Autologous Slings With Vesico-Vaginal Fistula Repair

Not Applicable

• Conditions: Vesicovaginal Fistula
• Interventions: Procedure: Pubococcygeus sling; Procedure: Rectus fascia sling

• Registration Number: NCT03236922
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-08-21
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-29
• Last Update Submitted: 2017-07-29
• Study First Posted: 2017-08-02
• Last Update Posted: 2017-08-02
• Primary Completion: 2018-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pubococcygeus Sling	Pubococcygeus sling	This is one anti-incontinence technique commonly used at the time of fistula surgery.
Rectus Fascia Sling	Rectus fascia sling	This is another anti-incontinence technique used at the time of fistula surgery, however, less commonly than the pubococcygeus.

Primary Outcome Measures

Name	Time	Method
Long-term Continence Status	Six months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Vesico-vaginal fistula repaired	One month after surgery	To ensure the VVF is still closed and was not compromised due to the sling

Trial Locations

Locations (1)

Fistula Care Center; 🇲🇼 Lilongwe, Malawi