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

June 3, 2024 updated by: University Hospital, Ghent

Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Flanders
      • Ghent, Flanders, Belgium, 9000
        • Ghent University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • lower or upper urinary tract dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Complete evaluation UDO and fMRI
Evaluation including both urodynamic evaluation and functional MRI testing
Diagnostic test: 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.
Other Names:
  • UDO
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)
Other Names:
  • fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
through study completion, an average of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

University of Zurich
University Ghent

Investigators

  • Principal Investigator: Bieke Samijn, PhD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 5, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BC-10572

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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