An interventional study of Pubococcygeus sling and Rectus fascia sling in Vesicovaginal Fistula, sponsored by Baylor College of Medicine. Status unknown at 1 site in Malawi. Open to female participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-02.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
This is one anti-incontinence technique commonly used at the time of fistula surgery.
Procedure: Pubococcygeus sling
This is another anti-incontinence technique used at the time of fistula surgery, however, less commonly than the pubococcygeus.
Procedure: Rectus fascia sling
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
Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra.
Also known as: rectus fascia graft
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.
Time frame: Six months after surgery
Vesico-vaginal fistula repaired
To ensure the VVF is still closed and was not compromised due to the sling
Time frame: One month after surgery
Plan to share: Yes — No.
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vaginal Fistula
Baylor College of Medicine