Testing two devices for managing urinary incontinence caused by obstetric fistula in Ghana.
Effectiveness and acceptability of two insertable device models for non-surgical management of obstetric fistula in Ghana: a randomized crossover trial
['FUNDING_R01'] · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · NIH-11228570
This study is testing two different devices to help women in Ghana manage urinary incontinence caused by obstetric fistula, so if you're waiting for surgery or have had surgery that didn't work, you can try out a silicone cup and another device that connects to a bag to see which one works better and feels more comfortable for you.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO (nih funded) |
| Locations | 1 site (SAN FRANCISCO, UNITED STATES) |
| Trial ID | NIH-11228570 on ClinicalTrials.gov |
What this research studies
This research investigates the effectiveness and acceptability of two different insertable devices designed to help manage urinary incontinence resulting from obstetric fistula. Women in Ghana who are awaiting surgery or have had unsuccessful surgery will participate in a trial comparing a silicone vaginal cup and a modified version that connects to a urine collection bag. Participants will use each device for 24 hours in a randomized order, allowing researchers to assess how well each option works and how acceptable they are to users. The study aims to provide a non-surgical management option for women suffering from this condition.
Who could benefit from this research
Good fit: Ideal candidates are women in Ghana suffering from obstetric fistula-related urinary incontinence who are either awaiting surgical repair or have had unsuccessful surgery.
Not a fit: Patients who have successfully undergone surgical repair for obstetric fistula may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could provide women with a viable non-surgical option to manage urinary incontinence, improving their quality of life.
How similar studies have performed: While the use of insertable devices for menstrual management has shown promise, this specific approach for obstetric fistula management is novel and has not been extensively tested.
Where this research is happening
SAN FRANCISCO, UNITED STATES
- UNIVERSITY OF CALIFORNIA, SAN FRANCISCO — SAN FRANCISCO, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: EL AYADI, ALISON M — UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- Study coordinator: EL AYADI, ALISON M
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.