Autologous Slings With Vesico-Vaginal Fistula Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-08-31

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.

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Detailed Description

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Conditions

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Vesicovaginal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pubococcygeus Sling

This is one anti-incontinence technique commonly used at the time of fistula surgery.

Group Type ACTIVE_COMPARATOR

Pubococcygeus sling

Intervention Type PROCEDURE

The pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra.

Rectus Fascia Sling

This is another anti-incontinence technique used at the time of fistula surgery, however, less commonly than the pubococcygeus.

Group Type ACTIVE_COMPARATOR

Rectus fascia sling

Intervention Type PROCEDURE

Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra.

Interventions

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Pubococcygeus sling

The pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra.

Intervention Type PROCEDURE

Rectus fascia sling

Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra.

Intervention Type PROCEDURE

Other Intervention Names

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pubococcygeal sling pubococcygeus graft rectus fascia graft

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes