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

Tracking Information
First Received Date ^ICMJE	January 26, 2009
Last Updated Date	August 2, 2012
Start Date ^ICMJE	January 2009
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 2, 2012)	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)
Original Primary Outcome Measures ^ICMJE (submitted: January 28, 2009)	Discomfort measured on a Visual Analog Scale (VAS) [ Time Frame: After each catheterisation ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00832078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 28, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Test Catheter Pilot Study in Healthy Volunteers
Official Title ^ICMJE	Test Catheter Pilot Study in Healthy Volunteers
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Device: SpeediCath Compact Male CH 12 hydrophilic coated intermitten compact catheter Device: Speedicath CH 12 hydrophilic coated intermittent coated catheter
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	28
Completion Date	April 2009
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT00832078
Other Study ID Numbers ^ICMJE	DK058CC
Has Data Monitoring Committee	No
Responsible Party	Coloplast A/S
Study Sponsor ^ICMJE	Coloplast A/S
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Coloplast A/S
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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