By InvitationNot Applicable

An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males

United States100 participantsStarted 2025-11-24

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 range18 Years

SexMALE

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Inclusion criteria

✓. Adult male participants ≥ 18 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
✕. Is expected to have an overnight urine output exceeding 1500 mL. This may include, but is not limited to, individuals with polyuria or those receiving diuretic therapy; 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

What they're measuring

Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).

Timeframe: From enrollment up to 14 days of treatment

Trial details

NCT IDNCT07282860

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Urinary Incontinence trials