NCT05955560

Male External Catheters' Comparison of Comfort and Efficacy

Evaluating the Efficacy and Comfort of the PureWick Male External Catheter Against a Comparator in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Prospective, Randomized, Crossover, Single-blind, Single Center Healthy Volunteer Study conducted over 1 day, with 2 voids using the PureWick (PW) Male external catheter (MEC) vs. comparator Sage PrimoFit™. This study is designed to assess the performance, comfort, and ease of use of the PW Male external catheter as compared to the comparator product.

Detailed description

In this prospective, post-market, crossover, single-blind, single center healthy volunteer study, healthy males will be randomized 1:1 to a treatment sequence using two devices (PureWick™ Male External Catheter and Sage PrimoFit™) and followed for 1 day through 2 voids. Approximately 50 participants will be enrolled in this study to obtain 44 evaluable subjects. This study is designed to assess the performance, comfort, and ease of use of the PW Male external catheter. The purpose of this study is to provide clinical evidence to compare the effectiveness and comfort of PureWick™ Male against a comparator for non-invasive urine output management in patients with varying male anatomy. Specifically, the study will collect data about how the male external catheters perform when participants are positioned on their side using a turning wedge with the head of the bed elevated, mimicking common patient positioning in the hospital setting.

Conditions

• Non-invasive Urine Output Management

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-12
• Primary completion: 2023-06-16
• Completion: 2023-06-16
• First posted: 2023-07-21
• Last updated: 2024-08-27
• Results posted: 2024-08-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study