Actively Recruiting
Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
Led by University of California, San Francisco · Updated on 2025-12-22
100
Participants Needed
3
Research Sites
193 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
K
Korle-Bu Teaching Hospital, Accra, Ghana
Collaborating Sponsor
AI-Summary
What this Trial Is About
The investigators propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity.
CONDITIONS
Official Title
Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female with vesicovaginal fistula confirmed by dye test and clinical exam at least 3cm from the urethral opening
- Adequate vaginal capacity to accommodate the cup as determined by a physician
- Willing to insert and remove the cup or cup+
- Clear understanding of the study procedures
- Willing to participate fully
- Fistula not yet repaired or previous surgery failed, with at least 6 months since surgery
- If previous fistula repair, at least 3 months post-delivery
- If recent birth, age 18 years or older or an emancipated minor
- Able to speak English or a local language
You will not qualify if you...
- Any rectovaginal fistula
- Urinary leakage less than 6ml over 6 hours
- Candidates for catheterization who could heal without surgery (less than 3 months post-delivery)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Mercy Women's Catholic Hospital
Mankessim, Ghana
Actively Recruiting
2
Tamale Fistula Center
Tamale, Ghana
Actively Recruiting
3
Gynocare Women's and fistula hospital
Eldoret, Kenya
Enrolling by Invitation
Research Team
N
Nessa E Ryan, PhD
CONTACT
A
Alison M El Ayadi, ScD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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