Using insertable devices to manage obstetric fistula
Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula: a Randomized Crossover Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 15 Years and up |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 3 sites (Mankessim and 2 other locations) |
| Trial ID | NCT05444504 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women with confirmed vesicovaginal fistula who are at least 18 years old and willing to use the insertable devices.
Not a fit: Patients with rectovaginal fistulas or those who have minimal urinary leakage may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Mankessim and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.