Comparison of Two Intermittent Urinary Catheters

• ClinicalTrials.gov Identifier: NCT01284361
• Recruitment Status: Completed
• First Posted: January 27, 2011
• Results First Posted: December 1, 2016
• Last Update Posted: February 1, 2017
• Sponsor: Hollister Incorporated
• Information provided by (Responsible Party): Hollister Incorporated

Study Description

Brief Summary:

This is an unblinded, multi-center, randomized, controlled, cross-over study assessing wheel-chair bound, male user preference and catheter characteristics of two intermittent urinary catheters. Subjects enrolled in the study will be randomized to order of catheter use. Individual participation will consist of approximately 1 week of product use. The null hypothesis to be tested is there no difference between catheters.

Condition or disease	Intervention/treatment	Phase
Urinary Retention	Device: 30 cm Intermittent Catheter; Device: 40 cm Intermittent Catheter	Not Applicable

Detailed Description:

1. is male and at least 18 years of age.
2. is self-catheterizing at least 3 times a day.
3. has been performing catheterizations for at least 2 months.
4. is wheelchair bound.
5. is able to use a size 12 or 14 French straight catheter.
6. is willing and able to follow the study protocol and Investigator's instructions.
7. is in the opinion of the Investigator, qualified to participate.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter
• Study Start Date: October 2010
• Actual Primary Completion Date: August 2011
• Actual Study Completion Date: August 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: 30 cm Intermittent Catheter; Intervention was the test of a 30 cm catheter compared to standard commercial 40 cm catheter in a cross-over design.	Device: 30 cm Intermittent Catheter; Randomized cross-over; Other Name: Apogee Intermittent Catheter
Active Comparator: 40 cm Intermittent Catheter; Active comparator 40 cm commercial catheter was compared to experimental 30 cm catheter in a cross-over design.	Device: 40 cm Intermittent Catheter; randomized cross-over; Other Name: Apogee Intermittent Catheter

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants [ Time Frame: 1 week ]
   Percentage of participants that preferred the 40 cm catheter

Secondary Outcome Measures :

1. Assessment of Ease of Use Characteristics [ Time Frame: 1 week ]
   Ease of insertion, removal, and control while catheterizing were assessed using a 5 point Likert scale. The numbers recorded are the percentage of the "top" two responses on a 5 point Likert scale. On one scale this includes 1) Very Easy or 2) Easy, on a scale ranging from 1) Very Easy to 5) Very Difficult. On the other scale this includes 1) Strongly Agree or 2) Agree on a scale ranging from 1) Strongly Agree to 5) Strongly Disagree.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• is male and at least 18 years of age
• is self-catheterizing at least 3 times a day
• has been performing catheterizations for at least 2 months
• wheelchair bound
• is able to use a size 12 or 14 French straight catheter
• is willing and able to follow the study protocol and Investigator's instructions
• is, in the opinion of the Investigator, qualified to participate

Exclusion Criteria:

• has cognitive impairments that preclude completion of study protocol
• cannot communicate as determined by the Investigator
• has an existing medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate or in the interpretation of the results
• has a symptomatic urinary tract infection determined by interview
• has a retracted penis
• has participated in a study during the previous 30 days involving catheterization
• has been diagnosed with an enlarged prostate
• has urethral strictures, false passages, or urethral obstruction

Contacts and Locations

Locations

United States, Georgia

Shepherd Center and Crawford Research Institute

Atlanta, Georgia, United States, 30309-1465

United States, Illinois

Mark Drug Medical Supply

Wheeling, Illinois, United States, 60090

United States, Missouri

Restored Images

Kansas City, Missouri, United States, 64119

United States, Tennessee

Vanderbilt University

Nashville, Tennessee, United States, 37235

Sponsors and Collaborators

Hollister Incorporated

Investigators

• Study Director: Rita Kaurs, MSHSA MT NMT; Hollister Incorporated

More Information

Additional Information:

Catheter length preference in wheelchair-using men who perform routine clean intermittent catheterization 

Publications of Results:

Costa JA, Menier M, Doran TJ, Köhler TS. Catheter length preference in wheelchair-using men who perform routine clean intermittent catheterization. Spinal Cord. 2013 Oct;51(10):772-5. doi: 10.1038/sc.2013.76. Epub 2013 Jul 30.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10:CD006008. doi: 10.1002/14651858.CD006008.pub5. Review.

• Responsible Party: Hollister Incorporated
• ClinicalTrials.gov Identifier: NCT01284361
• Other Study ID Numbers: 4875-I
• First Posted: January 27, 2011
• Results First Posted: December 1, 2016
• Last Update Posted: February 1, 2017
• Last Verified: December 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Published in Spinal Cord (2013) 51, 772-775

Keywords provided by Hollister Incorporated:

intermittent catheter; preference

Additional relevant MeSH terms:

Urinary Retention; Urination Disorders; Urologic Diseases