CompletedNot Applicable

This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting.

United States171 participantsStarted 2024-10-31

Plain-language summary

This post-market study will assess the performance of and user experience with the PureWick™ System in a home setting. The study will also observe safety of the study device and collect information from participants about their quality of life before and after using the device.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Adult Female Participants greater than or equal to 18 years of age at the time of signing the informed consent.
✓. Currently use diapers or equivalent at night for urine output management.
✓. Willing to comply with all study procedures in this CIP.
✓. 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

Performance of the PureWick System in the home setting

Timeframe: From enrollment to the end of treatment at 4 weeks

Safety of the PureWick System in the home setting

Timeframe: From enrollment to the end of treatment at 4 weeks

Trial details

NCT IDNCT06666426

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Adult Nocturnal Enuresis trials