A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation

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.

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.

Inclusion Criteria:

• Provision of informed consent
• Males and females aged 18 years and over
• Experienced users of LoFric Primo with a minimum of one month of use
• Practice CIC with LoFric Primo at least 3 times per day
• Adults able to read, write and understand information given to them regarding the study

Exclusion Criteria:

• Ongoing symptomatic UTI
• Suspicions of possible poor compliance with CIC during the study period
• Previous enrolment or randomisation of treatment in the present study
• Pregnancy
• Subjects not able to perform self-catheterisation