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Consumer Evaluation of Intermittent Catheter Product Modifications

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Locations
United States
Study Type
Interventional
Intervention
Currently marketed Hydrophillic Intermittent Catheter
Test Hydrophilic Intermittent Catheter
Sponsored by
Hollister Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Incontinence focused on measuring Intermittent Catheterization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hollister Incorporated

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Current users of Hollister standard with tip hydrophilic intermittent catheters

New users of Hollister standard with tip hydrophilic intermittent catheters

Arm Description

Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters.

Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 27, 2020
Last Updated
August 1, 2022
Sponsor
Hollister Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT04619992
Brief Title
Consumer Evaluation of Intermittent Catheter Product Modifications
Official Title
Consumer Evaluation of Intermittent Catheter Product Modifications
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
August 17, 2021 (Actual)
Study Completion Date
August 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hollister Incorporated

4. Oversight

Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Intermittent Catheterization

7. Study Design

Primary Purpose
Other
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Current users of Hollister standard with tip hydrophilic intermittent catheters
Arm Type
Other
Arm Description
Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters.
Arm Title
New users of Hollister standard with tip hydrophilic intermittent catheters
Arm Type
Other
Arm Description
Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.
Intervention Type
Device
Intervention Name(s)
Currently marketed Hydrophillic Intermittent Catheter
Intervention Description
Currently marketed Hollister standard with tip hydrophilic intermittent catheter
Intervention Type
Device
Intervention Name(s)
Test Hydrophilic Intermittent Catheter
Intervention Description
Hollister standard with tip hydrophilic intermittent catheter with design enhancements
Primary Outcome Measure Information:
Title
Acceptability of Test Hydrophilic Intermittent Catheter
Description
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
Title
Preference of Test Hydrophilic Intermittent Catheter
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hollister Incorporated
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Consumer Evaluation of Intermittent Catheter Product Modifications

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