Consumer Evaluation of an Investigational Intermittent Catheter
Recruiting now · Not applicable
Conditions studied: Urinary Retention, Neurogenic Bladder
In brief
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 facts
- Study ID
- NCT07714694
- Run by
- Hollister Incorporated
- People needed
- 50
- Starts
- 2026-07-09
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 22 and older. Sex: male. Healthy volunteers: not accepted.
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:
- Hollister Incorporated VaPro Pocket Nelaton Tip (clear protective tip) (SKU 70144)
- Hollister Incorporated VaPro Pocket Coude (blue protective tip) (SKU 77144)
- Hollister Incorporated VaPro Coude (blue protective tip) (SKU 73144)
- Hollister Incorporated VaPro Plus Nelaton (clear protective tip) (SKU 74144)
- Hollister Incorporated VaPro Plus Pocket Nelaton (clear protective tip) (SKU 71144)
- Hollister Incorporated Onli Nelaton (SKU: 82144-30)
- Hollister Incorporated Onli Coudé (SKU: 85144)
- Wellspect LoFric Origo Nelaton (SKU: 443 14 40)
- Wellspect LoFric Origo Tiemann/Coudé (SKU: 444 14 40)
- Wellspect LoFric Origo Flexible Coudé with protective sleeve (SKU: 449 14 40)
- Wellspect LoFric Origo Flexible Coudé with insertion grip (SKU: 447 14 40)
- Coloplast SpeediCath Standard Male (SKU: 28414)
- Coloplast SpeediCath Male Coudé Tip (SKU: 28494)
- Coloplast SpeediCath Flex Coudé Pro (SKU: 20014)
- Convatec GentleCath Glide Male Straight Tip (SKU: 421567)
- Convatec GentleCath Glide Male Tiemann Tip (SKU: 421910)
- Convatec GentleCath Air Male Straight Tip (SKU:510690)
- Convatec GentleCath Air Male Coude Tip (SKU:510696)
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:
- Acthar Gel
- corticotropin
- Agamree
- vamorolone
- budesonide
- Cortef
- hydrocortisone
- Cortrophin Gel
- corticotrophin
- dexamethasone
- deflazacort
- prednisone
- Emflaza
- Eohilia
- fludrocortisone
- Jaythari
- Orapred ODT
- prednisolone
- Pyquvi
- Rayos
- Tarpeyo
- Uceris
Where it is running
- Hollister Incorporated — Libertyville, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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