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 apolyvinyl 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 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. CONCLUSIONS: The 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.
RCT Entities:
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 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. CONCLUSIONS: The 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.
Authors: Carmen Chifiriuc; Valentina Grumezescu; Alexandru Mihai Grumezescu; Crina Saviuc; Veronica Lazăr; Ecaterina Andronescu Journal: Nanoscale Res Lett Date: 2012-04-10 Impact factor: 4.703