Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms
VOLT
An Open-label Study of the Efficacy and Safety of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients With Overactive Bladder Symptoms VOLT: VESIcare® Open-Label Trial
1 other identifier
interventional
2,225
1 country
198
Brief Summary
To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2004
Shorter than P25 for phase_3
198 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 19, 2007
CompletedFirst Posted
Study publicly available on registry
April 20, 2007
CompletedSeptember 18, 2014
September 1, 2014
10 months
April 19, 2007
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms
Weeks 4, 8 and 12
Secondary Outcomes (2)
Percentage of patients satisfied with 5mg treatment
Week 12
Percentage of patients obtaining additional benefit with increase to 10mg dose
week 12
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Symptoms of OAB (urgency, with or without urge incontinence, usually with frequency and nocturia) for ≥3 or more months.
- Patients may be included if they are on another OAB medication; however, patients must washout from other OAB medications for at least 7 days prior to receiving solifenacin succinate. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.
You may not qualify if:
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
- Evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
- Clinically significant outflow obstruction (benign prostatic hyperplasia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (198)
Unknown Facility
Bay Minette, Alabama, 35607, United States
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Birmingham, Alabama, 35205, United States
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Birmingham, Alabama, 35209, United States
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Birmingham, Alabama, 35233, United States
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Decatur, Alabama, 35603, United States
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Huntsville, Alabama, 35801, United States
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Oro Valley, Arizona, 85739, United States
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Phoenix, Arizona, 85012, United States
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Phoenix, Arizona, 85051, United States
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Scottsdale, Arizona, 85260, United States
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Tucson, Arizona, 85712, United States
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Little Rock, Arkansas, 72204, United States
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Little Rock, Arkansas, 72205, United States
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Beverly Hills, California, 90211, United States
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Buena Park, California, 90620, United States
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Corte Madera, California, 94925, United States
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Culver City, California, 90232, United States
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Fresno, California, 93720, United States
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Fullerton, California, 92835, United States
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Huntington Beach, California, 92647, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90048, United States
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Mission Viejo, California, 92692, United States
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Modesto, California, 95350, United States
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Oceanside, California, 92056, United States
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Orange, California, 92868, United States
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Orange, California, 92869, United States
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Paramount, California, 90723, United States
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Pomona, California, 91767, United States
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Sacramento, California, 95823, United States
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San Bernadino, California, 92404, United States
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San Diego, California, 92108, United States
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Torrance, California, 90505, United States
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Tustin, California, 92780, United States
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Upland, California, 91786, United States
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Vista, California, 92084, United States
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Aurora, Colorado, 80012, United States
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Colorado Springs, Colorado, 80909, United States
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Fort Collins, Colorado, 80524, United States
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Wheat Ridge, Colorado, 80033, United States
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Avon, Connecticut, 06001, United States
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Hartford, Connecticut, 06106, United States
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Wilmington, Delaware, 19808, United States
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Brandon, Florida, 33511, United States
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Coral Gables, Florida, 33134, United States
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Coral Springs, Florida, 33065, United States
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Delray Beach, Florida, 33444, United States
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Fort Myers, Florida, 33908, United States
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Ft.Lauderdale, Florida, 33308, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32025, United States
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Merritt Island, Florida, 32952, United States
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Miami, Florida, 33186, United States
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Okeechobee, Florida, 34972, United States
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Orlando, Florida, 32806, United States
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Pembroke Pines, Florida, 33026, United States
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Pembroke Pines, Florida, 33027, United States
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Pembroke Pines, Florida, 33028, United States
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Royal Palm Beach, Florida, 33411, United States
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Tampa, Florida, 33624, United States
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Wellington, Florida, 33414, United States
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Albany, Georgia, 31701, United States
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Atlanta, Georgia, 30342, United States
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Conyers, Georgia, 30013, United States
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Decatur, Georgia, 30032, United States
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Marietta, Georgia, 30060, United States
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Roswell, Georgia, 30076, United States
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Snellville, Georgia, 30078, United States
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Woodstock, Georgia, 30189, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60628, United States
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Evanston, Illinois, 60201, United States
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Greenville, Illinois, 62246, United States
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Libertyville, Illinois, 60048, United States
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Mattoon, Illinois, 61938, United States
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Park Ridge, Illinois, 60068, United States
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Indianapolis, Indiana, 46237, United States
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Mason City, Iowa, 50401, United States
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Arkansas City, Kansas, 67005, United States
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Newton, Kansas, 67114, United States
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Shawnee, Kansas, 66203, United States
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Topeka, Kansas, 66614, United States
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Wichita, Kansas, 67207, United States
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New Orleans, Louisiana, 70115, United States
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Shreveport, Louisiana, 71106, United States
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Baltimore, Maryland, 21212, United States
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Glen Burnie, Maryland, 21601, United States
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Milford, Massachusetts, 01757, United States
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Watertown, Massachusetts, 02472, United States
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Battle Creek, Michigan, 49017, United States
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Dearborn, Michigan, 48123, United States
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Detroit, Michigan, 48201, United States
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Grand Rapids, Michigan, 49544, United States
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Grand Rapids, Michigan, 49546, United States
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Kalamazoo, Michigan, 49009, United States
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Saint Clair Shores, Michigan, 48081, United States
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Saint Louis Park, Minnesota, 55416, United States
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Gulfport, Mississippi, 39501, United States
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Jackson, Mississippi, 39202, United States
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Independence, Missouri, 64055, United States
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Jackson, Missouri, 63755, United States
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Kansas City, Missouri, 64112, United States
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Liberty, Missouri, 64068, United States
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Manchester, Missouri, 63021, United States
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Springfield, Missouri, 65804, United States
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St Louis, Missouri, 63117, United States
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St Louis, Missouri, 63141, United States
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Missoula, Montana, 59801, United States
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Omaha, Nebraska, 68114, United States
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Omaha, Nebraska, 68134, United States
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Omaha, Nebraska, 68137, United States
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Henderson, Nevada, 89014, United States
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Reno, Nevada, 89511, United States
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East Orange, New Jersey, 07018, United States
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Englewood, New Jersey, 07631, United States
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Fair Lawn, New Jersey, 07410, United States
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New Brunswick, New Jersey, 08901, United States
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Perth Amboy, New Jersey, 08861, United States
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Princeton, New Jersey, 08540, United States
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Albuquerque, New Mexico, 87108, United States
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Albuquerque, New Mexico, 87109, United States
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Albany, New York, 12208, United States
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Brooklyn, New York, 11203, United States
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Brooklyn, New York, 11219, United States
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Lake Success, New York, 11042, United States
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Liverpool, New York, 13088, United States
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Mineola, New York, 11501, United States
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New York, New York, 10021, United States
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Poughkeepsie, New York, 12601f, United States
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Rochester, New York, 14609, United States
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Rochester, New York, 14622, United States
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Rochester, New York, 14642, United States
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The Bronx, New York, 10461, United States
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Asheboro, North Carolina, 27205, United States
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Cary, North Carolina, 27511, United States
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Charlotte, North Carolina, 28204, United States
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Charlotte, North Carolina, 28211, United States
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Columbus, North Carolina, 28722, United States
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Greensboro, North Carolina, 27401, United States
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Raleigh, North Carolina, 27606, United States
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Raleigh, North Carolina, 27612, United States
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Canton, Ohio, 44708, United States
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Cincinnati, Ohio, 45236, United States
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Cleveland, Ohio, 44113, United States
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McConnelsville, Ohio, 43756, United States
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Mentor, Ohio, 44060, United States
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Painesville, Ohio, 44077, United States
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Zanesville, Ohio, 43701, United States
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Norman, Oklahoma, 73071, United States
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Tulsa, Oklahoma, 74104, United States
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Tulsa, Oklahoma, 74146, United States
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Bend, Oregon, 97701, United States
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Portland, Oregon, 97210, United States
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Woodburn, Oregon, 97071, United States
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Allentown, Pennsylvania, 18102, United States
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Allentown, Pennsylvania, 18104, United States
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Bala-Cynwyd, Pennsylvania, 19004, United States
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Beaver, Pennsylvania, 15009, United States
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Bensalem, Pennsylvania, 19020, United States
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Bethel Park, Pennsylvania, 15102, United States
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Camp Hill, Pennsylvania, 17011, United States
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Dauphin, Pennsylvania, 17018, United States
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Duncansville, Pennsylvania, 16635, United States
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Elkins Park, Pennsylvania, 19027, United States
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Harrisburg, Pennsylvania, 17110, United States
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Philadelphia, Pennsylvania, 19114, United States
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Philadelphia, Pennsylvania, 19140, United States
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Phoenixville, Pennsylvania, 19460, United States
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Pittsburgh, Pennsylvania, 15206, United States
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Williamsport, Pennsylvania, 17701, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Simpsonville, South Carolina, 29681, United States
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Bartlett, Tennessee, 38134, United States
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Greeneville, Tennessee, 37745, United States
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Johnson City, Tennessee, 37601, United States
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Murfreesboro, Tennessee, 37130, United States
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Nashville, Tennessee, 37203, United States
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New Tazewell, Tennessee, 37825, United States
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Austin, Texas, 78705, United States
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Austin, Texas, 78759, United States
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Corsicana, Texas, 75110, United States
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Dallas, Texas, 75230, United States
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Dallas, Texas, 75231, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77074, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78229, United States
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Tomball, Texas, 77375, United States
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Salt Lake City, Utah, 84107, United States
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Sandy City, Utah, 84094, United States
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Charlottesville, Virginia, 22908, United States
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Hampton, Virginia, 23666, United States
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Vienna, Virginia, 22180, United States
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Seattle, Washington, 98133, United States
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Spokane, Washington, 99204, United States
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Tacoma, Washington, 98450, United States
Unknown Facility
Huntington, West Virginia, 25701, United States
Related Publications (6)
Capo' JP Jr, Laramee C, Lucente V, Fakhoury A, Forero-Schwanhaeuser S. Solifenacin treatment for overactive bladder in Hispanic patients: patient-reported symptom bother and quality of life outcomes from the VESIcare Open-Label Trial. Int J Clin Pract. 2008 Jan;62(1):39-46. doi: 10.1111/j.1742-1241.2007.01644.x. Epub 2007 Nov 23.
PMID: 18036164BACKGROUNDMallett V, Burks D, Garely AD, Smith N. Solifenacin treatment for overactive bladder in black patients: patient-reported symptom bother and health-related quality of life outcomes. Curr Med Res Opin. 2007 Apr;23(4):821-31. doi: 10.1185/030079907x178847.
PMID: 17407639BACKGROUNDGarely AD, Kaufman JM, Sand PK, Smith N, Andoh M. Symptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT). Clin Ther. 2006 Nov;28(11):1935-46. doi: 10.1016/j.clinthera.2006.11.010.
PMID: 17213014BACKGROUNDGarely AD, Lucente V, Vapnek J, Smith N. Solifenacin for overactive bladder with incontinence: symptom bother and health-related quality of life outcomes. Ann Pharmacother. 2007 Mar;41(3):391-8. doi: 10.1345/aph.1H581. Epub 2007 Mar 6.
PMID: 17341526BACKGROUNDSand PK, Steers WD, Dmochowski R, Andoh M, Forero-Schwanhaeuser S. Patient-reported most bothersome symptoms in OAB: post hoc analysis of data from a large, open-label trial of solifenacin. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):667-75. doi: 10.1007/s00192-009-0840-y. Epub 2009 Mar 10.
PMID: 19434385BACKGROUNDCapo' JP, Lucente V, Forero-Schwanhaeuser S, He W. Efficacy and tolerability of solifenacin in patients aged >/= 65 years with overactive bladder: post-hoc analysis of 2 open-label studies. Postgrad Med. 2011 Jan;123(1):94-104. doi: 10.3810/pgm.2011.01.2250.
PMID: 21293089DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2007
First Posted
April 20, 2007
Study Start
June 1, 2004
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
September 18, 2014
Record last verified: 2014-09