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Not yet recruitingPhase 4

Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease

Sequential Multiple Assignment Randomized Trial to Treat Urinary Symptoms in Parkinson Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests habit-based treatment and mirabegron, a medicine, for overactive bladder in people with Parkinson disease. It looks at whether using both treatments helps when one alone does not, and what affects how well treatment works.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Parkinson disease diagnosed by a board-certified nerve doctor with special training in movement disorders.
  • Score 7 or higher on an overactive bladder symptom survey. Symptoms include sudden urges to pee, with or without leaks, and often peeing more during the day and night, without an infection or another clear cause.

Who can't join

  • Serious memory or thinking problems: a MoCA test score below 18, or a phone MoCA score below 13. A depression survey score of 10 or higher also rules out joining.
  • Past intensive training of the muscles that control pee; certain bladder-control implants or sling surgery; or Botox shots in the bladder within the past 12 months.
  • A urine tube that stays in place, more than 150 mL of pee left after emptying the bladder, or a uterus that drops past the vaginal opening.
  • Poorly controlled diabetes, with an A1c blood test above 9% in the past 3 months. You may join if bladder symptoms remain after diabetes control improves.
  • Long-term kidney failure treated with hemodialysis, a treatment that filters blood; ongoing surgery or external radiation for urinary or genital cancer; or an unstable illness likely to cause a hospital stay or death within 3 months.
  • Allergy to this type of medicine or another reason mirabegron is unsafe for you. This includes past sudden trouble passing pee that required a urine tube.
  • Current bladder-relaxing medicine use, unless stopped for one week before joining. Blood found in pee under a microscope without infection requires clearance from a urinary specialist and the study doctor.
  • Recent dose changes: water pills or alpha-blockers must have a steady dose for at least 4 weeks. Dutasteride or finasteride must have a steady dose for at least 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 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

Study sites (3)

GA

PA

UT