Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital Fistula Repair

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ABSTRACT Female genital fistula is a debilitating injury that affects 2 to 3 million women, mostly in sub-Saharan Africa. Women with fistula have uncontrollable leakage of urine and/or feces (among other physical symptoms), are heavily stigmatized, and experience high psychiatric morbidity. Preliminary evidence has identified risk of fistula recurrence, incontinence, and pregnancy complications following fistula repair. However, the evidence base regarding the factors contributing to these adverse outcomes is severely underdeveloped, limiting the development of clinical interventions to reduce these adverse risks to women, preventing them from re- experiencing the consequences of fistula, and to improve pregnancy outcomes and quality of life. In an effort to improve the physical and psychosocial quality of life for women affected by fistula, we propose to address the critical gaps in knowledge on risk of adverse outcomes following fistula repair by conducting a longitudinal cohort study of 800 women repaired for fistula in 9 Ugandan facilities. We seek to identify predictors of post-repair fistula breakdown and recurrence (Aim 1), to identify predictors and characteristics of post-repair incontinence (Aim 2), and to engage key stakeholders in a theory-guided iterative process to develop a roadmap of intervention strategies likely to be feasible and acceptable within this setting (Aim 3). Our approach overcomes limitations to prior research through employing a longitudinal design; focusing on a broad range of patient, fistula, and behavioral characteristics; and enrolling the largest number of women (800) with the longest follow-up (3 years) to date for robust estimation. Data will be collected at time of surgery and at 2 weeks, 6 weeks, 3 months, and quarterly thereafter for 3 years through a combination of interview-administered patient questionnaire and structured medical record abstraction, with clinical exams conducted per standard of care and as necessary based on symptom experiences. In-depth interviews with key stakeholders (n~80, including longitudinal participants and a range of other important roles) guided by prevalent behavior and implementation change theories will help us to understand facilitators and barriers of behavior and implementation targets to inform potential intervention strategies at multiple levels. Our sample size will allow us to detect a minimum difference in effect of 20% for all outcomes. Analyses will describe estimate the individual and joint-effects of patient, fistula, fistula repair, and post-repair characteristics on incidence of post-repair fistula breakdown and recurrence and incontinence using proportional hazards frailty survival models. Our findings will inform counseling and clinical care models for optimizing post-repair outcomes for women following fistula repair.