Consumer Evaluation of an Investigational Intermittent Catheter
Eligible age
22+ yrs
Accepts
Men
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Hollister Incorporated
You may qualify if…
- ✓ 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)
You may not qualify if…
- ✕ is currently receiving chemotherapy, has received chemotherapy within the past 30 days, or is scheduled to receive chemotherapy during the study (i.e., in the next 34 days)
- ✕ is currently undergoing, has previously underwent, or is planning to undergo radiation therapy to the bladder, prostate, or rectum during the study (i.e., in the next 34 days)
- ✕ is currently using one or more of the following oral or injectable steroid therapies for 30 days or more:
- ✕ 1. Acthar Gel
- ✕ 2. corticotropin
- ✕ 3. Agamree
- ✕ 4. vamorolone
- ✕ 5. budesonide
Where it's recruiting
Libertyville
Source: ClinicalTrials.gov · NCT07714694 · last updated 2026-07-20