PureWick™ Adolescent Study

Not Applicable

Completed

• Conditions: Healthy Volunteers, Adolescent
• Interventions: Device: PureWick System

• Registration Number: NCT06631313
• Lead Sponsor: C. R. Bard

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-28
• Primary Completion: 2024-09-10
• Study Completion: 2024-09-25
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

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

Exclusion Criteria

1. Has urinary retention
2. Incontinent to feces
3. Has any irritation, wound, open lesion at the device application site.
4. For females: currently menstruating without use of an internal device, e.g. tampon or menstrual cup, during the execution of the study.
5. For females: currently pregnant at time of consenting (self-reported)
6. Currently enrolled in or has previously been enrolled in or has completed nursing or other clinical training and courses.
7. Has ever been employed as a home health aide or homecare provider.
8. 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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PureWick System	PureWick System	-

Primary Outcome Measures

Name	Time	Method
Performance of the PureWick System in adolescents after HCP placement and self-placement	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
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 Ease of Use	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 OR where 1= Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, and 5 = Strongly Agree.
IFU Comprehension	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	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.

Trial Locations

Locations (1)

TKL Research, Inc.; 🇺🇸 Fair Lawn, New Jersey, United States