Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease
| Status: | Completed |
|---|---|
| Conditions: | Overactive Bladder, Parkinsons Disease, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/12/2018 |
| Start Date: | September 2012 |
| End Date: | August 2017 |
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.
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.
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2
sites
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