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This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting.
Sponsor: C. R. Bard
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.
Official title: 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
Key Details
Gender
MALE
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2025-03-21
Completion Date
2025-06-15
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
PureWick® Urine Collection 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.
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.
Locations (2)
Finlay Medical Research
Greenacres City, Florida, United States
Trialfinity Clinical Research Center
Hamilton, New Jersey, United States