Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Sponsored by VA Office of Research and Development
About this study
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.
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 that the investigators optimize the care of urinary symptoms for Veterans with PD. In the non-PD population, pelvic floor muscle contractions diminish bladder muscle contraction and recent evidence dem…
Where this study is enrolling (3)
- I'm interested
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia
- I'm interested
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania
- I'm interested
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah
Who can participate
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 recommended diagnostic cut point for dementia in PD.
- ✕Previous intensive pelvic floor muscle exercise training
- ✕Clinically significant depression as measured by a Geriatric Depression Scale-Short Form score of 10 or higher which could affect motivation to fully engage in the intervention
- ✕Use of an indwelling urinary catheter
- ✕Post-void residual urine measurement by bladder ultrasound of \> 150 mL
- ✕Severe uterine prolapse past the vaginal introitus
- ✕Poorly controlled diabetes defined by a hemoglobin A1c (HgbA1c) of \>9.0% within the last 3 months. Participants with poorly controlled diabetes will be offered enrollment if the OAB symptoms persist after improvement in diabetes control
- ✕Chronic renal failure and on hemodialysis
- ✕Genitourinary cancer with ongoing surgical or external beam radiation treatment
- ✕Previous artificial urinary sphincter, sling procedure or implanted sacral neuromodulation device
- ✕History of bladder-injection of botulinum toxin in the last 12 months
- ✕Any unstable health condition expected to result in hospitalization or death within in the next 3 months as determined by principal investigator.
- ✕Hypersensitivity to drug class
- ✕Contraindication to the study drug (mirabegron) including history of acute urinary retention requiring catheterization
- ✕Current use of a bladder relaxant - permitted to enroll after one-week washout
- ✕Hematuria on microscopic examination in the absence of infection. A urologic consultation will be recommended, and enrollment will depend on clearance by a urologist and agreement by the site PI that entry into the treatment protocol is not contraindicated
- ✕If on diuretic, dose should be stable for at least 4 weeks
- ✕If taking an alpha-blocker, dose should be stable for at least 4 weeks
- ✕If taking dutasteride or finasteride, dose should be stable for at least 6 months
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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.