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NCT04619992 Clinical Trial

Consumer Evaluation of Intermittent Catheter Product Modifications

Urinary Incontinence Clinical Trial

Official title:
Consumer Evaluation of Intermittent Catheter Product Modifications

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04619992
Other study ID # 6009-CONT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 14, 2020
Est. completion date August 17, 2021

Study information
Verified date August 2022
Source Hollister Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date August 17, 2021
Est. primary completion date August 17, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility A. Inclusion Criteria for Arm 1 Subject who: 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 B. Exclusion Criteria for Arm 1 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 C. Inclusion Criteria for Arm 2 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 D. Exclusion Criteria for Arm 2 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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

Locations
Country Name City State
United States Hollister Incorporated Libertyville Illinois

Sponsors (1)
Lead Sponsor Collaborator
Hollister Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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