Brain Activity During Bladder Filling: Pilot Study of an fMRI Protocol
NCT ID: NCT05255692
Last Updated: 2024-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
6 participants
INTERVENTIONAL
2025-05-01
2026-09-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Complete evaluation UDO and fMRI
Evaluation including both urodynamic evaluation and functional MRI testing
invasive urodynamic evaluation
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 filling
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)
Interventions
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invasive urodynamic evaluation
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 filling
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
35 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
University of Zurich
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Bieke Samijn, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent University Hospital
Ghent, Flanders, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BC-10572
Identifier Type: -
Identifier Source: org_study_id
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