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Quality of Life Intermittent Catheter Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01523743
First received: January 9, 2012
Last updated: August 2, 2012
Last verified: August 2012
History of Changes

January 9, 2012
August 2, 2012
November 2011
April 2012   (final data collection date for primary outcome measure)
Quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters
Same as current
Complete list of historical versions of study NCT01523743 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Quality of Life Intermittent Catheter Study
Quality of Life Intermittent Catheter Study - A Prospective, Randomized, Cross-over, Multicenter Study Comparing Quality of Life Using Compact Versus Standard Urinary Intermittent Catheters

The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Neurogenic Bladder Dysfunction Nos
  • Device: SpeediCath Compact
    The SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra.
    Other Names:
    • SpeediCath®Compact Male, for male participants
    • SpeediCath®Compact Female, for female participants
  • Device: Standard care
    The coated intermittent catheter normally used by subject
  • Experimental: Compact catheter
    Compact intermittent catheter
    Intervention: Device: SpeediCath Compact
  • Active Comparator: Standard Care
    Standard Care: Coated intermittent catheter normally used by subject
    Intervention: Device: Standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
May 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is at least 18 years of age
  • Has given written informed consent
  • Has neurogenic bladder dysfunction
  • Has used coated intermittent catheter as primarily bladder emptying method for at least 6 months
  • Is able to self-catheterise
  • Is able to use SpeediCath® compact catheters
  • If spinal cord injury subject, injury must have occurred more than 12 months ago
  • Covered by Social security system

Exclusion Criteria:

  • Has used SpeediCath® compact catheters (not including screening for this investigation)
  • Is admitted to rehabilitation centre
  • Subjects using primarily catheter sets
  • Is pregnant or breast-feeding
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   France,   Germany,   Norway,   Sweden
 
NCT01523743
CP220
No
Coloplast A/S
Coloplast A/S
Not Provided
Principal Investigator: Emmanuel Chartier-Kastler, Proff Hôpital Raymond poincarè, Service d'Urologie, Garches, France
Coloplast A/S
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP