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

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT02783014
• Lead Sponsor: 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).

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.

Study Timeline

• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-26
• Study Start: 2016-06
• Primary Completion: 2017-05
• Study Completion: 2020-03-13
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of perfusion activity in the Limbic System	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

Name	Time	Method
Determination on the relationship of perfusion activity in the limbic system and anxiety.	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.

Trial Locations

Locations (1)

EvergreenHealth; 🇺🇸 Kirkland, Washington, United States