Autologous Slings With Vesico-Vaginal Fistula Repair

Study Overview
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Brief Summary
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It is clear from multiple accounts in the literature that patients with a vesico-vaginal fistula (VVF) involving the bladder neck and/or proximal urethra have a high likelihood of residual incontinence. Performing subsequent surgeries after the initial VVF repair risks additional complications. Therefore, placement of an autologous sling at the time of initial VVF repair would not only assist in covering the fistula, but would also imitate the physiologic support that would theoretically improve urethral function. A rectus fascia sling would most naturally provide this support and warrants testing against the success of the PC sling. Using the Goh scoring criteria, Goh class 3 and 4 VVF's are the type most involving the urethra. Therefore, this group of patients is the target population for this study. As there is currently no standard of care for repairing large urethral defects, this procedural technique combined with otherwise standardized fistula repair would not introduce any foreseeable harm to patients.

Official Title
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Pubococcygeus Versus Rectus Sheath Sling for Goh Class 3 and 4 Vesico-vaginal Fistulas: a Randomized Controlled Trial

Conditions
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Vesicovaginal Fistula

Intervention / Treatment
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* Procedure: Pubococcygeus sling
* Procedure: Rectus fascia sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with vesico-vaginal fistulas classified as Goh 3 or 4 at the time of surgery Patients who have consented for an autologous sling Patients who have not previously undergone repair attempt Exclusion Criteria: Patients who require an abdominal approach to the VVF repair Patients found at surgery not to have a Goh 3 or 4 class VVF Patients requiring a complete urethral reconstruction Patients who have undergone previous attempt at repair Patients who require an alternative tissue grafting other than the rectus fascia or pubbococcygeus decided by the surgeon at the time of surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pubococcygeus Sling<br>This is one anti-incontinence technique commonly used at the time of fistula surgery. | Procedure: Pubococcygeus sling<br>* The pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra.<br>* Other names: pubococcygeus graft;|
| Active Comparator: Rectus Fascia Sling<br>This is another anti-incontinence technique used at the time of fistula surgery, however, less commonly than the pubococcygeus. | Procedure: Rectus fascia sling<br>* Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra.<br>* Other names: rectus fascia graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Continence Status | Residual stress incontinence is commonly experienced by this patient population, therefore a dye test to ensure the fistula is still closed and a cough test to determine any incontinence will be performed. | Six months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vesico-vaginal fistula repaired | To ensure the VVF is still closed and was not compromised due to the sling | One month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstetric fistula, anti-incontinence techniques