Clinical Trial: Comparison of Microtrauma in Urethra After Usage of Different Catheters

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized Cross-over Study on Urethral Microtrauma After Intermittent Catheterization.

Brief Summary:

The study is undertaken to investigate if the urethral microtrauma, caused by intermittent catheterization, differs between three hydrophilic catheters for intermittent catheterization, LoFric; SpeediCath (SC) and SpeediCath Compact Male (SCCM). The study is a prospective, randomised, cross-over, single-centre study.

Each subject will be randomized to use three different catheter types. Three catheterizations will be performed with each catheter type during one day, with at least two hours between each catheterization. The washout period between catheter switch will be at least one week.

The primary objective is to evaluate urethral microtrauma for three hydrophilic catheters with regards to hematuria after intermittent catheterization.

The secondary objectives are to evaluate urethral microtrauma for three hydrophilic catheters with regards to pyuria and subjective evaluation after intermittent catheterization.

The safety of the three catheters will be evaluated in terms of adverse advents, non-serious and serious, rated for causality.

The hypothesis that level of hematuria is equal after using different catheters will be tested using Wilcoxon signed rank test. The hypothesis will be rejected if the p-value is less than 5%.


Detailed Summary:
Sponsor: Wellspect HealthCare

Current Primary Outcome: Hematuria [ Time Frame: Approximately 2 hours after last catheterization ]

Blood in urine (measured by microscopic urine sediment evaluation) will be assessed at the first normal micturition after three catheterizations. Comparison will be made between study catheter/visit days.


Original Primary Outcome:

Current Secondary Outcome:

  • Hematuria [ Time Frame: At first, second and third catheterization, approximately 2 hours apart ]
    Blood in urine (measured by microscopic urine sediment evaluation). Comparison will be made between study catheter/visit days.
  • Pyuria [ Time Frame: At first, second and third catheterization, approximately 2 hours apart ]
    White blood cells in urine (measured by microscopic urine sediment evaluation). Comparison will be made between study catheter/visit days.
  • Pyuria [ Time Frame: Approximately 2 hours after last catheterization ]
    White blood cells in urine (measured by microscopic urine sediment evaluation) will be assessed at first normal micturition after three catheterizations. Comparison will be made between study catheter/visit days.


Original Secondary Outcome:

Information By: Wellspect HealthCare

Dates:
Date Received: April 24, 2012
Date Started: April 2012
Date Completion:
Last Updated: January 31, 2014
Last Verified: January 2014