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.

Study Overview

• Status: Completed
• Conditions: Urinary Catheterization
• Intervention / Treatment: Device: LoFric Primo (POBE) single-use urinary catheter; Device: LoFric Primo (PVC) single-use urinary catheter

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-1090
    • Medical University of Vienna, Department of Urology
• Germany
  • Greifswald, Germany, 17487
    • NRZ Greifswald
  • Mönchengladbach, Germany, 41063
    • Kliniken Maria Hilf GmbH, Zentrum für Kontinenz und Neuro-Urologie, Krankenhaus St. Franziskus
  • Tübingen, Germany, 72076
    • BG-Klinik Tübingen
• Italy
  • Firenze, Italy, 50139
    • Ospedale Careggi, Unità Spinale
  • Torino, Italy
    • Primario U.O. Neuro-Urologia, Direttore Dipartimento delle Mielolesioni
• Netherlands
  • Bergen op Zoom, Netherlands, 4624 VT
    • Ziekenhuis Lievensberg, Afdeling Urologie
  • Dordrecht, Netherlands, 3300 AK
    • Albert Schweitzer Ziekenhuis, locatie Dordwijk
  • Eindhoven, Netherlands, 5602 ZA
    • Catharina Ziekenhuis
  • Nijmegen, Netherlands, 6500 HB
    • Radboud Univesity Nijmegen Medical Centre
• Sweden
  • Göteborg, Sweden, 413 45
    • Verksamhet Urologi, Sahlgrenska Universitets sjukhuset
• United Kingdom
  • Sheffield, United Kingdom, S10 2JF
    • Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital
  • Stanmore, United Kingdom, HA7 4LP
    • Royal National Orthopaedic Hospital, Spinal Injuries Unit, Brockley Hill Stanmore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LoFric Primo (POBE) single-use urinary catheter	Device: LoFric Primo (POBE) single-use urinary catheter; LoFric Primo (POBE) single-use urinary catheter
ACTIVE_COMPARATOR: LoFric Primo (PVC) single-use urinary catheter	Device: LoFric Primo (PVC) single-use urinary catheter; LoFric Primo (PVC) single-use urinary catheter

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Investigators: Principal Investigator: Alfred J Witjes, Prof Dr, Radboud Univesity Nijmegen Medical Centre

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): March 1, 2008
• Study Completion (ACTUAL): March 1, 2008

Study Registration Dates

• First Submitted: September 15, 2008
• First Submitted That Met QC Criteria: September 15, 2008
• First Posted (ESTIMATE): September 16, 2008

Study Record Updates

• Last Update Posted (ACTUAL): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: YA-CLO-0002