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.

Inclusion criteria:

• 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
• If previous fistula repair, ≥3mo post-delivery
• If recent birth, age 18+ or emancipated minor
• Speak English or local language

Exclusion criteria:

• 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.

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.

Data will be available after primary and secondary analyses have been completed.

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.