Retention, UrinaryNCT07384559
Exploratory Study Investigating the Urinary Bladder During Intermittent Catheterization in Healthy and Spinal Cord Injured Male and Female Subjects Using an Upright MRI Scanner
A study testing MRI scan in people with Retention, Urinary, run by Coloplast A/S.
Trial summary
This is an exploratory study investigating morphological and physiological changes of the lower urinary tract and surrounding structures during IC use in individuals with SCI, and during normal voiding and IC use in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retention, Urinary
- What is being tested?
- MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has given written informed consent
- Is at least 18 years old
- Has full legal capacity
- Is able (assessed by investigator) and willing to adhere to study procedures during study duration
- Is able (assessed by investigator) to remain seated in the MRI scanner for minimum 20 minutes*
- Known with SCI for a minimum of 1 year*
- Has used IC as primary bladder emptying method for at least 3 months* * Only for SCI subjects
Who cannot join
- Is participating in any other clinical investigation during this investigation
- Has previously completed this investigation
- Has any known allergic or hypersensitive reactions to any device or its ingredients used in the investigation
- Is pregnant
- Has had surgical procedures performed in the lower urinary tract.
- Has active/recurrent bladder cancer
Show all 10Show fewer
- Has experienced autonomic dysreflexia within the last 2 years
- Has any MRI-scanning contraindications, according to MR check list provided by the site (e.g. active implants like pacemaker, cochlear implant, event recorder, implanted insulin pump)
- Has symptoms of UTI at times of inclusion, as judged by the investigator.
- Has a body weight that exceeds the maximum of 150kg max
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is an exploratory study investigating morphological and physiological changes of the lower urinary tract and surrounding structures during IC use in individuals with SCI, and during normal voiding and IC use in healthy individuals.
- Conditions
- Retention, Urinary
- Being tested
- MRI scan
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanOther
MRI scan of SCI and healthy male/female subjects during catheterization
| Study group | Role | What they receive |
|---|---|---|
| MRI scan | Other | MRI scan of SCI and healthy male/female subjects during catheterization Receives: Other: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is the quality of the 3D MRI images performed at Visit 2 sufficient for further use/analysis? (Y/N).
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start2 Mar 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retention, UrinaryStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To obtain usable MRI 3D images of lower urinary tract and surroundings during voiding (healthy subjects) and during bladder emptying with IC (healthy subjects and SCI subjects).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Walter Wigger-Alberti, M.D., Principal investigator, Eurofins bioskin GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384559
- Sponsor's protocol ID
- CP386
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Investigating the Urinary Bladder During Intermittent Catheterization in Healthy and Spinal Cord Injured Male and Female Subjects Using an Upright MRI Scanner
- ClinicalTrials.gov ID
- NCT07384559
- Acronym / sponsor ID
- CP386
- Conditions
- Retention, Urinary
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 3 Feb 2026 (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.
This is an exploratory study investigating morphological and physiological changes of the lower urinary tract and surrounding structures during IC use in individuals with SCI, and during normal voiding and IC use in healthy individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To obtain usable MRI 3D images of lower urinary tract and surroundings during voiding (healthy subjects) and during bladder emptying with IC (healthy subjects and SCI subjects).
| Arm | Type | Receives |
|---|---|---|
| MRI scan | Other | Other: MRI scanMRI scan of SCI and healthy male/female subjects during catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has given written informed consent
- Is at least 18 years old
- Has full legal capacity
- Is able (assessed by investigator) and willing to adhere to study procedures during study duration
- Is able (assessed by investigator) to remain seated in the MRI scanner for minimum 20 minutes*
Key exclusion criteria (10 listed)
- Is participating in any other clinical investigation during this investigation
- Has previously completed this investigation
- Has any known allergic or hypersensitive reactions to any device or its ingredients used in the investigation
- Is pregnant
- Has had 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 |
|---|---|---|
| MRI scanMRI scan of SCI and healthy male/female subjects during catheterization | Other | MRI scan |
Primary outcome
Is the quality of the 3D MRI images performed at Visit 2 sufficient for further use/analysis? (Y/N).
Time frame: up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Pelvic Health Electrically Evoked Recording (PEER) 2 Study
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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.
Walter Wigger-Alberti, M.D. principal investigator
Eurofins bioskin GmbH
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan in people with Retention, Urinary, run by Coloplast A/S.
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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Grigo, PhD (+49 17 28 49 34 17, DEKAGR@coloplast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is the quality of the 3D MRI images performed at Visit 2 sufficient for further use/analysis? (Y/N). (time frame: up to 28 days). 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 3 Feb 2026.