Test Catheter Pilot Study in Healthy Volunteers (Test catheter)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00832078
First received: January 26, 2009
Last updated: August 2, 2012
Last verified: August 2012

January 26, 2009
August 2, 2012
January 2009
April 2009   (final data collection date for primary outcome measure)
Discomfort [ Time Frame: After each catheterisation ] [ Designated as safety issue: Yes ]
Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)
Discomfort measured on a Visual Analog Scale (VAS) [ Time Frame: After each catheterisation ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00832078 on ClinicalTrials.gov Archive Site
  • Handling [ Time Frame: After each catheterisation ] [ Designated as safety issue: No ]
  • Preference [ Time Frame: At study termination ] [ Designated as safety issue: No ]
  • Haematuria [ Time Frame: After each catheterisation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Test Catheter Pilot Study in Healthy Volunteers
Test Catheter Pilot Study in Healthy Volunteers

The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Healthy
  • Device: SpeediCath Compact Male
    CH 12 hydrophilic coated intermitten compact catheter
  • Device: Speedicath
    CH 12 hydrophilic coated intermittent coated catheter
  • Group A
    SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2
    Interventions:
    • Device: SpeediCath Compact Male
    • Device: Speedicath
  • Group B
    SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2
    Interventions:
    • Device: SpeediCath Compact Male
    • Device: Speedicath
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older
  • Male
  • Signed informed consent
  • Negative urine multistix

Exclusion Criteria:

  • Abnormalities, diseases or surgical procedures performed in the lower urinary tract
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00832078
DK058CC
No
Coloplast A/S
Coloplast A/S
Not Provided
Not Provided
Coloplast A/S
August 2012

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