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Evaluation of Residual Urine After Intermittent Catheterisation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00324233
First received: May 9, 2006
Last updated: November 29, 2012
Last verified: November 2012
History of Changes

May 9, 2006
November 29, 2012
April 2006
June 2006   (final data collection date for primary outcome measure)
Residual Urine Measured by Ultra Sound [ Time Frame: 2 ] [ Designated as safety issue: No ]
Primary outcome: residual urine measured by ultra sound.
Complete list of historical versions of study NCT00324233 on ClinicalTrials.gov Archive Site
  • Subjectively Measured Handling [ Designated as safety issue: No ]
  • Subjectively Measured Insertion of the Catheter [ Designated as safety issue: No ]
  • Secondary outcomes:
  • Hematuria measured by urine multi dipstick
  • Subjective measured discomfort
  • Subjective measured Handling
  • Subjective measured insertion of the catheter
Not Provided
Not Provided
 
Evaluation of Residual Urine After Intermittent Catheterisation
Evaluation of Residual Urine After Intermittent Catheterisation - Comparison of 2 Hydrophilic Coated, Intermittent Catheters

Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Healthy
  • Device: Intermittent catheter
    SpeediCath catherter (SC) for intermittent catherisation
  • Device: Compact intermittent catheter
    SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males
  • Active Comparator: SC
    Speedicath (SC) catheter is a catheter for intermittent catherisation
    Intervention: Device: Intermittent catheter
  • Experimental: SCCM
    SpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males
    Intervention: Device: Compact intermittent catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male
  • 18 years and above
  • A negative urine dip-stick
  • Have signed informed written consent to participate

Exclusion Criteria:

  • The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00324233
DK052CC
Not Provided
Coloplast A/S
Coloplast A/S
Not Provided
Principal Investigator: Per Bagi, MD Rigshospitalet, Denmark
Coloplast A/S
November 2012

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