Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT05444504
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
15 Years
Study:
NCT05444504
Study Brief:
Protocol Section:
NCT05444504