PACTR202209466217416Recruiting未知
Effectiveness and Acceptability of two models of an Insertable Vaginal Cup for Non-surgical management of obstetric fistula in Ghana: a hybrid type 1 randomized crossover trial
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Korle Bu Teaching Hospital
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 13 Year(s) to 18 Year(s) (—)
- Sex
- Female
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.
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