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ENROLLING BY INVITATION
NCT07282860
NA

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

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.

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

Interventions

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.

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