N/A N=43 Other

PureWick™ Adolescent Study

Healthy Volunteers, Adolescent

Bottom Line

View on ClinicalTrials.gov: NCT06631313 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcome: Primary: Performance of the PureWick System in Adolescents After HCP Placement and Self-placement — 90.40; 93.09; 87.15; 90.41 Percentage of urine captured

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PureWick System (Device)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: C. R. Bard
Primary completion: Sep 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Performance of the PureWick System in Adolescents After HCP Placement and Self-placement	90.40; 93.09; 87.15; 90.41; 92.95; 95.19	—
SECONDARY Participant Comfort	4.4; 4.3; 4.2; 4.3; 4.7; 4.0	—
SECONDARY Participant Ease of Use	4.4; 4.3; 5.0; 4.7	—
SECONDARY IFU Comprehension	4.8; 4.7; 4.8; 4.7; 4.7; 4.6	—
SECONDARY HCP Ease of Use	5.0; 5.0; 5.0; 5.0	—

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06631313). 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.