An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males

This post-market study will assess the performance of and user satisfaction with the PureWick™ Male External Catheter in a home setting. The study will also observe safety of the study device and collect information from participants about their experience using the device.

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.