Comparison of Two Intermittent Urinary Catheters

December 2, 2016 updated by: Hollister Incorporated

User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309-1465
        • Shepherd Center and Crawford Research Institute
    • Illinois
      • Wheeling, Illinois, United States, 60090
        • Mark Drug Medical Supply
    • Missouri
      • Kansas City, Missouri, United States, 64119
        • Restored Images
    • Tennessee
      • Nashville, Tennessee, United States, 37235
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Apogee Intermittent Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants
Time Frame: 1 week
Percentage of participants that preferred the 40 cm catheter
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hollister Incorporated

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

January 21, 2011

First Submitted That Met QC Criteria

January 25, 2011

First Posted (Estimate)

January 27, 2011

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4875-I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Published in Spinal Cord (2013) 51, 772-775

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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