Consumer Evaluation of an Investigational Intermittent Catheter

Part of paid clinical trials in Libertyville, Illinois.

Sponsor
Hollister Incorporated
Study ID
NCT07714694
Status
Recruiting
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Conditions

  • Neurogenic Bladder
  • Urinary Retention

Eligibility Criteria

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

Interventions

  • An intermittent urethral urinary catheter with a tip, tube and drainage eyelets — DEVICE
    An intermittent urethral urinary catheter with a tip, tube and drainage eyelets

Study Details

This clinical study is designed to evaluate the initial safety and performance of an investigational intermittent urinary catheter in people who use intermittent catheterization. Participants will use the study catheter and provide feedback on their experience, including ease of insertion, advancement through the urethra, bladder drainage, withdrawal, comfort, confidence, satisfaction, and overall ease of use. Safety will be evaluated through reported health changes and adverse events. Device performance and user experience will be assessed using participant questionnaires and comparisons with the participant's current intermittent catheter, including questions related to catheter handling, comfort during catheterization, perceived ability to empty the bladder, likelihood of future use, and product preference. The study is intended to generate descriptive information on the initial clinical use of the investigational catheter and to help characterize its safety, usability, comfort, satisfaction, and performance relative to participants' current intermittent catheter products.

Key Dates

First listed
Jul 20, 2026
Start date
Jul 9, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Catheter
    Participants will first use 30 of their usual intermittent catheters and then switch to 30 study catheters in a fixed-sequence, within-participant design. All participants receive the same study catheter; responses from the usual-catheter period provide within-participant control context.

Primary Outcome Measure

Incidence of Health Changes and Adverse Events During Usual-Catheter and Investigational-Catheter Use [ Time Frame: Through completion of both catheter-use periods, approximately 6 to 20 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hollister IncorporatedLibertyvilleIllinois60048
Hollister Incorporated
[email protected]
(847) 680-1000

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