ClinicalTrials.Veeva

Menu

Autologous Slings With Vesico-Vaginal Fistula Repair

Baylor College of Medicine logo

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems