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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00892450 |
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.
Condition | Intervention |
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Parkinson's Disease Overactive Bladder |
Drug: Oxybutynin and darifenacin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study |
Official Title: | Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease: A Randomized, Double-Blind, Crossover Pilot Study |
Estimated Enrollment: | 22 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
crossover design
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Drug: Oxybutynin and darifenacin
Participants with overactive bladder will take each medication for 4 weeks.
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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.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
United States, Pennsylvania | |
VA Medical Center, Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Jayne R. Wilkinson, MD | VA Medical Center, Philadelphia |
Responsible Party: | Department of Veterans Affairs ( Wilkinson, Jayne - Principal Investigator ) |
Study ID Numbers: | 01143 |
Study First Received: | April 28, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00892450 History of Changes |
Health Authority: | United States: Federal Government |
Overactive bladder symptoms Parkinson's disease darifenacin oxybutynin cognition |
Oxybutynin Urinary Bladder, Overactive Neurotransmitter Agents Ganglion Cysts Cystocele Cholinergic Antagonists Basal Ganglia Diseases Urinary Bladder Diseases Central Nervous System Diseases Cholinergic Agents |
Brain Diseases Neurodegenerative Diseases Muscarinic Antagonists Signs and Symptoms Darifenacin Urologic Diseases Parkinson Disease Movement Disorders Peripheral Nervous System Agents Parkinsonian Disorders |
Urinary Bladder, Overactive Parasympatholytics Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Basal Ganglia Diseases Physiological Effects of Drugs Neurodegenerative Diseases Brain Diseases Cholinergic Agents Signs and Symptoms Urologic Diseases Movement Disorders |
Oxybutynin Urinary Bladder Diseases Nervous System Diseases Central Nervous System Diseases Pharmacologic Actions Muscarinic Antagonists Urological Manifestations Darifenacin Parkinson Disease Autonomic Agents Parkinsonian Disorders Peripheral Nervous System Agents |