Effectiveness and Acceptability of two models of an Insertable Vaginal Cup for Non-surgical management of obstetric fistula in Ghana
Not Applicable
Recruiting
- Conditions
- VESICOVAGINAL FISTULA
- Registration Number
- PACTR202209466217416
- Lead Sponsor
- Korle Bu Teaching Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 100
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
Women who are candidates for catheterization who could be healed without surgery will be excluded as they are <3mo post-delivery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in volume of observed urine leakage <br>Urine leakage will be measured in mL using pad weight
- Secondary Outcome Measures
Name Time Method