Fistula Reintegration Pilot (NCT04748653) | Clinical Trial Compass
CompletedNot Applicable
Fistula Reintegration Pilot
Uganda12 participantsStarted 2021-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Undergoing surgery for female genital fistula
* Age 18 or above, or emancipated minor per Ugandan law
Exclusion Criteria:
* No further criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Planned Intervention Sessions That Were Delivered
Timeframe: 6 weeks
2
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.