Hematuria Clinical Trial
Official title:
A Randomized Cross-over Study on Urethral Microtrauma After Intermittent Catheterization.
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%.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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