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More info
You can access this
clinical trial
if you have
Hematuria
and you are
over 18
years old
-
The phase for this study is not defined.
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The purpose

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%.

Provided treatments

  • Device: LoFric
  • Device: SpeediCath
  • Device: SpeediCath Compact Male
Tris trial is registered with FDA with number: NCT01600443. The sponsor of the trial is Wellspect HealthCare and it is looking for 21 volunteers for the current phase.
Official trial title:
A Randomized Cross-over Study on Urethral Microtrauma After Intermittent Catheterization.