HealthyNCT00324233
Evaluation of Residual Urine After Intermittent Catheterisation
A study testing Intermittent catheter and Compact intermittent catheter in people with Healthy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. 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
- Healthy
- What is being tested?
- Intermittent catheter and Compact intermittent catheter
- 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
- Apr 2006to Jun 2006
- 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
- Male
- 18 years and above
- A negative urine dip-stick
- Have signed informed written consent to participate
Who cannot join
- The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Residual Urine After Intermittent Catheterisation - Comparison of 2 Hydrophilic Coated, Intermittent Catheters
Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.
- Conditions
- Healthy
- Being tested
- Intermittent catheter, Compact intermittent catheter
- Keywords
- Residual urine, Hematuria, Ultra sound
- Medical subject headings
- Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent catheterDevice
SpeediCath catherter (SC) for intermittent catherisation
Compact intermittent catheterDevice
SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males
| Study group | Role | What they receive |
|---|---|---|
| SC | Active comparator | Speedicath (SC) catheter is a catheter for intermittent catherisation Receives: Device: Intermittent catheter |
| SCCM | Experimental | SpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males Receives: Device: Compact intermittent catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Urine Measured by Ultra Sound
Measured: 2
Secondary outcomes (2)
Subjectively Measured Handling
Subjectively Measured Insertion of the Catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2006 (estimated)
- Study startApr 2006
- Primary completionJun 2006
- Study completionJun 2006
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 HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Bagi, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324233
- Sponsor's protocol ID
- DK052CC
- Status last verified
- Nov 2012
- First submitted
- 9 May 2006
- Last updated
- 1 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Residual Urine After Intermittent Catheterisation - Comparison of 2 Hydrophilic Coated, Intermittent Catheters
- ClinicalTrials.gov ID
- NCT00324233
- Acronym / sponsor ID
- DK052CC
- Conditions
- Healthy
- Keywords
- Residual urine, Hematuria, Ultra sound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 10 May 2006 (estimated)
- Results
- Posted 1 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SC | Active comparator | Device: Intermittent catheterSpeedicath (SC) catheter is a catheter for intermittent catherisation |
| SCCM | Experimental | Device: Compact intermittent catheterSpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- 18 years and above
- A negative urine dip-stick
- Have signed informed written consent to participate
Key exclusion criteria (1 listed)
- The test participant has previous or current congenital deformity, diseases or operation 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 catheterSpeediCath catherter (SC) for intermittent catherisation | Device | SC |
| Compact intermittent catheterSpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males | Device | SCCM |
Primary outcome
Residual Urine Measured by Ultra Sound
Time frame: 2
2 secondary outcomes
Subjectively Measured Handling
Subjectively Measured Insertion of the Catheter
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2013.
- 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.
Per Bagi, MD principal investigator
Copenhagen University Hospital, 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 Intermittent catheter and Compact intermittent catheter in people with Healthy, 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: finished, as of the sponsor's last update on 1 Jan 2013. 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 1 Jan 2013). 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?
Residual Urine Measured by Ultra Sound (time frame: 2). 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 1 Jan 2013.