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Investigating Central Mechanisms of Overactive Bladder in Adults With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02783014
Recruitment Status : Unknown
Verified June 2018 by Pinky Agarwal, MD, EvergreenHealth.
Recruitment status was:  Active, not recruiting
First Posted : May 26, 2016
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Pinky Agarwal, MD, EvergreenHealth

Brief Summary:

This study investigates the central mechanisms of Overactive Bladder (OAB) in Patients with Parkinson's Disease (PD).

The plan is to enroll 10 adults with Parkinson's disease and Overactive bladder (PD + OAB) and 10 adults with Parkinson's disease only (PD). Both groups will undergo fMRI (functional MRI).


Condition or disease
Parkinson's Disease

Detailed Description:

Overactive bladder (OAB) is a physical problem that causes strong urges to urinate, frequent urination, and sometimes urinary incontinence (accidental loss of urine control) commonly in patients with Parkinson' disease (PD) severely impacting their quality of life.

Unfortunately OAB in adults with PD is difficult to treat. This is largely because the mechanisms underlying OAB in adults with PD are not known. Recent functional MRI (fMRI) studies suggest that certain areas of the brain have an important role in OAB. Blood oxygenation level dependent (BOLD) fMRI is an imaging technique in which neural activity of a region of the brain can be measured by fluctuation in the BOLD signal. It is hoped that the findings of this study will allow the development of new treatments for adults with Parkinson's disease and overactive bladder.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Case-control Study Investigating Central Mechanisms of Overactive Bladder in Adults With Parkinson's Disease and Overactive Bladder and Adults With Parkinson's Disease Only
Study Start Date : June 2016
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Comparison of perfusion activity in the Limbic System [ Time Frame: 1 hour functional Magnetic Resonance Imaging (fMRI) ]
    Comparison of the perfusion activity in the limbic system between subjects with Parkinson's Disease and Overactive Bladder and Parkinson's disease only using Blood Oxygenation Level Dependent (BOLD) functional Magnetic Resonance Imaging (fMRI) contrast maps. It will be performed at the second visit.


Secondary Outcome Measures :
  1. Determination on the relationship of perfusion activity in the limbic system and anxiety. [ Time Frame: 1 hour functional Magnetic Resonance Imaging (fMRI) - 10 Minutes questionnaire. ]
    Determination of the relationship of perfusion activity in the limbic system and anxiety scores (using Zung's Self-rating Anxiety Scale (SAS)) in subjects with Parkinson's Disease and Overactive Bladder.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
10 adults with Parkinson's disease (PD) and Overactive Bladder (OAB) and 10 adults with PD only.
Criteria

Inclusion Criteria:

  • Diagnosis of PD by United Kingdom (UK) brain bank criteria.
  • PD patients with and without OAB as per bladder questionnaire.
  • No change in PD medications after screening, with no dose changes during the study, except that pro re nata (PRN) doses of carbidopa/levodopa will be allowed to address periodic worsening of parkinsonian symptoms.
  • Patient willing and able to complete study questionnaires.
  • Use of other medication that could influence bladder function, will be permitted as long as the dose is stable during the study.
  • Patient expects to have valid health insurance for the duration of the study period.

Exclusion Criteria:

  • Women who are breast-feeding, pregnant or have the potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures).
  • Cognitive deficits that in the opinion of the investigator would interfere with the subject's ability to give informed consent or perform study testing.
  • Evidence of Urinary Tract Infection (UTI) at screening.
  • Bladder pain or history of chronic inflammation such as interstitial cystitis, recurrent UTIs, bladder stones, bladder obstruction, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs.
  • Adults who have an interstim device in place.
  • Claustrophobia, occupational risk for ferrous metal in the eye, or having an implantable medical device or foreign body precluding fMRI (e.g. cardiac pacemaker, metallic fragment, orthopedic hardware).
  • Intravesical botulinum toxin treatment within the previous six months of screening.
  • Use of indwelling catheter or self-catheterization.
  • Any other serious and/or unstable medical condition

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): NCT02783014


Locations
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United States, Washington
EvergreenHealth
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
EvergreenHealth
Investigators
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Principal Investigator: Pinky Agarwal, MD EvergreenHealth
Publications:

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Responsible Party: Pinky Agarwal, MD, MD, FAAN, EvergreenHealth
ClinicalTrials.gov Identifier: NCT02783014    
Other Study ID Numbers: PADB-2016-01
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pinky Agarwal, MD, EvergreenHealth:
overactive bladder
Additional relevant MeSH terms:
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Parkinson Disease
Urinary Bladder, Overactive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations