Status:
UNKNOWN
Feasibility of the Menstrual Cup for VVF
Lead Sponsor:
University of Ghana Medical School
Collaborating Sponsors:
New York University College of Global Public Health
NYU Langone Health
Conditions:
Vaginal Fistula
Vesico Vaginal Fistula
Eligibility:
FEMALE
15+ years
Phase:
NA
Brief Summary
This study examines the feasibility and acceptability of the vaginal menstrual cup for short-term management of vesicovaginal fistula (VVF) among 11 women seeking treatment at a health facility in Gha...
Detailed Description
Vesicovaginal fistula (VVF) is a debilitating maternal morbidity that largely results from complications of prolonged, obstructed labor when the trapped fetal head applies direct pressure to pelvic/va...
Eligibility Criteria
Inclusion
- Patient seeking surgical repair for VVF
- VVF confirmed by gynecologic examination
- Adequate vaginal capacity to accommodate the menstrual cup
- Fistula high in vagina (determined at gynecologic examination)
- Willingness to insert and remove the device by one's self
Exclusion
- Technically difficult to insert and or remove the menstrual cup (eg severely scarred vagina)
- Unable or unwilling to learn to insert and remove the menstrual cup
- Patient who declines consent or is incapable of consent
- Presence of rectovaginal fistula (RVF) or combined RVF and VVF
- Fistula low in the vagina precluding collection of urine by the menstrual cup
Key Trial Info
Start Date :
August 8 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 25 2019
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03414060
Start Date
August 8 2016
End Date
January 25 2019
Last Update
October 19 2018
Active Locations (1)
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1
Mercy Women's Catholic Hospital
Mankessim, Central Region, Ghana