A Multicenter, Double-Blind, Randomized, Parallel Group Study Comparing Polyvinyl Chloride and Polyvinyl Chloride-Free Catheter Materials

PurposeIn this study we compared a polyvinyl chloride catheter with a new polyvinyl chloride-free catheter with the same hydrophilic coating, and determined whether patient perception of ease and comfort of clean intermittent catheterization was independent of the catheter material.Materials and MethodsThis investigation was designed as a randomized, double-blind, parallel group, multicenter study. Eligible patients were experienced users of clean intermittent catheterization with a polyvinyl chloride catheter for a minimum of 1 month before randomization. They were randomized to continue to use the polyvinyl chloride catheter or switch to a polyvinyl chloride-free catheter for 4 weeks. Both catheters had a similar appearance. Patient perception of ease and comfort of clean intermittent catheterization was scored with questionnaires, and adverse events were documented.ResultsA total of 195 patients were recruited from 6 countries and 13 centers for the intent to treat analysis, and 179 were used for the per protocol analysis. Before randomization 94% to 98% of the patients rated the polyvinyl chloride catheter as easy or manageable to handle during different phases of clean intermittent catheterization and overall 92% of patients were satisfied. Of the eligible patients satisfaction was reported by 89% randomized to continue using the polyvinyl chloride catheter and by 78% randomized to switch to the polyvinyl chloride-free catheter (not significant). The rate of adverse events was low and comparable between the 2 groups.ConclusionsThe study confirms that clean intermittent catheterization is easy and safe. Conversion from a polyvinyl chloride to a polyvinyl chloride-free core catheter material does not alter patient perception of catheterization.