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Nocturnal Enuresis clinical trials

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NCT ID: NCT05710718 Enrolling by invitation - Nocturnal Enuresis Clinical Trials

PureWick™ France and U.S. At-Home Pilot Study

Start date: October 31, 2023
Phase: N/A
Study type: Interventional

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.