Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.
NCT ID: NCT00611026
Last Updated: 2011-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2417 participants
INTERVENTIONAL
2008-02-29
2009-10-31
Brief Summary
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A Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Tolterodine ER
The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.
2
Placebo
Placebo treatment will be once daily(QD) for 12 weeks.
3
Fesoterodine
The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.
Interventions
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Tolterodine ER
The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.
Placebo
Placebo treatment will be once daily(QD) for 12 weeks.
Fesoterodine
The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.
Eligibility Criteria
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Inclusion Criteria
* Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
* Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.
Exclusion Criteria
* Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
* OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
* Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Enterprise, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Chandler, Arizona, United States
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Peoria, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Clovis, California, United States
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Fresno, California, United States
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Fresno, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Upland, California, United States
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Vista, California, United States
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Westlake Village, California, United States
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Englewood, Colorado, United States
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New London, Connecticut, United States
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Bonita Spring, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Lake Worth, Florida, United States
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Leesburg, Florida, United States
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Longwood, Florida, United States
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Loxahatchee Groves, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Pembroke Pines, Florida, United States
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Stuart, Florida, United States
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Tallahassee, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Meridian, Idaho, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Avon, Indiana, United States
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Evansville, Indiana, United States
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Noblesville, Indiana, United States
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Overland Park, Kansas, United States
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Overland Park, Kansas, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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Baltimore, Maryland, United States
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Bel Air, Maryland, United States
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North Dartmouth, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Royal Oak, Michigan, United States
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Troy, Michigan, United States
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Edina, Minnesota, United States
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Sartell, Minnesota, United States
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Olive Branch, Mississippi, United States
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Picayune, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Hamilton, New Jersey, United States
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Williamsville, New York, United States
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Cary, North Carolina, United States
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Raleigh, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Bensalem, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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Cumberland, Rhode Island, United States
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Pawtucket, Rhode Island, United States
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Anderson, South Carolina, United States
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Greer, South Carolina, United States
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Summerville, South Carolina, United States
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Johnson City, Tennessee, United States
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Nashville, Tennessee, United States
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New Tazewell, Tennessee, United States
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Beaumont, Texas, United States
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Beaumont, Texas, United States
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Bryan, Texas, United States
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Plano, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Midvale, Utah, United States
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West Jordan, Utah, United States
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Arlington, Virginia, United States
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Charlottesville, Virginia, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Virginia Beach, Virginia, United States
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Weber City, Virginia, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Salvador, Estado de Bahia, Brazil
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Pernik, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Surrey, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Oshawa, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Barranquilla, Atlántico, Colombia
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Bogotá, Colombia, Colombia
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Alajuela, Alajuela Province, Costa Rica
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Cartago, Cartago Province, Costa Rica
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San José, Provincia de San José, Costa Rica
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Berlin, , Germany
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Berlin, , Germany
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Grünstadt, , Germany
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Hamburg, , Germany
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Krumbach, , Germany
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Leipzig, , Germany
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Marburg, , Germany
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Muelheim A.d. Ruhr, , Germany
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München, , Germany
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München, , Germany
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Heraklion/Voutes, Crete, Greece
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Alexandroupoli, , Greece
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Athens, Maroussi, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Debrecen, , Hungary
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Győr, , Hungary
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Nyíregyháza, , Hungary
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Salgótarján, , Hungary
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Szentes, , Hungary
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Hyderabad, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Nadiād, Gujarat, India
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Bengaluru, Karnataka, India
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Pune, Maharashtra, India
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New Delhi, , India
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Beaumont, Dublin, Ireland
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Dublin, , Ireland
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Riga, , Latvia
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Kaunas, , Lithuania
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Vilnius, , Lithuania
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Gdynia, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Słupsk, , Poland
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Bucharest, București, Romania
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Bucharest, Sector 5,, Romania
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Sibiu, Sibiu County, Romania
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Arad, , Romania
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Singapore, Singapore, Singapore
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Nitra, , Slovakia
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Považská Bystrica, , Slovakia
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Prešov, , Slovakia
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Trenčín, , Slovakia
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Zvolen, , Slovakia
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Claremont, Cape Town, South Africa
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Bloemfontein, Free State, South Africa
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Vosloorus, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Durban, KwaZulu-Natal, South Africa
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Pietermaritzburg, KwaZulu-Natal, South Africa
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Pretoria, , South Africa
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Roodepoort, , South Africa
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Jeonju, Jeollabuk-do, South Korea
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Busan, , South Korea
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Daegu, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Santander, Cantabria, Spain
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Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain
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Madrid, Madrid, Spain
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San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Karlskoga, , Sweden
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Malmo, , Sweden
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Norrköping, , Sweden
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Örebro, , Sweden
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Skövde, , Sweden
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Stockholm, , Sweden
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Chernivtsi, , Ukraine
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Dnipropetrovsk, , Ukraine
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Kyiv, , Ukraine
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Uzhhorod, , Ukraine
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Zaporizhzhia, , Ukraine
Countries
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References
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Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.
Related Links
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Other Identifiers
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A0221046
Identifier Type: -
Identifier Source: org_study_id
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