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

Completed · Not applicable

Conditions studied: Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT06850259

Run by

C. R. Bard

People needed

15

Starts

2025-03-21

Expected to finish

2025-06-15

Last updated by the study team

2025-06-29

Who can join

Age: 65 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Finlay Medical Research — Greenacres City, Florida, United States
• Trialfinity Clinical Research Center — Hamilton, New Jersey, United States

Full record on ClinicalTrials.gov

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