Consumer Evaluation of Intermittent Catheter Product Modifications

• Sponsor: Hollister Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04619992
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.1
• Patients Per Site Per Month: 6.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Device: Currently marketed Hydrophillic Intermittent Catheter; Device: Test Hydrophilic Intermittent Catheter

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Consumer Evaluation of Intermittent Catheter Product Modifications
• Actual Study Start Date: Oct 14, 2020
• Actual Primary Completion Date: Aug 17, 2021
• Actual Study Completion Date: Aug 17, 2021

Arms and Interventions

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: Currently marketed Hydrophillic Intermittent Catheter; Currently marketed Hollister standard with tip hydrophilic intermittent catheter; Device: Test Hydrophilic Intermittent Catheter; Hollister standard with tip hydrophilic intermittent catheter with design enhancements

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

1. 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

1. 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

1. 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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hollister Incorporated	Libertyville	Illinois	United States	60048

Sponsors and Collaborators

• Hollister Incorporated

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 13, 2021

More Information

Publications

None provided.

• Responsible Party: Hollister Incorporated
• ClinicalTrials.gov Identifier: NCT04619992
• Other Study ID Numbers: 6009-CONT
• First Posted: Nov 6, 2020
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Hollister Incorporated: Intermittent Catheterization
• Additional relevant MeSH terms: Urinary Incontinence

Study Results

Participant Flow

Arm/Group Title	Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters	New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
Arm/Group Description	Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters. Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements	Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters. Currently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements
Period Title: Overall Study
STARTED	55	7
COMPLETED	54	7
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters	New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters	Total
Arm/Group Description	Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters. Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements	Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters. Currently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements	Total of all reporting groups
Overall Participants	54	7	61
Age, Customized (Count of Participants)
<18 years	0 0%	0 0%	0 0%
18-29 years	8 14.8%	0 0%	8 13.1%
30-39 years	12 22.2%	0 0%	12 19.7%
40-49 years	11 20.4%	1 14.3%	12 19.7%
50-59 years	10 18.5%	2 28.6%	12 19.7%
60-69 years	9 16.7%	1 14.3%	10 16.4%
70-79 years	3 5.6%	3 42.9%	6 9.8%
80-89 years	1 1.9%	0 0%	1 1.6%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	54 100%	7 100%	61 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	54 100%	7 100%	61 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters	New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
Arm/Group Description	Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters. Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements	Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters. Currently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements
Measure Participants	54	7
'Strongly agree' or 'Agree'	45 83.3%	4 57.1%
Neither agree nor disagree	4 7.4%	2 28.6%
'Disagree' or 'Strongly disagree'	5 9.3%	1 14.3%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters	New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
Arm/Group Description	Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters. Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements	Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters. Currently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements
Measure Participants	54	7
'Strongly agree' or 'Agree'	35 64.8%	4 57.1%
Neither agree nor disagree	11 20.4%	2 28.6%
'Disagree' or 'Strongly disagree'	8 14.8%	1 14.3%

Adverse Events

Time Frame	Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
Arm/Group Title	Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters		New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
Arm/Group Description	Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters. Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements		Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters. Currently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements
All Cause Mortality
	Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters		New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/7 (0%)
Serious Adverse Events
	Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters		New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters		New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/54 (13%)		1/7 (14.3%)
Gastrointestinal disorders
Gastrointestinal discomfort	1/54 (1.9%)	1	0/7 (0%)	0
Infections and infestations
Potential viral infection	1/54 (1.9%)	1	0/7 (0%)	0
Urinary Tract Infection	1/54 (1.9%)	1	0/7 (0%)	0
Product Issues
Urethral discomfort	0/54 (0%)	0	1/7 (14.3%)	1
Renal and urinary disorders
Cloudy urine	1/54 (1.9%)	1	0/7 (0%)	0
Reduced urine flow and hip spasticity	1/54 (1.9%)	1	0/7 (0%)	0
Potential urethral narrowing	1/54 (1.9%)	1	0/7 (0%)	0
Surgical and medical procedures
Ankle surgery	1/54 (1.9%)	1	0/7 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.