PureWick™ Adolescent Study | Clinical Trial

Key information

Conditions

Healthy Volunteers, Adolescent

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TKL Research, Inc.

Fair Lawn, New Jersey, 07410, United States

About this study

The objective of this healthy volunteer study is to understand if external catheters are an effective alternative in the adolescent population in both male and female adolescents. The main question it aims to answer is: Do the PureWick Male and PureWick Flex female external catheters effectively capture urine in the adolescent population after both healthcare professional placement and self-placement? Participants will void while wearing the external catheter two times and answer brief questionnaires assessing perceived wetness, IFU comprehension, comfort and ease of use. Total study participation time is 2-3 hours in a single day.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy Adolescent Male or Female aged 12 through 21 years old
Able to independently and voluntarily void urine
Ability to speak and understand English.
Willing to comply with all study procedures in the protocol.
Provision of signed and dated informed consent form.

Exclusion criteria

Has urinary retention
Incontinent to feces
Has any irritation, wound, open lesion at the device application site.
For females: currently menstruating without use of an internal device, e.g. tampon or menstrual cup, during the execution of the study.
For females: currently pregnant at time of consenting (self-reported)
Currently enrolled in or has previously been enrolled in or has completed nursing or other clinical training and courses.
Has ever been employed as a home health aide or homecare provider.
Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.

Treatment and study plan

PureWick System

Device

The PureWick System consists of the PureWick Urine Collection System used with either the PureWick Male External Catheter or the PureWick Flex Female External Catheter, which are intended for non-invasive urine output management.

Primary outcomes

Performance of the PureWick System in Adolescents After HCP Placement and Self-placement

Time frame: 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 outcomes

Participant Comfort

Time frame: 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 Ease of Use

Time frame: 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
IFU Comprehension

Time frame: Approximately 2 hours after device placement

Overall IFU comprehension on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, and 5 = Strongly Agree.
HCP Ease of Use

Time frame: From date of first enrollment until the date of last patient completion, approximately 4 weeks

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.

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

A Prospective, Uncontrolled, Open-label Healthy Volunteer Study to Assess the Performance of the PureWick™ Male and PureWick™ Flex Female External Catheter Devices in Adolescents

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Oct 8, 2024
Registry last updated: Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.