Male External Catheters' Comparison of Comfort and Efficacy

NCT ID: NCT05955560

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-12
• Study Completion Date: 2023-06-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment Sequence 1

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

Group Type: OTHER

PureWick Male External Catheter

Intervention Type: DEVICE

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.

Sage PrimoFit

Intervention Type: DEVICE

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.

Treatment Sequence 2

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

Group Type: OTHER

PureWick Male External Catheter

Intervention Type: DEVICE

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.

Sage PrimoFit

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

PureWick MEC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria-Victoria Sena, RN

Role: PRINCIPAL_INVESTIGATOR

Tampa General Hospital

Locations

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

Tampa, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

UCC-23AC022

Identifier Type: -

Identifier Source: org_study_id