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A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study

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ClinicalTrials.gov Identifier: NCT00990093
Recruitment Status : Completed
First Posted : October 6, 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 that the test catheter is no less accepted than the SpeediCath (SC) catheter.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: test intermittent catheter Device: Intermittent catheterization Not Applicable

Detailed Description:
See brief summary

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Cross-over, Open-labelled Study Evaluating the Acceptance of Test Catheters Compared to SpeediCath Catheters
Study Start Date : November 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: test intermittent catheter
CH 12 hydrophilic coated catheter
Device: test intermittent catheter
CH 12 hydrophilic coated catheter
Other Name: Test catheter

Experimental: intermittent catheter
CH 12 hydrophilic coated catheter
Device: Intermittent catheterization
CH 12 hydrophilic catheter
Other Name: SpeediCath




Primary Outcome Measures :
  1. Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. [ Time Frame: 14 days ]

    Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.

    At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Has normal/impaired sensation in the urethra
  • Self-catheterises at least 4 times per day
  • Has used clean self-intermittent catheterisation for at least 14 days
  • Is able to open and prepare the catheters for catheterisation
  • Has signed the informed consent before any study related-activities.

Exclusion Criteria:

  • Has a symptomatic urinary tract infection as assessed by the investigator
  • Is mentally unstable as assessed by the investigator

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): NCT00990093


Locations
Denmark
Klinik for Rygmarvsskader
Hornbæk, Denmark, 3100
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Fin Biering-Sørensen, MD Klinik for Rygmarvsskader, Rigshospitalet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00990093     History of Changes
Other Study ID Numbers: CP062CC
First Posted: October 6, 2009    Key Record Dates
Results First Posted: September 5, 2012
Last Update Posted: September 5, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries