Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease (NCT07187466) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
United States146 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ne…