Autologous Slings With Vesico-Vaginal Fistula Repair

Baylor College of Medicine

Status: Unknown

Conditions: Vesicovaginal Fistula

Treatments: Procedure: Pubococcygeus sling; Procedure: Rectus fascia sling

Study type: Interventional

Funder types: Other

Identifiers

NCT03236922

H-38672

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Pubococcygeus Sling

Active Comparator group

Description:

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

Treatment:

Procedure: Pubococcygeus sling

Rectus Fascia Sling

Active Comparator group

Description:

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

Treatment:

Procedure: Rectus fascia sling