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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
Male
Accepts 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) 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Participants will first use 30 of their usual intermittent catheters and then will switch to 30 study catheters in a fixed-sequence, within-participant design. The study has one experimental arm because all participants receive the same study catheter; each participant serves as his own control through comparison of assessments made after the usual-catheter period and the study-catheter period.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: An intermittent urethral urinary catheter with a tip, tube and drainage eyelets
    An intermittent urethral urinary catheter with a tip, tube and drainage eyelets

Recruiting Locations

Hollister Incorporated
Libertyville, Illinois 60048
Contact:
Hollister Incorporated
(847) 680-1000
researchstudy@hollister.com

More Details

Status
Recruiting
Sponsor
Hollister Incorporated

Study Contact

Detailed 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 evaluated through reported health changes and adverse events. The study is intended to provide descriptive information regarding the initial safety, usability, and performance of the investigational catheter relative to participants' current intermittent catheter products.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.