Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- mirabegron
- Exercise-based behavioral therapy
Treatment groups
146 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov