Clinical trial NCT03236922: Autologous Slings With Vesico-Vaginal Fistula Repair
Official title: Pubococcygeus Versus Rectus Sheath Sling for Goh Class 3 and 4 Vesico-vaginal Fistulas: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vesicovaginal Fistula
Keywords: obstetric fistula, anti-incontinence techniques
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Long-term Continence Status
timeFrame: Six months after surgery
Secondary outcomes:
measure: Vesico-vaginal fistula repaired
timeFrame: One month after surgery
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Fistula Care Center
Study officials:
affiliation: Baylor College of Medicine
name: Rachel Pope, MD, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
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. doi: 10.1111/j.1471-0528.2004.00080.x.
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. doi: 10.1067/mob.2002.122247.
citation: 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.