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Updated: Jun 19, 2026
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Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices
Published on: November 29, 2024
A multicenter, double-blind, randomized, parallel group study comparing polyvinyl chloride and polyvinyl
J A Witjes1, G Del Popolo, M Marberger
1Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. f.witjes@uro.umcn.nl
The Journal of Urology
|October 20, 2009
Summary
Patient satisfaction with clean intermittent catheterization (CIC) remains high regardless of catheter material. Switching from a polyvinyl chloride catheter to a new polyvinyl chloride-free catheter did not significantly alter patient perception of ease or comfort during CIC.
Area of Science:
- Urology
- Biomaterials Science
Background:
- Clean intermittent catheterization (CIC) is a widely used procedure for bladder management.
- Catheter material can influence patient comfort and adherence to treatment.
Purpose of the Study:
- To compare patient perception of ease and comfort between a standard polyvinyl chloride (PVC) catheter and a novel PVC-free catheter with identical hydrophilic coating.
- To determine if the catheter material impacts patient experience during CIC.
Main Methods:
- A randomized, double-blind, parallel-group, multicenter study.
- Experienced CIC users were randomized to either continue with their PVC catheter or switch to a PVC-free catheter for 4 weeks.
- Patient-reported outcomes on ease and comfort were assessed via questionnaires, alongside adverse event monitoring.
Main Results:
- High baseline satisfaction (92%) with PVC catheters was reported.
- Satisfaction rates were 89% for the PVC group and 78% for the PVC-free group, a difference that was not statistically significant.
- Adverse event rates were low and comparable between both catheter groups.
Conclusions:
- Clean intermittent catheterization is confirmed as an easy and safe procedure.
- Transitioning from a PVC to a PVC-free catheter material does not significantly change patient-reported perceptions of the catheterization experience.
