N/A
N=59
Male External Catheters' Comparison of Comfort and Efficacy
Non-invasive Urine Output Management
Bottom Line
View on ClinicalTrials.gov: NCT05955560 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Performance of the PureWick MEC Against an Established Comparator — 97.8; 90.7; 91.1; 85.2 Percentage of urine captured — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PureWick Male External Catheter (Device); Sage PrimoFit (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- C. R. Bard
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance of the PureWick MEC Against an Established Comparator |
97.8; 90.7; 91.1; 85.2 | 0.04 sig |
| SECONDARY Performance of the PureWick MEC in Morbidly Obese Subpopulation |
99.7; 83.5; 80.8; 79.3 | — |
| SECONDARY Participant Comfort |
3.85; 3.69; 3.71; 3.41; 3.57; 3.62 | — |
| SECONDARY Participant Comfort Scale Survey |
4.29; 3.92; 4.0; 3.58; 3.84; 3.92 | — |
| SECONDARY Ease of Use by Health Care Professional (HCP) |
4.59; 4.58; 4.71; 4.81 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05955560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.