Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management

Study Overview
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Brief Summary
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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.

Detailed Description
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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 two fistula care centers in Ghana 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.

Official Title
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Effectiveness and Acceptability of Two Insertable Device Models for Non-surgical Management of Obstetric Fistula in Ghana: a Randomized Crossover Trial

Conditions
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Fistula, Obstetric Fistula, Fistula, Urinary, Fistula, Vaginal

Intervention / Treatment
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* Device: Cup
* Device: Cup+


Participation Criteria
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Eligibility Criteria
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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 Women who are candidates for catheterization who could be healed without surgery will be excluded as they are <3mo post-delivery.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The investigators will compare two intervention models 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 (Table 1). Using a crossover design for efficiency, the investigators will randomize 100 participants to one of two sequences of leaking freely, cup, and cup+ at two fistula care centers in Ghana, then re-randomize to continue using the cup or cup+ at home for up to 3 months. This design includes repeated measures of leakage (4 per participant, total obs=400), uses participants as their own controls, reduces the risk of confounding due to intervention order, and captures usual leaking variability through multiple measures.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>24 hours of use each of leaking freely, leaking freely, cup, and then cup+ | Device: Cup<br>* an insertable vaginal cup ('cup')<br>Device: Cup+<br>* the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity<br>|
| Other: Group 2<br>24 hours of use each of leaking freely, cup, cup+, and then cup | Device: Cup<br>* an insertable vaginal cup ('cup')<br>Device: Cup+<br>* the cup attached via rubber tubing to a leg-secured urine collection bag ('cup+') for greater urine holding capacity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in volume of observed urine leakage | Urine leakage will be measured in mL using pad weight | baseline to 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline vs. 8 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. | 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. | 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. | 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. | 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. | 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. | 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 | baseline vs. 8 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. | 8 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. | baseline vs. 1 month, 2 months, and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menstrual cup, Urinary incontinence, Fistula, Obstetric Fistula, Fistula, Vaginal, Fistula, Urinary, Women's health, Quality of LIfe