Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease (URGE-PD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01018264|
Recruitment Status : Completed
First Posted : November 23, 2009
Results First Posted : May 27, 2015
Last Update Posted : October 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder in Parkinson's Disease||Drug: solifenacin succinate (VESIcare) Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||URGE-PD: A Multi-site, Double-blind, Randomized, Placebo Controlled Trial of Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
|Experimental: solifenacin succinate (VESIcare)||
Drug: solifenacin succinate (VESIcare)
up to 10mg every day orally
|Placebo Comparator: placebo||
placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
- Number of Micturations Per 24 Hour Period [ Time Frame: 12 weeks ]The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson's disease (PD) patients as measured by voiding diaries.
- Number of Urinary Incontinence Episodes Per 24 Hour Period [ Time Frame: 12 weeks ]This scale it the mean number of urinary incontinence episodes per 24 hour period, as assessed by a 3-day bladder diary. The goal is to examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity.
- Unified Parkinson's Disease Rating Scale (UPDRS) Total [ Time Frame: 12 weeks ]To examine the effect of solifenacin succinate (VESIcare) on Parkinson's disease severity. The UPDRS total score ranges from 0 (no disability) to 199 (total disability).
- Parkinson's Disease Quality of Life Scale (PDQOL) [ Time Frame: 12 weeks ]This scale is used to assess quality of life in Parkinson's Disease patients. Parkinson's disease quality of life scale has a possible point range from 37 (worst outcome) to 185 (best outcome). The goal of this outcome measure is to examine the effect of solifenacin succinate (VESIcare) on quality of life.
- Number of Nocturia Episodes Per 24 Hour Period [ Time Frame: 12 weeks ]To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018264
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|University of South Florida|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Atlanta, Georgia, United States, 30329|
|Principal Investigator:||Theresa Zesiewicz, MD||University of South Florida|