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

Wellspect HealthCare

Status: Completed

Conditions: Urinary Catheterization

Treatments: Device: LoFric Primo (POBE) single-use urinary catheter; Device: LoFric Primo (PVC) single-use urinary catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00753298

YA-CLO-0002

Details and patient eligibility

About

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.

Enrollment: 195 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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195 participants in 2 patient groups

LoFric Primo (POBE) single-use urinary catheter

Experimental group

Treatment:

Device: LoFric Primo (POBE) single-use urinary catheter

LoFric Primo (PVC) single-use urinary catheter

Active Comparator group

Treatment:

Device: LoFric Primo (PVC) single-use urinary catheter