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

Purpose: In 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 Methods: This 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.Results: A total of 195 patients were recruited from 6 countries and 13 centers for the intent to treat analysis, and 179 were used for...