Autologous Slings With Vesico-Vaginal Fistula Repair

Baylor College of Medicine22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Vesicovaginal Fistula

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Six months after surgery

Secondary Outcomes

Vesico-vaginal fistula repaired

To ensure the VVF is still closed and was not compromised due to the sling

Time frame: One month after surgery