Status:
UNKNOWN
Autologous Slings With Vesico-Vaginal Fistula Repair
Lead Sponsor:
Baylor College of Medicine
Conditions:
Vesicovaginal Fistula
Eligibility:
FEMALE
18-90 years
Phase:
NA
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 incontinenc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03236922
Start Date
June 1 2016
End Date
August 1 2019
Last Update
August 2 2017
Active Locations (1)
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1
Fistula Care Center
Lilongwe, Malawi