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Evaluation of a New Catheter Material for Intermittent Catheterization

Wellspect HealthCare · 2011
ClinicalTrials.gov · Datasets · License: Public Domain · 2011
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The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e. clinically non-inferior when using POBE 2.0 compared to PVC. Secondary objectives are to evaluate the safety and the subject's perception associated with the use of the catheters, assessed by the recording of adverse events and the ease of handling by means of a subjective assessment scale.
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