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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise-based behavioral therapy | Experimental | Pelvic floor muscle exercise-based behavioral therapy |
|
| Behavioral control | Placebo Comparator | Mirrored Star Drawing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise-based behavioral therapy | Behavioral | Pelvic floor muscle exercise training, bladder training, fluid management, constipation management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bladder diary | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Questionnaire | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E. Camille Vaughan, MD, MS | Atlanta VAMC/Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham VAMC | Birmingham | Alabama | 35233 | United States | ||
| Atlanta VA Medical Center |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053158 | Nocturia |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D032763 | Behavior Control |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D004191 | Behavioral Disciplines and Activities |
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| Behavioral control | Behavioral | Mirrored star drawing |
|
| Decatur |
| Georgia |
| 30033 |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |