Fistula Reintegration Pilot

May 21, 2025 updated by: University of California, San Francisco

Comprehensive Reintegration Assistance for Women With Obstetric Fistula

This is a pilot study to test the feasibility and acceptability of a multi-component facility-based intervention designed to be provided adjunct to genital fistula surgery incorporating: health education, psychosocial counseling, physiotherapy, and economic investment. We will include a total of 30 women in the study, and follow them for 6-months using a mixed-methods strategy for feasibility and acceptability assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Mulago Specialized Women's and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undergoing surgery for female genital fistula
  • Age 18 or above, or emancipated minor per Ugandan law

Exclusion Criteria:

  • No further criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multi-component reintegration intervention
There is one arm for the feasibility and acceptability study - all intervention participants will receive the intervention: health education, psychosocial counseling, physiotherapy, and economic investment.
Behavioral: Multi-component reintegration intervention
The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Planned Intervention Sessions That Were Delivered
Time Frame: 6 weeks
Number of planned intervention session over the total number of planned interention sessions
6 weeks
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Overall Experience With the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.
Time Frame: 6 weeks
Number of participants reporting to be "satisfied" or "very satisfied" about their overall experience participating in the intervention on a five-point Likert scale at six weeks over the total number of participants.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Reintegration Score
Time Frame: Baseline and 6 months
Mean change in reintegration score from pre-intervention (baseline) to post (6 months) on the post-fistula repair reintegration instrument (range 0-100, higher indicating better)
Baseline and 6 months
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Health Education Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants
Time Frame: 6 weeks
Number of participants reporting to be "satisfied" or "very satisfied" about their experience participating in the health education component of the intervention on a five-point Likert scale at six weeks over the total number of participants.
6 weeks
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience Participating in the Psychosocial Counseling Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Participants.
Time Frame: 6 weeks
Number of participants reporting to be "satisfied" or "very satisfied" about their experience participating in the psychosocial counseling component of the intervention on a five-point Likert scale at six weeks over the total number of participants.
6 weeks
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Physiotherapy Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.
Time Frame: 6 weeks
Number of participants reporting to be "satisfied" or "very satisfied" about their experience with the physiotherapy component of the intervention on a five-point Likert scale at six weeks over the total number of intervention participants.
6 weeks
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants
Time Frame: 6 weeks
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Makerere University
Mulago Hospital, Uganda
Mama, LLC

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

September 14, 2022

Study Completion (Actual)

September 14, 2022

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0527552
  • R00HD086232 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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