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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
mirabegron
DrugMirabegron 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
BehavioralThe 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.
Treatment groups
146 Participants
are divided into 3 treatment groupsGroup A: Drug Therapy GroupActive comparator 1 intervention
Group B: Behavioral Therapy GroupActive comparator 1 intervention
Group C: Combined Drug and Behavioral Therapy GroupActive comparator 2 interventions
Trial outcomes
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.
Time frame
baseline, 6-weeks, and 12-weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: