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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Urinary Catheterization

Intervention / Treatment
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* Device: LoFric Primo (POBE) single-use urinary catheter
* Device: LoFric Primo (PVC) single-use urinary catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LoFric Primo (POBE) single-use urinary catheter<br> | Device: LoFric Primo (POBE) single-use urinary catheter<br>* LoFric Primo (POBE) single-use urinary catheter<br>|
| Active Comparator: LoFric Primo (PVC) single-use urinary catheter<br> | Device: LoFric Primo (PVC) single-use urinary catheter<br>* LoFric Primo (PVC) single-use urinary catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's Perception Regarding Handling of Test Catheter Before Insertion | Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | At 4 weeks | 
| Subject's Perception Regarding Handling of Test Catheter at Insertion | Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | At 4 weeks | 
| Subject's Perception Regarding Handling of Test Catheter at Withdrawal | Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | At 4 weeks | 
| Subject's Perception Regarding Handling of Test Catheter After Withdrawal | Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) | At 4 weeks | 
| Subject's General Satisfaction With Test Catheter | Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified) | At 4 weeks | 
| Subject's Sensation When Using Test Catheter | Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain) | At 4 weeks |