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

NCT ID: NCT05255692

Last Updated: 2024-06-05

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-09-30

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

Conditions

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fMRI Research

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Complete evaluation UDO and fMRI

Evaluation including both urodynamic evaluation and functional MRI testing

Group Type EXPERIMENTAL

invasive urodynamic evaluation

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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UDO fMRI

Eligibility Criteria

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Inclusion Criteria

* Healthy adults

Exclusion Criteria

* lower or upper urinary tract dysfunction
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Ghent

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Belgium

Central Contacts

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Bieke Samijn, PhD

Role: CONTACT

+3293321938

Facility Contacts

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Bieke Samijn, PhD

Role: primary

+3293321938

Other Identifiers

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BC-10572

Identifier Type: -

Identifier Source: org_study_id

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