fMRI ResearchNCT05255692
Brain Activity During Bladder Filling: Pilot Study of an fMRI Protocol
A study testing invasive urodynamic evaluation and functional magnetic resonance imaging during bladder filling in people with fMRI Research, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016). Higher brain centers responsible for bladder function may be related to the presence of incontinence. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- fMRI Research
- What is being tested?
- invasive urodynamic evaluation and functional magnetic resonance imaging during bladder filling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2025to 30 Sep 2026
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
Who cannot join
- lower or upper urinary tract dysfunction
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ghent University Hospital
Ghent, Flanders, 9000
Bieke Samijn, PhD, +3293321938, bieke.samijn@ugent.be
About this study
Official title: Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research
Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016).
Higher brain centers responsible for bladder function may be related to the presence of incontinence.
The current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence.
Read the detailed description
Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016). Being more or completely dry could improve the quality of life and health status of the child and the social environment.
Higher brain centers responsible for bladder function may be related to the presence of incontinence. These higher brain centers could be correlated to the brain damage seen in children with CP.
The current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence. The study wants to validate if the defined fMRI paradigm can provide correct information concerning brain activity during bladder filling, to ensure usable results and comply with ethical demands for testing in children, the protocol will be tested and results validated during the pilot study with healthy adults. During the fMRI study, the bladder will be filled until FSF and NDV. Functional MRI-data will be obtained during the filling and emptying phase of the bladder on both volumes
- Conditions
- fMRI Research
- Being tested
- invasive urodynamic evaluation, functional magnetic resonance imaging during bladder filling
- Keywords
- Bladder control, functional magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
invasive urodynamic evaluationDiagnostic test
Also called UDO
Invasive urodynamic evaluation to define maximum cystometric capacity. By means of catheterisation the bladder gets filled and volumes en pressures are measured.
functional magnetic resonance imaging during bladder fillingDiagnostic test
Also called fMRI
Functional MRI is used to capture brain activity during tasks. The task in the current study is bladder infusion and withdrawal by means of the INFSYS-2 infusion/withdrawal pump (Leitner et al. 2017)
| Study group | Role | What they receive |
|---|---|---|
| Complete evaluation UDO and fMRI | Experimental | Evaluation including both urodynamic evaluation and functional MRI testing Receives: Diagnostic Test: invasive urodynamic evaluation; Diagnostic Test: functional magnetic resonance imaging during bladder filling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activated brain regions demonstrating brain activity
fMRI brain imaging data will be analyzed using FMRIB Software Library v6.0 (FSL).
Measured: through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 May 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for fMRI ResearchStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, University of Zurich
- Responsible party
- Sponsor
- Investigators
- Bieke Samijn, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255692
- Sponsor's protocol ID
- BC-10572
- Status last verified
- Jun 2024
- First submitted
- 24 Jan 2022
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research
- ClinicalTrials.gov ID
- NCT05255692
- Acronym / sponsor ID
- BC-10572
- Conditions
- fMRI Research
- Keywords
- Bladder control, functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent, University of Zurich
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 24 Feb 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.
Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016).
Higher brain centers responsible for bladder function may be related to the presence of incontinence.
The current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence.
Detailed description
Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016). Being more or completely dry could improve the quality of life and health status of the child and the social environment.
Higher brain centers responsible for bladder function may be related to the presence of incontinence. These higher brain centers could be correlated to the brain damage seen in children with CP.
The current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence. The study wants to validate if the defined fMRI paradigm can provide correct information concerning brain activity during bladder filling, to ensure usable results and comply with ethical demands for testing in children, the protocol will be tested and results validated during the pilot study with healthy adults. During the fMRI study, the bladder will be filled until FSF and NDV. Functional MRI-data will be obtained during the filling and emptying phase of the bladder on both volumes
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complete evaluation UDO and fMRI | Experimental | Diagnostic Test: invasive urodynamic evaluation, Diagnostic Test: functional magnetic resonance imaging during bladder fillingEvaluation including both urodynamic evaluation and functional MRI testing |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (1 listed)
- lower or upper urinary tract dysfunction
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 |
|---|---|---|
| invasive urodynamic evaluationAlso: UDOInvasive urodynamic evaluation to define maximum cystometric capacity. By means of catheterisation the bladder gets filled and volumes en pressures are measured. | Diagnostic test | Complete evaluation UDO and fMRI |
| functional magnetic resonance imaging during bladder fillingAlso: fMRIFunctional MRI is used to capture brain activity during tasks. The task in the current study is bladder infusion and withdrawal by means of the INFSYS-2 infusion/withdrawal pump (Leitner et al. 2017) | Diagnostic test | Complete evaluation UDO and fMRI |
Primary outcome
Activated brain regions demonstrating brain activity
Time frame: through study completion, an average of 6 weeks
fMRI brain imaging data will be analyzed using FMRIB Software Library v6.0 (FSL).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Bieke Samijn, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing invasive urodynamic evaluation and functional magnetic resonance imaging during bladder filling in people with fMRI Research, run by University Hospital, Ghent at 1 site in Belgium.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Jun 2024. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bieke Samijn, PhD (+3293321938, bieke.samijn@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activated brain regions demonstrating brain activity (time frame: through study completion, an average of 6 weeks). 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 5 Jun 2024.