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Clinical Trials/NCT05255692
NCT05255692
Not yet recruiting
Not Applicable

Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research

University Hospital, Ghent1 site in 1 country6 target enrollmentMay 1, 2025
ConditionsfMRI Research

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
fMRI Research
Sponsor
University Hospital, Ghent
Enrollment
6
Locations
1
Primary Endpoint
Activated brain regions demonstrating brain activity
Status
Not yet recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
May 1, 2025
End Date
September 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy adults

Exclusion Criteria

  • lower or upper urinary tract dysfunction

Outcomes

Primary Outcomes

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).

Study Sites (1)

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