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:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT05710718
Eligibility Criteria:
Inclusion Criteria:
1. Adult Female Participants \>18 years of age at the time of signing the informed consent.
2. Currently use diapers or equivalent at night for urine capture ("Change complet"(French term))
3. Willing to comply with all study procedures in the protocol
4. Provision of signed and dated informed consent form
Exclusion Criteria:
1. Has frequent episodes of bowel incontinence without a fecal management system in place; or
2. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
3. Has Urinary tract, vaginal or other chronic infections, active genital herpes; or
4. Has Urinary retention; or
5. Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or
6. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
7. Has any pre-existing neurological, psychiatric, or other condition that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator; or
8. Is known to be pregnant at time of enrollment (for women of childbearing age); or
9. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.
10. Is under supervision of a legally authorized representative.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05710718
Study Brief:
Protocol Section:
NCT05710718