Clinical trial NCT05437939: Adverse Outcomes Following Female Genital Fistula Repair
Official title: Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Female Genital Fistula
Incontinence
Keywords: Surgical repair breakdown
Obstetrics fistula
Fistula
Incontinence
Urine incontinence
Fistula repair
Fistula recurrence
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Infectious Diseases Research Collaboration, Uganda
name: Makerere University
First posted: 2022-06-29
Enrollment: 802
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to n=1000 women with successful (closed) vesicovaginal fistula repair who are 18 and older or 15-17 year old emancipated minors (per Ugandan law) will be eligible to participate from fistula surgery centers and hospitals participating in the study as recruitment sites.

Brief summary: Following genital fistula repair, fistula repair breakdown and recurrence, persistent and incidence incontinence are major adverse outcomes, limiting women's health and wellbeing. Using a prospective design, the investigators seek to identify modifiable risk factors to establish key targets for intervention, followed by qualitative work to refine the feasibility and acceptability of potential intervention strategies.

Detailed description: Although improved global surgical access has begun to reduce the significant physical, psychosocial, and economic consequences of fistula, women with successful surgery face adverse post-repair risks. Emerging research has identified post-repair fistula recurrence in up to 14% of women following surgery, with many recurrences occurring within the first 12 months. Post-repair incontinence continues in up to 33% of women despite closed fistula, with some women developing incident incontinence after previously successful resolution through fistula surgery. However, the limited evidence base on factors contributing to adverse outcomes limits interventions to improve women's health and quality of life following genital fistula repair.

The investigators hypothesize that important independent predictors of vesicovaginal fistula repair breakdown and recurrence will include indications of fistula severity, strenuous labor, early resumption of sexual intercourse and subsequent pregnancy. Further modifiable characteristics whose potential contribution the investigators seek to establish for these adverse outcomes include other post-repair behaviors and exposures. To test these hypotheses and explore additional contributors to adverse outcomes, the investigators will leverage the research infrastructure the investigators have developed at several fistula repair sites in Uganda to lead a 3-year longitudinal cohort study of up to 1000 women following genital fistula repair. The investigators will collect data on sociodemographic characteristics, fistula and repair-related characteristics at fistula repair, and data on post-repair behaviors and exposures quarterly. If participants report key symptoms (recurrence and incontinence), the investigators will confirm these outcomes by clinical validation through physical examination. The investigators will calculate incidence and establish temporal relationships of a range of exposures with adverse outcomes to identify key targets for intervention. The investigators will then engage key stakeholders in iterative qualitative work framed by key behavioral and implementation science theories to enhance translation of our quantitative findings into intervention strategies that are feasible and acceptable in this context. This mixed-methods work has a strong potential to directly influence programming to reduce adverse outcomes following genital fistula repair.

Aim 1: Identify predictors of post-repair fistula breakdown and recurrence. The investigators will use survival analysis methods to compare baseline and time-varying patient characteristics of women in our longitudinal cohort who develop post-repair fistula breakdown and recurrence compared to those who do not. Assessment will focus on mutable factors fistula repair-related characteristics and post-repair behaviors and exposures, accounting for immutable participant baseline sociodemographic and fistula characteristics.

Aim 2: Identify predictors and characteristics of post-repair incontinence. Specifically, the investigators seek to identify predictors of post-repair incontinence (see Aim 1) in our longitudinal cohort, focusing on: a) persistent incontinence following surgery at multiple time-points; and b) time to incident incontinence among women whose incontinence was initially resolved by surgery; using similar methods to Aim 1.

Aim 3: Identify feasible and acceptable strategies for modifying key risk factors of adverse outcome. To improve the translation of our research findings from Aims 1 and 2 into practice, the investigators will engage in an iterative process with key stakeholders to understand their perspectives on potential strategies for modifying important risk factors influencing post-repair fistula breakdown, recurrence, and incontinence. The investigators will purposively recruit a sub-sample of cohort participants (n=40) and other key stakeholders such as families, community members, and fistula care providers (n=40) for in-depth interview, followed by iterative participatory work with our qualitative sample to refine acceptability and feasibility concerns and ultimately to guide intervention strategy development.

Eligibility criteria: Inclusion Criteria:

* Vesicovaginal fistula
* Completed surgery with confirmed surgical closure
* Age 15 or above, with ages 15-17 meeting criteria for emancipated minor
* Capable of providing informed consent

Exclusion Criteria:

* None beyond above

Primary outcomes:
measure: Time to post-repair fistula breakdown
timeFrame: Through 36 months following study enrollment
measure: Time to post-repair urinary incontinence
timeFrame: Through 36 months following study enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University
Study officials:
affiliation: University of California, San Francisco
name: Alison El Ayadi, ScD
role: PRINCIPAL_INVESTIGATOR
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