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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-invasive Urine Output Management
• Intervention / Treatment: Device: PureWick Male External Catheter; Device: Sage PrimoFit

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 336020
      • USF Health Center for Advanced Medical Learning and Simulation (CAMLS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment Sequence 1; PureWick™ Male External Catheter is used first, followed by cross-over to Sage PrimoFit.	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.; Other Names: PureWick MEC; 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.
Other: Treatment Sequence 2; The Sage PrimoFit™ is used first, followed by cross-over to PureWick MEC.	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.; Other Names: PureWick MEC; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the PureWick MEC Against an Established Comparator	Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). Prior to each void, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants void into the device while laying in a bed with the absorbent pad underneath them. After each void, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) * 100.	Approximately 2 hours after device placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the PureWick MEC in Morbidly Obese Subpopulation	Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).	Approximately 2 hours after device placement
Participant Comfort	Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Uncomfortable, 2 = Uncomfortable, 3 = Neither Comfortable or Uncomfortable, 4 = Comfortable, and 5 = Very Comfortable. The last survey question related to likelihood to recommend the device ranged from 1-5 with higher scores indicating a better outcome, where 1 = Very Unlikely, 2 = Unlikely, 3 = Neither Likely Nor Unlikely, 4 - Likely, and 5 = Very Likely.	Approximately 2 hours after device placement
Participant Comfort Scale Survey	Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Uncomfortable, 2 = Uncomfortable, 3 = Neither Comfortable or Uncomfortable, 4 = Comfortable, and 5 = Very Comfortable. The last survey question related to likelihood to recommend the device ranged from 1-5 with higher scores indicating a better outcome, where 1 = Very Unlikely, 2 = Unlikely, 3 = Neither Likely Nor Unlikely, 4 - Likely, and 5 = Very Likely.	Approximately 2 hours after device placement
Ease of Use by Health Care Professional (HCP)	Ease of use score on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Difficult, 2 = Somewhat Difficult, 3 = Average Difficulty, 4 = Somewhat Easy, and 5 = Very Easy.	Approximately 2 hours after device placement

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Maria-Victoria Sena, RN, Tampa General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): June 16, 2023

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: UCC-23AC022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes