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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT07282860
Eligibility Criteria:
Inclusion Criteria:
1. Adult male participants ≥ 18 years of age at the time of signing the informed consent
2. Male anatomy at the time of enrollment
3. Currently use diapers, pads, or equivalent at night for urine output management
4. Willing to comply with all study procedures in this protocol
5. Provision of signed and dated informed consent form
Exclusion Criteria:
1. Has frequent episodes of bowel incontinence; or
2. Has chronic urinogenital infections, active genital herpes; or
3. Has Urinary retention; or
4. Is expected to have an overnight urine output exceeding 1500 mL. This may include, but is not limited to, individuals with polyuria or those receiving diuretic therapy; or
5. Has experience using study devices in the home setting within the last year; or
6. Is agitated, combative, and/or uncooperative and may remove the external catheter; or
7. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
8. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study; or
9. Is considered a vulnerable population.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07282860
Study Brief:
Protocol Section:
NCT07282860