New minimal invasive trocar-less system for the treatment of pelvic organ

prolapse: short and long term results of first 30 patients

Naama Marcus-Braun, Peter von Theobald *

Department of Gynecology Obstetrics and Reproductive Medicine, University Hospital of

Caen, France

* Corresponding author:
Prof. Peter von Theobald
Department of Gynecology Obstetrics and Reproductive Medicine
University Hospital of Caen
14033 Caen cedex, France
Tel : 00 33 2 31 27 25 33
Fax : 00 33 2 31 27 23 37
E. mail: vontheobald-p@chu-caen.fr

1
Abstract

Objective: to evaluate short and long term outcomes of the EndoFast Reliant system, a new

trocar-less technique for the treatment of genital prolapse.

Methods: this is a retrospective review, including all patients treated with the EndoFast

Reliant system between Mars 2007 and January 2010.

Results: thirty patients were operated with the system with 19 patients reaching more than 1

year follow-up. Perfect anatomical results were obtained for 26 patients and 3 patients

presented stage 1 prolapse post-operatively. There were neither intra-operative nor post-

operative mesh-related complications and we had one kit-related complication. Few cases of

de novo Stress urinary Incontinence and urgency were diagnosed however post-operative

voiding difficulties, dyspareunia and perineal pain were not observed.

Conclusions: the EndoFast Reliant system was found to be a safe and quick procedure with

very satisfactory anatomical and functional results. The trocar-less technique seems to reduce

potential intra and post-operative complications. Larger comparative studies are required

before final conclusions.

Key words: EndoFast Reliant system, Vaginal mesh, Trocar-less, Single vaginal incision,

Pelvic Organ Prolapse

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Introduction

In pelvic reconstructive surgery, recurrence of genital prolapse, especially of cystocele is one

of the main concerns and can reach up to 40% [Julian 1996, Whiteside 2004]. The high

recurrence rate of Pelvic Organ Prolapse (POP) after repair with autologous tissues along with

the introduction of mesh to treat incontinence by the TVT in the 90ies of the last century

[Ulmsten 1996], resulted in a dramatic progress and development of transvaginal mesh

surgery for the reinforcement of the vaginal wall. Most of the transvaginal kits available today

to treat Stress urinary Incontinence (SUI) and POP require trocars to introduce the mesh. The

trocars which pass blindly through the pelvic walls can cause intra and post-operative

complications including: haematomas, injury to the surrounding organs like bladder, urethra

or rectum and pain in cases of nerve capture or injury (Caquant 2008, Bako 2009, Jacquetin

2009, Eboue 2010, Marcus-Braun 2010). In the last 3 years, there is an attempt by the trans-

vaginal kit’s manufactures to find a solution for the introduction of the mesh which will be

less invasive, trocar-less and at the same time effective. Up to date, few trocar-less kits are

available in the market but publications regarding their safety, efficacy and outcomes are

lacking.

The EndoFast Reliant system (Endogun Medical Systems Ltd., Israel) is a minimally invasive

system for the treatment of POP using a single-incision, trocar-less technique. The system has

the approval of the U.S Food and Drug Administration (FDA) and is already commercialized

in certain countries. The system employs a novel technology for reinforcement of the vaginal

wall using Endogun’s Spider Fastener technology and consists of a polypropylene

monofilaments mesh and soft-tissue fasteners. The procedure is performed trans-vaginally

without any need of per-cutaneous incisions or blind trocar passages. The fasteners are easily

deployed through narrow spaces into soft tissue, and can support an average weight of 1.0 kg

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each, far more than required in a typical POP repair procedure (Alcalay M, abstract ICS

2009).

In the University Hospital of Caen we applied a protocol for the treatment of POP with trans-

vaginal mesh since 2001. While anticipating the advantages of minimal invasive trocar-less

kits, we started to use the EndoFast Reliant system in 2007. We thereby conclude our short

and long term results of the first 30 patients with regards to surgical technique, anatomical

results, functional outcome and complications.

Methods

A retrospective study was conducted in the University Hospital of Caen, including all patients

operated for the treatment of POP with the EndoFast Reliant system between Mars 2007 and

January 2010. The ethical committee of CNGOF (Collège National des Gynécologues et

Obstétriciens Français) approved the study. The aims of the study were to evaluate the short

and long term outcomes with regards to anatomical and functional results as well as intra- and

post-operative complications of the procedure.

Data were collected from the patient's files and included: demographic features, pre-operative

and post-operative evaluation including Pelvic Organ Prolapse Quantification (POP-Q),

functional symptoms and results. All patients were asked systematicly pre- and post-

operatively about urinary, defecation and pain symptoms. Questions included investigation of

SUI, urgency, voiding difficulties, nocturia, constipation, fecal or gas incontinence, perineal

pain and dyspareunia. Urodynamic testing and complimantery imaging tests were performed

upon need. Data regarding the operation included: anansthesia, intra-operative complications,

operation time, Visual Analogue Scale (VAS) at 12, 24 and 48 hours, pain killers and doses,

post-operative complications and hospital stay. Post-operative evaluation: POP-Q and

functional results were collected at each post-operative visit. Patients were followed 6 weeks,

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6 months and 1 year after the operation and were advised to return with any problem. Prolapse

stage was determined by using the ICS POP quantification and staging system (Auwad 2004).

Surgical technique

The EndoFast Reliant system consists of a polypropylene monofilaments mesh and soft-tissue

fasteners; Endogun’s Spider Fastener (Figure 1). The anterior mesh is designed for the

treatment of cystocele and has 4 arms. The posterior mesh is designed for the treatment of

central defect with or without accompanied rectocele or for the treatment of isolated rectocele

and has 4 arms. Both meshes are supplied with 2 sets of accessory arms which can be

trimmed according to vaginal length. The spider fastener attaches the mesh to the soft tissue

under direct view and/or palpation.

Anterior repair:

Dissection: a midline full thickness incision is performed on the anterior vagina extending up

to 2 or 3 centimetres from the urethral meatus. The bladder is dissected away from the vaginal

wall, leaving the Halban’s fascia on the epithelium. The para vesical fossas are opened until

the ischial spine and the arcus tendineous of the levator ani are reached posteriorly and the

ischiopubic rami anteriorly.

Mesh insertion using the Fixation Devices: The posterior part of the mesh is sutured to the

uterine cervix or to the vaginal vault with one or two absorbable sutures. The posterior arms

are fixed through the same incision by using the spider fasteners to the soft tissue which

covers the ischial spine, 1 cm laterally on both sides. The anterior arms are fixed through the

same incision to the fascia of the obturator muscle using the fasteners. The attachment of the 4

arms in these anatomical landmarks creates a tension-free, sub-vesical hammock to treat the

cystocele.

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Posterior repair:

Dissection: a midline full thickness incision is performed on the posterior vagina extending up

to 1 centimetre from the uterus cervix or vaginal vault. The para rectal fossas are opened until

the ischial spine and the sacrospinous ligaments are reached.

Mesh insertion using the Fixation Devices: The anterior part of the mesh is sutured to the

utero-sacral ligaments or to the vaginal vault with one or two absorbable sutures. The anterior

arms of the mesh are fixed to the sacrospinous ligaments, 2 cm from the ischial spine by using

the spider fasteners which are inserted through the same incision. In cases of rectocele, the

posterior arms are fixed to the elevator ani muscle on both sides after dissection of the rectum.

When both anterior and posterior repair are required, it is important to keep a complete

separation between the incisions and no connection between the anterior and the posterior

meshes. The dissections of the para-vesical and para-rectal fossas are made before the

insertion of the mesh. The posterior mesh is inserted first while correcting immediately the

central or posterior defect and facilitated the insertion of the anterior mesh.

Results

Between Mars 2007 and January 2010, 30 patients were operated in our department with the

EndoFast Reliant system. Up to date, 10 patients reached 24-30 months follow-up, 9 patients

reached between 12-18 months follow-up, 4 patients had 10 months follow-up, 8 patients

were followed 6 weeks post-operatively and one patient was lost for follow-up. Mean age was

65 years (range, 34-79), Mean BMI was 25.5 (range, 19.5-37.1) and mean parity was 2.7

(range, 0-6). Nine patients underwent the operation under spinal anaesthesia and 21 under

general anaesthesia.

Demographic features and POP-Q pre and post-operatively are presented in Table 1 and

Figure 2 demonstrates the stage of the prolapse before and after the operation. Functional

6
results with regards to urinary symptoms, defecations problems and pain are presented in

Table 2. Six patients went through anterior repair, 4 had posterior repair and 19 had

simultaneous anterior and posterior repair. Six patients had in addition sub-urethral sling for

SUI. Table 3 summarized the intra- and post-operative complications, mean operation time

and hospital stay. There were no intra-operative complications, neither post-operative nor

mesh-related complications. One patient had kit-related complication 2 months after the

operation which required the removal of one fastener who was found to be too superficial and

was disturbing her during sexual intercourse.

Mean VAS score for the 1st day was 1.1 (range, 0-4), for the 2nd day 1.5 (range, 0-6) and for

the 3rd day 1.2 (range, 0-3). Patients received pain killers during hospital stay according to our

protocol and the use of pain killers in the post-operative period is summarized in Figure 3.

Discussion

Vaginal wall reinforcement surgeries with transvaginal mesh for the treatment of POP are

well established in the literature with large series and randomized trials proving safety, high

cure rates and patient's satisfaction (Fatton 2007, Caquant 2008, Abdel-Fattah 2008, Eboue

2010, Sivaslioglu 2008, Nguyen 2008). While becoming the gold standard operations for the

treatment of POP, many commercial kits are available today for introduction of the mesh;

most of them are trocar-guided. The introducing of the mesh can cause intra and post

operative complications, especially when the anatomical knowledge of the pelvic structures

and the correct passage of the trocars is lacking.

The advantages of the trocar-less systems are gained mainly by bypassing the need of blind

trocar insertion. While reducing the probability for complications, the trocar-less system also

provides a quicker and less invasive operation. The EndoFast Reliant system which comprises

of a polypropylene monofilaments mesh (23g/m2) and soft tissue fasteners, is already

7
commercialized and has the approval of the FDA for the treatment of POP. The device has

been developed in order to enable direct and safe mesh attachment into pelvic soft tissue,

hence potentially reducing complications and post-operative morbidity, which are associated

with multiple incisions and the blind passage of trocars. The Endogun’s Spider Fastener can

be easily and directly deployed trans-vaginally in narrow spaces into the soft tissue via a

single vaginal incision and support substantially more weight than other available trocar-

guided techniques. In addition the system includes an extraction device which allows simple

intra-operative reversibility of fixation without causing damage to the tissue or the mesh. One

big advantage of the fasteners is their superficial hold of the tissue which can reduce the

possibility for muscle hematomas, nerve injury and post operative pain.

Our results with the EndoFast Reliant system for the first 30 patients are very satisfactory.

The procedure was found to be easy to learn and to implement, with rather short operative

time. We had neither intra-operative complications nor immediate post-operative

complications like hematomas, infections or voiding difficulties which are the most common

immediate post-operative complications after mesh surgeries (Eboue 2010). Hospital stay was

4 or 5 days for most patients and is consistent with our mean hospital stay for vaginal

surgeries which is 4.6 days (Eboue 2010). Hospital stay included a day before the operation,

the day of the operation and 2 or 3 days post-operatively. Post-operative pain during the first 3

post-operative days was low according to mean VAS score. Our pain killer's protocol

consists of 2 basic analgesic drugs and was admitted to the patients upon request. During the

first operative day, 41% of the patients needed only one analgesic drug or nothing and only

one patient required additional third drug for the management of pain. During the 2nd day,

almost 50% of the patients needed only one drug or nothing and 86% in the 3rd day.

The anatomical results were considered perfect for 26 out of 29 patients (89.6%) for a mean

follow-up of more than one year for the majority of our patients. Two patients had a stage 1

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cystocele (in both Ba at –1) one year after the operation which was not symptomatic and did

not require any additional intervention. One patient with pre-operative stage 3 cyctocele

(point Ba at +3) and uterine descend stage 2 (point C at +1), developed cervical elongation

(point C at –1) which was not symptomatic.

Stress urinary incontinence was diagnosed in 7 patients pre-operatively and 6 patients had

additional sub-urethral sling during the prolapse repair. Six other patients developed a certain

degree of de novo SUI after anterior repair (26%) but only 3 (13%) required sub-urethral

sling. The appearance of SUI after cystocele repair is discussed widely with contradiction

results regarding the effectiveness of prophylactic sub-urethral sling in cases of cystocele

repair and the de novo SUI rates which are varying from 2-45% (Haessler 2005, Kleeman

2006, Visco 2008). Out of 16 patients that had urgency symptoms pre-operatively, 11 (68.7%)

were cured by the repair of the prolapse and 2 patients developed de novo urgency. Five out

of 6 patients (83%) who suffered from incomplete voiding pre-operatively were cured by the

repair of the prolapse and there were no de novo cases. In our transobturator 4 arms mesh

series (Eboue C), we reported a rate of 15.6% of de novo incomplete voiding. The insertion of

the mesh with trocars can cause excessive tension on the bladder and therefore voiding

difficulties, although normally transient. The trocar-less system may permit a better

adjustment of the tension, thus less post-operative voiding difficulties are likely to occur. Five

patients had pre-operatively defecation problems which were associated to the rectocele. Two

patients had completely resolved symptoms post-operatively and 3 had substantial symptoms

relief.

Pre-operative dyspareunia due to the prolapse disappeared for 2 patients. There were no cases

of de novo dyspareunia or perineal pain. Dyspareunia and perineal pain are major

complications after mesh operations with great influence on women’s quality of life. The

dyspareunia rates are varying and in certain series reach 16.7% (Lowman 2008, Sentilhes

9
2008, Gauruder 2008, Altman 2009). Dyspareunia post transvaginal mesh surgery is mainly

related to over tension or mesh shrinkage; both are responsible for deformation of the vagina

and thereby causing dyspareunia. The use of 2 separated incisions with 2 separated meshes

when repairing anterior and posterior defects is to our mind the major reason for perfect

vaginal results without any deformation and therefore no signs of dyspareunia. Perineal pain

which is a rare complication (Caquant 2008, Bako 2009, Jacquetin 2009) can be caused by

post-operative hematoma or nerve captured or injury. The trocar-less systems probably can

decrease the rate of the muscles hematomas and therefore decreased this kind of post-

operative pain. The spider fastener are holding the mesh while capturing the fascia very

superficially, thus reducing the risk of nerve capture or injury.

Complications related to the adjuvant materials and risk factors are well described in the

literature [Collinet 2006, Mistrangelo 2007, Bako 2009] and infections have nearly

disappeared since the generalized use of knitted polypropylene monofilaments implants

[Klinge 2002, Jacquetin 2009]. The EndoFast Reliant system consists with a monofilaments

polypropylene mesh, 23g/m2 and up to date we had no mesh-related complications. One

patient required the removal of one too superficial fastener under local anaesthesia 8 weeks

after the operation and POP-Q stage after 1 year was 0. This complication was reported to the

company which designed the system with longer arms and developed a special retractor to

avoid superficial fastener attachment after this case.

This study has few shortcomings, mainly due to its retrospective and descriptive nature. It is,

therefore, susceptible to recall and interpretation biases. In addition, since it is a descriptive

case series, a control group is lacking and the results are compared to the literature. Never the

less, we are reporting the results of 30 patients with long-term outcomes for the majority of

the patients. Since few trocar-less kits are already available in the market without any

10
publications regarding their effectiveness and safety, we found our results with substantial

importance.

In conclusion: The EndoFast Reliant system is a minimally invasive system for the treatment

of POP using a single vaginal incision, trocar-less technique. The operation was found to be

safe, easy to learn and to implement and have the potential of reducing intra and post

operative complications with very satisfactory functional and anatomical results. Further

larger comparative studies are required before final conclusions.

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Table 2: Pre-operative functional symptoms and post-operative functional results and
Treatment
Pre-operative symptoms Post-operative Treatment
(n) Cure ongoing de novo
symptoms
SUI (7)* 6 1 6 re-op with sub-urethral
sling (3)

no treatment, symptoms
were not severe (4)

Urgency (16) 11 5 2 no treatment, symptoms

were not severe (3)

Anticholinergic trx. (4)

Incomplete voiding (6) 5 1 0 Resolved spontaneously

Defecations problems (5) 2 3 0 Symptoms improved

after the operation
Pain and dyspareunia (2) ** 2

* 6 patients were operated with additional sub-urethral sling

** 10 patients were not sexually active

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Table 3: operation time, hospital stay and complications with regards to the prolapse
repair

Mean
Mesh/kit
Mean Op hos Intra-op Post-op
related
time (min) stay complications complications
complications
(days)*
Ant. Repair † (7) 30 4.1 No No No

Pos. Repair †† (4) 35 4 No No No

1 patient:
removal of
one Spider
Ant.+pos. Repair †††
55.6 4.8 No No Fastener, 2
(19)
months post-
op: Fastener
too superficial

* including one day before the operation

† Anerior repair: anterior mesh placed under the cystocele

†† Posterior repair: posterior mesh placed over the rectocele and attached to the cervix or
vaginal vault
††† Anterior and posterior repair: 2 separated meshes placed under the cystocele and over the
rectocele with no connection between the meshes

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Figure 1 : The EndoFast Reliant system

17
Figure 2: pre and post operative prolapse stage

30
26
25

20
17

15 13

10

3
5

0 post-op

stage 3 pre-op
stage 2
stage 1
stage 0

* Post-operative stage was available only for 28 patients, one was lost for follow-up

Stage 0: No prolapse demonstrated

Stage 1: The most distal portion of the prolapse is greater than 1 cm above the level of the
hymen
Stage 2: The most distal portion of the prolapse is less than 1 cm above or below the level of
the hymen
Stage 3: The most distal portion of the prolapse is greater than 1 cm below the level of the
hymen, but protrudes no further than 2 cm less than the total vaginal length

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Figure 3: The use of pain killers in the post-operative period

The use of post-operative pain killers

protocol addition less nothing

20
16 15
13 14
11
9 8

3 4
1 0 1 0 1 0

1st day 2nd day 3rd day 4th day

* information was available for 29 patients

1st day - day of the operation

Protocol - includes 2 pain killers admitted IV: PARACETAMOL 1gr * 4/day +
KETOPROFEN 100mg * 2/day
Less - use of one drug only
Addition - additional third drug

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