Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital Fistula Repair: Protocol for a...

Female genital fistula is a traumatic debilitating injury, frequently caused by prolonged obstructed labor, affecting between 500,000-2 million women in lower-resource settings. Vesicovaginal fistula causes urinary incontinence. Other gynecologic, neurologic and orthopedic morbidity may occur during fistula development. Women with fistula are stigmatized; limit engagement in social, economic, or religious activities; and report high psychiatric morbidity. Improved global surgical access has reduced fistula consequences yet post-repair risks impacting quality of life and well-being include fistula repair breakdown or recurrence and ongoing or changing urine leakage or incontinence. Limited evidence on risk factors contributing to adverse outcomes hinders interventions to mitigate adverse events, protecting health and quality of life after surgery. This study seeks to identify predictors and characteristics of post-repair fistula breakdown and recurrence (Aim 1) and post-repair incontinence (Aim 2), and to identify feasible and acceptable intervention strategies (Aim 3).

This mixed-methods study incorporates a prospective cohort study of women with successful vesicovaginal fistula repair at approximately 12 fistula repair centers and affiliated care sites in Uganda (Aims 1-2) followed by qualitative inquiry among key stakeholders (Aim 3). Cohort participants will have a baseline visit at the time of surgery followed by data collection at 2 weeks, 6 weeks, 3 months and quarterly thereafter for 3 years. Primary predictors to be evaluated include patient-related factors, fistula-related factors, fistula repair-related factors, and post-repair behaviors and exposures, collected via structured questionnaire at all data collection points. Clinical exams will be conducted at baseline, 2 weeks post-surgery, and for outcome confirmation at symptom development. Primary outcomes are fistula repair breakdown or fistula recurrence and post-repair incontinence. In-depth interviews will be conducted with cohort participants (n ~ 40) and other key stakeholders (~ 40 including family, peers, community members and clinical/social service providers) to develop feasible and acceptable intervention concepts for adjustment of identified risk factors.

Participant recruitment is underway. This study is expected to identify key predictors that can directly improve fistula repair and post-repair programs and women's outcomes, optimizing health and quality of life. Furthermore, our study will create a comprehensive longitudinal dataset capable of supporting broad inquiry into post-fistula repair health.

ClinicalTrials.gov Identifier: NCT05437939.