CLINICAL ARTICLE

Laparoscopically assisted balloon vaginoplasty for

management of vaginal aplasia
A.M. El Saman, M.M.F. Fathalla

, A.M. Nasr, M.A. Youssef

Department of Obstetrics and Gynecology, Assiut University, Egypt
Received 20 November 2006; received in revised form 16 March 2007; accepted 11 April 2007
Abstract
Objective: To report the intra-operative and post-operative results of laparoscopically assisted
balloon vaginoplasty, a new technique for management of vaginal aplasia. Methods: Eight women
withvaginal aplasia dueto Mullerianagenesis who werereferredfor apareunia, dyspareunia. All had
a poor penetration score and sexual satisfaction score. A Foley's catheter was laparoscopically
inserted inthe space between the urethra and rectum. Gradual traction and distensionwereusedto
create a neovagina. Outcomes measured were intra-operative complications, post-operative
complications, length of the neovagina and post-operative complications and sexual satisfaction
score in both partners. Results: Mean operative time was 25.5+/5.5 min. No operative
complications were recorded. Pain scores ranged from zero to 30 points at rest and from 30 to 60
points during dressing, traction and distension. Penetration and satisfaction scores increased
significantly after the operation. Conclusions: Balloon vaginoplasty is a simple, safe and satisfactory
technique for management of blind vagina.
2007 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd.
All rights reserved.
KEYWORDS
Vaginal aplasia;
Laparoscopy;
Balloon vaginoplasty
1. Introduction
Current therapy for vaginal agenesis involves the creation of
a vagina and appropriate psychosocial support. Three dif-
ferent therapeutic modalities are available for creation of a
neovagina.
The first modality is non-surgical use of serial vaginal di-
lators. The Frank technique used hand-held vaginal dilators in
a squatting position [1]. Although dilation could be accom-
plished, the position was awkward, and the patient was unable
to do any other task during the hours of daily pressure required
[2]. The method of Ingram [1] used a patient's own trunk
weight to apply pressure while sitting on a stool or bicycle seat
but dilation may fail and some women prefer immediate
surgical repair rather resorting to the prolonged dilation tech-
niques [2].
Most of the surgical treatment methods depend on creation
of a space by dissection between urinary tract and rectumthat
is covered by a graft and a mould or a form is used to maintain
the latter. The cover for the space may be either split-
thickness skin, various segments of the colon, peritoneum,
myoperitoneal flaps, various skin flaps, buccal mucosal grafts,
Corresponding author. PO Box 30, Assiut, Egypt. Tel.: +20 88
2316205; fax: +20 88 2337333.
E-mail address: mofath@hotmail.com (M.M.F. Fathalla).
0020-7292/$ - see front matter 2007 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd.
All rights reserved.
doi:10.1016/j.ijgo.2007.04.013
avai l abl e at www. sci encedi r ect . com
www. el sevi er. com/ l ocat e/ i j go
International Journal of Gynecology and Obstetrics (2007) 98, 134137
fetal skingrafts, and amnion or Interceed [1]. Although surgery
is the gold standard, it requires a great deal of skill.
Complications ranged from graft loss, contracture, donor site
problems, uretheral sloughing to recto-vaginal fistula forma-
tion [3].
In the Vecchietti procedure [4,5], continuous progressive
pressure is exerted by an acrylic olive applied to the vaginal
dimple with gradual traction applied by a traction device that
draws the olive upward. This intervention yields very good
results in anatomic and sexual function. It, however, requires
a laparotomy and a prolonged post-operative hospital stay. A
laparoscopic Vecchietti [57] procedure was described but it
also requires high technical expertise.
This wide variety of methods shows that an ideal approach
has not yet been found. Unfortunately till now, no modality
fulfills the goals of safety, simplicity, effectiveness and high
acceptability [2].
2. Patients and methods
This work included eight cases with vaginal aplasia referred
to the Department of Obstetrics and Gynecology Assiut
University Hospital.
2.1. Pre-operative assessment and counseling
History included, in addition to demographic data, an
assessment of sexual performance and satisfaction that
were assessed by a visual analogue scale that was graduated
from zero to 100 divided into 10 compartments each
representing 10 points. The male partner was involved in
filling a similar visual scale with emphasis on 2 points, depth
of penetration, if present and satisfaction. Intravenous
urography and renal ultrasound were performed for possibi-
lity of associated renal anomalies.
Counseling included description of the procedure, advan-
tages, disadvantages, possible complications and alterna-
tives. The need for compliance with post-operative distension
and traction and early resumption of a regular sexual
intercourse were emphasized. Appropriate psychosocial
advice and support was offered. Informed consent was
obtained fromthe women and their partners. Ethical approval
of the department of Obstetrics andGynecology was obtained.
2.2. Technique
The procedure started with a diagnostic laparoscopy. After
thorough evaluation of the pelvic and other intra-abdominal
organs, the telescope was directed to visualize the pelvic
peritoneum. Meanwhile, pressure was exerted on the
vaginal dimple by a finger to identify abdominally the pelvic
peritoneum. Then, the catheter introducer carrying the
Foley's catheter (Fig. 1), a device that was developed by one
of the authors (AME) and manufactured in a local workshop,
was advanced in the midline immediately above the
symphysis pubis under vision intraperitoneally until it
touched the finger-elevated vaginal dimple. Then, the
catheter introducer perforated through the vaginal dimple.
To avoid injury of the bladder and urethra, the introducer
was applied under vision form above aided by a forward
retraction of the bladder dome away from the introducer. In
patients who had a rudimentary uterus, the space was
perforated behind the uterine knob to keep away from the
bladder. Rectal injury was avoided by perineal tactile
guidance of the introducer with backpressure on the dimple
to press the anterior rectal wall backwards so that the finger
forms a barrier between the site of perforation and the
rectum. A rectal examination followed the perforation of
the vaginal dimple to ascertain that the rectum was intact.
As the balloon appeared at the perineum it was inflated
with 10 cc saline. Then traction was done till disappearance
of the balloon carrying up the vaginal dimple above the
perineal plain. PovidoneIodine paint was applied on the
abdominal wall around the catheter. A Dexon 00 purse string
suture was tied around the catheter's abdominal opening
and around the catheter opening in the vaginal dimple. Then
a sterile gauze dressing, opened in the middle, was applied
to the wound around the abdominal wall catheter opening.
The catheter was then passed through the hole of a
supporting plate (a fenestrated metal plate that is placed
above the dressing to distribute the pressure evenly over the
dressing) and an umbilical cord clamp was applied on the
catheter to maintain traction on the catheter (Fig. 2).
3. Post-operative assessment and care
The post-operative care consisted of preventing infection
and controlled upward traction (2 cm a day) and controlled
distention (3 ml every other day) for 7 days.
Figure 1 The catheter introducer perforating through the
vaginal dimple.
Figure 2 Fenestrated metal plate.
135 Laparoscopically assisted balloon vaginoplasty for management of vaginal aplasia
Prevention of infection was done through antibiotic prophy-
laxis (Ampicillin 1 g/8 h as long as the catheter was in placeand
gentamycin 1.5 mg/kg/day for 48 h), daily abdominal port
dressing, in addition to perineal and vaginal care with ample
gentamycin cream application.
To help prevent pressure erosion and necrosis, counter
traction on the balloon from the perineal aspect, using a
silk suture anchored to the catheter tip, was applied every
2030 min during the first 6 h after the daily increase in
traction. Upward massage of upper thigh and inward massage
of perineal skin were also done to relieve the pressure exerted
by balloon traction and distension.
The catheter was removed after 7 days by deflating the
balloon and pulling it upwards. The patient was then dis-
chargedand advised to have regular sexual intercourse at least
three times weekly. Patients were scheduled for post-opera-
tive follow-up.
Follow-up was done one week after discharge from the
hospital. The vaginal length was measured from the apex
of the vagina to the external vulvar skin and the
penetration and satisfaction score were measured. There-
after, patients were scheduled to be seen monthly for three
months then every 3 months for the first year. Patients
were encouraged to come anytime they have a query or a
concern.
4. Results
4.1. Demographic characteristics
Patients' age at diagnosis ranged from 1518 years. The age
at operation was 2031 years. Three women were illiterate,
one could read and write, 2 had school education, and two
receiveduniversitydegrees. All weremarriedfor 672months.
Indication for referral was apareunia in 3 cases and dyspar-
eunia in the remaining 5 cases with poor sexual satisfaction in
all cases.
5. Pre-operative assessment
Six had complete Mullerian agenesis. One had a uterine knob
and one had a hemihypoplastic uterus with no active endo-
metrium. One had a supernumerary ureter on the right side.
No associated skeletal anomalies were found. Pre-operative
sexual satisfaction scores are shown in Table 1.
6. Operative and post-operative data
Operative time ranged from 1826 min with no intra-
operative complications. Post-operative pain scores ranged
Table 1 Pre-operative data of the study group
Case 1 Case 2 Case 3 Case 4 Case 5 Case 6 Case 7 Case 8
Age (years) 21 21 18 25 31 18 22 21
Residence Rural Rural Rural Rural Urban Rural Rural Rural
Penetrations scores/100 (patient) 0 10 0 20 30 10 0 0
Penetrations scores/100 (husband) 0 0 0 20 30 10 0 0
Satisfactions scores/100 (patient) 10 10 0 30 50 10 10 10
Satisfactions scores/100 (husband) 10 10 0 30 50 10 0 0
Depth of vaginal dimple 2 cm 2 cm 1 cm 3 cm 4 cm 2 cm 1 cm None
Table 2 Operative and post-operative findings
Case
1
Case
2
Case
3
Case
4
Case
5
Case
6
Case
7
Case
8
Operative time (minutes) 25 21 26 22 20 18 18 18
Intra-operative complications None None None None None None None None
Post-operative pain scores
During rest 20 10 30 00 40 30 10 40
During traction 40 30 50 30 50 60 30 50
Post-operative complications None Catheter balloon
burst
None Impending erosion
of Neovagina
a
None None None None
Hospitalization (days) 10 6 9 12 10 10 9 7
Penetrations scores/100 (patient) 80 60 80 90 90 90 80 70
Penetrations scores/100 (husband) 90 40 100 80 100 70 90 40
Satisfactions scores/100 (patient) 90 70 100 80 100 90 80 50
Satisfactions scores/100 (husband) 90 70 100 80 100 70 90 30
Depth of vaginal dimple 11 cm 6 cm 9 cm 11 cm 10 cm 12 cm 10 7 cm
a
Widening of the vaginal opening around the catheter.
136 A.M. El Saman et al.
from zero to fifty points at rest and 3060 points during
dressing. There was one case of minimal purulent discharge
around the catheter on the 7th post-operative day that
improved on increasing the frequency of wound care. There
was also one case of impending erosion of the neovagina
(widening of the catheter opening in the neovagina) due to
increased traction to 4 cm a day. Relieving the tension and
resuming it after 2 days at the regular pace. Hospital stay
was 612 days. Penetration and satisfactions scores were
increased for both partners as shown in Table 2.
7. Discussion
The initial results of this new procedure are quite encoura-
ging on terms of its simplicity and results. The procedure does
not require high expertise in laparoscopy and can be taught
easily to any gynecologist with basic laparoscopy skills.
The procedure does not involve perineal dissection, graft
harvesting or colonic surgery. This contributes to more pa-
tient's comfort and early coitus resumed without pain. It also
avoids all the cited complications of dissection between these
areas [1].
Although the laparoscopic version of Vechietti's procedures
is also simple, patient discomfort may be high at least initially
[4,5]. This may be because the acrylic olive used in the
Vechietti's procedures is hard and probably more compressive
than the soft and resilient catheter balloon. Should this be
proved in comparative studies of the two techniques, this
could be another asset of the balloon vaginoplasty. Balloon
vaginoplasty has an added benefit of distension of the balloon
creating width in addition to the gain in length offered by
gradual traction. This should contribute to a more satisfactory
intercourse.
In graft procedures, coitus is resumed after many weeks of
dilation and mould retention. Coitus with the present proce-
dure has been resumed once the patient was discharged from
the hospital with only minimal discomfort that improved few
days later.
Despite the simplicity of the procedure, the satisfaction of
both the patients and their husbands were high as demon-
strated by the satisfaction scores. However, longer follow-up is
needed to ascertain that the satisfaction and vaginal length
are maintained.
The need for appropriate wound care cannot be over-
emphasized. Also, catheter balloon distension has to be grad-
ual to avoid erosion of the vagina. Should this happen, it is
recommended to relieve the extra tension and delay the
traction and distension until healing is effected.
Inconclusion, this technique is a simpleand safealternative
for the management of vaginal aplasia. More studies are need-
ed concerning the effectiveness in more patients. Longer
follow-up is also necessary before recommending this techni-
que for clinical practice.
References
[1] Nichols D, Randall C. Creation of a neovagina. In: Nichols D,
Randall V, editors. Vaginal surgery, 4thedition. Baltimore: Williams
& Wilkins; 2000. p. 47599.
[2] Roberts C, Haber M, Rock J. Vaginal creation for Mllerian agenesis
transactions of the Twenty-Seventh Scientific Meeting of The
Society of Gynecologic Surgeons 2001, Part 1; 2001. p. 1856.
[3] Ohashi S, Ikumal K, Koyasn Y, et al. Laparoscopic reconstruc-
tion of vagina using sigmoid autograft. Surg Endosc 1996;10:
101921.
[4] Veronikis DK, McClure GB, Nichols DH. The Vecchietti operation
for constructing a neovagina: indications, instrumentation, and
techniques. Obstet Gynecol Aug 1997;90(2):3014.
[5] Gauwerky JF, Wallwiener D, Bastert G. An endoscopically
assisted technique for construction of a neovagina. Arch Gynecol
Obstet 1992;252(2):5963.
[6] Kaloo P, Cooper M. Laparoscopic-assisted Vecchietti procedure
for creation of a neovagina: an analysis of five cases. Aust N Z J
Obstet Gynaecol 2002;42(3):30710.
[7] Borruto F, Chasen ST, Chervenak FA, Fedele L. The Vecchietti
procedure for surgical treatment of vaginal agenesis: compar-
ison of laparoscopy and laparotomy. Int J Gynaecol Obstet
1999;64(2):1538.
137 Laparoscopically assisted balloon vaginoplasty for management of vaginal aplasia