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Treating Urinary Symptoms in Parkinson's Disease

This study is looking into different ways to treat overactive bladder (OAB) symptoms in people with Parkinson's Disease. Researchers want to see if combining treatments helps those who don't respond to just one. The treatments being studied are mirabegron, a medication that helps relax the bladder, and exercise-based behavioral therapy, which is a training program to help with urinary symptoms. You may be able to join if you have a Parkinson's diagnosis from a movement disorder specialist and significant OAB symptoms (an ICIQ-OAB score of 7 or higher). The study will measure how well these treatments work using the ICIQ-OAB symptom score at the start, after 6 weeks, and after 12 weeks. The study aims to enroll 146 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 146 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 weeks, with symptom scores measured at baseline, 6 weeks, and 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07187466

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

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
VA Office of Research and Development
~146 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:mirabegronExercise-based behavioral therapy

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ICIQ-OAB
Measured over baseline, 6-weeks, and 12-weeks

Conditions

Overactive Bladder
Parkinson Disease

Explore related trials

Overactive BladderParkinson Disease

Where it's being run

3 sites across 3 states
Georgia1
Pennsylvania1
Utah1

Study leadership

  • Elizabeth Camille Vaughan, MD MS · PRINCIPAL_INVESTIGATOR · Atlanta VA Medical and Rehab Center, Decatur, GA

Who to contact

Taressa Sergent
[email protected]
(404) 321-1611 · ext. 5023
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • ICIQ-OABbaseline, 6-weeks, and 12-weeks

    The primary outcome measure at 12 weeks will be urinary symptom severity as measured by the International Consultation on Incontinence Questionnaire-Overactive Bladder module (ICIQ-OAB). Scores range from 0 to 16 with higher scores indicating worse symptom frequency. The symptom score will be collected at 3 time points during the study: baseline, 6-weeks, and 12-weeks.