Urinary FunctionNCT05560594
Investigate Bladder and Prostate During Emptying With Intermittent Catheter
A study testing Coloplast SpeediCath CH12 standard male intermittent catheter in people with Urinary Function, run by Coloplast A/S at 1 site in Denmark.
Trial summary
Explorative study investigating the urinary bladder and prostate during intermittent catheterization in healthy male adults by use of MR-scanning. 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
- Urinary Function
- What is being tested?
- Coloplast SpeediCath CH12 standard male intermittent catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Feb 2022to 25 Aug 2022
- Phase
- Interventional
- 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
- Male
- Has given written informed consent
- Be at least 18 years of age and have full legal capacity
Who cannot join
- Participate in any other clinical investigation
- Has symptoms of UTI (Investigator's judgement)
- Has known abnormalities and/or diseases in the bladder and/ or the lower urinary tract
- Has had previous disease or surgery in lower urinary tract
- Has any MR-scanning contraindication - according to "MR check list"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Explorative Study Investigating the Urinary Bladder and Prostate During Intermittent Catheterization in Healthy Male Adults by Use of MR-scanning.
Explorative study investigating the urinary bladder and prostate during intermittent catheterization in healthy male adults by use of MR-scanning.
Read the detailed description
12 healthy male adults will be enrolled in the investigation. The study includes one study visit where MR-scans of the bladder and prostate will be performed during normal voiding as baseline measurement followed by measurements during emptying of the bladder with an intermittent catheter (SpeediCath CH12 standard male intermittent catheter).
- Conditions
- Urinary Function
- Being tested
- Coloplast SpeediCath CH12 standard male intermittent catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast SpeediCath CH12 standard male intermittent catheterDevice
Drainage of the bladder through the urethra when using the SpeediCath standard male intermittent catheter.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent catheter | Other | Coloplast SpeediCath CH12 male intermittent catheter Receives: Device: Coloplast SpeediCath CH12 standard male intermittent catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder morphology
Evaluate bladder morphology and behavior during emptying of the bladder by performance of 3D and dynamic MRI
Measured: Within 1 year after termination
Bladder behavior
Evaluate bladder behavior when emptying the bladder with an intermittent catheter evaluated by performance of 3D and dynamic MRI
Measured: Within 1 year after termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start27 Feb 2022
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary FunctionStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Explore the behavior of the urinary bladder and prostate during emptying the bladder with an intermittent catheter. By use of 3D scanning techniques and dynamic MRI, the objective is to investigate behavior of bladder emptying using an intermittent catheter compared to the voluntary bladder emptying.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Bagi, PI, Principal investigator, Per.bagi@regionh.dk /+45 35 45 83 10
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560594
- Sponsor's protocol ID
- CP336
- Status last verified
- Oct 2022
- First submitted
- 2 Aug 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorative Study Investigating the Urinary Bladder and Prostate During Intermittent Catheterization in Healthy Male Adults by Use of MR-scanning.
- ClinicalTrials.gov ID
- NCT05560594
- Acronym / sponsor ID
- CP336
- Conditions
- Urinary Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2022 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 29 Sep 2022 (actual)
- 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.
Explorative study investigating the urinary bladder and prostate during intermittent catheterization in healthy male adults by use of MR-scanning.
Detailed description
12 healthy male adults will be enrolled in the investigation. The study includes one study visit where MR-scans of the bladder and prostate will be performed during normal voiding as baseline measurement followed by measurements during emptying of the bladder with an intermittent catheter (SpeediCath CH12 standard male intermittent catheter).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Explore the behavior of the urinary bladder and prostate during emptying the bladder with an intermittent catheter. By use of 3D scanning techniques and dynamic MRI, the objective is to investigate behavior of bladder emptying using an intermittent catheter compared to the voluntary bladder emptying.
| Arm | Type | Receives |
|---|---|---|
| Intermittent catheter | Other | Device: Coloplast SpeediCath CH12 standard male intermittent catheterColoplast SpeediCath CH12 male intermittent catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male
- Has given written informed consent
- Be at least 18 years of age and have full legal capacity
Key exclusion criteria (5 listed)
- Participate in any other clinical investigation
- Has symptoms of UTI (Investigator's judgement)
- Has known abnormalities and/or diseases in the bladder and/ or the lower urinary tract
- Has had previous disease or surgery in lower urinary tract
- Has any MR-scanning contraindication - according to "MR check list"
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 |
|---|---|---|
| Coloplast SpeediCath CH12 standard male intermittent catheterDrainage of the bladder through the urethra when using the SpeediCath standard male intermittent catheter. | Device | Intermittent catheter |
Primary outcome
Bladder morphology
Time frame: Within 1 year after termination
Evaluate bladder morphology and behavior during emptying of the bladder by performance of 3D and dynamic MRI
Bladder behavior
Time frame: Within 1 year after termination
Evaluate bladder behavior when emptying the bladder with an intermittent catheter evaluated by performance of 3D and dynamic MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
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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, PI principal investigator
Per.bagi@regionh.dk /+45 35 45 83 10
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coloplast SpeediCath CH12 standard male intermittent catheter in people with Urinary Function, 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 3 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 18 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bladder morphology (time frame: Within 1 year after termination). The study lists 2 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 18 Oct 2022.