Autologous Slings With Vesico-Vaginal Fistula Repair

July 29, 2017 updated by: Jeffrey Wilkinson, Baylor College of Medicine

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Lilongwe, Malawi
        • Fistula Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pubococcygeus Sling
This is one anti-incontinence technique commonly used at the time of fistula surgery.
Procedure: Pubococcygeus sling
The pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra.
Other Names:
  • pubococcygeal sling
  • pubococcygeus graft
Active Comparator: Rectus Fascia Sling
This is another anti-incontinence technique used at the time of fistula surgery, however, less commonly than the pubococcygeus.
Procedure: Rectus fascia sling
Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra.
Other Names:
  • rectus fascia graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term Continence Status
Time Frame: 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.
Six months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vesico-vaginal fistula repaired
Time Frame: One month after surgery
To ensure the VVF is still closed and was not compromised due to the sling
One month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Study Director: Rachel Pope, MD, MPH, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

August 21, 2016

First Submitted That Met QC Criteria

July 29, 2017

First Posted (Actual)

August 2, 2017

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

July 29, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-38672

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

No.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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