Spinal Cord InjuriesNCT00990093

A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study

A study testing test intermittent catheter and Intermittent catheterization in people with Spinal Cord Injuries, run by Coloplast A/S at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Spinal Cord Injuries
What is being tested?: test intermittent catheter and Intermittent catheterization
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteDenmark
Study dates: Nov 2009to Mar 2010
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
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

At least 18 years of age
Has normal/impaired sensation in the urethra
Self-catheterises at least 4 times per day
Has used clean self-intermittent catheterisation for at least 14 days
Is able to open and prepare the catheters for catheterisation
Has signed the informed consent before any study related-activities.

Who cannot join

Has a symptomatic urinary tract infection as assessed by the investigator
Is mentally unstable as assessed by the investigator

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Klinik for Rygmarvsskader
Hornbæk, 3100

Other trials in Denmark

About this study

Official title: A Randomised, Cross-over, Open-labelled Study Evaluating the Acceptance of Test Catheters Compared to SpeediCath Catheters

The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.

Read the detailed description

See brief summary

Conditions: Spinal Cord Injuries
Being tested: test intermittent catheter, Intermittent catheterization
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

test intermittent catheterDevice
Also called Test catheter
CH 12 hydrophilic coated catheter
Intermittent catheterizationDevice
Also called SpeediCath
CH 12 hydrophilic catheter

Study groups in NCT00990093
Study group	Role	What they receive
test intermittent catheter	Experimental	CH 12 hydrophilic coated catheter Receives: Device: test intermittent catheter
intermittent catheter	Experimental	CH 12 hydrophilic coated catheter Receives: Device: Intermittent catheterization

What is being measured

The primary outcome is the main question the study is designed to answer.

Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.
Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.
At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Mar 2010

First posted6 Oct 2009 (estimated)
Study startNov 2009
Primary completionMar 2010
Study completionMar 2010

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuriesStudies 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: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00990093
Sponsor's protocol ID: CP062CC
Status last verified: Aug 2012
First submitted: 5 Oct 2009
Last updated: 5 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.
PubMed 34699062
Chartier-Kastler E, Lauge I, Ruffion A, Goossens D, Charvier K, Biering-Sorensen F. Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study. Spinal Cord. 2011 Jul;49(7):844-50. doi: 10.1038/sc.2011.5. Epub 2011 Feb 22.
PubMed 21339763

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
Recruiting
Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
Spinal Cord Injuries
Recruiting
Informational Needs of Caregivers of Patients With Neuromotor Disease in Rehabilitation Hospitalization: Validation Study of the QBI-R/V
Neuro-Degenerative Diseases, Care Givers
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Implementation Study on Hospital-to-home Advanced Rehabilitation Technologies (ART)
Brain Injuries

All Spinal Cord Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Cross-over, Open-labelled Study Evaluating the Acceptance of Test Catheters Compared to SpeediCath Catheters
ClinicalTrials.gov ID: NCT00990093
Acronym / sponsor ID: CP062CC
Conditions: Spinal Cord Injuries
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 6 Oct 2009 (estimated)
Results: Posted 5 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.

Detailed description

See brief summary

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
test intermittent catheter	Experimental	Device: test intermittent catheterCH 12 hydrophilic coated catheter
intermittent catheter	Experimental	Device: Intermittent catheterizationCH 12 hydrophilic coated catheter

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

At least 18 years of age
Has normal/impaired sensation in the urethra
Self-catheterises at least 4 times per day
Has used clean self-intermittent catheterisation for at least 14 days
Is able to open and prepare the catheters for catheterisation

Key exclusion criteria (2 listed)

Has a symptomatic urinary tract infection as assessed by the investigator
Is mentally unstable as assessed by the investigator

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
test intermittent catheterAlso: Test catheterCH 12 hydrophilic coated catheter	Device	test intermittent catheter
Intermittent catheterizationAlso: SpeediCathCH 12 hydrophilic catheter	Device	intermittent catheter

Primary outcome

Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.
Time frame: 14 days
Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days. At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)

Results and safety

Results posted to the registry on 5 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A: First Test Catheter Then Standard Catheter	19	15
B: First Standard Catheter Then Test Catheter	17	15

Primary outcome: Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.

Time frame: 14 days. Mean (Standard Deviation). Unit: units on a scale

Measure	Test Catheter n = 30	Standard Catheter n = 30
Value	1.59 (2.28)	1.94 (2.24)

Population analysed: Six participants discontinued the study in the first test period, i.e. before visit 2 at which the first catheter evaluation was to be given. The primary outcome was the catheter evaluation on discomfort, and these six participants did not contribute to the ITT analysis of the primary outcome.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Catheter	0 of 32 (0%)	1 of 32 (3.1%)	Not reported
Standard Catheter	0 of 34 (0%)	1 of 34 (2.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34699062Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.
Derived from this study: PubMed 21339763Chartier-Kastler E, Lauge I, Ruffion A, Goossens D, Charvier K, Biering-Sorensen F. Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study. Spinal Cord. 2011 Jul;49(7):844-50. doi: 10.1038/sc.2011.5. Epub 2011 Feb 22.

Related trials for Spinal Cord Injuries

Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
Recruiting
Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
Spinal Cord Injuries
Recruiting
Informational Needs of Caregivers of Patients With Neuromotor Disease in Rehabilitation Hospitalization: Validation Study of the QBI-R/V
Neuro-Degenerative Diseases, Care Givers
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Implementation Study on Hospital-to-home Advanced Rehabilitation Technologies (ART)
Brain Injuries

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.

Fin Biering-Sørensen, MD principal investigator

Klinik for Rygmarvsskader, Rigshospitalet

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing test intermittent catheter and Intermittent catheterization in people with Spinal Cord Injuries, run by Coloplast A/S at 1 site in Denmark.

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 6 inclusion and 2 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 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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 5 Sep 2012). 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?

Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00990093, which also lists 2 linked publications.

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 5 Sep 2012.