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

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

NCT07282860

Run by

C. R. Bard

People needed

120

Starts

2025-11-21

Expected to finish

2026-06-22

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Is considered a vulnerable population.

Where it is running

• Lakeview Clinical Research, LLC — Guntersville, Alabama, United States
• Novak Clinical Research — Tucson, Arizona, United States
• American Institute of Research — Los Angeles, California, United States
• Finlay Medical Research — Greenacres City, Florida, United States
• Finlay Medical Research — Miami, Florida, United States
• Sonar Clinical Research — Atlanta, Georgia, United States
• Eagle Clinical Research — Chicago, Illinois, United States
• Vida Clinical Studies — Dearborn Heights, Michigan, United States
• Trialfinity Clinical Research Center — Hamilton, New Jersey, United States
• Inno MDR Clinical — Hamilton, New Jersey, United States
• Albuquerque Clinical Trials — Albuquerque, New Mexico, United States
• Prime Global Research — The Bronx, New York, United States
• Monroe Biomedical Research — North Charleston, South Carolina, United States
• Trio Clinical Trials — Houston, Texas, United States
• R&H Clinical Research — Katy, Texas, United States

Full record on ClinicalTrials.gov

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