Document Detail


A multicenter, double-blind, randomized, parallel group study comparing polyvinyl chloride and polyvinyl chloride-free catheter materials.
MedLine Citation:
PMID:  19837425     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
J A Witjes; G Del Popolo; M Marberger; O Jonsson; H P Kaps; C R Chapple
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2009-10-17
Journal Detail:
Title:  The Journal of urology     Volume:  182     ISSN:  1527-3792     ISO Abbreviation:  J. Urol.     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2009-11-12     Completed Date:  2009-11-30     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0376374     Medline TA:  J Urol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2794-8     Citation Subset:  AIM; IM    
Affiliation:
Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. f.witjes@uro.umcn.nl
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MeSH Terms
Descriptor/Qualifier:
Double-Blind Method
Equipment Design
Female
Humans
Male
Middle Aged
Polyvinyl Chloride*
Urinary Catheterization / instrumentation*
Chemical
Reg. No./Substance:
9002-86-2/Polyvinyl Chloride
Comments/Corrections
Comment In:
J Urol. 2009 Dec;182(6):2561-2   [PMID:  19836770 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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