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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Cup
Devicean insertable vaginal cup ('cup')
Cup+
Devicethe cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Group 1Other 2 interventions
Group B: Group 2Other 2 interventions
Trial outcomes
Primary outcomes
1
Mean change in volume of observed urine leakage
Urine leakage will be measured in mL using pad weight
Time frame
baseline to 6 hoursSecondary outcomes
1
Mean change in volume of perceived urine leakage
Perceived urine leakage will be measured by the International Consultation on Incontinence Questionnaire SF (ICIQ-SF). This score ranges from 0-21 with higher scores indicating greater incontinence.
Time frame
baseline vs. 6 hours, 24 hours,1 month, 2 months and 3 months2
Mean change in WHO Quality of Life BREF (WHOQOL-BREF) score
Quality of life will be measured using the WHOQOL-BREF. The score ranges from 0-100 with higher scores indicating higher quality of life.
Time frame
baseline vs. 24 hours, 1 month, 2 months and 3 months3
Mean change in fistula-related stigma scale
Stigma will be measured using the fistula-related stigma scale, and enacted and internalized subscales. This score ranges from 0-100 with higher scores indicating higher stigma.
Time frame
baseline vs. 1 month, 2 months and 3 months4
Mean change in fistula management costs over time
Fistula management costs will be calculated by combining the total material costs and lost wages in Ghanaian Cedi (local currency) over time. Time in minutes will inform calculations of lost wages using prevailing wage rates for the study population. The mean change in cost will be from baseline to 3 months.
Time frame
baseline vs. 1 month, 2 months, and 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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