Fistula Reintegration Pilot

Not Applicable

Completed

• Conditions: Urinary Incontinence; Female Genital Fistula
• Interventions: Behavioral: Multi-component reintegration intervention

• Registration Number: NCT04748653
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Study Start: 2021-08-01
• Primary Completion: 2022-09-14
• Study Completion: 2022-09-14
• Results First Submitted: 2025-03-25
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Results First Posted: 2025-05-22
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

• No further criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multi-component reintegration intervention	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Planned Intervention Sessions That Were Delivered	6 weeks	Number of planned intervention session over the total number of planned interention sessions
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.	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.

Secondary Outcome Measures

Name	Time	Method
Change in Reintegration Score	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)
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	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.
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 participating in the psychosocial counseling component of the intervention on a five-point Likert scale at six weeks over the total number of participants.
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 physiotherapy component of the intervention on a five-point Likert scale at six weeks over the total number of intervention participants.
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	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

Trial Locations

Locations (1)

Mulago Specialized Women's and Children's Hospital; 🇺🇬 Kampala, Uganda