Brain Areas Involved in Bladder Filling and Contraction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02477241|
Recruitment Status : Unknown
Verified June 2015 by Sajjad Rahmana'i, Maastricht University Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 22, 2015
Last Update Posted : June 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Urinary Bladder, Overactive||Procedure: Uroflowmetry Device: fMRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Brain Areas Involved in the Sensation of Bladder Filling in Healthy Females and Untreated Females With Overactive Bladder (OAB) Using fMRI and Water Pressure Urodynamics|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
Healthy female subjects
Healthy female subjects with or without overactive bladder undergoing functional MRI brain and urodynamic study.
A cystometric test measures how much urine the bladder can hold, how much pressure builds up inside the bladder as it stores urine, and how full it is when the urge to urinate begins. Uroflowmetry is the measurement of urine speed and volume.
Other Name: urodynamic investigation
Functional magnetic resonance imaging or functional MRI (fMRI) is a functional neuroimaging procedure using MRI technology that measures brain activity by detecting associated changes in blood flow. This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases.
- Bladder pressure changes during the filling phase with water pressure [ Time Frame: up to two hours ]urodynamics during the fMRI study.
- HADS questionnaire (self-administered) screening for anxiety and depression [ Time Frame: cross-sectional; filling out the HADS questionnaire (15 minutes) ]A secondary goal is to assess the correlation between bladder filling (Primary Outcome Measure) and subjects' bladder sensations in combination with psychological anxiety and depression status, which are both measured (screened for) through administering one questionnaire: the Hospital Anxiety and Depression Score (HADS) questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477241
|Contact: Sajjad Rahnama'i, M.D. PhDemail@example.com|
|Contact: Jamie M. Drossaerts, M.D.||firstname.lastname@example.org|
|Maastricht University Medical Centre|
|Maastricht, Limburg, Netherlands, 6202AZ|
|Principal Investigator:||Gommert A. van Koeveringe, M.D. PhD||Maastricht University Medical Centre, Head of Department of Urology|