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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
Sponsor:
Information provided by (Responsible Party):
Sajjad Rahmana'i, Maastricht University Medical Center

Brief Summary:
Overactive Bladder syndrome (OAB) is a medical condition with symptoms of urgency, with or without incontinence, usually with frequency and nocturia, with no proven infection or obvious pathology 1. This study will explore the relationship between OAB, obstruction and the micro contractions as well as the brain areas involved in both normal desire to void and urgency, gaining a better understanding of the bladder pathophysiology and in the future allowing better strategy of treatment options for patients suffering from OAB.

Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Procedure: Uroflowmetry Device: fMRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Healthy female subjects
Healthy female subjects with or without overactive bladder undergoing functional MRI brain and urodynamic study.
Procedure: Uroflowmetry
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

Device: fMRI
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.




Primary Outcome Measures :
  1. Bladder pressure changes during the filling phase with water pressure [ Time Frame: up to two hours ]
    urodynamics during the fMRI study.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Healthy Subjects

Inclusion Criteria:

  • Healthy female subjects above 18 years of age.
  • Has provided written informed consent prior to any study related procedures.

Overactive bladder patients

Inclusion Criteria:

  • Female subjects above 18 years of age.
  • Has provided written informed consent prior to any study related procedures.
  • History of signs and symptoms of OAB including urinary frequency, urgency or urge incontinence for greater than or equal to 3 months.
  • At the screening visit, the subject should be either naïve to OAB treatment (e.g. no prior history of medications to treat lower urinary tract symptoms (LUTS), including OAB) or currently on treatment for LUTS (including OAB) and is willing to undergo a washout period for 3 weeks.

Healthy subjects:

Exclusion Criteria:

  1. History of lower urinary tract symptoms (LUTS), including OAB.
  2. History of stress urinary incontinence, urethral sphincter incompetence and neurogenic detrusor overactivity.
  3. History of signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis).
  4. History of bladder outlet obstruction (not including detrusor-overactivity) for example bladder/vesico-uterine prolapse (> grade II) or chronic obstruction.
  5. History of urinary tract surgery less than or equal to 6 months prior to screening.
  6. Has an indwelling catheter or permanent catheter fitted.
  7. History of pelvic area radiotherapy treatment.
  8. Uncontrolled diabetes mellitus.
  9. History of fibromyalgia.
  10. Pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants, injectable contraceptives, sexual abstinence and vasectomized partner).
  11. Pregnancy within 6 months before screening or breast feeding within 3 months before screening.
  12. History of positive hepatitis A, B surface antigen, hepatitis C antibody or HIV test results.
  13. Any use of drugs of abuse within 3 months prior to screening visit.
  14. History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to screening visit.
  15. History of drinking more than 14 units of alcohol per week within 3 months prior to screening visit.
  16. Has any changes to prescribed medication or to dose of prescribed medication less than or equal to 1 month prior to screening which in the opinion of the Investigator, will interfere with the study procedures or compromise safety.
  17. Is currently receiving or has a history of treatment with alpha blockers, beta receptor blockers or agonists, botulinum toxin (less than 12 months), resiniferatoxin or pelvic floor muscle relaxants less than or equal to 9 months prior to screening.
  18. Any clinically significant abnormality following the investigator's review of screening physical examination.
  19. Any clinically significant history of any other disease or disorder- gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator.
  20. Abnormal pulse and/or blood pressure measurements at the screening visit as follows: Pulse <40 or >90 bpm; systolic blood pressure >140 mmHg; diastolic blood pressure >90 mmHg; blood pressure and pulse measurements after subject has rested for 10 minutes.
  21. Employees of the University of Maastricht involved in the study.
  22. Claustrophobia, preventing a patient to have an fMRI scan
  23. Patients with any metal implants in the body (except dental implants) that would prevent the patients to undergo fMRI scan.

For overactive bladder subjects Refer to healthy subjects exclusion criteria number 2 to number 23.


Information from the National Library of Medicine

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


Contacts
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Contact: Sajjad Rahnama'i, M.D. PhD 0031433877262 s.rahnamai@mumc.nl
Contact: Jamie M. Drossaerts, M.D. 0031433877262 j.drossaerts@outlook.com

Locations
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Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6202AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Gommert A. van Koeveringe, M.D. PhD Maastricht University Medical Centre, Head of Department of Urology

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Responsible Party: Sajjad Rahmana'i, M.D. PhD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02477241    
Other Study ID Numbers: NL52605.068.15
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015
Keywords provided by Sajjad Rahmana'i, Maastricht University Medical Center:
overactive bladder syndrome
urgency urinary incontinence
fMRI
urodynamics
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms