PureWick™ Adolescent Study

C. R. Bard

Status: Completed

Conditions: Healthy Volunteers, Adolescent

Treatments: Device: PureWick System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06631313

UCC-23AC023

Details and patient eligibility

About

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

Full description

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.

Enrollment: 43 patients

Sex: All

Ages: 12 to 21 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

PureWick System

Experimental group

Treatment:

Device: PureWick System