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Mulisa: Adverse Outcomes Following Female Genital Fistula Repair

Sponsor
University of California, San Francisco (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05437939
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), Infectious Diseases Research Collaboration, Uganda (Other), Makerere University (Other)
1,000
Enrollment
1
Location
44.5
Anticipated Duration (Months)
22.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identifying Opportunities for Prevention of Adverse Outcomes Following Female Genital
    Actual Study Start Date :
    May 20, 2022
    Anticipated Primary Completion Date :
    May 1, 2025
    Anticipated Study Completion Date :
    Feb 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Time to post-repair fistula breakdown [Through 36 months following study enrollment]

      Proportion of women who experience fistula breakdown (a reopening of the fistula following repair, prior to the complete healing or de novo fistula occurrence as confirmed by a positive methylene blue dye test) and reported as the incidence by the total person-time observed and measured up to 36 months following index fistula repair

    2. Time to post-repair urinary incontinence [Through 36 months following study enrollment]

      Proportion of women who experience post-repair incontinence (as measured through urinary incontinence with confirmed negative methylene blue dye test indicated complete fistula closure) measured up to 36 months following index fistula repair

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Makerere University Kampala Uganda

    Sponsors and Collaborators

    • University of California, San Francisco
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    • Infectious Diseases Research Collaboration, Uganda
    • Makerere University

    Investigators

    • Principal Investigator: Alison El Ayadi, ScD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT05437939
    Other Study ID Numbers:
    • A137001
    • R01HD101570
    First Posted:
    Jun 29, 2022
    Last Update Posted:
    Jul 1, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of California, San Francisco
    Surgical repair breakdown
    Obstetrics fistula
    Fistula
    Incontinence
    Urine incontinence
    Fistula repair
    Fistula recurrence
    Additional relevant MeSH terms:
    Fistula

    Study Results

    No Results Posted as of Jul 1, 2022