Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
Recruiting
N/A
Interventional Study
Obstetric Fistula
Fistula
Fistula, Urinary
Fistula, Vaginal
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 15 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 100 (estimated)
- Sponsor
- University of California, San Francisco · Other
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About This Trial
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'),…
Trial Locations
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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…
Contacts