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

NCT07187466 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: RRD6-001-24W
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Overactive Bladder; Parkinson Disease

Keywords

Urinary Bladder, Overactive; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• ICIQ-OAB

  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.

  baseline, 6-weeks, and 12-weeks

Study Arms (3)

Drug Therapy Group

ACTIVE COMPARATOR

Participants who are randomized to drug therapy will receive mirabegron 25mg at visit 2 (randomization visit).

Drug: mirabegron

Behavioral Therapy Group

ACTIVE COMPARATOR

Participants who are randomized to exercise-based behavioral therapy will receive a comprehensive training program administered individually by a trained nurse practitioner interventionist to address urinary incontinence and other lower urinary tract symptoms.

Behavioral: Exercise-based behavioral therapy

Combined Drug and Behavioral Therapy Group

ACTIVE COMPARATOR

At 6 weeks post-randomization, participants will complete the ICIQ-OAB questionnaire. Participants reporting less than 2 points reduction will be re-randomized to either continue their initial treatment assignment or receive combination therapy by adding the alternate treatment strategy, thus participants initially treated with mirabegron will add behavioral therapy and participants initially treated with behavioral therapy will add mirabegron.

Drug: mirabegron; Behavioral: Exercise-based behavioral therapy

Interventions

mirabegron DRUG

Mirabegron is a beta-3-agonist, which acts upon the noradrenergic system and avoids the cognitive and gastrointestinal side effects of anticholinergic bladder relaxants.

Also known as: Myrbetriq

Combined Drug and Behavioral Therapy Group; Drug Therapy Group

Exercise-based behavioral therapy BEHAVIORAL

The exercise-based behavioral therapy is a comprehensive training program administered individually by a trained nurse practitioner interventionist to address urinary incontinence and other lower urinary tract symptoms.

Behavioral Therapy Group; Combined Drug and Behavioral Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104-4551, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148-0001, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Parkinson Disease

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Elizabeth Camille Vaughan, MD MS

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taressa Sergent

CONTACT

(404) 321-1611; Taressa.Sergent@va.gov

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Sequential Multiple Assignment Randomized Trial (SMART) design offers an efficient strategy to understand both intervention and patient factors that will inform an individualized treatment plan. With a SMART design, Aim 1 will determine if non-responders to behavioral or drug treatment (expected to be 50% of population) demonstrate a clinically significant response to combination behavior and drug treatment compared to a single treatment approach. In Aim 2, the investigators will determine patient factors that influence optimized treatment of urinary symptoms in Veterans with PD.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 23, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (3)