Autologous Slings With Vesico-Vaginal Fistula Repair

NCT03236922 | Unknown DMC

• 1 other identifier: H-38672
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Vesicovaginal Fistula

Keywords

obstetric fistula, anti-incontinence techniques

Outcome Measures

Primary Outcomes (1)

• Long-term Continence Status

  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 Outcomes (1)

• Vesico-vaginal fistula repaired

  One month after surgery

Study Arms (2)

Pubococcygeus Sling

ACTIVE COMPARATOR

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

Procedure: Pubococcygeus sling

Rectus Fascia Sling

ACTIVE COMPARATOR

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

Procedure: Rectus fascia sling

Interventions

Pubococcygeus sling PROCEDURE

The pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra.

Also known as: pubococcygeal sling, pubococcygeus graft

Pubococcygeus Sling

Rectus fascia sling PROCEDURE

Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra.

Also known as: rectus fascia graft

Rectus Fascia Sling

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Fistula Care Center

Lilongwe, Malawi

Location

Related Publications (5)

• Ascher-Walsh CJ, Capes TL, Lo Y, Idrissa A, Wilkinson J, Echols K, Crawford B, Genadry R. Sling procedures after repair of obstetric vesicovaginal fistula in Niamey, Niger. Int Urogynecol J. 2010 Nov;21(11):1385-90. doi: 10.1007/s00192-010-1202-5. Epub 2010 Jun 17.

  PMID: 20556597 BACKGROUND

• Browning A. Risk factors for developing residual urinary incontinence after obstetric fistula repair. BJOG. 2006 Apr;113(4):482-5. doi: 10.1111/j.1471-0528.2006.00875.x. Epub 2006 Feb 20.

  PMID: 16489933 RESULT

• Browning A. Prevention of residual urinary incontinence following successful repair of obstetric vesico-vaginal fistula using a fibro-muscular sling. BJOG. 2004 Apr;111(4):357-61. doi: 10.1111/j.1471-0528.2004.00080.x.

  PMID: 15008773 RESULT

• Carey MP, Goh JT, Fynes MM, Murray CJ. Stress urinary incontinence after delayed primary closure of genitourinary fistula: a technique for surgical management. Am J Obstet Gynecol. 2002 May;186(5):948-53. doi: 10.1067/mob.2002.122247.

  PMID: 12015520 RESULT

• Pope R, Browning A, Chipungu E, George JOM, Tamimu M, Wilkinson J. Prophylactic Autologous Slings at the Time of Obstetric Fistula Repair: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):78-84. doi: 10.1097/SPV.0000000000000745.

  PMID: 31145227 DERIVED

MeSH Terms

Conditions

Vesicovaginal Fistula

Condition Hierarchy (Ancestors)

Vaginal Fistula; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Fistula; Urinary Fistula; Urogenital Abnormalities; Urinary Bladder Diseases; Urologic Diseases; Genital Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel Pope, MD, MPH

  Baylor College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: August 21, 2016
• First Posted: August 2, 2017
• Study Start: June 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2019
• Last Updated: August 2, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

MA (1)