Consumer Evaluation of Intermittent Catheter Product Modifications

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: Currently marketed Hydrophillic Intermittent Catheter; Device: Test Hydrophilic Intermittent Catheter

• Registration Number: NCT04619992
• Lead Sponsor: Hollister Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-14
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-06
• Primary Completion: 2021-08-17
• Study Completion: 2021-08-17
• Results First Submitted: 2022-06-02
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-01
• Last Update Submitted: 2022-08-01
• Results First Posted: 2022-08-03
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New users of Hollister standard with tip hydrophilic intermittent catheters	Test Hydrophilic Intermittent Catheter	Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.
Current users of Hollister standard with tip hydrophilic intermittent catheters	Test Hydrophilic Intermittent Catheter	Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters.
New users of Hollister standard with tip hydrophilic intermittent catheters	Currently marketed Hydrophillic Intermittent Catheter	Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.

Primary Outcome Measures

Name	Time	Method
Preference of Test Hydrophilic Intermittent Catheter	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.
Acceptability of Test Hydrophilic Intermittent Catheter	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.

Trial Locations

Locations (1)

Hollister Incorporated; 🇺🇸 Libertyville, Illinois, United States