Spinal Cord InjuryPhase 1NCT01292941
Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
A Phase 1 study testing Intermittent catheterisation, NonCE marked intermittent catheter/red and NonCE marked intermittent catheter/green in people with Spinal Cord Injury, run by Coloplast A/S at 1 site in Denmark.
Trial summary
To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC) Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Intermittent catheterisation, NonCE marked intermittent catheter/red and NonCE marked intermittent catheter/green
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Jun 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • ≥18 years
- Male
- Signed informed consent
- Negative urine stix (erythrocytes, leucocytes and nitrite)
Who cannot join
- • Abnormalities, diseases or surgical procedures performed in the lower urinary tract
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)
Read the detailed description
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.
Coloplast have developed a new intermittent catheters. In this investigation this new test catheter will be compared with SpeediCat by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.
55 healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.
- Conditions
- Spinal Cord Injury
- Being tested
- Intermittent catheterisation, NonCE marked intermittent catheter/red, NonCE marked intermittent catheter/green, NonCE marked intermittent catheter/blue
- 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.
Intermittent catheterisationDevice
Also called SpeediCath
Speedicath, Intermittent catheterisation
NonCE marked intermittent catheter/redDevice
Also called Paris
Paris, Intermittent catheterisation
NonCE marked intermittent catheter/greenDevice
Also called Paris
Paris, Intermittent catheter
NonCE marked intermittent catheter/blueDevice
Also called Paris
Paris, Intermittent catheter
| Study group | Role | What they receive |
|---|---|---|
| Active comparator/Yellow catheter | Active comparator | SpeediCath coated catheter Receives: Device: Intermittent catheterisation |
| NonCE marked intermittent catheter/red | Experimental | Not described Receives: Device: NonCE marked intermittent catheter/red |
| NonCE marked intermittent catheter/green | Experimental | Not described Receives: Device: NonCE marked intermittent catheter/green |
| NonCE marked intermittent catheter/Blue | Experimental | Not described Receives: Device: NonCE marked intermittent catheter/blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort during catheterisation measured by VAS-scale (0-10)
A subject is assesing a VAS scale after each catheterisation.
Measured: 10 measurements in an 11 week period. 10 min after each catheterisation
Secondary outcomes (4)
Safety
Safety is evalueted continues while the subjects are testing the devices
Measured: During the investigation 11 Weeks per subject
Discomfort during urination post catheterisation
Subjects own assesment. Yes or no can be answered to discomfort during urination post catheterisation
Measured: 10 measurements in an 11 week period. 10 min after each catheterisation
Haematuria
Urine test after each catheterisation, and measured on a urine stix
Measured: 10 measurements in an 11 week period. 10 min after each catheterisation
Handling during insertion, withdrawal
Ease of use assessed by nurses, measured on a 5 point scale
Measured: 10 measurements in an 11 week period. 10 min after each catheterisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Why it stopped: Product development project closed prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Susanne Gürtler, CTM, Study director, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292941
- Sponsor's protocol ID
- CP065CC
- Status last verified
- Aug 2015
- First submitted
- 9 Feb 2011
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01292941
- Acronym / sponsor ID
- CP065CC
- Conditions
- Spinal Cord Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Product development project closed prematurely
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)
Detailed description
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.
Coloplast have developed a new intermittent catheters. In this investigation this new test catheter will be compared with SpeediCat by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.
55 healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active comparator/Yellow catheter | Active comparator | Device: Intermittent catheterisationSpeediCath coated catheter |
| NonCE marked intermittent catheter/red | Experimental | Device: NonCE marked intermittent catheter/red |
| NonCE marked intermittent catheter/green | Experimental | Device: NonCE marked intermittent catheter/green |
| NonCE marked intermittent catheter/Blue | Experimental | Device: NonCE marked intermittent catheter/blue |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • ≥18 years
Key exclusion criteria (1 listed)
- • Abnormalities, diseases or surgical procedures performed in the lower urinary tract
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 |
|---|---|---|
| Intermittent catheterisationAlso: SpeediCathSpeedicath, Intermittent catheterisation | Device | Active comparator/Yellow catheter |
| NonCE marked intermittent catheter/redAlso: ParisParis, Intermittent catheterisation | Device | NonCE marked intermittent catheter/red |
| NonCE marked intermittent catheter/greenAlso: ParisParis, Intermittent catheter | Device | NonCE marked intermittent catheter/green |
| NonCE marked intermittent catheter/blueAlso: ParisParis, Intermittent catheter | Device | NonCE marked intermittent catheter/Blue |
Primary outcome
Discomfort during catheterisation measured by VAS-scale (0-10)
Time frame: 10 measurements in an 11 week period. 10 min after each catheterisation
A subject is assesing a VAS scale after each catheterisation.
4 secondary outcomes
Safety
Time frame: During the investigation 11 Weeks per subject
Discomfort during urination post catheterisation
Time frame: 10 measurements in an 11 week period. 10 min after each catheterisation
Haematuria
Time frame: 10 measurements in an 11 week period. 10 min after each catheterisation
Handling during insertion, withdrawal
Time frame: 10 measurements in an 11 week period. 10 min after each catheterisation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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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.
Susanne Gürtler, CTM study director
Coloplast A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intermittent catheterisation, NonCE marked intermittent catheter/red and NonCE marked intermittent catheter/green in people with Spinal Cord Injury, 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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 7 Aug 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 during catheterisation measured by VAS-scale (0-10) (time frame: 10 measurements in an 11 week period. 10 min after each catheterisation). 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 7 Aug 2015.