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

Completed · Not applicable

Conditions studied: Nocturnal Enuresis

In brief

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.

Key facts

Study ID

NCT05710718

Run by

C. R. Bard

People needed

17

Starts

2023-10-31

Expected to finish

2024-08-25

Last updated by the study team

2025-07-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 the protocol
• Provision of signed and dated informed consent form

You may not qualify if…

• Has frequent episodes of bowel incontinence without a fecal management system in place; or
• Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
• Has Urinary tract, vaginal or other chronic infections, active genital herpes; or
• Has Urinary retention; or
• Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or
• Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
• 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
• Is known to be pregnant at time of enrollment (for women of childbearing age); or
• Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.
• Is under supervision of a legally authorized representative.

Where it is running

• Smiths Medical Center — Dunwoody, Georgia, United States
• Weill Cornell Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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