Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease
Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms of
 tremor, slowness of movement, and stiffness, leading to progressive disability and loss of
 independence. Lower urinary tract symptoms (LUTS), including urinary incontinence (UI),
 urgency, and/or nocturia, are common non-motor symptoms that further diminish the already
 compromised quality of life for adults living with PD. Behavioral interventions for UI -
 including pelvic floor muscle exercise (PFME) therapy - have proven efficacy in randomized
 controlled trials and are free of side effects. Exercise-based behavioral therapy for UI
 requires individuals to learn a motor skill (PFME) and implement an adaptive behavioral
 strategy that incorporates the PFME to suppress urinary urgency and prevent UI.

 We will conduct a two-site, randomized controlled trial to assess the efficacy of PFME-based
 behavioral therapy to treat urinary symptoms in adults with PD. After stratification by UI
 severity, PD severity, and gender, a group of 60 subjects (30 in each group) will be
 randomized to receive behavioral therapy or a behavioral control over 8 weeks in order to
 achieve a sample size of 50 individuals (25 in each group) who complete the study. A 6-month
 follow-up is planned in the treatment group.

 We hypothesize that:

 1. PD participants who are randomized to the exercise-based behavioral therapy group (Group
 A) will report a significant reduction in weekly frequency of UI episodes compared to PD
 participants in the behavioral control group (Group B). The primary outcome, frequency
 of UI, will be measured using a seven-day bladder diary.

 2. Compared to PD participants in Group B, the reduction in UI frequency in Group A will be
 clinically meaningful as measured by a corresponding improvement on questionnaires of
 satisfaction and quality of life as well as a decline in other urinary symptoms
 including urgency and nocturia.
Inclusion Criteria:

 -  Clinical diagnosis of Parkinson's disease determined by a board-certified neurologist
 with specialty training in movement disorders

 -  ≥ 4 weekly episodes of UI and at least one episode per week associated with feelings
 of urgency, where urgency is defined as the complaint of a sudden compelling desire to
 void which is difficult to defer

 -  Willingness to attend clinic visits

 -  Willingness to keep 7-day bladder diaries throughout the study period

 Exclusion Criteria:

 -  Significant cognitive impairment, as indicated by a Montreal Cognitive Assessment
 (MoCA) score of < 18.

 -  Inability to produce an interpretable 7-day bladder diary at baseline

 -  Previous intensive PFME training

 -  Clinically significant depression as measured by a Geriatric Depression Scale-Short
 Form score ≥ 10 which could affect motivation to fully engage in the intervention

 -  Use of an indwelling urinary catheter

 -  Bladder outlet obstruction defined as having been prescribed in-and-out
 catheterization in the past 12 months, having a post-void residual urine volume by
 bladder ultrasound of ≥ 200 mL or a peak voiding flow rate of ≤ 4 mL/min on a void ≥
 125 mL in volume

 -  Severe uterine prolapse past the vaginal introitus

 -  Poorly controlled diabetes defined by a hemoglobin A1c (HgbA1c) of >8.0%

 -  Chronic renal failure and on hemodialysis

 -  Poorly controlled congestive heart failure or poorly controlled chronic obstructive
 pulmonary disease on physical exam

 -  Genitourinary cancer with ongoing surgical or external beam radiation treatment

 -  Any unstable health condition expected to result in hospitalization or death within in
 the next 3 months as determined by principal investigator.