Fistula Reintegration Pilot

Urinary Incontinence Clinical Trial

Official title:

Comprehensive Reintegration Assistance for Women With Obstetric Fistula

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748653
• Other study ID #: P0527552
• Secondary ID: R00HD086232
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: December 2022
• Source: University of California, San Francisco
• Contact: Alison El Ayadi, ScD, MPH
• Phone: 415.659.8367
• Email: alison.elayadi[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No further criteria

Related Conditions & MeSH terms

• Female Genital Fistula
• Fistula
• Urinary Incontinence

Intervention

Behavioral:
• Multi-component reintegration intervention
The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.

Locations

Country	Name	City	State
Uganda	Mulago Specialized Women's and Children's Hospital	Kampala

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Makerere University, Mama, LLC, Mulago Hospital, Uganda

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of planned intervention sessions that were delivered	Number of participants who received each planned intervention session over the total number of participants enrolled.	6 weeks
Primary	Proportion of participants indicating satisfied or very satisfied with the intervention.	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.	6 weeks
Secondary	Change in reintegration score	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
Secondary	Change in quality of life	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)	Baseline and 6 months