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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

October 5, 2009
August 2, 2012
November 2009
March 2010   (final data collection date for primary outcome measure)
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)
Discomfort [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00990093 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study
A Randomised, Cross-over, Open-labelled Study Evaluating the Acceptance of Test Catheters Compared to SpeediCath Catheters

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

See brief summary
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Cord Injuries
  • Device: test intermittent catheter
    CH 12 hydrophilic coated catheter
    Other Name: Test catheter
  • Device: Intermittent catheterization
    CH 12 hydrophilic catheter
    Other Name: SpeediCath
  • Experimental: test intermittent catheter
    CH 12 hydrophilic coated catheter
    Intervention: Device: test intermittent catheter
  • Experimental: intermittent catheter
    CH 12 hydrophilic coated catheter
    Intervention: Device: Intermittent catheterization
Chartier-Kastler E, Lauge I, Ruffion A, Goossens D, Charvier K, Biering-Sørensen F. Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study. Spinal Cord. 2011 Jul;49(7):844-50. Epub 2011 Feb 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00990093
CP062CC
No
Coloplast A/S
Coloplast A/S
Not Provided
Principal Investigator: Fin Biering-Sørensen, MD Klinik for Rygmarvsskader, Rigshospitalet
Coloplast A/S
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP