Fistula Reintegration Pilot

NCT04748653 | Completed Results

• 2 other identifiers: P0527552R00HD086232
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Genital Fistula; Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• Percentage of Planned Intervention Sessions That Were Delivered

  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.

  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 Outcomes (5)

• Change in Reintegration Score

  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

  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.

  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

Study Arms (1)

Multi-component reintegration intervention

EXPERIMENTAL

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

Interventions

Multi-component reintegration intervention BEHAVIORAL

The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.

Multi-component reintegration intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No further criteria

Sponsors & Collaborators

• University of California, San Francisco: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Makerere University: collaborator
• Mama, LLC: collaborator
• Mulago Hospital, Uganda: collaborator

Study Sites (1)

Mulago Specialized Women's and Children's Hospital

Kampala, Uganda

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alison El Ayadi, Associate Professor
• Organization: University of California San Francisco

alison.elayadi@ucsf.edu

415-476-5877

Study Officials

• Alison El Ayadi, ScD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention incorporates 15 health education sessions, 6 psychosocial counseling sessions, 15 physiotherapy sessions, and an economic investment.

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: August 1, 2021
• Primary Completion: September 14, 2022
• Study Completion: September 14, 2022
• Last Updated: May 22, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)