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Fistula Reintegration Pilot

Primary Purpose

Female Genital Fistula, Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Multi-component reintegration intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Female Genital Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • No further criteria

Sites / Locations

  • Mulago Specialized Women's and Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multi-component reintegration intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of planned intervention sessions that were delivered
Number of participants who received each planned intervention session over the total number of participants enrolled.
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.

Secondary Outcome Measures

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)
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)

Full Information

First Posted
February 5, 2021
Last Updated
December 14, 2022
Sponsor
University of California, San Francisco
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Makerere University, Mama, LLC, Mulago Hospital, Uganda
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1. Study Identification

Unique Protocol Identification Number
NCT04748653
Brief Title
Fistula Reintegration Pilot
Official Title
Comprehensive Reintegration Assistance for Women With Obstetric Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Makerere University, Mama, LLC, Mulago Hospital, Uganda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Genital Fistula, Urinary Incontinence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The intervention incorporates 15 health education sessions, 6 psychosocial counseling sessions, 15 physiotherapy sessions, and an economic investment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multi-component reintegration intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multi-component reintegration intervention
Intervention Description
The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.
Primary Outcome Measure Information:
Title
Proportion of planned intervention sessions that were delivered
Description
Number of participants who received each planned intervention session over the total number of participants enrolled.
Time Frame
6 weeks
Title
Proportion of participants indicating satisfied or very satisfied with the intervention.
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in reintegration score
Description
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)
Time Frame
Baseline and 6 months
Title
Change in quality of life
Description
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)
Time Frame
Baseline and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing surgery for female genital fistula Age 18 or above, or emancipated minor per Ugandan law Exclusion Criteria: No further criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alison El Ayadi, ScD, MPH
Phone
415.659.8367
Email
alison.elayadi@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Abner Korn
Phone
415.885.7788
Email
abner.korn@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison El Ayadi, ScD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mulago Specialized Women's and Children's Hospital
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justus Barageine, MD PhD
Email
barageine@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Fistula Reintegration Pilot

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