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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 10, 2016
Last verified: October 2016
  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: 30 cm Intermittent Catheter
Device: 40 cm Intermittent Catheter

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:
  • Percentage of Participants [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Percentage of participants that preferred the 40 cm catheter


Secondary Outcome Measures:
  • Assessment of Ease of Use Characteristics [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Ease of insertion, removal, and control while catheterizing were assessed using a 5 point Likert scale. The numbers recorded are the proportions 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.


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: 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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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:
Publications:
Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT01284361     History of Changes
Other Study ID Numbers: 4875-I 
Study First Received: January 21, 2011
Results First Received: December 2, 2013
Last Updated: October 10, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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

ClinicalTrials.gov processed this record on December 08, 2016