Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease: A Randomized, Double-blind, Crossover Pilot Study|
- compare cognitive side effects [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Drug: Oxybutynin and darifenacin
Participants with overactive bladder will take each medication for 4 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892450
|United States, Pennsylvania|
|VA Medical Center, Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Jayne R Wilkinson, MD||VA Medical Center, Philadelphia|