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
  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 April 17, 2014