Sequential Multiple Assignment Randomized Trial to Treat Urinary Symptoms in Parkinson Disease
VA Office of Research and Development
Summary
The purpose of this study is to learn about different treatments for overactive bladder symptoms in Parkinson's Disease. The investigators want to find out if people who do not respond to one treatment (either behavioral or drug treatment) will respond to combined treatment. The investigators also want to find out what factors influence whether someone responds to the treatments.
Description
While PD is often characterized by the motor symptoms of the disease (tremor, bradykinesia, rigidity), non-motor symptoms such as urinary symptoms correlate more closely with impaired well-being as the disease progresses. The urinary symptoms of overactive bladder (OAB), including urgency, frequency, and nocturia, with or without urinary incontinence, are the most common urinary symptoms of PD. Because OAB symptoms, such as incontinence and nocturia, are associated with falls (a cause of increased mortality in PD), spouse/caregiver stress, and, ultimately institutionalization, it is critical t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Clinical diagnosis of PD determined by a board-certified neurologist with specialty training in movement disorders * An ICIQ-OAB Symptom Score of 7 or higher, which indicates clinically significant symptoms of OAB, defined as presence of urinary urgency with or without urgency incontinence usually with increased daytime frequency and nocturia in the absence of infection or other obvious pathology Exclusion Criteria: * Significant cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of \< 18 or a telephone-MoCA score \< 13, which is the rec…
Interventions
- Drugmirabegron
Mirabegron is a beta-3-agonist, which acts upon the noradrenergic system and avoids the cognitive and gastrointestinal side effects of anticholinergic bladder relaxants.
- BehavioralExercise-based behavioral therapy
The exercise-based behavioral therapy is a comprehensive training program administered individually by a trained nurse practitioner interventionist to address urinary incontinence and other lower urinary tract symptoms.
Locations (3)
- Atlanta VA Medical and Rehab Center, Decatur, GADecatur, Georgia
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAPhiladelphia, Pennsylvania
- VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake City, Utah