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The purpose of this research study is to investigate the cognitive (thinking, memory, knowledge, intelligence) side effects of two medications commonly used to treat overactive bladder (OAB) symptoms in veteran patients with Parkinson's disease (PD) seen at the Philadelphia PADRECC.
This study will be a double-blinded cross-over clinical trial design to assess the prevalence of cognitive effects, the efficacy, and the effect on quality of life (QOL) of two anticholinergic medications commonly used in the treatment of overactive bladder (OAB): oxybutynin and darifenacin. This will be done by use of a well-established and validated computer-based cognitive battery. Secondary endpoints will assess efficacy of anticholinergic therapy on symptoms of OAB via QOL questionnaire and participant urinary diaries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | crossover design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin and darifenacin | Drug | Participants with overactive bladder will take each medication for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| compare cognitive side effects | 10 weeks |
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Inclusion Criteria:
Diagnosis of idiopathic PD (ICD9=332.0)
MMSE 24, able to give informed consent and complete questionnaires and voiding diaries.
Urological work-up within 3 months of enrollment to:
Rule out treatable causes of urinary symptoms
Documented symptoms OAB on screening 3-day voiding diary:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayne R Wilkinson, MD | VA Medical Center, Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C005419 | oxybutynin |
| C101207 | darifenacin |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| 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 |