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

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

March 21, 2025

Primary Completion Date

June 15, 2025

Study Completion Date

June 15, 2025

Conditions
Urinary Incontinence
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.

Trial Locations (2)

33467

Finlay Medical Research, Greenacres City

08619

Trialfinity Clinical Research Center, Hamilton

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Becton, Dickinson and Company

INDUSTRY

lead

C. R. Bard

INDUSTRY