An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males

Part of paid clinical trials in Guntersville, Alabama.

Sponsor
C. R. Bard
Study ID
NCT07282860
Status
Enrolling By Invitation

Conditions

  • Urinary Incontinence

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PureWick System — DEVICE
    The PureWick™ System consists of the PureWick™ Urine Collection System used with the PureWick™ Male External Catheter (MEC), which is intended for non-invasive urine output management in male patients. The PureWick™ MEC is a single-use, non-sterile, commercially available device, which is Class I, 510(K) exempt.
  • UltraFlex Self-Adhering Male External Catheter — DEVICE
    UltraFlex™ is a self-adhering male external catheter used for the drainage of urine. The catheter is applied by the patient or caregiver. The self-adhering male external catheter is designed for the management of adult male urinary incontinence.

Study Details

This post-market study will assess the performance of and user satisfaction with the PureWick™ Male External Catheter in a home setting. The study will also observe safety of the study device and collect information from participants about their experience using the device.

Key Dates

Start date
Nov 24, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Treatment Sequence 1
    PureWick System used first, followed by crossover to UltraFlex
  • Experimental: Treatment Sequence 2
    UltraFlex is used first, followed by crossover to PureWick System

Primary Outcome Measure

Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). [ Time Frame: From enrollment up to 14 days of treatment ]

Locations (8)

FacilityCityStateZIPSite coordinators
Lakeview Clinical Research, LLCGuntersvilleAlabama35976-
American Institute of ResearchLos AngelesCalifornia90017-
Finlay Medical ResearchGreenacres CityFlorida33467-
Finlay Medical ResearchMiamiFlorida33126-
Trialfinity Clinical Research CenterHamiltonNew Jersey08619-
Albuquerque Clinical TrialsAlbuquerqueNew Mexico87102-
Prime Global ResearchThe BronxNew York10456-
Monroe Biomedical ResearchNorth CharlestonSouth Carolina29406-

Find similar trials in Guntersville, AL

By research site
Lakeview Clinical Research, LLC· Guntersville, ALAmerican Institute of Research· Los Angeles, CAFinlay Medical Research· Greenacres City, FLFinlay Medical Research· Miami, FLTrialfinity Clinical Research Center· Hamilton, NJAlbuquerque Clinical Trials· Albuquerque, NM

Related Studies