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

Not Applicable

Not yet recruiting

• Conditions: fMRI Research
• Interventions: Diagnostic Test: invasive urodynamic evaluation; Diagnostic Test: functional magnetic resonance imaging during bladder filling

• Registration Number: NCT05255692
• Lead Sponsor: University Hospital, Ghent

Brief 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.

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 Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-02-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05
• Study Start: 2025-05-01
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Healthy adults

Exclusion Criteria

• lower or upper urinary tract dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Complete evaluation UDO and fMRI	invasive urodynamic evaluation	Evaluation including both urodynamic evaluation and functional MRI testing
Complete evaluation UDO and fMRI	functional magnetic resonance imaging during bladder filling	Evaluation including both urodynamic evaluation and functional MRI testing

Primary Outcome Measures

Name	Time	Method
Activated brain regions demonstrating brain activity	through study completion, an average of 6 weeks	fMRI brain imaging data will be analyzed using FMRIB Software Library v6.0 (FSL).

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Flanders, Belgium