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
Inclusion Criteria7
- VVF confirmed by dye test and clinical exam at least 3cm from the external urethral orifice (regardless of size), adequate vaginal capacity to accommodate the cup (per physician)
- Willing to insert and remove cup/cup+
- Clear understanding of the study procedures
- Willing to participate fully, not yet been repaired or previously failed surgical repair, at least 6mo post-surgery
- If previous fistula repair, ≥3mo post-delivery
- If recent birth, age 18+ or emancipated minor
- Speak English or local language
Exclusion Criteria3
- Any rectovaginal fistula
- Urinary leakage <6ml over 6 hours
- Women who are candidates for catheterization who could be healed without surgery will be excluded as they are <3mo post-delivery.
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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