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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
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Device: SpeediCath Compact Male
Device: Speedicath

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Test Catheter Pilot Study in Healthy Volunteers

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2
 Device: SpeediCath Compact Male
CH 12 hydrophilic coated intermitten compact catheter
Device: Speedicath
CH 12 hydrophilic coated intermittent coated catheter
Group B
SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2
 Device: SpeediCath Compact Male
CH 12 hydrophilic coated intermitten compact catheter
Device: Speedicath
CH 12 hydrophilic coated intermittent coated catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832078

Locations
Denmark
Rigshopsitalet
Copenhagen, København Ø, Denmark, 2100
Sponsors and Collaborators
Coloplast A/S
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00832078     History of Changes
Other Study ID Numbers: DK058CC
Study First Received: January 26, 2009
Results First Received: January 9, 2012
Last Updated: August 2, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee

ClinicalTrials.gov processed this record on May 22, 2013