NCT06850259

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

A Comparative Crossover Study on the Safety, Efficacy, and Patient Reported Satisfaction of the PureWick™ System With an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: Male
• Age: 65 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 15 men requiring the use of diapers or pads 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 efficacy endpoint is the mean capture rate. The primary safety endpoint is the number of device-related AEs requiring medical intervention. Capture rates and Adverse Events are assessed daily throughout each 7-day treatment phase. Sleep disturbance is assessed at baseline and every 7 days during treatment. End of study preference questionnaire is completed at the end of treatment. Device adherence is assessed by the proportion of device wear nights that the study device became dislodged. Tolerability is assessed by number of nights of actual device use.

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: 2025-03-21
• Primary completion: 2025-06-15
• Completion: 2025-06-15
• First posted: 2025-02-27
• Last updated: 2025-06-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study