Male External Catheters' Comparison of Comfort and Efficacy (MECCE)

C. R. Bard

Status: Completed

Conditions: Non-invasive Urine Output Management

Treatments: Device: Sage PrimoFit; Device: PureWick Male External Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05955560

UCC-23AC022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult Male Patient ≥ 18 years old
2. Male anatomy at time of enrollment
3. Ability to speak and understand English
4. Willing to comply with all study procedures in this protocol
5. Able to independently void urine
6. Provision of signed and dated informed consent form

Exclusion criteria

1. Urinary incontinence which does not allow the subject to spontaneously void
2. Frequent episodes of bowel incontinence
3. Has Urinary Retention
4. Has any irritation, wound, open lesion, at the application site, on the genitalia, perineum, or sacrum
5. Recent surgery of the external urogenital tract, penis, or pubic area
6. Not able to comply with study procedures independently without required assistance
7. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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59 participants in 2 patient groups

Treatment Sequence 1

Other group

Description:

PureWick™ Male External Catheter is used first, followed by cross-over to Sage PrimoFit.

Treatment:

Device: PureWick Male External Catheter

Device: Sage PrimoFit

Treatment Sequence 2

Other group

Description:

The Sage PrimoFit™ is used first, followed by cross-over to PureWick MEC.

Treatment:

Device: PureWick Male External Catheter

Device: Sage PrimoFit