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Obstetric Fistula clinical trials

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NCT ID: NCT05444504 Recruiting - Fistula Clinical Trials

Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management

COPE
Start date: April 15, 2023
Phase: N/A
Study type: Interventional

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.