Clinical Research Directory
Browse clinical research sites, groups, and studies.
An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males
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 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
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-11-24
Completion Date
2026-06
Last Updated
2025-12-15
Healthy Volunteers
No
Conditions
Interventions
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.
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 (8)
Lakeview Clinical Research, LLC
Guntersville, Alabama, 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
Trialfinity Clinical Research Center
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