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.
1 other identifier
interventional
195
6 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2007
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 15, 2008
CompletedFirst Posted
Study publicly available on registry
September 16, 2008
CompletedResults Posted
Study results publicly available
June 2, 2009
CompletedNovember 11, 2021
September 1, 2012
1.2 years
September 15, 2008
April 6, 2009
November 10, 2021
Conditions
Outcome Measures
Primary Outcomes (6)
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
Study Arms (2)
LoFric Primo (POBE) single-use urinary catheter
EXPERIMENTALLoFric Primo (PVC) single-use urinary catheter
ACTIVE COMPARATORInterventions
LoFric Primo (POBE) single-use urinary catheter
LoFric Primo (PVC) single-use urinary catheter
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Medical University of Vienna, Department of Urology
Vienna, A-1090, Austria
NRZ Greifswald
Greifswald, 17487, Germany
Kliniken Maria Hilf GmbH, Zentrum für Kontinenz und Neuro-Urologie, Krankenhaus St. Franziskus
Mönchengladbach, 41063, Germany
BG-Klinik Tübingen
Tübingen, 72076, Germany
Ospedale Careggi, Unità Spinale
Florence, 50139, Italy
Primario U.O. Neuro-Urologia, Direttore Dipartimento delle Mielolesioni
Torino, Italy
Ziekenhuis Lievensberg, Afdeling Urologie
Bergen op Zoom, 4624 VT, Netherlands
Albert Schweitzer Ziekenhuis, Locatie Dordwijk
Dordrecht, 3300 AK, Netherlands
Catharina Ziekenhuis
Eindhoven, 5602 ZA, Netherlands
Radboud Univesity Nijmegen Medical Centre
Nijmegen, 6500 HB, Netherlands
Verksamhet Urologi, Sahlgrenska Universitets sjukhuset
Gothenburg, 413 45, Sweden
Sheffield Teaching Hospitals NHS Foundation trust, Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
Royal National Orthopaedic Hospital, Spinal Injuries Unit, Brockley Hill Stanmore
Stanmore, HA7 4LP, United Kingdom
Results Point of Contact
- Title
- Head of Therapeutic Area Health Care
- Organization
- Astra Tech AB
Study Officials
- PRINCIPAL INVESTIGATOR
Alfred J Witjes, Prof Dr
Radboud Univesity Nijmegen Medical Centre
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2008
First Posted
September 16, 2008
Study Start
January 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
November 11, 2021
Results First Posted
June 2, 2009
Record last verified: 2012-09