CompletedNot Applicable

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

United States17 participantsStarted 2023-10-31

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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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 the protocol
✓. Provision of signed and dated informed consent form

Exclusion criteria

✕. 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

What they're measuring

Daily Average Urine Capture Rate (Percentage)

Timeframe: Daily for 28 days during each treatment phase

Daily Average Skin Irritation Score Using the Draize Scale

Timeframe: Daily for 28 days during each treatment phase

Trial details

NCT IDNCT05710718

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-25

Results submitted2025-05-02

View on ClinicalTrials.gov More Nocturnal Enuresis trials