NCT05444504 Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
| NCT ID | NCT05444504 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Obstetric Fistula |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-04-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-04-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Alison El Ayadi, ScD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05444504 clinical trial?
This trial is open to female participants only, aged 15 Years or older, studying Obstetric Fistula. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05444504 currently recruiting?
Yes, NCT05444504 is actively recruiting participants. Contact the research team at ryann01@nyu.edu for enrollment information.
Where is the NCT05444504 trial being conducted?
This trial is being conducted at Mankessim, Ghana, Tamale, Ghana, Eldoret, Kenya.
Who is sponsoring the NCT05444504 clinical trial?
NCT05444504 is sponsored by University of California, San Francisco. The principal investigator is Alison El Ayadi, ScD at University of California, San Francisco. The trial plans to enroll 100 participants.