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

Wellspect HealthCare195 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

195

Conditions

Urinary Catheterization

Interventions

LoFric Primo (POBE) single-use urinary catheterDEVICE

LoFric Primo (POBE) single-use urinary catheter

LoFric Primo (PVC) single-use urinary catheterDEVICE

LoFric Primo (PVC) single-use urinary catheter

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Medical University of Vienna, Department of Urology

Vienna, Austria

NRZ Greifswald

Greifswald, Germany

Kliniken Maria Hilf GmbH, Zentrum für Kontinenz und Neuro-Urologie, Krankenhaus St. Franziskus

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: At 4 weeks

Data from ClinicalTrials.gov

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