Vesicovaginal Fistula Clinical Trial
Official title:
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00911014 -
Access to Healthcare, Patient Comprehension and Future Plans of Women Undergoing Surgery for a Vesicovaginal Fistula in Niamey, Niger
|
N/A |