Using insertable devices to manage obstetric fistula
Official title: Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula: a Randomized Crossover Trial
Run by University of California, San Francisco · NCT05444504 · Data updated 2026-11-12
This study tests whether a new vaginal cup can help women with urinary incontinence from obstetric fistula feel better while they wait for surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 15 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 3 sites (Mankessim and 2 other locations) |
| Status | Recruiting |
| Started | April 15, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT05444504 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women with confirmed vesicovaginal fistula who are at least 18 years old and willing to use the insertable devices.
✕Probably not a fit
Patients with rectovaginal fistulas or those who have minimal urinary leakage may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness and acceptability of an insertable vaginal cup for managing urinary incontinence caused by obstetric fistula. Participants will be women awaiting fistula surgery or those whose previous surgery was unsuccessful. The study will compare two intervention models: a standard vaginal cup and a modified version connected to a urine collection bag. The trial will involve a cross-over design with 100 participants observed over four days to assess the performance and user satisfaction of each device.
Why it matters
Potential benefit: If successful, this study could provide a non-surgical management option for women suffering from obstetric fistula-related urinary incontinence.
How similar studies have gone: While the use of insertable devices for menstrual management has been studied, this specific application for obstetric fistula management is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Mercy Women's Catholic Hospital
Mankessim, Ghana Recruiting -
Tamale Fistula Center
Tamale, Ghana Recruiting -
Gynocare Women's and fistula hospital
Eldoret, Kenya Enrolling by invitation
Study contacts
- Principal investigator: Alison El Ayadi, ScD — University of California, San Francisco
- Study coordinator: Nessa E Ryan, PhD
- Email: ryann01@nyu.edu
- Phone: 17048062062
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.