NCT03236922

Autologous Slings With Vesico-Vaginal Fistula Repair

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vesicovaginal Fistula

Interventions

Type	Name	Description
PROCEDURE	Pubococcygeus sling	The pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra.
PROCEDURE	Rectus fascia sling	Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra.

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-08-01
• Completion: 2019-08-01
• First posted: 2017-08-02
• Last updated: 2017-08-02

Locations

1 site across 1 country: Malawi