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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Catheterization (Clean, Intermittent Urinary Catheterization)

NCT number NCT01295281
Study type Interventional
Source Wellspect HealthCare
Contact
Status Completed
Phase N/A
Start date March 2011
Completion date May 2011