Male External Catheters' Comparison of Comfort and Efficacy

Not Applicable

Completed

Conditions: Non-invasive Urine Output Management

Interventions: Device: PureWick Male External Catheter
Device: Sage PrimoFit

Registration Number: NCT05955560

Lead Sponsor: C. R. Bard

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 59

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 2	PureWick Male External Catheter	The Sage PrimoFit™ is used first, followed by cross-over to PureWick MEC.
Treatment Sequence 1	PureWick Male External Catheter	PureWick™ Male External Catheter is used first, followed by cross-over to Sage PrimoFit.
Treatment Sequence 2	Sage PrimoFit	The Sage PrimoFit™ is used first, followed by cross-over to PureWick MEC.
Treatment Sequence 1	Sage PrimoFit	PureWick™ Male External Catheter is used first, followed by cross-over to Sage PrimoFit.

Primary Outcome Measures

Name	Time	Method
Performance of the PureWick MEC Against an Established Comparator	Approximately 2 hours after device placement	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.

Secondary Outcome Measures

Name	Time	Method
Performance of the PureWick MEC in Morbidly Obese Subpopulation	Approximately 2 hours after device placement	Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).
Participant Comfort	Approximately 2 hours after device placement	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.
Participant Comfort Scale Survey	Approximately 2 hours after device placement	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.
Ease of Use by Health Care Professional (HCP)	Approximately 2 hours after device placement	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.