PureWick™ At-Home Pilot Study

In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate.

Inclusion Criteria:Adult Female Participants >18 years of age at the time of signing the informed consent.Currently use diapers or equivalent at night for urine capture ("Change complet"(French term))Willing to comply with all study procedures in this protocolProvision of signed and dated informed consent formExclusion Criteria:Has frequent episodes of bowel incontinence without a fecal management system in place; orHas moderate to heavy menstruation and cannot use a tampon or menstrual cup; orHas Urinary tract, vaginal or other chronic infections, active genital herpes; orHas Urinary retention; orIs agitated, combative, and/or uncooperative and may remove the external catheter or pouch; orHas any wound, open lesion or irritation on the genitalia, perineum, or sacrum; orHas 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; orIs known to be pregnant at time of enrollment (for women of childbearing age); orAny other condition that, in the opinion of the investigator, would preclude them from participating in the study.