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Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
Sponsor: University of California, San Francisco
Summary
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.
Official title: Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula: a Randomized Crossover Trial
Key Details
Gender
FEMALE
Age Range
15 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-04-15
Completion Date
2027-01-01
Last Updated
2025-12-22
Healthy Volunteers
No
Interventions
Cup
an insertable vaginal cup ('cup')
Cup+
the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity
Locations (3)
Mercy Women's Catholic Hospital
Mankessim, Ghana
Tamale Fistula Center
Tamale, Ghana
Gynocare Women's and fistula hospital
Eldoret, Kenya