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

Not Applicable

Completed

• Conditions: Urinary Catheterization
• Interventions: Device: LoFric Primo (POBE) single-use urinary catheter; Device: LoFric Primo (PVC) single-use urinary catheter

• Registration Number: NCT00753298
• Lead Sponsor: Wellspect HealthCare

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2008-09-15
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-16
• Results First Submitted: 2009-04-06
• Results First Submitted QC: 2009-04-06
• Results First Posted: 2009-06-02
• Status Verified: 2012-09
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LoFric Primo (POBE) single-use urinary catheter	LoFric Primo (POBE) single-use urinary catheter	-
LoFric Primo (PVC) single-use urinary catheter	LoFric Primo (PVC) single-use urinary catheter	-

Primary Outcome Measures

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

Trial Locations

Locations (13)

Medical University of Vienna, Department of Urology; 🇦🇹 Vienna, Austria

Ziekenhuis Lievensberg, Afdeling Urologie; 🇳🇱 Bergen op Zoom, Netherlands

Albert Schweitzer Ziekenhuis, Locatie Dordwijk; 🇳🇱 Dordrecht, Netherlands

Radboud Univesity Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

NRZ Greifswald; 🇩🇪 Greifswald, Germany

Kliniken Maria Hilf GmbH, Zentrum für Kontinenz und Neuro-Urologie, Krankenhaus St. Franziskus; 🇩🇪 Mönchengladbach, Germany

BG-Klinik Tübingen; 🇩🇪 Tübingen, Germany

Primario U.O. Neuro-Urologia, Direttore Dipartimento delle Mielolesioni; 🇮🇹 Torino, Italy

Ospedale Careggi, Unità Spinale; 🇮🇹 Firenze, Italy

Verksamhet Urologi, Sahlgrenska Universitets sjukhuset; 🇸🇪 Göteborg, Sweden

Sheffield Teaching Hospitals NHS Foundation trust, Royal Hallamshire Hospital; 🇬🇧 Sheffield, United Kingdom

Royal National Orthopaedic Hospital, Spinal Injuries Unit, Brockley Hill Stanmore; 🇬🇧 Stanmore, United Kingdom