Mankessim

Obstetric fistula is a serious condition causing severe urinary incontinence, leading to stigma and reduced quality of life for affected women, mostly in sub-Saharan Africa. This research aims to evaluate and compare two insertable vaginal device models as non-surgical options to manage fistula-related urinary leakage, especially for women awaiting surgery or those whose surgery was unsuccessful. The study also explores user and implementer acceptance of these devices and estimates the costs involved in non-surgical fistula management. The trial compares a silicone vaginal cup alone ('cup') and the cup connected by rubber tubing to a leg-secured urine collection bag ('cup+') for increased urine capacity. Participants use each intervention as well as a no-device leaking period in a crossover design over four days, with each treatment used for 24 hours including day and night. After this, participants are re-randomized to use either the cup or cup+ at home for three months to assess longer-term use and acceptability. Participants will be closely monitored during the study with urine leakage measurements over six hours and self-reported quality of life assessments over one to three months. Data collection includes clinical checklists, interviews, and surveys to assess effectiveness, acceptability, and cost. The total observation includes four days of crossover use followed by three months of home use, aiming to provide a practical and acceptable non-surgical management option for fistula urinary incontinence.