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Clinical trial Recruiting at 1 site Interventional Ages 22 and up Men only

Investigational Intermittent Catheter: First Look at Safety and Usability

Official title: Consumer Evaluation of an Investigational Intermittent Catheter

Run by Hollister Incorporated · NCT07714694 · Data updated 2026-11-12

This study tests a new intermittent catheter in adult men who already self-catheterize to see if it is safe and easy to use compared with their current catheter.

Quick facts

Study typeInterventional
Ages22 Years and up
SexMen only
Enrollment50 (estimated)
SponsorHollister Incorporated
Industry-sponsored
Drugs / interventionschemotherapy, radiation, prednisone
Locations1 site (Libertyville, Illinois)
StatusRecruiting
StartedJuly 9, 2026
Main results expectedOctober 2026
Study endsOctober 2026
Registry record updatedJuly 20, 2026
Trial IDNCT07714694 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adult men in the USA who self-catheterize at least 3 times daily and currently use a hydrophilic intermittent catheter.

Probably not a fit

Patients not meeting inclusion criteria or who do not experience improved usability or comfort may not benefit from this device.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm, within-participant study conducted in the United States. Participants will use 30 of their usual hydrophilic catheters followed by 30 of the investigational catheter, completing daily questionnaires about use and health changes. The study collects data on ease of insertion and withdrawal, comfort, confidence, satisfaction, bladder drainage, and overall usability, and compares the investigational catheter to the participant’s current product. Safety will be monitored through adverse events and health changes. The goal is to describe initial safety, usability, and performance of the investigational catheter relative to existing products.

Why it matters

Potential benefit: If successful, the investigational catheter could offer improved comfort or handling and inform future development and patient choice.

How similar studies have gone: Previous similar studies have used within-subject comparisons to describe early safety and usability of new intermittent catheters.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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)
  4. Hollister Incorporated VaPro Plus Nelaton (clear protective tip) (SKU 74144)
  5. Hollister Incorporated VaPro Plus Pocket Nelaton (clear protective tip) (SKU 71144)
  6. Hollister Incorporated Onli Nelaton (SKU: 82144-30)
  7. Hollister Incorporated Onli Coudé (SKU: 85144)
  8. Wellspect LoFric Origo Nelaton (SKU: 443 14 40)
  9. Wellspect LoFric Origo Tiemann/Coudé (SKU: 444 14 40)
  10. Wellspect LoFric Origo Flexible Coudé with protective sleeve (SKU: 449 14 40)
  11. Wellspect LoFric Origo Flexible Coudé with insertion grip (SKU: 447 14 40)
  12. Coloplast SpeediCath Standard Male (SKU: 28414)
  13. Coloplast SpeediCath Male Coudé Tip (SKU: 28494)
  14. Coloplast SpeediCath Flex Coudé Pro (SKU: 20014)
  15. Convatec GentleCath Glide Male Straight Tip (SKU: 421567)
  16. Convatec GentleCath Glide Male Tiemann Tip (SKU: 421910)
  17. Convatec GentleCath Air Male Straight Tip (SKU:510690)
  18. Convatec GentleCath Air Male Coude Tip (SKU:510696)
  19. Convatec GentleCath Hydrophilic, 14FR, Straight (SKU: 508996)
  20. Convatec GentleCath Hydrophilic, 14FR, Coude (SKU: 509001)
  21. Convatec Cure - Hydrophilic Cure Catheter Straight Tip (SKU: HM14)
  22. Convatec Cure - Hydrophilic Cure Catheter Coudé Tip (SKU: HM14C)
  23. Bard - Magic3® Go Male, 14FR, Straight (SKU:53814G)
  24. Bard - Magic3® Go Male, 14FR, Coude (SKU:50814G)
  25. Bard - Magic3®, 14FR, Straight (SKU: 53614G)
  26. Bard - Magic3®, 14FR, Straight (SKU: 53614) aa. Bard - Magic3®, 14FR, Coude (SKU: 50614)
* is willing and able to follow the study protocol procedures including completing online questionnaires as demonstrated by signing the Informed Consent
* is willing to switch from their current, typical intermittent catheter to the study-provided study products (e.g., study catheters) during the latter portion of the study
* is willing to provide permission via the study informed consent and HIPAA Authorization Form for study staff to contact prescribing healthcare provider for a copy of their active prescription. Alternatively subject can opt to provide study staff with their active prescription.

Exclusion Criteria:

* 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
  6. Cortef
  7. hydrocortisone
  8. Cortrophin Gel
  9. corticotrophin
  10. dexamethasone
  11. deflazacort
  12. prednisone
  13. Emflaza
  14. Eohilia
  15. fludrocortisone
  16. Jaythari
  17. Orapred ODT
  18. prednisolone
  19. Pyquvi
  20. Rayos
  21. Tarpeyo
  22. Uceris
* currently has urinary tract infection (UTI) symptoms or has been diagnosed with a UTI by a healthcare provider in the last 2 weeks
* has a retracted penis
* has skin irritation or lesions (sores) on the penis
* Performs non-urethral catheterization
* Has participated in a study involving actual use of a study urethral IC (i.e. inserting/removing) within the last 30 days
* Is currently an employee of Hollister Incorporated or any other intermittent catheter manufacturer.

Where it's running

  • Hollister Incorporated
    Libertyville, Illinois, United States     Recruiting

Study contacts

  • Principal investigator: Jessica Simmons — Hollister Incorporated

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.