RecruitingNot Applicable

Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management

Ghana, Kenya100 participantsStarted 2023-04-15

Plain-language 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.

Who can participate

Age range15 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * 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 criteria: * 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.

What they're measuring

Mean change in volume of observed urine leakage

Timeframe: baseline to 6 hours

Trial details

NCT IDNCT05444504

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-01

Contact for this trial

Nessa E Ryan, PhD

17048062062 ryann01@nyu.edu