Corporal Michael J. Crescenz VA Medical Center
This is an unblinded, non-randomized National Institute of Health (NIH) Stage I of Behavioral Intervention Development trial. The investigators will enroll 20 subjects with Parkinson disease (PD) for a series of 20 of N-of-1 trials. The investigators will use a single-arm crossover titration/reversal design ("ON" \[A\] vs. "OFF" \[B\]) with up to 4 periods. All participants will follow the sequence ABAB. Each period will last up to 10 weeks, allowing for sufficient time for up-titration and onset of drug action, and down-titration and washout. Each participant will have the option to participate in less (2-3) or more (3-4) periods depending on whether additional information is needed to make an informed decision about continuing or discontinuing the overactive bladder (OAB) antimuscarinic at the end of the study. The intervention drug will be an OAB antimuscarinic, previously prescribed to the participants by their physician. The investigators will reduce the dose of each OAB antimuscarinic by 25-50% every 1-2 weeks during the "OFF" \[B\] period, with the goal to completely discontinue the medication.
Inclusion Criteria: 1. 60+ years old at time of enrollment 2. Have a diagnosis of Parkinson disease (PD) made by a movement disorders specialist 3. Life expectancy of at least six months 4. Are on an antimuscarinic for overactive bladder (OAB) symptoms (without concurrent use of a beta-3 agonist) for at least 3 months 5. Are able to provide informed consent 6. Are able to complete online surveys/questionnaires 7. Are able to receive telephone calls and Zoom calls/telehealth meeting Exclusion Criteria: 1. Have untreated or uncontrolled hypertension (blood pressure \[BP\] ≥180/110 mmHg), 2. H…
During the "ON" \[A\] period (up to 10 weeks), the participant will continue taking their overactive bladder antimuscarinic at their maintenance dose. During the "OFF" \[B\] period (i.e., deprescribing), which will last up to 10 weeks, the antimuscarinic dose will be gradually tapered by 25%-50% every 1-2 weeks until the lowest effective dose or complete discontinuation is achieved. Alternative treatment with mirabegron (pharmacologic) may be initiated, as clinically indicated, if the participant experiences intolerable recurrence of overactive bladder symptoms after discontinuation of the antimuscarinic.