Fistula Reintegration Pilot

Not Applicable

Recruiting

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-15
• Primary Completion: 2023-02-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

• No further criteria

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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
Proportion of participants indicating satisfied or very satisfied with the intervention.	6 weeks	Number of participants reporting to be "satisfied" or "very satisfied" about their overall experience with each intervention module on a five-point Likert scale at six weeks over the total number of participants completing each module.
Proportion of planned intervention sessions that were delivered	6 weeks	Number of participants who received each planned intervention session over the total number of participants enrolled.

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	Baseline and 6 months	Mean change in quality of life score from pre-intervention (baseline) to post (6 months) on the World Health Organization Quality of Life Abbreviated Form measure (range 0-100, higher indicating better)
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)

Trial Locations

Locations (1)

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