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

NCT02783014 | Completed

• 1 other identifier: PADB-2016-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson's Disease

Keywords

overactive bladder

Outcome Measures

Primary Outcomes (1)

• Comparison of perfusion activity in the Limbic System

  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.

  1 hour functional Magnetic Resonance Imaging (fMRI)

Secondary Outcomes (1)

• Determination on the relationship of perfusion activity in the limbic system and anxiety.

  1 hour functional Magnetic Resonance Imaging (fMRI) - 10 Minutes questionnaire.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

10 adults with Parkinson's disease (PD) and Overactive Bladder (OAB) and 10 adults with PD only.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• EvergreenHealth: lead

Study Sites (1)

EvergreenHealth

Kirkland, Washington, 98034, United States

Location

Related Publications (17)

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MeSH Terms

Conditions

Parkinson Disease; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pinky Agarwal, MD

  EvergreenHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FAAN

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 26, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: March 13, 2020
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)