Adverse Outcomes Following Female Genital Fistula Repair
NCT ID: NCT05437939
Last Updated: 2025-05-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Total Enrollment
802 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-05-20
Study Completion Date
2026-07-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Female Genital Fistula
Incontinence
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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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
* 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
Minimum Eligible Age
15 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
collaborator
Infectious Diseases Research Collaboration, Uganda
OTHER
Sponsor Role
collaborator
Makerere University
OTHER
Sponsor Role
collaborator
University of California, San Francisco
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Alison El Ayadi, ScD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Makerere University
Kampala, , Uganda
Site Status
Countries
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Uganda
References
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El Ayadi AM, Obore S, Kirya F, Miller S, Korn A, Nalubwama H, Neuhaus J, Getahun M, Eyul P, Twine R, Andrew EVW, Barageine JK. Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital Fistula Repair: Protocol for a Mixed-Methods Study in Uganda. Res Sq [Preprint]. 2023 May 5:rs.3.rs-2879899. doi: 10.21203/rs.3.rs-2879899/v1.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A137001
Identifier Type: -
Identifier Source: org_study_id
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