Parkinson's Disease Clinical Trial
Official title:
Behavioral Therapy to Treat Urinary Incontinence in Parkinson's Disease
Background: Parkinson's disease affects up to 3% of persons over the age of 65. Lower
urinary tract symptoms are a frequent cause of diminished quality of life in elderly persons
and occur in up to 40% of persons with Parkinson's disease. While the exact mechanisms have
not been determined, detrusor hyperactivity (hyperactivity of the bladder muscle) leading to
symptoms of overactive bladder and urge incontinence is common. Behavioral and
exercise-based therapies have relatively no side effects and have been shown to be an
effective treatment for urge symptoms of overactive bladder in the aged population.
Hypothesis and Specific Aims: Behavioral therapy using pelvic floor muscle exercises will
result in a 50% decrease in the number of incontinence episodes in elderly persons (age >
50) with Parkinson's disease. The specific aims for this pilot study include the following:
1. Complete a course of behavioral therapy using computer-assisted biofeedback in 20
subjects with UI associated with PD and determine how many potential subjects need to
be screened and enrolled to achieve this sample size.
2. Determine the proportion of these patients who achieve a 50% or greater reduction in UI
episodes.
3. Examine whether responsiveness is associated with characteristics of the Parkinson's
disease, in particular disease severity as measured by the Unified Parkinson's Disease
Rating Scale (UPDRS).
4. Assess the effectiveness of behavioral therapy without the use of computer-assisted
biofeedback instruction in 10 additional subjects with PD and UI.
Methods: The first 20 participants will be enrolled in an 8-week treatment trial of
behavioral therapies and pelvic floor muscle exercises with computer-assisted biofeedback.
Ten additional participants will be enrolled in the 8-week treatment trial of behavioral
therapy, but will not have computer-assisted biofeedback. Voiding diaries as well as urinary
symptom and quality of life questionnaires will be used to assess response.
If persons with Parkinson's disease can complete the treatment trial and achieve a reduction
in episodes of urinary incontinence with behavioral techniques this would lay the foundation
for a larger, placebo-controlled trial. Assessment of responsiveness associated with
severity of Parkinson's disease would also provide important information about the utility
of this treatment strategy.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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