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Fistula Reintegration Pilot

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ClinicalTrials.gov Identifier: NCT04748653
Recruitment Status : Not yet recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Makerere University
Mama, LLC
Mulago Hospital, Uganda
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Female Genital Fistula Urinary Incontinence Behavioral: Multi-component reintegration intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The intervention incorporates 15 health education sessions, 6 psychosocial counseling sessions, 15 physiotherapy sessions, and an economic investment.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comprehensive Reintegration Assistance for Women With Obstetric Fistula
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: 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.
Behavioral: Multi-component reintegration intervention
The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.




Primary Outcome Measures :
  1. Proportion of planned intervention sessions that were delivered [ Time Frame: 6 weeks ]
    Number of participants who received each planned intervention session over the total number of participants enrolled.

  2. Proportion of participants indicating satisfied or very satisfied with the intervention. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in reintegration score [ Time Frame: 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)

  2. Change in quality of life [ Time Frame: Baseline and 6 months ]
    Mean change in quality of life score from pre-intervention (baseline) to post (6 months) on the WHO QOL-BREF measure (range 0-100, higher indicating better)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No further criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748653


Contacts
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Contact: Alison El Ayadi, ScD, MPH 415.659.8367 alison.elayadi@ucsf.edu
Contact: Abner Korn 415.885.7788 abner.korn@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Makerere University
Mama, LLC
Mulago Hospital, Uganda
Investigators
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Principal Investigator: Alison El Ayadi, ScD, MPH University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04748653    
Other Study ID Numbers: P0527552
R00HD086232 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Fistula
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Pathological Conditions, Anatomical