New trial aims to ease bladder troubles in Parkinson's patients
NCT ID NCT07187466
First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times
Summary
This study tests two treatments—mirabegron (a drug) and exercise-based behavioral therapy—for overactive bladder in people with Parkinson's disease. Researchers want to see if combining treatments helps those who don't respond to one alone. The trial will involve 146 participants and measure symptom changes over 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mirabegron (Myrbetriq) and exercise-based behavioral therapy
- What this could lead to
- If successful, this could provide a clear treatment plan for managing overactive bladder symptoms in people with Parkinson's disease, improving their quality of life.
- What could go wrong
- This is a phase 4 trial with 146 participants, so results may not apply to everyone. The treatments may not work for all, and mirabegron can cause side effects like increased blood pressure or urinary tract infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 146 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004, United States
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Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551, United States
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VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Giving Parkinson's patients a say may boost their Brain's ability to learn movement
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- Can tango rewire the brain? dance program tested for Parkinson's and dementia
- Can a workout after walking practice help Parkinson's patients learn better?