Urinary CatheterizationNCT00753298
A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation
A study testing LoFric Primo (POBE) single-use urinary catheter and LoFric Primo (PVC) single-use urinary catheter in people with Urinary Catheterization, run by Wellspect HealthCare at 13 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Catheterization
- What is being tested?
- LoFric Primo (POBE) single-use urinary catheter and LoFric Primo (PVC) single-use urinary catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Jan 2007to Mar 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
Netherlands4 sites
Ziekenhuis Lievensberg, Afdeling Urologie
Bergen op Zoom, 4624 VT
Albert Schweitzer Ziekenhuis, Locatie Dordwijk
Dordrecht, 3300 AK
Catharina Ziekenhuis
Eindhoven, 5602 ZA
Radboud Univesity Nijmegen Medical Centre
Nijmegen, 6500 HB
Germany3 sites
NRZ Greifswald
Greifswald, 17487
Kliniken Maria Hilf GmbH, Zentrum für Kontinenz und Neuro-Urologie, Krankenhaus St. Franziskus
Mönchengladbach, 41063
BG-Klinik Tübingen
Tübingen, 72076
Italy2 sites
Ospedale Careggi, Unità Spinale
Florence, 50139
Primario U.O. Neuro-Urologia, Direttore Dipartimento delle Mielolesioni
Torino
United Kingdom2 sites
Sheffield Teaching Hospitals NHS Foundation trust, Royal Hallamshire Hospital
Sheffield, S10 2JF
Royal National Orthopaedic Hospital, Spinal Injuries Unit, Brockley Hill Stanmore
Stanmore, HA7 4LP
Austria1 site
Medical University of Vienna, Department of Urology
Vienna, A-1090
Sweden1 site
Verksamhet Urologi, Sahlgrenska Universitets sjukhuset
Gothenburg, 413 45
About this study
Official title: 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.
- Conditions
- Urinary Catheterization
- Being tested
- LoFric Primo (POBE) single-use urinary catheter, LoFric Primo (PVC) single-use urinary catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| LoFric Primo (POBE) single-use urinary catheter | Experimental | Not described Receives: Device: LoFric Primo (POBE) single-use urinary catheter |
| LoFric Primo (PVC) single-use urinary catheter | Active comparator | Not described Receives: Device: LoFric Primo (PVC) single-use urinary catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startJan 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfred J Witjes, Prof Dr, Principal investigator, Radboud Univesity Nijmegen Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753298
- Sponsor's protocol ID
- YA-CLO-0002
- Status last verified
- Sep 2012
- First submitted
- 15 Sep 2008
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00753298
- Acronym / sponsor ID
- YA-CLO-0002
- Conditions
- Urinary Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Posted 2 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LoFric Primo (POBE) single-use urinary catheter | Experimental | Device: LoFric Primo (POBE) single-use urinary catheter |
| LoFric Primo (PVC) single-use urinary catheter | Active comparator | Device: LoFric Primo (PVC) single-use urinary catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LoFric Primo (POBE) single-use urinary catheterLoFric Primo (POBE) single-use urinary catheter | Device | LoFric Primo (POBE) single-use urinary catheter |
| LoFric Primo (PVC) single-use urinary catheterLoFric Primo (PVC) single-use urinary catheter | Device | LoFric Primo (PVC) single-use urinary catheter |
Primary outcome
Subject's Perception Regarding Handling of Test Catheter Before Insertion
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Subject's Sensation When Using Test Catheter
Time frame: At 4 weeks
Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred J Witjes, Prof Dr principal investigator
Radboud Univesity Nijmegen Medical Centre
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LoFric Primo (POBE) single-use urinary catheter and LoFric Primo (PVC) single-use urinary catheter in people with Urinary Catheterization, run by Wellspect HealthCare at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands, Germany, Italy, United Kingdom, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject's Perception Regarding Handling of Test Catheter Before Insertion (time frame: At 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.