Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15+
SponsorUniversity of California, San Francisco
About this trial
The investigators propose a clinical trial and nested qualitative study to 1) quantify the effectiveness of an insertable vaginal cup to manage fistula urinary incontinence, 2) examine user and implementer acceptability, and 3) quantify fistula management cost. Two intervention models will be compared among women awaiting fistula surgery or whose surgery was unsuccessful: 1) a vaginal cup ('cup'), and 2) the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cup
- Cup+
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of California, San Francisco
Lead sponsor
Korle-Bu Teaching Hospital, Accra, Ghana
Collaborator
Restore Health
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Gynocare Women's and Fistula Hospital, Eldorat, Kenya
Collaborator
Source ClinicalTrials.gov