An interventional study of Cup and Cup+ in Obstetric Fistula, Fistula and Fistula, Urinary, sponsored by University of California, San Francisco. Recruiting at 3 sites in 2 countries. Open to female participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care
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.
Obstetric fistula is a traumatic maternal morbidity resulting in severe urinary incontinence that increases stigma and reduces quality of life. The estimated two million women with fistula, most in sub-Saharan Africa, face substantial multi-level barriers to surgical repair. Women need an acceptable non-surgical option for therapeutic management of fistula-related urinary incontinence, yet no non-surgical standard of care exists. Use of an insertable silicone vaginal cup has great potential for fistula management; it is effective for menstrual management and efficacious at reducing short-term fistula urinary leakage.
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. Using a cross-over design for efficiency, 100 participants will be randomized to one of two sequences of leaking freely, cup, and cup+ at fistula centers in Ghana, Kenya, and Uganda and observed for four days (total observations=400). Each treatment (cup, cup+ or leaking freely) is used for 24h for day and night use, then crossover. Data are captured through self-report and clinical checklist. On day 4, participants are re-randomized to use cup or cup+ at home for 3 months. Acceptability assessment is informed by implementation and health behavior theory.
Aim 1. To quantify the effectiveness and comparative effectiveness of the cup and cup+. The trial will compare objective and patient-reported measures of effectiveness of the cup and cup+ to leaking freely and of the cup to the cup+. Short-term assessment will be objective (urinary leakage; 8, 24hrs), long-term assessment will be patient-reported (QoL; 1-3 months).
Aim 2. To examine acceptability of cup and cup+. User and implementer acceptability will be assessed using a sequential explanatory mixed-methods design. Acceptability among trial participants will be measured longitudinally (1-3 months). User and implementer acceptability will be examined within in-depth interviews of selected trial participants (n\~30) at 3 months and potential implementers (ob/gyns, midwives/nurses, community health workers, n\~20).
Aim 3. To explore the material and opportunity costs to non-surgical fistula management. Surveys and time motion study among trial participants at facility and community will estimate direct and indirect costs of fistula management from a patient perspective. The long-term goal of the proposed work is to overcome barriers to comprehensive fistula care and increase quality of life through an acceptable, non-surgical option for therapeutic management of fistula.
219 studies on the registry are indexed under Fistula; 49 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 152 interventional studies indexed under Fistula.
Browse Fistula studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
24 hours of use each of leaking freely, leaking freely, cup, and then cup+
Device: Cup · Device: Cup+
24 hours of use each of leaking freely, cup, cup+, and then cup
Device: Cup · Device: Cup+
an insertable vaginal cup ('cup')
the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity
Mean change in volume of observed urine leakage
Urine leakage will be measured in mL using pad weight
Time frame: baseline to 6 hours
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 months
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 months
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 months
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 months
Mean change in sleep satisfaction using the WHO sleep index
Sleep satisfaction using the adapted WHO sleep index. The score ranges from 1-5 where 1 is least satisfied and 5 is very satisfied.
Time frame: baseline vs. 1 month, 2 months, and 3 months
Mean change in Coping Orientation to Problems Experienced Inventory (BRIEF) Coping scale
Coping will be measured using the modified BRIEF Coping scale. The score ranges from 0-100 with higher scores indicating better coping.
Time frame: baseline vs. 1 month, 2 months, and 3 months
Mean change in perceived empowerment over time
Empowerment change in the proportion of users across physical mobility, participation in income-generating activities, bodily autonomy, household decision making, reproductive autonomy, and social participation. Individual measures will be captured using a scale of 1-5, with 1 indicating lower empowerment and 5 higher.
Time frame: baseline vs. 1 month, 2 months, and 3 months
Changes in perceived safety over time
change in the proportion of users who report any adverse events with use of the intervention model at 1, 2, and 3-month follow up
Time frame: baseline vs. 6 hours, 24 hours, 1 month, 2 months, and 3 months
Changes in user acceptability of the intervention over time
Proportion of users who report the intervention as acceptable measured across domains including easy to insert, remove, clean, comfortable to wear, interference with activities, perceived efficacy, self-efficacy, intent to use, and reported using a mean acceptability scale (based on composite score of acceptability items) regarding the intervention model. Standardized range will be 0-100, with higher values meaning greater acceptability and lower values lower acceptability.
Time frame: 6 hours vs. 24 hours, 1 month, 2 months, and 3 months
Changes in post-fistula repair reintegration scale
Reintegration will be measured using the post-fistula repair reintegration scale and subdomains comfort with relatives, relationship, general life satisfaction, family needs, and social engagement. The score ranges from 0-100 with higher scores indicating higher reintegration/functional status.
Time frame: baseline vs. 1 month, 2 months, and 3 months
Plan to share: Yes — Quantitative data will be deidentified and made available after all study publications have been completed without cost to researchers and analysts. Qualitative data and associated documentation will be available to users under a data-sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be available after primary and secondary analyses have been completed.
Access criteria: Data access requests should include 1) Indicate title of their study, a brief rationale for the proposal, the methods of analysis, and the inclusion and exclusion criteria; 2) Include the approval of their Institutional Review Board/ Committee on Human Research; 3) Indicate what they plan to do with the data; 4) Include assurances that they will not share the data with others without the written permission of Dr. El Ayadi; 5) Commit to using the data only for research purposes; 6) Commit to securing the data using appropriate computer technology; 7) Commit to destroying or returning the data after analyses are completed, and; 8) Agree to give proper credit in any publications resulting from the data via citation of the grant and the investigators who obtained the data. Researchers will have to sign a Data Use Agreement that includes these terms, as well as a commitment that they will not attempt to identify individual respondents.
Data sharing details ↗ · datadryad.org
Started Apr 2023 (actual). Primary completion is estimated for Dec 2026, 44 months after the start.
Of 45 non-industry interventional studies with no phase under Fistula, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 56. This study's planned 44 months is above that.
Counting every sponsor, half of 51 studies reached it within 23 months; a quarter within 14 and three quarters within 52.
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