Brain Activity During Bladder Filling: Pilot Study of an fMRI Protocol

Study Overview
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Brief Summary
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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
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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

Official Title
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Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research

Conditions
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fMRI Research

Intervention / Treatment
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* Diagnostic Test: invasive urodynamic evaluation
* Diagnostic Test: functional magnetic resonance imaging during bladder filling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults Exclusion Criteria: lower or upper urinary tract dysfunction

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complete evaluation UDO and fMRI<br>Evaluation including both urodynamic evaluation and functional MRI testing | Diagnostic Test: invasive urodynamic evaluation<br>* Invasive urodynamic evaluation to define maximum cystometric capacity. By means of catheterisation the bladder gets filled and volumes en pressures are measured.<br>* Other names: UDO;Diagnostic Test: functional magnetic resonance imaging during bladder filling<br>* 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)<br>* Other names: fMRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activated brain regions demonstrating brain activity | fMRI brain imaging data will be analyzed using FMRIB Software Library v6.0 (FSL). | through study completion, an average of 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder control, functional magnetic resonance imaging