Male External Catheters' Comparison of Comfort and Efficacy

Study Overview
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Brief Summary
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A Prospective, Randomized, Crossover, Single-blind, Single Center Healthy Volunteer Study conducted over 1 day, with 2 voids using the PW Male external catheter 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
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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.

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

Conditions
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Non-invasive Urine Output Management

Intervention / Treatment
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* Device: PureWick Male External Catheter
* Device: Sage PrimoFit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each subject acts as his own control, and therefore the difference in treatments is derived from a within-subject comparison.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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). | Approximately 2 hours after device placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the PureWick MEC in patients that are unable to use traditional sheath condom catheters | 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 score on a 5-point Likert scale | Approximately 2 hours after device placement | 
| Ease of use by HCP | Ease of use score on a 5-point Likert scale | Approximately 2 hours after device placement |