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

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

NCT02783014•EvergreenHealth

View on ClinicalTrials.gov

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).

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.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

EvergreenHealth

Kirkland, Washington, United States

Key Dates

Start Date

June 1, 2016

Primary Completion Date

May 1, 2017

Completion Date

March 13, 2020

Last Updated

August 17, 2021

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

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Parkinson's Disease

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RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

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Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations