# Effectiveness and acceptability of two insertable device models for non-surgical management of obstetric fistula in Ghana: a randomized crossover trial

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2022 · $375,988

## Abstract

PROJECT SUMMARY
Obstetric fistula is a traumatic maternal morbidity resulting in severe urinary incontinence that increases stigma
and reduces quality of life. The 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. We 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.

## Key facts

- **NIH application ID:** 10422976
- **Project number:** 1R01HD108236-01
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Alison M El Ayadi
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $375,988
- **Award type:** 1
- **Project period:** 2022-04-01 → 2026-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10422976

## Citation

> US National Institutes of Health, RePORTER application 10422976, Effectiveness and acceptability of two insertable device models for non-surgical management of obstetric fistula in Ghana: a randomized crossover trial (1R01HD108236-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10422976. Licensed CC0.

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