Clinical trial NCT02783014: Investigating Central Mechanisms of Overactive Bladder in Adults With Parkinson's Disease
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: overactive bladder
Lead sponsor: EvergreenHealth
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 10 adults with Parkinson's disease (PD) and Overactive Bladder (OAB) and 10 adults with PD only.

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).

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 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

Primary outcomes:
measure: Comparison of perfusion activity in the Limbic System
timeFrame: 1 hour functional Magnetic Resonance Imaging (fMRI)
Secondary outcomes:
measure: Determination on the relationship of perfusion activity in the limbic system and anxiety.
timeFrame: 1 hour functional Magnetic Resonance Imaging (fMRI) - 10 Minutes questionnaire.
Other outcomes:
Locations:
city: Kirkland
country: United States
facility: EvergreenHealth
state: Washington
Study officials:
affiliation: EvergreenHealth
name: Pinky Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
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