Consumer Evaluation of Intermittent Catheter Product Modifications

Hollister

Status: Completed

Conditions: Urinary Incontinence

Treatments: Device: Test Hydrophilic Intermittent Catheter; Device: Currently marketed Hydrophillic Intermittent Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT04619992

6009-CONT

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Current users of Hollister standard with tip hydrophilic intermittent catheters

Other group

Description:

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

Treatment:

Device: Test Hydrophilic Intermittent Catheter

New users of Hollister standard with tip hydrophilic intermittent catheters

Other group

Description:

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

Treatment:

Device: Test Hydrophilic Intermittent Catheter

Device: Currently marketed Hydrophillic Intermittent Catheter