Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital Fistula Repair: Protocol for a Mixed‑Methods Study in Uganda
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Date
2025
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Reproductive Health
Abstract
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, and other morbidity may occur during fistula development. Women with fistula are stigmatized, limit
social and economic engagement, and experience psychiatric morbidity. Improved 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. This study aims to quantify these adverse
risks and inform clinical and counseling interventions to optimize women’s health and quality of life following fistula
repair through: identifying predictors and characteristics of post-repair fistula breakdown and recurrence (Objective 1)
and post-repair incontinence (Objective 2), and to identify feasible and acceptable intervention strategies (Objective
3).
This mixed-methods study incorporates a prospective cohort of women with successful vesicovaginal
fistula repair at approximately 12 fistula repair centers in Uganda (Objectives 1-2) followed by qualitative inquiry
among key stakeholders (Objective 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 inform feasibility and acceptability of recommendations.
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Citation
El Ayadi, A. M., Obore, S., Kirya, F., Miller, S., Korn, A., Nalubwama, H., ... & Barageine, J. K. (2024). Identifying opportunities for prevention of adverse outcomes following female genital fistula repair: protocol for a mixed-methods study in Uganda. Reproductive Health, 21(1), 2. https://doi.org/10.1186/s12978-023-01732-7