Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT02686957
Eligibility Criteria:
Inclusion Criteria:
In order to be eligible, study participants must meet the following criteria:
* Had a fistula closed at discharge, as measured by a dye test (this include women dry and those with residual incontinence);
* Willing and able to provide written informed consent (assent for minors);
* Had a urinary or recto-vaginal fistula;
* Agree to participate in follow-up visits (every six months) from consent date and for the duration of the study;
* Agree to stay in Guinea for the duration of the study.
Exclusion Criteria:
Potential participants meeting any of the following criteria will not be enrolled in the study:
* Refusal to give free and informed consent;
* Surgery done outside the study sites;
* Incomplete medical records;
* Incontinence unrelated to urinary or recto-vaginal fistula.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02686957
Study Brief:
Protocol Section:
NCT02686957