Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
Recruiting now · Not applicable
Conditions studied: Obstetric Fistula, Fistula, Fistula, Urinary, Fistula, Vaginal
In brief
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.
Key facts
- Study ID
- NCT05444504
- Run by
- University of California, San Francisco
- People needed
- 100
- Starts
- 2023-04-15
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-14
Who can join
Age: 15 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Mercy Women's Catholic Hospital — Mankessim, Ghana (enrolling)
- Tamale Fistula Center — Tamale, Ghana (enrolling)
- Gynocare Women's and fistula hospital — Eldoret, Kenya
Full record on ClinicalTrials.gov
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