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Test Catheter Pilot Study in Healthy Volunteers (Test catheter)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00832078
First Posted: January 29, 2009
Last Update Posted: September 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Coloplast A/S
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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 ]
    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 ]
  • Preference [ Time Frame: At study termination ]
  • Haematuria [ Time Frame: After each catheterisation ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832078


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

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00832078     History of Changes
Other Study ID Numbers: DK058CC
First Submitted: January 26, 2009
First Posted: January 29, 2009
Results First Submitted: January 9, 2012
Results First Posted: September 5, 2012
Last Update Posted: September 5, 2012
Last Verified: August 2012