Clinical trial NCT05955560: Male External Catheters' Comparison of Comfort and Efficacy
Official title: Evaluating the Efficacy and Comfort of the PureWick Male External Catheter Against a Comparator in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-invasive Urine Output Management
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2023-07-21
Enrollment: 59
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each subject acts as his own control, and therefore the difference in treatments is derived from a within-subject comparison.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Performance of the PureWick MEC Against an Established Comparator
timeFrame: Approximately 2 hours after device placement
Secondary outcomes:
measure: Performance of the PureWick MEC in Morbidly Obese Subpopulation
timeFrame: Approximately 2 hours after device placement
measure: Participant Comfort
timeFrame: Approximately 2 hours after device placement
measure: Participant Comfort Scale Survey
timeFrame: Approximately 2 hours after device placement
measure: Ease of Use by Health Care Professional (HCP)
timeFrame: Approximately 2 hours after device placement
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Health Center for Advanced Medical Learning and Simulation (CAMLS)
state: Florida
Study officials:
affiliation: Tampa General Hospital
name: Maria-Victoria Sena, RN
role: PRINCIPAL_INVESTIGATOR
References: