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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT03414060
Eligibility Criteria:
Inclusion Criteria:
1. Patient seeking surgical repair for VVF
2. VVF confirmed by gynecologic examination
3. Adequate vaginal capacity to accommodate the menstrual cup
4. Fistula high in vagina (determined at gynecologic examination)
5. Willingness to insert and remove the device by one's self
Exclusion Criteria:
1. Technically difficult to insert and or remove the menstrual cup (eg severely scarred vagina)
2. Unable or unwilling to learn to insert and remove the menstrual cup
3. Patient who declines consent or is incapable of consent
4. Presence of rectovaginal fistula (RVF) or combined RVF and VVF
5. Fistula low in the vagina precluding collection of urine by the menstrual cup
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
15 Years
Study:
NCT03414060
Study Brief:
Protocol Section:
NCT03414060