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

Part of paid clinical trials in Decatur, Georgia.

Sponsor
VA Office of Research and Development
Study ID
NCT07187466
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Drug Therapy Group
    Participants who are randomized to drug therapy will receive mirabegron 25mg at visit 2 (randomization visit).
  • Active Comparator: Behavioral Therapy Group
    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.
  • Active Comparator: Combined Drug and Behavioral Therapy Group
    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.

Primary Outcome Measure

ICIQ-OAB [ Time Frame: baseline, 6-weeks, and 12-weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033-4004
Taressa Sergent
[email protected]
(404) 321-1611
Elizabeth Camille Vaughan, MD MS (PRINCIPAL_INVESTIGATOR)
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAPhiladelphiaPennsylvania19104-4551
James F Morley, MD
[email protected]
215-823-5934
VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake CityUtah84148-0001
Alayne Markland, DO
[email protected]

Find similar trials in Decatur, GA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Atlanta VA Medical and Rehab Center, Decatur, GA· Decatur, GACorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA· Philadelphia, PAVA Salt Lake City Health Care System, Salt Lake City, UT· Salt Lake City, UT

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