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Test Catheter Pilot Study in Healthy Volunteers (Test catheter)

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ClinicalTrials.gov Identifier: NCT00832078
Recruitment Status : Completed
First Posted : January 29, 2009
Results First Posted : September 5, 2012
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Device: SpeediCath Compact Male Device: Speedicath Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Test Catheter Pilot Study in Healthy Volunteers
Study Start Date : January 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Handling [ Time Frame: After each catheterisation ]
  2. Preference [ Time Frame: At study termination ]
  3. Haematuria [ Time Frame: After each catheterisation ]


Information from the National Library of Medicine

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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

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

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