Vesicovaginal Fistula
Conditions
Keywords
obstetric fistula, anti-incontinence techniques
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.
Interventions
PROCEDURERectus fascia sling
Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra.
PROCEDUREPubococcygeus sling
The pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Continence Status | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vesico-vaginal fistula repaired | One month after surgery | To ensure the VVF is still closed and was not compromised due to the sling |
Countries
Malawi
Outcome results
None listed