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OpenTrials
Completed

NCT Number: NCT04619992

Consumer Evaluation of Intermittent Catheter Product Modifications

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Primary location

Hollister Incorporated

Libertyville, Illinois, 60048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Currently marketed Hydrophillic Intermittent Catheter

Device

Currently marketed Hollister standard with tip hydrophilic intermittent catheter

Test Hydrophilic Intermittent Catheter

Device

Hollister standard with tip hydrophilic intermittent catheter with design enhancements

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hollister Incorporated

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2020
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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