Autologous Slings With Vesico-Vaginal Fistula Repair

Vesicovaginal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03236922
• Other study ID #: H-38672
• Status: Active, not recruiting
• Phase: N/A
• First received: August 21, 2016
• Last updated: July 29, 2017
• Start date: June 2016
• Est. completion date: August 2019

Study information

• Verified date: July 2017
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: August 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Vaginal Fistula
• Vesicovaginal Fistula

Intervention

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

Locations

Country	Name	City	State
Malawi	Fistula Care Center	Lilongwe

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

Malawi, 

References & Publications (4)

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. — View Citation

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. — View Citation

Browning A. Risk factors for developing residual urinary incontinence after obstetric fistula repair. BJOG. 2006 Apr;113(4):482-5. Epub 2006 Feb 20. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vesico-vaginal fistula repaired	To ensure the VVF is still closed and was not compromised due to the sling	One month after surgery