Testing Treatments for Bladder Overactivity in People With Parkinson Disease
Tests exercise therapy and mirabegron for bladder symptoms in adults with Parkinson disease.
Plain-language title generated from the registry record
Registry title: Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Key facts
- Where
- Decatur, Philadelphia, and Salt Lake City, United StatesSee the 3 sites
- Phase
- Phase 4
Where in United States
- Atlanta VA Medical and Rehab Center, Decatur, GADecatur, United StatesNo longer taking part
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAPhiladelphia, United StatesNo longer taking part
- VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake City, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- VA Office of Research and Development
- Trial code
- NCT07187466
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
Sequential Multiple Assignment Randomized Trial to Treat Urinary Symptoms in Parkinson Disease
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.
Inclusion: Clinical diagnosis of Parkinson's Disease (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: Previous intensive pelvic floor muscle exercise training; Previous artificial urinary sphincter, sling procedure or implanted sacral neuromodulation device; Current use of a bladder relaxant - permitted to enroll after one-week washout; 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 Parkinson's Disease (PD); Chronic renal failure and on hemodialysis; Genitourinary cancer with ongoing surgical or external beam radiation treatment; 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; 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 overactive bladder (OAB) symptoms persist after improvement in diabetes control; 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; 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 milliliters (mL); Severe uterine prolapse past the vaginal introitus; 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.