) 179 168 11.5 % -0.41 [ -0.71, -0.11 ]

3 No concealment of allocation
Subtotal (95% CI) 0 0 0.0 % 0.0 [ 0.0, 0.0 ]
Total (95% CI) 349 341 100.0 % -0.14 [ -0.24, -0.03 ]
-2 -1 0 1 2
incontinence - not cured or improved (difference in PFMT).
Outcome: 9 Women’s perception of change in incontinence - not cured or improved (difference in PFMT)

Burns 1993 31/40 36/43 17.5 % 0.93 [ 0.75, 1.15 ]
Johnson 2000 2/10 2/10 1.0 % 1.00 [ 0.17, 5.77 ]
Morkved 2002 27/48 32/46 16.5 % 0.81 [ 0.59, 1.11 ]
Subtotal (95% CI) 98 99 35.0 % 0.87 [ 0.72, 1.05 ]

Burgio 2002b 20/53 45/65 20.4 % 0.55 [ 0.37, 0.80 ]
Goode 2003 20/47 38/40 20.7 % 0.45 [ 0.32, 0.63 ]
Pages 2001 10/13 21/27 6.9 % 0.99 [ 0.69, 1.42 ]
Wang 2004 17/34 21/34 10.6 % 0.81 [ 0.53, 1.24 ]
Wilson 1987 9/15 13/15 6.5 % 0.69 [ 0.44, 1.09 ]
Subtotal (95% CI) 162 181 65.0 % 0.62 [ 0.52, 0.74 ]

Total (95% CI) 260 280 100.0 % 0.71 [ 0.62, 0.81 ]
0.01 0.1 1 10 100

Analysis 6.10. Comparison 6 Subgroup assessment, Outcome 10 Leakage episodes in 24 hours (difference
in PFMT).
Outcome: 10 Leakage episodes in 24 hours (difference in PFMT)
Berghmans 1996 20 0.12 (0.19) 20 0.2 (0.19) 7.2 % -0.41 [ -1.04, 0.21 ]
Burns 1993 40 0.71 (0.86) 43 1.14 (1.43) 14.9 % -0.36 [ -0.79, 0.08 ]
Laycock 2001a 22 1.2 (1.29) 16 1.13 (1.42) 6.8 % 0.05 [ -0.59, 0.70 ]
McClurg 2006 10 1.1 (1.2) 10 1.4 (2) 3.6 % -0.17 [ -1.05, 0.70 ]
Sherman 1997 22 2.9 (6.53) 16 5.25 (7.24) 6.7 % -0.34 [ -0.99, 0.31 ]
Smidt 1997 17 6.22 (11.43) 15 11.98 (11.29) 5.6 % -0.49 [ -1.20, 0.21 ]
Subtotal (95% CI) 142 131 48.9 % -0.30 [ -0.54, -0.06 ]

Burgio 2002a 36 0.86 (1.53) 37 0.96 (1.63) 13.4 % -0.06 [ -0.52, 0.40 ]
Burgio 2002b 37 0.87 (1.47) 38 0.96 (1.63) 13.7 % -0.06 [ -0.51, 0.40 ]
Goode 2003 66 0.64 (0.87) 67 1.07 (1.73) 24.1 % -0.31 [ -0.65, 0.03 ]
Subtotal (95% CI) 139 142 51.1 % -0.18 [ -0.41, 0.06 ]

Total (95% CI) 281 273 100.0 % -0.24 [ -0.40, -0.07 ]
-2 -1 0 1 2
ADDITIONAL TABLES
Table 1. PFMT + BF versus PFMT
Study Group Intervention Duration Supervision
Berghmans 1996 Control: PFMT: Vaginal palpation 12 treatment sessions, 25 Specialized

PFMT according to PERFECT to 35 minutes physical
was used to confirm a per session, therapist
Table 1. PFMT + BF versus PFMT (Continued)
correct vPFMC. The pro- 4 weeks

gram consisted of infor-
mation, pelvic floor re-
education, homework ex-
ercises and toilet regime.
Exercises in supine, side,
standing and crawling po-
sition. Participants began
with 4 sets of 10 contrac-
tions (5 quick and 5 sus-
tained) and increased by
10 per set until 30 times
per set were realised. Par-
ticipants received an iden-
tical homework exercise
programme to practice 3
times every day
Experimental: PFMT: As above. 12 treatment sessions, 25 Specialized

PFMT + clinic EMG BF to 35 minutes physical
BF: vaginal probe (Ver- per session, therapist
imed Inc., Coral Springs, 4 weeks
FL, USA) attached to a
portable electromyograph
(Myaction 12 of Uniphy
BV, Son, The Nether-
lands). Participants re-
ceived both visual and
acoustical signals
Burgio (b) 2002 * Control: Written/home PFMT: 8 weeks none

Written/home PFMT Participants received writ-
ten instruction for PFMT,
including location of PFM
and details of The Knack.
45 vPFMC/day, typically
3x15 day. Performed in
various body positions,
and integrated with daily
activity. Progressed to 10
sec hold, with equal period
of relaxation. No health
professional contact for 8
weeks
Experimental: Home/clinic PFMT: 4 4 treatment session, nurse practitioner

Clinic/home PFMT + clinic visits, where they 8 weeks
clinic ASP BF were taught skills and
strategies for preventing
incontinence + instructed
with the same home exer-
cises as above.
BF: At the first visit

anorectal BF was pro-
vided, by inserting a 3-
balloon probe into the
rectum. Movement was
displayed on a computer
monitor.
If the participant had not
achieved
at least 50% improvement
by the third visit, they un-
derwent combined blad-
der-sphincter biofeedback
Burns 1993 Control: PFMT: booklet was given. 8 treatment sessions, 25 to BF trained nurse
PFMT Videotape describing ex- 35 minutes
ercise protocol. Partici- per session,
pants began with 4 sets of 8 weeks
20 (10 quick and 10 sus-
tained) contractions and
increased by 10 per set
over 4 weeks until a daily
max. of 200 exercises was
attained
Experimental: PFMT: participants were 8 treatment sessions, 20 BF trained nurse

PFMT + clinic EMG BF instructed to relax and minutes
contract the PFM for 3 per session,
seconds, then relax un- 8 weeks
til precontraction reading
was obtained.Then con-
tract and encouraged to
sustain 10 sec, and again
relax to a precontraction
resting state. Protocol was
performed 10 times, each
visit
BF: Patients were taught
how to perform a vPFMC,
using a vaginal probe
(EMS-10, EMS-20, Far-
rall Instruments, Grand
Island NE) attached to
an electromyograph (J&
J Model D-200). Vi-
sual feedback was pro-

vided through a graph on
a screen
Glavind 1996 * Control: PFMT: 2-3 indi- 2 to 3 treatment sessions, Physiotherapist

PFMT vidual treatment sessions. 4 weeks
10 contractions (5 to 10
sec hold) each in supine,
sitting and standing posi-
tion, at least 3 times day,
as often as possible
Experimental: PFMT: as above 4 treatment sessions, 4 Physiotherapist

PFMT + clinic EMG and BF: 4 BF treatment ses- weeks
ASP BF sions. Biofeedback
performed by a vaginal
surface electrode (Dantec
21L20, Skovlunde, Den-
mark) (EMG) and a rectal
catheter (ASP)
Goode 2003 * Control: Written/home 8 weeks None

Written/home PFMT PFMT: a self-help booklet
with written instructions
was given. Adapted text
from Burgio 1989 .Pro-
vided information: isolat-
ing the PFM, progressive
home exercise, self-moni-
toring and bladder control
strategies
Experimental: PFMT: participants were 4 treatment sessions, 20 Nurse practitioner

PFMT + clinic (VSP + given verbal and written minutes each,
ASP) BF instructions for 3 sessions 8 weeks
of PFMT daily. Each ses-
sion 15 repetitions of 2-
to 4 second contractions,
with equal relaxation in-
tervals. Progressed to max
10 sec hold and 10 sec
rest. Advised to exercise in
different positions. Stress
and urge strategies and
’the Knack’ (DeLancey
1997) were taught during
the second and third visit.
Bladder diary reviewed at
each clinic visit.
Clinic BF: Manometric

feedback of anal sphinc-
ter pressure (PFM) and
rectal pressure (reflecting
intra-abdominal pressure)
was used in the first treat-
ment session to help the
woman identify the PFM
and teach how to perform
a correct vPFMC, with-
out contracting the ab-
dominal muscles. If the
woman experience <50%
improvement, the BF was
repeated during the 3rd
session
Laycock 2001 Control: PFMT: digital vaginal pal- 6 treatment sessions, Physiotherapist
PFMT pation was used to con- 3 months
firm a vPFMC. Individ-
ualised written instruc-
tions were provided for all
participants. Encouraged
to repeat their individu-
alised scheme during ev-
ery day 10-minute exercise
sessions, in different posi-
tions. All participants kept
a bladder diary
Experimental: PFMT: as above. 6 treatment sessions, Physiotherapist

PFMT + home VSP BF Home VSP BF: a vagi- 3 months
nal probe was inserted in
the vagina (PFX, Cardio
Design, Australia). Partic-
ipants were instructed to
squeeze the PFM. The
squeeze was shown on a
monitor
McClurg 2006 Control: PFMT: a training pro- Weekly treatments ses- Physiotherapist
PFMT + Advice gram was developed ac- sions, 30 minutes per ses-
cording to the PERFECT sion,
scheme. Participants were 9 weeks
instructed to practice their
individualised scheme 5x
a day. Relaxation time
was double the contrac-
tion time. Integration of

exercises into daily activi-
ties was encouraged.
Advice: advice on lifestyle

interventions; in-
cluding weight reduction,
quitting smoking, reliev-
ing constipation, caffeine
reduction, fluid manage-
ment, reducing emotional
stress and correcting faulty
habit pattern of frequent
urination + urgency strate-
gies and ’The Knack’
(DeLancey 1997) were
taught and advice on good
voiding position was pro-
vided. Information also
given in a leaflet
Experimental: PFMT: as above. Weekly treat- Physiotherapist

PFMT + Advice + clinic ment sessions, 30 minutes
and home EMG BF Advice: as above. per session,
9 weeks
Clinic and
home EMG BF: a Neu-
rotac TES (Verity Medi-
cal Ltd.) and a Periform
intravaginal probe (Neen
Health Care) were used to
record EMG activity. Vi-
sual and auditory feedback
was provided during con-
traction and relaxation of
the PFM. BF was given at
each visit as well as used at
home
Morkved 2002 Control: Clinic PFMT: individual 16 treatment sessions, Physical therapist
PFMT PFMT sessions, once per 6 months
week during the first 2
months, fortnightly dur-
ing the next 4 months.
vPFMC was confirmed
in supine position with
straight legs. Each visit:
3 sets of 10 contrac-
tions, holding each con-
traction for 6-8 seconds,

then adding 3-4 fast con-
tractions on top of each
sustained contraction (Bo
1990).
Home PFMT: 3 sets of

10 high intensity contrac-
tions per day.
Experimental: Clinic PFMT: as above. 16 treatment sessions, Physicial therapist

PFMT + clinic and home 6 months
VSP BF Home PFMT: as above +
using the BF apparatus.
Clinic and home BF: a

vaginal probe was placed
inside the vagina (BF-
106 Biofeedback, Vita-
con, Norway) to measure
VSP. Both vaginal and anal
surface EMG were placed.
Stored data could be used
for treatment templates.
Templates were adjusted
when PFM strength had
increased
Pages 2001 * Control: PFMT: 90-min introduc- 20 treatment sessions, 1 Physiotherapist

group PFMT tory group session (educa- hour each, 4 weeks
tion about pathogenesis,
effect respiration, move-
ment, body weight and
stress on pelvic floor func-
tion). Digital contraction
strength (according to Fis-
cher); vPFMC confirmed.
Supervised group therapy,
5 times a week for a train-
ing period of 4 weeks. 100
vPFMC with the activities
of daily living and 10 min
twice a day in lying posi-
tion
Experimental: PFMT: 90-min introduc- 20 treatment sessions, 15 Physiotherapist

individual PFMT + clinic tory group session + 30 minutes each, 4 weeks
VSP BF min BF introduction. In-
dividual treatment ses-
sions. Four sets of 10
vPFMC per session.
BF: The BF apparatus

(Gemini 2000 TM appa-
ratus Wiest, Berlin, Ger-
many) provided vi-
sual and acoustic feedback
and consisted of a vaginal
pressure sensor and trans-
former, connected to a
monitor. Results displayed
in cm H2 O; representing
the pressure changes be-
tween relaxation and con-
traction pressure
Schmidt 2009 Control: 1 information session; de- ’Fortnightly reviews’, 12 None

home PFMT scription of the PFM, weeks
anatomical position, func-
tion of exercises + relation-
ship to UI
Home PFMT: in supine
position, a series of rapid
contractions (consisting of
2 sec contraction and 4 sec
rest) followed by a series
of slow contractions (con-
sisting of 4 sec contraction
and 4 sec rest), repeated 3
times with a rest interval
Experimental: 1 information session as ’Fortnightly reviews’, 12 None

home PFMT + home VSP above. weeks
BF Home PFMT: as above.
Home VSP BF: device
included a vaginal probe
(silicone cuff with ring
electrodes) that measured
pressure during exercise.
Cuff was connected to a
pressure sensor that pro-
duced an electrical signal.
An exercise program + the
intensity of each contrac-
tion was showed on a LCD
display
Shepherd 1983 Control: PFMT: series of graded ex- 6 treatment sessions, Physiotherapist
PFMT ercises performed daily at 6 weeks
home. A vPFMC was con-

firmed by the use of a per-
ineometer. Weekly visit to
physiotherapist
Experimental: PFMT: as above. 6 treatment sessions, Physiotherapist

PFMT + home VSP BF 6 weeks
Home VSP BF: use of per-
ineometer daily at home.
Inflatable balloon, placed
in the vagina. Strength
of muscle squeeze was
recorded
Sherman 1997 Control: Clinic PFMT: BF system 4 treatment sessions, 8 A therapist trained in
PFMT + BT was used as timer, no vi- weeks Kegel’s exercises and BF
sual
signals were shown. Par-
ticipants were instructed
to squeeze the PFM as if
they were squeezing a tam-
pon, while keeping other
muscles quiet. Regime: 10
sec contraction/10 sec re-
laxation, repeated 5 times
within each set, with a 30
sec break between each of
the 5 sets.
Home PFMT: women

were instructed to practice
above regime for 20 min-
utes a day.
BT: Bladder
training schedule; starting
every 1 hour and working
up to every 2 hours, and
urgency strategies
Experimental: Clinic PFMT: as above 4 treatment sessions, 8 A therapist trained in

PFTM + BT + clinic and with different use of BF weeks Kegel’s exercises and BF
home EMG BF device.
BT: as above.
Clinic BF: perivaginal sen-

sors + an abdominal sen-
sor (model SRS-4509, self
regulation systems, Red-

mond, WA) were placed.
EMG activity from the
PFM was shown in blue,
abdominal activity in red.
The BF equipment (I-410
J&J BF System, Poulsbo,
Washington) was
connected to a computer.
Home BF: participants re-

ceived a home trainer de-
vice for the first week
of treatment (MyoTrac2,
model 9500, Montreal
Quebec Canada)
Smidt 1997 Control: PFMT: participants had Weekly (different)

PFMT at least 7 treatments. The treatment sessions, be- Physiotherapist
program consisted of in- tween 7 and 12 times
formation about the PFM,
toilet regime and home-
work exercises. Women
began with 10 repeti-
tions with a duration
of 20 seconds and this
was extended to 30 rep-
etitions with a duration
of 1 minute. They ex-
ercised in different posi-
tions and in stress related
circumstances (e.g. cough-
ing, jumping)
Experimental: PFMT: as above. Weekly treatment (different)

PFMT + clinic BF sessions, between 7 and 12 Physiotherapist
BF: My- times
ofeedback: A Myoaction-
12 (Uniphy) device was
used.
Tejero 2008 * Control: One 40 minute session 12 weeks? Once by physiotherapist

home PFMT with physiotherapist for
education and teaching of
home programme of PFM
exercises
Experimental: PFMT: Supervised PFM 12 treatment Physiotherapist

clinic PFMT + BF exercises. sessions, 40 minutes each
BF: no additional infor-

mation.
Wang 2004 * Control: (Indi- 12 weeks Weekly check ups by phys-

home PFMT vidualised) home PFMT: iotherapist?
patients were instructed
to perform PFM contrac-
tions at home, according
to the PERFECT scheme.
Instructed to practice at
least 3 times daily and
in different positions, and
contract PFM during urge
to void
Experimental: Clinic PFMT + BF: pa- BF twice a week, for 12 Physiotherapist

clinic/home PFMT + tients were trained with an weeks
clinic EMG BF intravaginal electromyo-
gram probe (Periform,
Neen Health- Care). Each
patient was instructed to
contract or relax her PFM
following the visual EMG
signals.
Home PFMT: PERFECT

scheme assessed before
treatment was used as an
auxiliary home program
for these patients. Con-
tract PFM during urge to
void
Wilson 1987 * Control: Home PFMT: one session 6 weeks 1 session with physiother-
home PFMT of pelvic floor exercises in apist,
the physiotherapy depart- none
ment + instruction sheet
for PFE at home (Ad-
vised to exercise in differ-
ent positions, while listen-
ing to running water. En-
couraged to increase con-
tractions from 5 to 10 and
advised to relax the other
muscles.)
Experimental: Clinic PFMT: Partic- 12 treatment 2 physiotherapists

clinic PFMT + clinic VSP ipants were instructed to sessions,
BF perform 3 series of 6 con- 6 weeks.
tractions (5 sec each, then

rest for 15 sec) and rest for
2 min between each series.
VSP BF: a vaginal peri-

neometer was placed, con-
nected by plastic tubing
to a manometer. A visual
signal showed the contrac-
tion of the PFM
* = difference in PFMT between both arms
ASP = anal squeeze pressure, BF= biofeedback, BT = bladder training, EMG = electromyography, F = feedback, max = maximum or
maximal, min = minute(s), PERFECT = power or pressure, endurance, repetitions, fast contractions, every contraction timed, PFM =
pelvic floor muscle, PFMT = pelvic floor muscle training, sec = second(s), UI = urinary incontinence, VFMC = voluntary pelvic floor
muscle contraction, VSP = vaginal squeeze pressure
Table 2. PFMT + F versus PFMT
Burgio (a) 2002* Control: PFMT: Participants re- 8 weeks None

PFMT written ceived written instruction
instructions for PFMT, including
location of PFMT and
details of The Knack.
45 vPFMC/day, typically
3x15 day. Performed in
various body positions,
and integrated with daily
activity. Progressed to 10
sec hold, with equal period
of relaxation. No health
professional contact for 8
weeks
Experimental: PFMT: as above, with four 4 clinic visits, 8 weeks Nurse practitioner
home/clinic PFMT + ver- clinic visits
bal F
F: verbal feedback was
based on DVP, used in
the first treatment ses-
sion. If no contraction
could be detected vagi-
nally, verbal feedback was
given of voluntary exter-
nal anal sphincter con-
traction. Teaching was re-
Table 2. PFMT + F versus PFMT (Continued)
peated if patients did not

improve by at least 50% by
their 3rd visit
Tsai 2009* Control: PFMT: instructions from 12 weeks None

PFMT written instruc- a printed handout. In-
tions structed to contract the
slow-twitch fibres first, fol-
lowed quickly by the fast-
twitch fibres, 30 times a
day. Beginning with a du-
ration of 2 sec of each con-
traction, increasing to 10
sec, with a 10 sec relax-
ation period between them
Experimental: PFMT: same program as 4 treatment sessions, Weekly

PFMT + verbal F above. + monthly clinic 12 weeks phone contact with physi-
visit. 4 clinic visits, 12 cian (researcher).
check ups by phone.
Verbal F: digital vaginal

palpation (in supine lying)
3-5 cm inside vaginal inlet.
Participants were asked to
contract the PFM multiple
times while the physician
provided verbal feedback,
until correct way of con-
tracting was established
F = feedback, PFM = pelvic floor muscle, max = maximum or maximal, min = minute(s), PFMT = pelvic floor muscle training, sec =
second(s), VFMC = voluntary pelvic floor muscle contraction.
Table 3. PFMT + F + BF versus PFMT
Williams 2006* Control: PFMT PFMT: par- 6 clinic visits, Nurse

ticipants received leaflet 12 weeks
detailing the location of
PFM; functional informa-
tion about PFM, 3 step de-
scription of how to per-
form VPFMC and instruc-
tion on how frequently to
perform VPFMC. 6 vis-
its (fortnightly) with nurse;
Table 3. PFMT + F + BF versus PFMT (Continued)
kept exercise diary
Experimental: PFMT + Individualised exercise reg- 6 clinic visits, Nurse

verbal F + clinic VSP BF imen with goals: time to 12 weeks
hold max contraction 2
sec longer than able to at
initial assessment, 1 more
max contraction than able
to at initial assessment, 2
more quick contractions
than able to at initial assess-
ment, 4 or more sets per
day. 6 visits (fortnightly)
with nurse for digital PFM
assessment, and perineom-
etry
Verbal F: initial digital as-
sessment and verbal F to
teach a VPFMC.
Clinic VSP BF: perineom-

etry at initial session and
other 5 clinic visits
BF= biofeedback, F = feedback, max = maximum or maximal, min = minute(s), PFM = pelvic floor muscle, PFMT = pelvic floor
muscle training, sec = second(s), VFMC = voluntary pelvic floor muscle contraction, VSP = vaginal squeeze pressure
Table 4. PFMT + BF versus PFMT + F
Aksac 2003* Control: PFMT: 3 sets per day of 8 clinic visits, 8 weeks. Health professional.
PFMT + F 10 vPFMC, with 5 sec
hold and 10 sec rest. Pro-
gressed at 2 weeks to 10
sec hold and 20 sec rest.
F: PFM exercises were

taught in lithotomy po-
sition, using vaginal pal-
pation technique. Partici-
pants were instructed to r*
= difference in PFMT be-
tween both armselax the
abdominal and buttock
muscles
Table 4. PFMT + BF versus PFMT + F (Continued)
Experimental: PFMT: participants were 8 clinic visits, 8 weeks. Health professional.

PFMT + BF instructed to perform the
exercises 3 times per week
for 8 weeks. Every session
lasted 20 min and con-
sisted of 40 cycles with 10
sec of activity followed by
20 sec of relaxation.
BF: PFM exercises were

taught in lithotomy po-
sition via a Myomed-932
device, vaginal probe in
EMG pressure mode. In-
formation about the con-
traction was presented
back by both visual and
auditory feedback
Burgio (c) 2002 Control: Home/clinic PFMT: 4 4 clinic visits, Nurse practitioner
PFMT + F clinic visits, where they 8 weeks
were taught skills and
strategies for preventing
incontinence + instructed
with the same home ex-
ercises; 45 vPFMC/day,
typically 3 x15 day. Per-
formed in various body
positions, and integrated
with daily activity. Pro-
gressed to 10 sec hold,
with equal period of relax-
ation
F: verbal feedback was
based on digital vagi-
nal palpation, used in
the first treatment ses-
sion. If no contraction
could be detected vagi-
nally, verbal feedback was
given of voluntary exter-
nal anal sphincter con-
traction. Teaching was re-
peated if patients did not
improve by at least 50%
by their 3rd visit
Experimental: Home/clinic PFMT: as 4 clinic visits, Nurse practitioner

PFMT + BF above. 8 weeks
BF: At the first visit

anorectal BF was pro-
vided, by inserting a 3-
balloon probe into the
rectum. Movement was
displayed on a computer
monitor. If the partici-
pant had not achieved at
least 50% improvement
by the third visit, they un-
derwent combined blad-
der-sphincter
biofeedback
Johnson 2000 Control: PFMT: 8 8 clinic visits, Physical therapist

PFMT + Advice + F supervised treatment ses- 8 weeks
sions + pictures and writ-
ten instructions for home
PFMT.
Home PFMT: Progress-
ing PFMT; one set of 10
one sec contractions with
one sec rest, 3 times a day
in lying or sitting position
in week one. In week 2:
2 times a day; PFM con-
traction holding for 10 sec
and relaxing for 10 sec,10
times. vPFMC was con-
firmed.
Advice: urge suppression

techniques + fluid, diet
and lifestyle modifica-
tion. Abdominal exercises
(pelvic tilts, bridging and
crunches) and diaphrag-
matic breathing.
verbal F: not further de-

fined.
Experimental: PFMT: as above. 8 clinic visits, 8 weeks Physical therapist

PFMT + Advice + clinic
EMG BF Advice: as above.
Clinic EMG BF: surface

electrodes were placed
around the anal sphincter
at 3 o’clock and 9 o’clock
place-
ments with the ground
electrode placed on the
buttock. Visual feedback
about the vPFMC was
provided back to the
woman through a line
graph on a screen (My-
oexerciser III Verimed In-
ternational Inc)
Tisseverasinge 2006 Control: PFMT: 4 clinic visits, 10 weeks + Physiotherapist

PFMT + BT + F instructions about PFM 3 months follow up.
anatomy and PFM func-
tion. Individualised pro-
gram for number of repe-
titions. All were advised to
practice 3 times daily for
6 months, in different po-
sitions (sitting, lying and/
or standing).
BT: instructed in blad-

der training (Wyman and
Fantl 1991) and urge
strategies. + behavioral
training consisting of ad-
vice about dietary fibre
and fluids and defeca-
tion technique was taught
(Markwell et al 1998)
F: PFM strength was
determined after vagi-
nal palpation according
to PERFECT (Laycock
1994). a vPFMC was as-
sessed as a squeeze around
the pelvic opening and an
inward lift (Kegel 1948).
Tactile feedback about the
vPFMC was only given at
the initial visit. The use of
accessory muscles was dis-
couraged. Measurements
of the PFM displacements

were collected by ultra-
sound, but subjects were
not allowed to view the
monitor. After the ini-
tial visit, only verbal F
based on clinical observa-
tion was provided
Experimental: PFMT: as above. 4 clinic visits, 10 weeks + Physiotherapist

PFMT + BT + US BF BT: as above. 3 months follow up.
BF: vPFMC
was confirmed by observ-
ing movement of the pos-
terior bladder wall (Bo
et al 2003 and Sherburn
et al. 2005) on transab-
dominal US (GE Medi-
cal, USA). A 2-5 MHz
curved linear array trans-
ducer was used for imag-
ing the ’lift’ component.
BF of the vPFMC was
provided by visual F, using
the transabdominal US at
each of the 4 visits
Tsai 2002* Control: PFMT: four stage PFMT 8 clinic visits, 8 weeks. Principal investigator;
PFMT + Advice + F (based on Kegel 1951) health
, including 1) muscle professional.
awareness 2) strengthen-
ing 3) endurance train-
ing and 4) muscle uti-
lization training. Training
standardised despite in-
dividual’s baseline EMG
data. Week 4: ’strengthen-
ing’ exercise x 15, 3 times
daily.
Advice: PFM awareness

and dietary education, lo-
cation and function of
PFM.
clinic F: Oral guidance

was provided by the in-
vestigator to help the sub-
jects performing PFM ex-

ercises
Experimental: PFMT: as above, but pro- 8 clinic visits, 8 weeks. Principal investigator;
PFMT + Advice + clinic gramme individually tai- health professional.
EMG BF lored, based on individ-
ual EMG baseline data,
with progression towards
45 vPFMC daily.
Advice: as above.
Clinic BF: 2-channel per-

ineal surface EMG BF
was used to visually pro-
vide information on the
PFM function; one chan-
nel represented abdomi-
nal muscle activity and
the other PFM activity
BF= biofeedback, BT = bladder training, EMG = electromyography, F = feedback, max = maximum or maximal, min = minute(s),
PERFECT = power or pressure, endurance, repetitions, fast contractions, every contraction timed, PFM = pelvic floor muscle, PFMT
= pelvic floor muscle training, sec = second(s), US = ultrasound, VFMC = voluntary pelvic floor muscle contraction.
Table 5. PFMT + BF versus PFMT + BF
Aukee 2002 Control: PFMT: At the first visit 5 clinic appointments, Physiotherapist
PFMT + clinic BF participants were educated 12 weeks
on the pelvic anatomy.
VPFMC taught and con-
firmed by EMG. Written
and verbal instructions for
home training: 20 min/day,
5 times a week, including
long and short duration ex-
ercises. Advised to practise
PFMT at rest and during
daily exercises. 4 clinic visits
with BF, at each session 3 x 5
sec contractions with 10 sec
intervals were performed in
supine and standing posi-
tion for later analysis
clinic BF: during the 5
Table 5. PFMT + BF versus PFMT + BF (Continued)
clinic visits a vaginal probe

was inserted which was con-
nected to EMG sensors.
Progress was shown through
graphic displays
Experimental: PFMT: as above 5 clinic appointments, Physiotherapist

PFMT + clinic BF + home clinic BF: as above 12 weeks
BF
home BF:
a home device was given to
the participants. Femiscan
(MegaElektronics, Kuopio,
Finland) consists of a vagi-
nal probe connected to
headphones and provides a
training program, a sound
processor for verbal instruc-
tions and sufficient memory
for one month of training.
While using the BF equip-
ment, the women could
move around without re-
strictions. As the woman
contracts her PFM, she is
told if she has met the pre-
scribed goal or target mus-
cle contraction. The tar-
gets were set from an of-
fice-based computer and
the participant could wit-
ness her progress through
graphic displays of results
Wong 2001 Control: Introductory session in- 8 clinic visits, Physiotherapist

PFMT + clinic vaginal BF cluded aetiology of SUI and 4 weeks
teaching of VPFMC (verbal
instruction)
PFMT: (from session 2 on-

wards) 5 sets of 3 ’fast’ con-
tractions (participants in-
structed to contract as hard
as possible), 2 ’slow’ con-
tractions (participants in-
structed to hold contraction
as long as possible), with
10 sec rest after each fast
contraction and 1 min after
Table 5. PFMT + BF versus PFMT + BF (Continued)
each slow contraction, three

min rest between sets.
Clinic
vaginal BF: (from session 2
onwards) A vaginal probe,
using the PRS9300 System
(Incare Medical Products),
was inserted into the vagina.
EMG data was presented
back to the women by a
graph on a screen. 2 sessions
per week for a total of 8 ses-
sions
Experimental: PFMT: as above. 8 clinic visits, Physiotherapist

PFMT + clinic vaginal BF 4 weeks
+ clinic abdominal EMG Clinic vaginal BF: as above.
BF Abdominal BF: a surface
electrode was attached to
the abdominal wall. To
record the activity of the ab-
dominus rectus, electrodes
were placed on both sides of
the umbilicus
BF= biofeedback, EMG = electromyography, min = minute(s), PFM = pelvic floor muscle, , PFMT = pelvic floor muscle training, sec
= second(s), VFMC = voluntary pelvic floor muscle contraction.
Table 6. Trialists’ rationale for adding feedback (F) or biofeedback (BF) to pelvic floor muscle training (PFMT)
Study Rationale for adding F or BF to PFMT, as described by the trialist
Aksac 2003 [conference abstract] BF is a form of learning or re-education in which the participant is retrained within
a closed feedback loop. Results of two methods ( F vs BF) for teaching pelvic floor muscle exercises were
compared.
[discussion] BF is one of the ways of teaching pelvic floor muscle (PFM) contraction. This method provides
both visual and auditory feedback in teaching to contract the muscles correctly
Aukee 2002 [conference abstract] Not stated.
[comment] The benefit of the EMG BF is that this device facilitates the acquisition of physiologic responses
that are otherwise undetected.
[Aukee 2004, discussion] EMG home BF offers the possibility of demonstrating contraction strength to the
participants and may thereby increase their motivation.
No additional rationale stated for clinic + home BF compared to clinic BF only, except from the assumption
Table 6. Trialists’ rationale for adding feedback (F) or biofeedback (BF) to pelvic floor muscle training (PFMT) (Continued)
that more privacy would lead to more improvement
Berghmans 1996 [introduction] BF was is the technique whereby information regarding ’hidden’ physiological processes is
displayed in a form understandable to the patient, to permit self regulation of these events (Krebs 1990). BF
can be used to teach an incontinent patient to be selective in the use of pelvic floor muscles. BF will enhance
to effect of the exercise programme. Support of BF in the beginning of therapy is of vital importance.
[discussion and thesis] BF is most important for optimal physiological improvement during the first treatments
Burgio 2002 anorectal BF was used to help patients identify pelvic floor muscles and teach them how to contract and relax
these muscles selectively while keeping abdominal muscles relaxed.
verbal F based on digital vaginal palpation was used in the first treatment with the aim to teach them how
to contract the pelvic floor muscles. Verbal F on voluntary external anal sphincter contraction was given if
contraction could not be detected vaginally
Burns 1993 [randomization] The BF therapy included one coaching session of 20 minutes to teach participants how to
contract and relax the pubococcygeus muscle.
[discussion] Biofeedback provided a mechanism for clients to identify the appropriate muscle as well as a
sense of accomplishment as they increased their contraction scores.
Castleden 1983 [abstract] Suggested that BF may play an important in instructing the patient on the correct use of the pelvic
floor muscles.
[introduction] Objective information provided by a perineometer might increase motivation.
[results] Subjectively the patients liked to be able to measure their improvement and thought the machine
confirmed that they were practising the right exercises
Glavind 1996 [abstract] BF is a method of pelvic floor rehabilitation using a surface electrode inserted into the vagina and
a catheter in the rectum.
BF is a method which teaches women (who are not aware of their pelvic floor muscles) how to contract the
pelvic floor muscles or how to avoid a simultaneous rise in intra-abdominal pressure.
[discussion] It was indicated that women who received BF were more motivated for training afterwards
Goode 2003 [intervention] anorectal BF was used to help participants how to identify and isolate the pelvic floor muscles
and teach them how to contract these muscles selectively while keeping abdominal muscles relaxed.
Johnson 2000 [introduction and background] BF is often used to teach and to enhance pelvic floor exercises and learn to
control isolation and endurance of the correct muscle. BF is thought to be a valuable tool in educating women
(who are unable to perform a pelvic floor muscle contraction following written and verbal instruction) on the
location and use of their pelvic floor muscles. Skills learned through biofeedback can also be used to inhibit
bladder contraction; thus this treatment can also be utilized for urgency incontinence.
[discussion] BF or F as a learning style was provided to keep women motivated and competitive against
themselves.
Laycock 2001 [background] A variety of BF devices has been developed that are thought to increase the participant’s
motivation for training. BF is a means of informing a participant about a certain body function of which he/
she might otherwise be unaware, so that this function can be modified.
McClurg 2006 [intervention] Verbal encouragement was provided to reinforce strength and endurance and encourage max-
imum relaxation
[discussion] BF was used to increase proprioception of the pelvic floor muscles and facilitate contraction and
relaxation.
Morkved 2002 [introduction] BF has been defined as a group of experimental procedures where an external sensor is used to
give an indication on bodily processes (Schwartz 1977). BF on pelvic floor function has been used to make
women more aware of muscle function and to enhance and motivate patients’ effort during training.
[discussion] Surface EMG aims to measure recruitment of activated motor units. Squeeze pressure aims to
measure muscle strength including both activated motor units and the effect of muscle volume. The use of
an apparatus during training may motivate many women. Described that it has been suggested that BF can
teach women how to contract correctly and that they can learn faster.
Pages 2001 [background] BF aims to teach women how to perform exercises and perform them properly.
[discussion] BF helps to isolate the pelvic floor muscles.
Schmidt 2009 [introduction] BF defined as the process of recording physical activity and showing it to the participant
(Moore 2000).
BF is a useful method to re-educate pelvic floor muscles and treat multiple voiding symptoms.
[discussion] BF is useful to promote correct control of contraction and visualization, because many women
cannot, at first, contract their pelvic floor muscles, and require some type of motivation.
By using BF the woman can correct or enhance the exercise.
Shepherd 1983 Not rationale stated.
Sherman 1997 No rationale stated, but teaching was described in discussion.
Smidt 1997 [introduction] BF useful as means for teaching women (who are not aware of their pelvic floor muscles) how
to contract their pelvic floor muscles
Taylor 1986 [discussion] BF device is useful in early identification of the correct muscle and a motivating factor in
increasing the strength of contractions.
Tejero 2008 Not rationale stated.
Tisseverasinghe 2006 [thesis] Using either visual (BF) or tactile (F) feedback as knowledge of results (KR), provides information
about the correctness of the PFM contraction. KR provides information to guide these women during this
initial stage of learning of getting the idea of a correct PFM contraction.
Tsai 2002 [thesis; statement of the problem] BF serves as a teaching technique, which is based on operant conditioning
and facilitates learning by providing patients with immediate and observable information about physical
performance.
BF is used to teach patients to selectively contract and relax their pelvic floor muscles, while keeping other
muscle groups, such as abdominal muscles, relaxed. [...] It has also been demonstrated that skills learned
through biofeedback can be used to inhibit bladder contractions in the treatment of urge incontinence
(Neggard, Kreder & Lepic, 1996) [...] Since biofeedback is relatively more expensive than verbal instruction
and requires greater expertise to use, additional research is needed to evaluate its effectiveness relative to verbal
instruction
[thesis; methodology] the aim was to compare two different instruction methods (F vs. BF)
[thesis Instrumentation and Measures] Surface EMG monitoring techniques offer greater convenience than
the traditional approach of using an intra-vaginal balloon to measure intra-vaginal pressure.
[thesis; intervention] verbal instruction or BF assisted instruction were used (depending upon treatment
group assignment) to teach subjects to correctly perform the component of PFMT programme
Tsai 2009 [discussion] Verbal F after digital vaginal palpation can be a useful strategy in assisting women properly
perform their exercises
Wang 2004 No rationale stated.
Williams 2006 No rationale stated.
Wilson 1987 [patients and methods] BF was used to make women more easily aware of which muscles to contract.
[discussion] BF is useful for teaching the woman how to perform a vPFMC. It also allows an objective
assessment of contractility and encourages women during treatment.
Wong 2001 [introduction] BF was used to teach women with stress urinary incontinence to minimise the abdominal
muscle contractions during pelvic floor muscle exercises.
[discussion] The use of BF appears to improve compliance with an exercise programme and enables progress
to be monitored
[ ] = source of information in paper
underline = our emphasis (with regard to inferred or stated purpose)
BF= biofeedback, EMG = electromyography, F = feedback, PFMT = pelvic floor muscle training, VFMC = voluntary pelvic floor
muscle contraction.
HISTORY
Review first published: Issue 7, 2011
CONTRIBUTIONS OF AUTHORS
Development of title and protocol were undertaken by RH and all other authors. Titles, abstracts and trials were independently screened
for eligibility by RH and JHS. Appraisal of quality and data extraction were undertaken by RH, JHS, MJH and PH. Cross checking
of screening and data extraction was undertaken by RH, JHS and MJH. Data were entered by RH and analysed and interpreted by
RH, JHS, and PH. Writing of the review was done by RH, JHS and PH and edited by and commented on by MJH, JPWR and PH.
Methodological advice was provided by PH. There was no funding for the review.
DECLARATIONS OF INTEREST
None declared.
SOURCES OF SUPPORT
Internal sources
• Academic Medical Centre, Amsterdam, Netherlands.
• University of Otago, Dunedin, New Zealand.
External sources
• No sources of support supplied
DIFFERENCES BETWEEN PROTOCOL AND REVIEW

We used a subgroup analysis in the review (no difference in PFMT versus difference in PFMT programme) that was not anticipated
as one of the four pre-specified possibilities at protocol stage.
INDEX TERMS
Medical Subject Headings (MeSH)

Biofeedback, Psychology [methods; ∗ physiology]; Exercise Therapy [∗ methods]; Feedback, Physiological [∗ physiology]; Muscle Con-
traction [physiology]; Pelvic Floor; Urinary Incontinence, Stress [∗ rehabilitation]; Urinary Incontinence, Urge [∗ rehabilitation]
MeSH check words
Female; Humans

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Feedback or biofeedback to augment pelvic floor muscle

training for urinary incontinence in women (Review)

Herderschee R, Hay-Smith EJC, Herbison GP, Roovers JP, Heineman MJ

Feedback or biofeedback to augment pelvic floor muscle

Editorial group: Cochrane Incontinence Group.

PLAIN LANGUAGE SUMMARY

Definitions jointly recommended by the International Inconti-

Why it is important to do this review

Search methods for identification of studies

Assessment of reporting biases Description of studies

Feedback and Biofeedback (BF)

Trial Measurement Trialists definition Our categorisation

Morkved 2002 Self report of severity, 5 point scale “unproblematic” cured

Pages 2001 “Subjective improvement” “no incontinence episodes” cured

Sherman 1997 Subject’s rating of severity of problem “non existing” cured

Wang 2004 Subjective improvement, 3 “resolved” cured

Wilson 1987 Subjective improvement, 3 point “much improved” improved

Not cured or improved (Analysis 1.2)

Symptom Distress (Analysis 4.7)

Other outcomes of interest, not pre-specified: Pad and paper

Characteristics of included studies [ordered by study ID]

Methods 3-arm RCT, parallel design.

Participants 50 women with USI, from a single centre in Turkey.

Interventions Details of PFMT, F and BF in Table 4

Outcomes Primary endpoint: 8 weeks.

Notes Dropouts: nothing stated

Bias Authors’ judgement Support for judgement

Incomplete outcome data (attrition bias) Unclear risk No dropouts reported.

Other bias Unclear risk Funding or financial assistance: unclear.

Methods 2- arm RCT, parallel design

Participants 35 women with USI, from a single centre in Finland.

Interventions Details of PFMT, clinic BF and home BF in Table 5

Outcomes Primary endpoint: 12 weeks.

Bias Authors’ judgement Support for judgement

Other bias Unclear risk Funding or financial assistance: not stated.

Methods 2- arm RCT, parallel design.

Interventions Details of PFMT and BF in Table 1

Outcomes Primary endpoint: 4 weeks.

Bias Authors’ judgement Support for judgement

Other bias Unclear risk Funding or financial assistance: not stated.

Methods 3- arm RCT, parallel design.

mented, average 2 or more urge incontinence episodes/week, urge predominant pattern

Interventions Details of PFMT, F in Table 2

Outcomes Primary endpoint: 8 weeks

Bias Authors’ judgement Support for judgement

1. participants analysed in group to which

Selective reporting (reporting bias) Low risk

Other bias Low risk Funding or financial assistance: yes, source

Methods See Burgio (a) 2002.

Participants See Burgio (a) 2002.

Interventions Details of PFMT and BF in Table 1

Outcomes See Burgio (a) 2002.

Bias Authors’ judgement Support for judgement

See Burgio (a) 2002

Other bias Low risk See Burgio (a) 2002

Methods See Burgio (a) 2002.

Participants See Burgio (a) 2002.

Interventions Details of PFMT, verbal F and BF in Table 4

Outcomes See Burgio (a) 2002.

Bias Authors’ judgement Support for judgement

Other bias Low risk See Burgio (a) 2002

Methods 3- arm RCT, parallel design.

Interventions Details of PFMT and BF in Table 1