Urinary Incontinence Clinical Trial
Official title:
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.
n/a
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