Consumer Evaluation of Intermittent Catheter Product Modifications

Study Overview
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Brief Summary
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This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.

Official Title
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Consumer Evaluation of Intermittent Catheter Product Modifications

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: Currently marketed Hydrophillic Intermittent Catheter
* Device: Test Hydrophilic Intermittent Catheter


Participation Criteria
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Eligibility Criteria
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A. Inclusion Criteria for Arm 1 Subject who: is male and at least 18 years of age 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 B. Exclusion Criteria for Arm 1 Subject who: is currently undergoing chemotherapy, radiation or steroid therapy has a symptomatic urinary tract infection (UTI) is currently using a coude intermittent catheter product to perform catheterization performs non-urethral catheterization C. Inclusion Criteria for Arm 2 Subject who: is male and at least 18 years of age 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 D. Exclusion Criteria for Arm 2 Subject who: is currently undergoing chemotherapy, radiation or steroid therapy has a symptomatic urinary tract infection (UTI) is currently using a coude intermittent catheter product to perform catheterization performs non-urethral catheterization is unable to use a Hollister standard with tip hydrophilic intermittent catheter

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Current users of Hollister standard with tip hydrophilic intermittent catheters<br>Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters. | Device: Test Hydrophilic Intermittent Catheter<br>* Hollister standard with tip hydrophilic intermittent catheter with design enhancements<br>|
| Other: New users of Hollister standard with tip hydrophilic intermittent catheters<br>Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters. | Device: Currently marketed Hydrophillic Intermittent Catheter<br>* Currently marketed Hollister standard with tip hydrophilic intermittent catheter<br>Device: Test Hydrophilic Intermittent Catheter<br>* Hollister standard with tip hydrophilic intermittent catheter with design enhancements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Test Hydrophilic Intermittent Catheter | Users will rate if Test device is an acceptable alternative to currently marketed device. Acceptability will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is an acceptable alternative to currently marketed catheter. | 10 days | 
| Preference of Test Hydrophilic Intermittent Catheter | Users will rate if Test device is preferred to currently marketed device. Preference will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is preferred to currently marketed catheter. | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intermittent Catheterization