Consumer Evaluation of Intermittent Catheter Product Modifications
NCT ID: NCT04619992
Last Updated: 2022-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
62 participants
INTERVENTIONAL
2020-10-14
2021-08-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Current users of Hollister standard with tip hydrophilic intermittent catheters
Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters.
Test Hydrophilic Intermittent Catheter
Hollister standard with tip hydrophilic intermittent catheter with design enhancements
New users of Hollister standard with tip hydrophilic intermittent catheters
Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.
Currently marketed Hydrophillic Intermittent Catheter
Currently marketed Hollister standard with tip hydrophilic intermittent catheter
Test Hydrophilic Intermittent Catheter
Hollister standard with tip hydrophilic intermittent catheter with design enhancements
Interventions
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Currently marketed Hydrophillic Intermittent Catheter
Currently marketed Hollister standard with tip hydrophilic intermittent catheter
Test Hydrophilic Intermittent Catheter
Hollister standard with tip hydrophilic intermittent catheter with design enhancements
Eligibility Criteria
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Inclusion Criteria
1. is male and at least 18 years of age
2. has been performing unassisted, self-catheterizations, with a Hollister standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month
Subject who:
1. is male and at least 18 years of age
2. has been performing unassisted, self-catheterizations, with a non-standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month
Exclusion Criteria
1. is currently undergoing chemotherapy, radiation or steroid therapy
2. has a symptomatic urinary tract infection (UTI)
3. is currently using a coude intermittent catheter product to perform catheterization
4. performs non-urethral catheterization
Subject who:
1. is currently undergoing chemotherapy, radiation or steroid therapy
2. has a symptomatic urinary tract infection (UTI)
3. is currently using a coude intermittent catheter product to perform catheterization
4. performs non-urethral catheterization
5. is unable to use a Hollister standard with tip hydrophilic intermittent catheter
18 Years
MALE
No
Sponsors
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Hollister Incorporated
INDUSTRY
Responsible Party
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Locations
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Hollister Incorporated
Libertyville, Illinois, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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6009-CONT
Identifier Type: -
Identifier Source: org_study_id
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