Spinal Cord InjuryNCT01142115
Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers
A study testing Intermittent catheter CP063CC and SpeediCath in people with Spinal Cord Injury, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised. 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 catheter CP063CC and SpeediCath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to May 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Male
- signed informed Consent,
- Neg. urine multistix
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
Official title: Comparative Study of Two Different Urine Catheters.
The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.
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 has developed a new intermittent catheter. In this investigation this new test catheter will be compared with SpeediCath 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.
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 catheter CP063CC, SpeediCath
- 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 catheter CP063CCDevice
Also called Intermittent catheter,
intermittent catheterisation
SpeediCathDevice
Also called Intermittent catheter
intermittent catheterisation
| Study group | Role | What they receive |
|---|---|---|
| Monza | Experimental | nonCE marked intermittent catheter Receives: Device: Intermittent catheter CP063CC |
| control | Active comparator | SpeediCath coated catheter Receives: Device: Intermittent catheter CP063CC; Device: SpeediCath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort Measured on the Visual Analog Scale (VAS)
Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).
Measured: 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
Secondary outcomes (5)
Irritation During Voiding After Catheterization
After each catheterization subjects were asked if they felt any irritation during voiding with answer option yes or no.
Yes - they experienced irritation. No - they did not experience irritation.
Measured: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Ease of Use Measured on a 5 Point Scale: Insertion Effort
After each catheterization the nurse who conducted the catheterization answered how the catheter insertion had been.
There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy
Measured: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Ease of Use Measured on a 5 Point Scale: Withdrawal Effort
After each catheterization the nurse who conducted the catheterization answered how the catheter withdrawal had been.
There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy
Measured: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Visible Blood
Visual blood observed on the catheter or in the urine in connection to catheterization.
The nurse who conducted the catheterization could answer yes or no as follows:
Yes = visible blood observed. No = no visible blood observed.
Measured: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Haematuria
Negative or positive result on a multistix urin analysis.
Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter.
Measured: 2 hours after catheterisation at visits 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rikke Otttesen, CTM, Study director, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142115
- Sponsor's protocol ID
- CP063CC
- Status last verified
- Oct 2011
- First submitted
- 4 May 2010
- Last updated
- 7 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two Different Urine Catheters.
- ClinicalTrials.gov ID
- NCT01142115
- Acronym / sponsor ID
- CP063CC
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Posted 9 Aug 2011
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 the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.
Detailed description
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.
Coloplast has developed a new intermittent catheter. In this investigation this new test catheter will be compared with SpeediCath 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.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monza | Experimental | Device: Intermittent catheter CP063CCnonCE marked intermittent catheter |
| control | Active comparator | Device: Intermittent catheter CP063CC, Device: SpeediCathSpeediCath coated catheter |
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 or older
- Male
- signed informed Consent,
- Neg. urine multistix
Key exclusion criteria (2 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 catheter CP063CCAlso: Intermittent catheter,intermittent catheterisation | Device | Monza, control |
| SpeediCathAlso: Intermittent catheterintermittent catheterisation | Device | control |
Primary outcome
Discomfort Measured on the Visual Analog Scale (VAS)
Time frame: 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).
5 secondary outcomes
Irritation During Voiding After Catheterization
Time frame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Ease of Use Measured on a 5 Point Scale: Insertion Effort
Time frame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Ease of Use Measured on a 5 Point Scale: Withdrawal Effort
Time frame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Visible Blood
Time frame: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
Haematuria
Time frame: 2 hours after catheterisation at visits 1 and 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- 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.
Rikke Otttesen, 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 study testing Intermittent catheter CP063CC and SpeediCath 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 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 7 Oct 2011. 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 9 Aug 2011). 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 the Visual Analog Scale (VAS) (time frame: 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1). 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 Oct 2011.