Consumer Evaluation of Intermittent Catheter Product Modifications

N/ACompletedNCT04619992

Hollister Incorporated62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Urinary Incontinence

Interventions

Currently marketed Hydrophillic Intermittent CatheterDEVICE

Currently marketed Hollister standard with tip hydrophilic intermittent catheter

Test Hydrophilic Intermittent CatheterDEVICE

Hollister standard with tip hydrophilic intermittent catheter with design enhancements

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hollister Incorporated

Libertyville, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 10 days

Data from ClinicalTrials.gov

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