Consumer Evaluation of Intermittent Catheter Product Modifications

August 1, 2022 updated by: Hollister Incorporated
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Hollister Incorporated

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional 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
Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters.
Device: Test Hydrophilic Intermittent Catheter
Hollister standard with tip hydrophilic intermittent catheter with design enhancements
Other: 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.
Device: Test Hydrophilic Intermittent Catheter
Hollister standard with tip hydrophilic intermittent catheter with design enhancements
Device: Currently marketed Hydrophillic Intermittent Catheter
Currently marketed Hollister standard with tip hydrophilic intermittent catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Test Hydrophilic Intermittent Catheter
Time Frame: 10 days
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
Time Frame: 10 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hollister Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2020

Primary Completion (Actual)

August 17, 2021

Study Completion (Actual)

August 17, 2021

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 6, 2020

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 1, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6009-CONT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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