Comparison of Two Intermittent Urinary Catheters

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated
ClinicalTrials.gov Identifier:
NCT01284361
First received: January 21, 2011
Last updated: October 17, 2013
Last verified: July 2012
  Purpose

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 Intervention
Urinary Retention
Device: test and control intermittent urinary catheters

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter

Further study details as provided by Hollister Incorporated:

Primary Outcome Measures:
  • preference for length [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    proportion of subjects favoring one length over the other


Secondary Outcome Measures:
  • appreciation of user characteristics [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    ease of insertion, removal, and control while catheterizing rated using a 5 point Likert scale


Enrollment: 91
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: test Device: test and control intermittent urinary catheters
randomized cross-over
Active Comparator: control Device: test and control intermittent urinary catheters
randomized cross-over

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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/Charriere 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284361

Locations
United States, Georgia
Shepherd Center and Crawford Research Institute
Atlanta, Georgia, United States
United States, Illinois
Mark Drug Medical Supply
Wheeling, Illinois, United States
United States, Missouri
Restored Images
Kansas City, Missouri, United States
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States
Sponsors and Collaborators
Hollister Incorporated
Investigators
Study Director: Rita Kaurs, MSHSA MT NMT Hollister Incorporated
  More Information

No publications provided by Hollister Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT01284361     History of Changes
Other Study ID Numbers: 4875-I
Study First Received: January 21, 2011
Last Updated: October 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hollister Incorporated:
intermittent catheter
preference

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014