At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-centre, Double-blind, Randomized, Parallel Groups Study Comparing PVC and Polyolefin-based Elastomer (POBE) as Catheter Materials, Outcomes Will be Measured by Subject Perception.
In Brief
A clinical study evaluating LoFric Primo (POBE) single-use urinary catheter and LoFric Primo (PVC) single-use urinary catheter for Urinary Catheterization. Completed, enrolled 195 participants across 13 sites in 6 countries.
Detailed Summary
The study is designed as a randomized, double-blind, parallel-group, multi centre study comparing perception and tolerability of investigational product and comparator. In the randomized part of the study the subjects will be given either LoFric Primo (POBE) or the comparator LoFric Primo (PVC) for use over 4 weeks. The hypothesis is that subject perception and satisfaction of POBE is equal to or better than for PVC.
Study Details
Timeline
Interventions
LoFric Primo (POBE) single-use urinary catheter
LoFric Primo (PVC) single-use urinary catheter