N/A
Completed N=12
Fistula Reintegration Pilot
Female Genital Fistula · Urinary Incontinence
Source: ClinicalTrials.gov NCT04748653 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Percentage of Planned Intervention Sessions That Were Delivered — 96.2 percentage of planned sessions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Planned Intervention Sessions That Were Delivered |
96.2 | — |
| PRIMARY 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. |
12 | — |
| SECONDARY Change in Reintegration Score |
30.5 | — |
| SECONDARY 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 |
12 | — |
| SECONDARY 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. |
12 | — |
| SECONDARY 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. |
12 | — |
| SECONDARY 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 |
12 | — |
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
Data sourced from ClinicalTrials.gov (NCT04748653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.