Consumer Evaluation of an Investigational Intermittent Catheter
Hollister Incorporated
Summary
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.
Description
This is a prospective, single-arm, fixed-sequence, within-participant clinical evaluation of an investigational intermittent catheter. Eligible adult male participants in the United States who currently use hydrophilic intermittent catheters will first use 30 of their usual catheters and then 30 study catheters. During both catheter-use periods, participants will complete daily questionnaires regarding catheter use and health changes and will complete evaluation forms assessing ease of use, catheter performance, comfort, confidence, satisfaction, and comparative preference. Safety will be eval…
Eligibility
- Age range
- 22+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * is living in the USA * is male * is at least 22 years of age * can speak, read, and write in English * is self-catheterizing 3 or more times a day * has been performing unassisted, self-catheterizations, with a Hydrophilic IC, for at least 1 month * currently uses one of the hydrophilic ICs (length=40cm; size=Ch. 14) listed below: 1. Hollister Incorporated VaPro Pocket Nelaton Tip (clear protective tip) (SKU 70144) 2. Hollister Incorporated VaPro Pocket Coude (blue protective tip) (SKU 77144) 3. Hollister Incorporated VaPro Coude (blue protective tip) (SKU 73144)…
Interventions
- DeviceAn intermittent urethral urinary catheter with a tip, tube and drainage eyelets
An intermittent urethral urinary catheter with a tip, tube and drainage eyelets
Location
- Hollister IncorporatedLibertyville, Illinois