CompletedNot Applicable

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

United States15 participantsStarted 2025-03-21

Plain-language summary

This post-market study will assess the performance of and user satisfaction with the PureWick™ Male External Catheter in a home setting. The study will also observe safety of the study device and collect information from participants about their experience using the device.

Who can participate

Age range65 Years

SexMALE

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Inclusion criteria

✓. Adult male participants ≥ 65 years of age at the time of signing the informed consent
✓. Male anatomy at the time of enrollment
✓. Currently use diapers, pads, or equivalent at night for urine output management
✓. Willing to comply with all study procedures in this protocol
✓. Provision of signed and dated informed consent form

Exclusion criteria

✕. Has frequent episodes of bowel incontinence; or
✕. Has chronic urinogenital infections, active genital herpes; or
✕. Has Urinary retention; or
✕. Has experience using study devices in the home setting within the last year; or
✕. Is agitated, combative, and/or uncooperative and may remove the external catheter; or
✕. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
✕. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study; or
✕. Is considered a vulnerable population.

What they're measuring

Performance of the PureWick MEC in the Home Setting

Timeframe: Daily for 7 days during each treatment phase

Number of device-related Adverse events requiring medical intervention

Timeframe: Daily for 7 days during each treatment phase

Trial details

NCT IDNCT06850259

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-15

View on ClinicalTrials.gov More Urinary Incontinence trials