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A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00990093
First received: October 5, 2009
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.


Condition Intervention
Spinal Cord Injuries
 Device: test intermittent catheter
Device: Intermittent catheterization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Cross-over, Open-labelled Study Evaluating the Acceptance of Test Catheters Compared to SpeediCath Catheters

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.

    At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)



Enrollment: 36
Study Start Date: November 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: test intermittent catheter
CH 12 hydrophilic coated catheter
 Device: test intermittent catheter
CH 12 hydrophilic coated catheter
Other Name: Test catheter
Experimental: intermittent catheter
CH 12 hydrophilic coated catheter
 Device: Intermittent catheterization
CH 12 hydrophilic catheter
Other Name: SpeediCath

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Has normal/impaired sensation in the urethra
  • Self-catheterises at least 4 times per day
  • Has used clean self-intermittent catheterisation for at least 14 days
  • Is able to open and prepare the catheters for catheterisation
  • Has signed the informed consent before any study related-activities.

Exclusion Criteria:

  • Has a symptomatic urinary tract infection as assessed by the investigator
  • Is mentally unstable as assessed by the investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990093

Locations
Denmark
Klinik for Rygmarvsskader
Hornbæk, Denmark, 3100
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Fin Biering-Sørensen, MD Klinik for Rygmarvsskader, Rigshospitalet
  More Information

No publications provided by Coloplast A/S

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

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00990093     History of Changes
Other Study ID Numbers: CP062CC
Study First Received: October 5, 2009
Results First Received: January 9, 2012
Last Updated: August 2, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France: The national physicians authority

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013