Evaluating Two Insertable Vaginal Devices to Manage Urinary Leakage in Women with Obstetric Fistula

What this Trial Is About

This research aims to evaluate two insertable vaginal devices for managing urinary leakage caused by obstetric fistula, a condition that severely impacts quality of life and carries social stigma. The study compares a vaginal cup alone and the cup connected to a leg-attached urine collection bag to increase urine holding capacity. It involves women awaiting fistula surgery or those with unsuccessful surgery, addressing the need for a non-surgical management option in settings with limited access to repair. Participants will use each intervention and a period of leaking freely in a crossover design over four days, with each condition lasting 24 hours, including day and night use. After this short-term phase, participants are re-randomized to use either the cup or the cup device at home for three months. Data collection includes self-reports and clinical checklists to assess device effectiveness, acceptability, and costs. Throughout the study, participants will undergo assessments of urine leakage volume, quality of life, stigma, sleep satisfaction, coping skills, empowerment, safety perception, and device acceptability at multiple time points up to three months. The study also examines material and opportunity costs associated with fistula management. The total observation includes intensive short-term monitoring followed by longer-term home use and follow-up evaluations.

Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management