NCT07282860

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

A Randomized, Controlled Crossover Study on the Safety, Efficacy, and Patient Reported Outcome Measures Comparing the PureWick™ System With an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: C. R. Bard · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 100 adult men requiring the use of diapers, pads or equivalent at night for urine management will take part in this prospective, open-label, crossover trial. Participants will be 1:1 randomized to a treatment sequence using two devices: the PureWick™ System (PureWick™ Male External Catheter \& PureWick™ Urine Collection System) and the UltraFlex™ Self-Adhering Male External Catheter. Participants will use each urine management device overnight while sleeping for a period of 7 days with a 2-day washout period in between. Total duration of participation is approximately 16 days. The primary endpoint is the mean urine capture rate. The secondary endpoints include the number of device-related AEs requiring medical intervention (safety), device satisfaction and preference questionnaires, and sleep disturbance (quality of life). Capture rates and adverse events are assessed daily throughout each 7-day treatment phase. Patient satisfaction is assessed at the end of each treatment phase. Patient preference is evaluated at study completion. Sleep disturbance is assessed at baseline and every 7 days during treatment.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	PureWick System	The PureWick™ System consists of the PureWick™ Urine Collection System used with the PureWick™ Male External Catheter (MEC), which is intended for non-invasive urine output management in male patients. The PureWick™ MEC is a single-use, non-sterile, commercially available device, which is Class I, 510(K) exempt.
DEVICE	UltraFlex Self-Adhering Male External Catheter	UltraFlex™ is a self-adhering male external catheter used for the drainage of urine. The catheter is applied by the patient or caregiver. The self-adhering male external catheter is designed for the management of adult male urinary incontinence.

Timeline

• Start date: 2025-11-24
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-12-15
• Last updated: 2025-12-15

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study