Male External Catheters' Comparison of Comfort and Efficacy

NACompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

June 12, 2023

Primary Completion Date

June 16, 2023

Study Completion Date

June 16, 2023

Conditions
Non-invasive Urine Output Management
Interventions
DEVICE

PureWick Male External Catheter

The PureWick™ Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick™ Male External Catheter is a commercially available device which is Class I, 510(K) exempt.

DEVICE

Sage PrimoFit

The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt.

Trial Locations (1)

336020

USF Health Center for Advanced Medical Learning and Simulation (CAMLS), Tampa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

C. R. Bard

INDUSTRY

NCT05955560 - Male External Catheters' Comparison of Comfort and Efficacy | Biotech Hunter | Biotech Hunter