Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)
NCT ID: NCT00444925
Last Updated: 2015-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1712 participants
INTERVENTIONAL
2007-04-30
2008-07-31
Brief Summary
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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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Fesoterodine
Tablets
fesoterodine fumarate
4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks
Placebo
Tablets and capsules
placebo
once daily (OD)for 12 weeks
Tolterodine
Capsules
tolterodine tartrate
4 mg once daily (OD) for 12 weeks
Interventions
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fesoterodine fumarate
4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks
placebo
once daily (OD)for 12 weeks
tolterodine tartrate
4 mg once daily (OD) for 12 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with significant hepatic and renal disease or other significant unstable diseases.
* OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Homewood, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Carmichael, California, United States
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Orangevale, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Waterbury, Connecticut, United States
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Miami, Florida, United States
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Wellington, Florida, United States
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Atlanta, Georgia, United States
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Coeur d'Alene, Idaho, United States
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Sandpoint, Idaho, United States
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Aurora, Illinois, United States
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West Des Moines, Iowa, United States
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Newton, Kansas, United States
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Shrevport, Louisiana, United States
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Watertown, Massachusetts, United States
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Chaska, Minnesota, United States
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Lawrenceville, New Jersey, United States
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Albuquerque, New Mexico, United States
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Garden City, New York, United States
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Mineola, New York, United States
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Burlington, North Carolina, United States
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Concord, North Carolina, United States
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Huntersville, North Carolina, United States
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Dayton, Ohio, United States
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Allentown, Pennsylvania, United States
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Allentown, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Kingsport, Tennessee, United States
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Milan, Tennessee, United States
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Houston, Texas, United States
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Provo, Utah, United States
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Chesapeake, Virginia, United States
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Seattle, Washington, United States
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Menomonee Falls, Wisconsin, United States
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Antwerp, , Belgium
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Brussels, , Belgium
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Kortrijk, , Belgium
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Tessenderlo, , Belgium
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Salvador, Estado de Bahia, 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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Porto Alegre, Rio Grande do Sul, Brazil
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Campinas, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Victoria, British Columbia, Canada
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Saint John, New Brunswick, Canada
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Kitchener, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, 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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Sherbrooke, Quebec, Canada
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Rancagua, Región del Libertador General Bernardo O’Higgins, Chile
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Port Montt, , Chile
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Santiago, , Chile
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Bogota, Cundinamarca, Colombia
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Bogota, Cundinamarca, 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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Hradec Králové, , Czechia
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Jablonec nad Nisou, , Czechia
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Jindřichův Hradec, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Aalborg, , Denmark
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Aarhus N, , Denmark
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Glostrup Municipality, , Denmark
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Herlev, , Denmark
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Kolding, , Denmark
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Nykoebing Falster, , Denmark
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Roskilde, , Denmark
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Ahaus, , Germany
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Alzey, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Karlsruhe, , Germany
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Krumbach, , Germany
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Leipzig, , 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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Rosenheim, , Germany
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Athens, Attica, Greece
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Ioannina, Ipiros, Greece
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Rio, Patras, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Shatin, , Hong Kong
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Debrecen, , Hungary
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Nyíregyháza, , Hungary
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Szeged, , Hungary
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Szentes, , Hungary
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Hyderabad, Andhra Pradesh, India
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Hyderabad, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Jaipur, Rajasthan, India
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Vellore, Tamil Nadu, India
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Lucknow, Uttar Pradesh, India
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Latina, , Italy
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Padua, , Italy
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Siena, , Italy
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Batu Caves, Selangor, Malaysia
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Kuala Lumpur, , Malaysia
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Bergen, , Norway
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Hamar, , Norway
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Lysaker, , Norway
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Oslo, , Norway
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Oslo, , Norway
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Sandnes, , Norway
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Lima, Lima Province, Peru
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Surco, Lima region, Peru
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Lodz, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Arad, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Sibiu, , Romania
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Timișoara, , Romania
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Moscow, Russia, Russia
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Saint Petersburg, Russia, 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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Singapore, Singapore, Singapore
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Singapore, Singapore, Singapore
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Bloemfontein, Free State, South Africa
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Parktown, Gauteng, South Africa
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Vosloorus, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Pietermaritzburg, KwaZulu-Natal, South Africa
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Cape Town, , South Africa
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Pretoria, , South Africa
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Seoul, Korea, South Korea
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Daegu, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Getafe, Madrid, Spain
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Madrid, Madrid, Spain
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Valencia, Valencia, Spain
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Bilbao, Vizcaya, Spain
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Huskvarna, , Sweden
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Luleå, , Sweden
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Malmo, , Sweden
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Skövde, , Sweden
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Stockholm, , Sweden
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Frauenfeld, , Switzerland
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Lucerne, , Switzerland
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Niao-Sung Hsiang, Kaohsiung, Taiwan
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Hualien City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Chernivtsi, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Odesa, , 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.
Corcos J, Angulo JC, Garely AD, Carlsson M, Gong J, Guan Z; Fesoterodine Assessment and Comparison Versus Tolterodine (FACT) Study Group. Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder. Curr Med Res Opin. 2011 May;27(5):1059-65. doi: 10.1185/03007995.2011.565044. Epub 2011 Mar 23.
Related Links
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Other Identifiers
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A0221008
Identifier Type: -
Identifier Source: org_study_id
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