Clinical Trial

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

Study acronym: PUREST-M
Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Trial status changed: Enrolling by Invitation → Completed 2026-08-05
notable Enrollment increased: 100 -> 120 participants 2026-08-05
notable Trial sites expanded: 8 -> 15 locations 2026-08-05
Trial Details
NCT Number NCT07282860
Lead Sponsor C. R. Bard
Collaborators: Becton, Dickinson and Company
Conditions Urinary Incontinence
Enrollment 120 participants
Start Date 2025-11-21
Primary Completion 2026-06-22 (estimated)
Study Completion 2026-06-22 (estimated)
Updated on ClinicalTrials.gov 2026-08-04