Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula: a Randomized Crossover Trial
University of California, San Francisco
100 participants
Apr 15, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
an insertable vaginal cup ('cup')
the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity
Locations(3)
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NCT05444504