A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

February 25, 2014 updated by: Pfizer

A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.

This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2012

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1060AAA
        • Instituto Urológico Buenos Aires
      • Buenos Aires, Argentina, C1120AAS
        • Centro de Urología (CDU)
      • Buenos Aires, Argentina, C1405BCH
        • Instituto Médico Especializado (IME)
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V6T 5G1
        • Office of Dr. Peter Pommerville
      • Victoria, British Columbia, Canada, V8R 6T9
        • Can-Med Clinical Research
      • Victoria, British Columbia, Canada, V8R 6T9
        • Office of Dr. Nazmuddin Merali
      • Victoria, British Columbia, Canada, V8T 5G1
        • Can-Med Clinical Research Incorporated
    • Newfoundland and Labrador
      • Grand Falls-Windsor, Newfoundland and Labrador, Canada, A2A 2E2
        • Pharos Medical Research Ltd.
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Queen Elizabeth Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • McMaster Institute of Urology, St Joseph's Healthcare Hamilton
      • North Bay, Ontario, Canada, P1B 7K8
        • Office of Dr. Bernard Goldfarb
      • North York, Ontario, Canada, M2J 1V1
        • Stanley Flax Medical Professional Corporation
      • Oshawa, Ontario, Canada, L1H 7K4
        • Urotec
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital, University Health Network
      • Toronto, Ontario, Canada, M6A 3B5
        • Toronto Urology Clinical Study Group
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H3
        • Urology South Shore Research
      • Laval, Quebec, Canada, H7G 2E6
        • UroLaval
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Ultra-Med Inc.
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke
  • Chile
    • RM
      • Santiago, RM, Chile, 7500787
        • Clínica Uromed
      • Santiago, RM, Chile, 8380456
        • Hospital Clínico Universidad de Chile
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 0000
        • Fundacion Centro de Investigacion Clinica CIC
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 0000
        • Solano Y Terront Servicios Medicos Ltda / Unidad Integral de Endocrinologia Uniendo
  • Czech Republic
      • Benesov, Czech Republic, 25601
        • Urologická ambulance
      • Hradec Kralove, Czech Republic, 500 05
        • FN a LFUK Hradec Kralove/Urologicka klinika
      • Jablonec nad Nisou, Czech Republic, 466 60
        • Nemocnice Jablonec nad Nisou
      • Praha 1 - Nove Mesto, Czech Republic, 110 00
        • Urologicka Klinika
      • Praha 5, Czech Republic, 15006
        • Fakultni nemocnice v Motole
      • Praha 6 - Hradcany, Czech Republic, 160 00
        • Androgeos spol. s.r.o.
      • Znojmo, Czech Republic, 66902
        • Urologická ambulance
  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Roskilde, Denmark, 4000
        • Roskilde sygehus, Gynaekologisk/obstetrisk afdeling
  • Egypt
      • Cairo, Egypt
        • Al-Azhar University hospital
  • Finland
      • Kouvola, Finland, 45200
        • Kouvolan lääkäriasema
      • Kuopio, Finland, 70110
        • Lääkäriasema Cantti Oy
  • France
      • Lyon Cedex 03, France, 69437
        • Hopital Edouard Herriot
      • Nantes, France, 44093
        • CHU de Nantes - Hotel Dieu
      • Nimes Cedex 9, France, 30029
        • Hôpital CAREMEAU - Service Urologie/Andrologie
      • Paris, France, 75020
        • Hôpital Tenon - Service d'Urologie
  • Germany
      • Alzey, Germany, 55232
        • Arztpraxis
      • Berlin, Germany, 13125
        • Klinische Forschung Berlin-Buch GmbH
      • Berlin, Germany, 12627
        • Synexus Clinical Research GmbH
      • Bochum, Germany, 44787
        • Synexus Clinical Research GmbH
      • Dresden, Germany, 01069
        • Klinische Forschung Dresden Gmbh
      • Frankfurt am Main, Germany, 60596
        • Synexus Clinical Research GmbH
      • Goerlitz, Germany, 02826
        • Synexus Clinical Research GmbH
      • Hamburg, Germany, 22143
        • Clinical Research Hamburg
      • Hannover, Germany, 30159
        • Klinische Forschung Hannover - Mitte GmbH
      • Karlsruhe, Germany, 76199
        • Allgemeinmedizin Praktische Aerzte
      • Lauenburg, Germany, 21481
        • Arztpraxis
      • Leipzig, Germany, 04103
        • Synexus Clinical Research GmbH
      • Magdeburg, Germany, 39112
        • SMO MD GmbH
      • Moenchengladbach, Germany, 41061
        • CRS Clinical Research Service Moenchengladbach GmbH
      • Muelheim a.d. Ruhr, Germany, 45468
        • Praxisklinik Urologie Rhein-Ruhr
      • Reutlingen, Germany, 72764
        • Facharzt fuer Urologie
      • Schwerin, Germany, 19055
        • Klinische forschung Schwerin GmbH
  • Greece
      • Larisa, Greece, 41110
        • University General Hospital of Larisa/ Urology Department
      • Thessaloniki, Greece, 56429
        • General Hospital Papageorgiou
  • Hungary
      • Budapest, Hungary, 1036
        • Synexus Magyarorszag Kft.
      • Budapest, Hungary, 1204
        • Jahn Ferenc Del-pesti Korhaz, Urologiai Osztaly
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Urologiai Klinika
      • Nyiregyhaza, Hungary, 4400
        • Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Urologiai osztaly
  • Italy
      • Catanzaro, Italy, 88100
        • Università Magna Graecia di Catanzaro
      • Foggia, Italy, 71122
        • Clinica Urologica Centro Trapianti di rene
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 136-705
        • Department of Urology, Korea University Anam Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University College of Medicine, Department of Urology
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University of Korea Seoul St. Mary's Hospital, Department of Urology
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center, Department of Urology
  • Lithuania
      • Kaunas, Lithuania, 49449
        • Saules Seimos Medicinos Centras, JSC
      • Klaipeda, Lithuania, 94231
        • Mano Seimos Gydytojas, JSC
      • Vilnius, Lithuania, 01118
        • Seimos Gydytojas, JSC
  • Mexico
      • San Luis Potosi, Mexico, 78218
        • Hospital Lomas de San Luis Internacional
  • Norway
      • Elverum, Norway, 2408
        • Medi 3 Elverum AS
      • Hamar, Norway, 2317
        • Medi 3 Innlandet
      • Lierskogen, Norway, 3420
        • Norsk Helseklinikk AS, c/o Heiaklinikken
      • Stavanger, Norway, 4005
        • Forusakutten AS, Avdeling for oppdragsforskning
  • Philippines
      • Bacolod City, Philippines, 6100
        • Dr. Pablo O. Torre Memorial Hospital
      • Iloilo City, Philippines, 5000
        • St. Paul's Hospital
    • Cebu
      • Cebu City, Cebu, Philippines, 6000
        • Perpetual Succour Hospital of Cebu Inc.
  • Poland
      • Gdansk, Poland, 80-402
        • Klinika Urologii Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdansku
      • Lodz, Poland, 90-302
        • NZOZ Centrum Medyczne
      • Myslowice, Poland, 41-400
        • Centrum Urologiczne Sp. z o. o.
      • Torun, Poland, 87-100
        • NZOZ "Nasz Lekarz"
  • Russian Federation
      • Barnaul, Russian Federation, 656038
        • Non-governmental Healthcare Institution Departmental Clinical Hospital at Barnaul station OAO RZD
      • Rostov-on-Don, Russian Federation, 344022
        • Rostov State Medical University, Chair of Urology
      • Saint-Petersburg, Russian Federation, 199034
        • Research Institute of Obstetrics and Gynaecology D.O. Otta of North-west Department of RAMS
  • Slovakia
      • Bratislava, Slovakia, 811 06
        • URO clinic, s.r.o.
      • Bratislava, Slovakia, 820 07
        • Ruzinovska poliklinika, a.s.
      • Galanta, Slovakia, 924 22
        • Nemocnica s Poliklinikou Svateho Lukasa Galanta
      • Piestany, Slovakia, 921 01
        • UROX s.r.o.
      • Povazska Bystrica, Slovakia, 017 01
        • Centrum urologie Povazska Bystrica, s.r.o. urologicka ambulancia
      • Trencin, Slovakia, 911 71
        • Fakultna nemocnica Trencin
      • Zilina, Slovakia, 012 07
        • Fakultna nemocnica s poliklinikou Zilina
      • Zilina, Slovakia, 010 01
        • UROGYN,s.r.o.
      • Zvolen, Slovakia, 960 01
        • GYNPOR SK, s.r.o. Urogynekologicka ambulancia
  • South Africa
      • Roodepoort, South Africa, 1715
        • Mayo Centre
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0001
        • Clinical Research Unit
      • Vosloorus, Gauteng, South Africa, 1475
        • Clinix Private Clinic
  • Sweden
      • Eslov, Sweden, 241 23
        • Carema Specialistvard Eslov
      • Goteborg, Sweden, 413 28
        • Hagakliniken
      • Goteborg, Sweden, 413 45
        • CTC, Sahlgrenska sjukhuset/SU
      • Lund, Sweden, 222 22
        • ProbarE
      • Malmo, Sweden, 211 52
        • Center for Lakemedelsstudier
      • Skene, Sweden, 511 62
        • Ladulaas Kliniska Studier
      • Skovde, Sweden, 541 85
        • Verksamhet Urologi
      • Stockholm, Sweden, 141 86
        • Kvinnokliniken Karolinska Universitetssjukhuset Huddinge
      • Vallingby, Sweden, 162 68
        • S3 Clinical Research Centers
      • Vastervik, Sweden, 593 81
        • Vasterviks sjukhus, Kvinnokliniken
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Chang Gung Medical Foundation. Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital, Department of Urology
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital/Division of Urology
  • Ukraine
      • Chernivtsi, Ukraine, 58002
        • RMI "Chernivtsi Regional Clinical Hosp.", Dep. of Urology, BSMU, Chair of Surgery and Urology
      • Donetsk, Ukraine, 83002
        • City Hospital #4 of Donetsk, Woman Consultative Department
      • Donetsk, Ukraine
        • Department of Urology of Donetsk National Medical University at Central City Clinical Hospital #1
      • Donetsk, Ukraine
        • MTPI "Central City Clinical Hospital #1"/Donetsk National Medical University n.a. M. Gorkiy,
      • Uzhorod, Ukraine, 88000
        • Uzhorod City Outpatient Clinic, Prophylaxis Department
      • Vinnitsa, Ukraine, 21010
        • Vinnitsa Regional Clinical Dispensary of Endocrinology
      • Zaporizhzhia, Ukraine, 69600
        • Urology Dept of Zaporizhzhia Medical Academy of Postgraduate Education
  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
        • Cambridge University Hospital Trials NHS Trust
      • Glasgow, United Kingdom, G51 4TF
        • Southern General Hospital
      • Glasgow, United Kingdom, G69 7AD
        • Baillieston Health Centre
      • Hertfordshire, United Kingdom, WD2 6EB
        • Sheepcot Medical Centre
      • Sheffield, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital
    • Cornwall
      • Fowey, Cornwall, United Kingdom, PL23 1DT
        • Fowey River Practice
    • Devon
      • Plymouth, Devon, United Kingdom, PL5 3JB
        • Knowle House Surgery
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT7 2EB
        • Ormeau Health Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research, LLC
      • Birmingham, Alabama, United States, 35209
        • Urology Centers of Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc.
      • Huntsville, Alabama, United States, 35801
        • James Gordon McMurray, MD
      • Mobile, Alabama, United States, 36608
        • Mobile Ob-Gyn, P.C.
      • Montgomery, Alabama, United States, 36117
        • Montgomery Women's Health Associates, P.C.
      • Scottsboro, Alabama, United States, 35768
        • Scottsboro Quick Care Clinic
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Dedicated Clinical Research
      • Tucson, Arizona, United States, 85704
        • Genova Clinical Research
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Women's Clinic
      • Little Rock, Arkansas, United States, 72205
        • Lynn Institute of the Ozarks
      • Little Rock, Arkansas, United States, 72205
        • A Clinic For Women
      • Little Rock, Arkansas, United States, 72205
        • Larry S. Watkins, MD
      • Little Rock, Arkansas, United States, 72205
        • May Women's Health Clinic
    • California
      • Carmichael, California, United States, 95608
        • The Office of Dr. Simon Yassear, MD
      • Glendora, California, United States, 91741
        • Citrus Valley Medical Research, Inc.
      • La Mesa, California, United States, 91942
        • Grossmont Center for Clinical Research
      • Sacramento, California, United States, 95825
        • Sockolov and Sockolov APC
      • San Diego, California, United States, 92120
        • San Diego Clinical Trials
      • San Diego, California, United States, 92103
        • Genesis Center for Clinical Research
      • Santa Ana, California, United States, 92705
        • Clinical Innovations, Inc.
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Colorado
      • Denver, Colorado, United States, 80220
        • Genitourinary Surgical Consultants
      • Denver, Colorado, United States, 80113
        • Urology Associates, PC
      • Fort Collins, Colorado, United States, 80524
        • The Women's Clinic of Northern Colorado
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Women's Health Specialty Care
    • Florida
      • Aventura, Florida, United States, 33180
        • South Florida Medical Research
      • Aventura, Florida, United States, 33180
        • Uromedix
      • Bradenton, Florida, United States, 34208
        • Meridien Research
      • Brandon, Florida, United States, 33511
        • PAB Clinical Research
      • Brandon, Florida, United States, 33511
        • Florida Sleep Disorder Center of Brandon
      • Brandon, Florida, United States, 33511
        • Pulmonary Associates of Brandon
      • Brooksville, Florida, United States, 34601
        • Meridien Research
      • Crystal River, Florida, United States, 34429
        • Nature Coast Clinical Research
      • DeFuniak Springs, Florida, United States, 32435
        • Doctors Medical center of Walton County
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research, LLC
      • Destin, Florida, United States, 32541
        • SJS Clinical Research, Inc.
      • Fleming Island, Florida, United States, 32003
        • Fleming Island Center For Clinical Research
      • Fort Lauderdale, Florida, United States, 33316
        • M & O Clinical Research, LLC
      • Fort Myers, Florida, United States, 33908
        • Florida Urology Physicians
      • Hialeah, Florida, United States, 33016
        • Urological Research Network, LLC
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Lake Worth, Florida, United States, 33461
        • Altus Research
      • Leesburg, Florida, United States, 34748
        • OB-GYN Associates of Mid-Florida, PA
      • Miami, Florida, United States, 33175
        • New Horizon Research Center
      • Ocala, Florida, United States, 34474
        • Urology Health Team, PLLC
      • Pembroke Pines, Florida, United States, 33026
        • Broward Research Group
      • Plant City, Florida, United States, 33563
        • Clinical Research of Central Florida
      • Tallahassee, Florida, United States, 32308
        • Southeastern Research Group, Inc.
      • Tampa, Florida, United States, 33606
        • Meridien Research
      • West Palm Beach, Florida, United States, 33409
        • Advanced OBGYN Associates
      • Winter Haven, Florida, United States, 33880
        • Clinical Research of Central Florida
    • Georgia
      • Roswell, Georgia, United States, 30076
        • North Fulton Urology, PC
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
      • Woodstock, Georgia, United States, 30189
        • North Georgia Internal Medicine
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Women's Healthcare Associates dba Rosemark WomenCare Specialists
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Women's Health Practice
      • Chicago, Illinois, United States, 60612
        • Center For Women's Research
      • Galesburg, Illinois, United States, 61401
        • Medical and Surgical Specialists
      • Gurnee, Illinois, United States, 60031
        • Clinical Investigation Specialists, Inc.
    • Indiana
      • Avon, Indiana, United States, 46123
        • American Health Network of Indiana, LLC
      • Bloomington, Indiana, United States, 47403
        • Summit Research Institute
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
      • Greenfield, Indiana, United States, 46140
        • American Health Network of Indiana, LLC
      • Jeffersonville, Indiana, United States, 47130
        • Metropolitan Urology
      • Newburgh, Indiana, United States, 47630
        • Deaconess Clinic Gateway Health Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Healthcare
    • Kansas
      • Pratt, Kansas, United States, 67124
        • Health Science Research Center
      • Shawnee, Kansas, United States, 66218
        • Women's and Family Care dba GTC Research
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Kentucky Medical Research Center
      • Madisonville, Kentucky, United States, 42431
        • Commonwealth BioMedical Research
      • Mount Sterling, Kentucky, United States, 40353
        • Central Kentucky Research Associates, Inc.
      • Mount Sterling, Kentucky, United States, 40353
        • Mount Sterling Clinic
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • The Office of Dr. Myron I. Murdock, MD, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Boston Clinical Trials, Inc.
      • Brockton, Massachusetts, United States, 02301
        • Beacon Clinical Research, LLC
      • Hyannis, Massachusetts, United States, 02601
        • Clinical Research Center of Cape Cod, Inc.
      • North Dartmouth, Massachusetts, United States, 02747
        • Infinity Medical Research
      • Springfield, Massachusetts, United States, 01103
        • DM Clinical Research
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • CRC of Jackson
      • Jackson, Mississippi, United States, 39202
        • Mississippi Urology Clinic
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Mercy Health Research
      • St. Peters, Missouri, United States, 63376
        • Midwest Pharmaceutical Research
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Lincoln Internal Medicine Associates
      • Lincoln, Nebraska, United States, 68510
        • Women's Clinic of Lincoln, P.C.
      • Lincoln, Nebraska, United States, 68506
        • Family Health Care Center
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Clinical Research Center of Nevada
      • Las Vegas, Nevada, United States, 89130
        • Clinical Research Center of Nevada
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
        • Virtua Phoenix Ob-Gyn
      • Trenton, New Jersey, United States, 08611
        • Premier Research, Inc.
    • New York
      • Binghamton, New York, United States, 13901
        • United Medical Associates
      • Brooklyn, New York, United States, 11215
        • Brooklyn Urology Research Group
      • Garden City, New York, United States, 11530
        • Urological Surgeons of Long Island
      • Kingston, New York, United States, 12401
        • Premier Medical Group of the Hudson Valley
      • New Windsor, New York, United States, 12553
        • Mid Hudson Medical Research, PLLC
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley
      • Williamsville, New York, United States, 14221
        • Upstate Clinical Research Associates
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Kernodle Clinic, Inc.
      • Charlotte, North Carolina, United States, 28207
        • American Health Research
      • Concord, North Carolina, United States, 28025
        • Carolina Clinical Trials
      • Concord, North Carolina, United States, 28025
        • Carolina Urology Partners, PLLC
      • Harrisburg, North Carolina, United States, 28075
        • Carolinas Research Associates
      • Huntersville, North Carolina, United States, 28078
        • University Medical Associates
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Raleigh, North Carolina, United States, 27612
        • Wake Internal Medicine Consultants, Inc.
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • Hawthorne Medical Research, Inc.
      • Winston-Salem, North Carolina, United States, 27103
        • Hawthorne Medical Research, Inc. - Hawthorne OB/GYN Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45215
        • Patient Priority Clinical Sites, LLC
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc.
      • Columbus, Ohio, United States, 43213
        • Columbus Clinical Research
      • Columbus, Ohio, United States, 43213
        • Columbus Center for Women's Health Research
      • Dayton, Ohio, United States, 45432
        • Hometown Urgent Care and Research
      • Englewood, Ohio, United States, 45322
        • HWC Women's Research Center
      • Willoughby Hills, Ohio, United States, 44094
        • Ohio Clinical Research, LLC
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • The Office of Johnny B. Roy, MD
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, United States, 73109
        • Legacy Clinical Research, LLC
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Institute for Female Pelvic Medicine
      • Hopwood, Pennsylvania, United States, 15445
        • Laurel Highlands OB/GYN
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
      • Johnstown, Pennsylvania, United States, 15405
        • Richard Kastelic and Associates
      • Pittsburgh, Pennsylvania, United States, 15206
        • Clinical Trials Research Services, LLC
      • Pittsburgh, Pennsylvania, United States, 15212
        • Triangle Urological Group
      • State College, Pennsylvania, United States, 16801
        • Mount Nittany Medical Center Health Services Inc. dba Mount Nittany Physician Group
      • Uniontown, Pennsylvania, United States, 15401
        • Pish Medical Associates
      • West Reading, Pennsylvania, United States, 19611
        • Advanced Clinical Concepts
      • West Reading, Pennsylvania, United States, 19611
        • Woman's Clinic Ltd.
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Coastal Medical
      • East Providence, Rhode Island, United States, 02914
        • Safe Harbor Clinical Research
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • TLM Medical Services, LLC
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
      • West Columbia, South Carolina, United States, 29169
        • Southern Urogynecology
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Internal Medicine and Pediatric Associates of Bristol, PC
      • Bristol, Tennessee, United States, 37620
        • PMG Research of Bristol, LLC
      • Memphis, Tennessee, United States, 38120
        • Adams Patterson Gynocology and Obstetrics, PLLC
      • New Tazewell, Tennessee, United States, 37825
        • Heartland Medical PC
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Center for Clinical Research
      • Dallas, Texas, United States, 75224
        • RJE Clinical Research
      • Houston, Texas, United States, 77079
        • Memorial Clinical Associates dba MCA Research
      • Plano, Texas, United States, 75093
        • North Texas Family Medicine
      • Plano, Texas, United States, 75024
        • ACRC Trials (Administrative/Mailing Site)
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, United States, 78229
        • Seven Oaks Women's Center
      • San Antonio, Texas, United States, 78229
        • Institute for Women's Health
      • San Antonio, Texas, United States, 78299
        • Clinical Trials of Texas, Inc.
      • Temple, Texas, United States, 76508
        • Scott and White Healthcare
      • Temple, Texas, United States, 76502
        • Scott and White Healthcare
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research
      • Richmond, Virginia, United States, 23294
        • National Clinical Research - Richmond
      • Virginia Beach, Virginia, United States, 23455
        • Independence Family Medicine
    • Washington
      • Burien, Washington, United States, 98166
        • Seattle Urology Research Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Clinical Trials Center
      • Charleston, West Virginia, United States, 25304
        • CAMC Physicians Group
      • Charleston, West Virginia, United States, 25304
        • Charleston Internal Medicine, Inc.
      • Charleston, West Virginia, United States, 25304
        • Urologic Surgical Center
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Clinical Investigation Specialists, Inc.
      • Oregon, Wisconsin, United States, 53575
        • Dean Oregon Clinic
      • Wauwatosa, Wisconsin, United States, 53226
        • Allegiance Research Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence episodes per 24 hours and minimum of 8 micturitions per 24 hours.

Exclusion Criteria:

  • Other concurrent and concomitant medication or disease that could put the subjects at additional risk or interfere with the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral, 1 tablet per day, 12 weeks duration
Experimental: Fesoterodine 8mg
Drug: Fesoterodine 8mg
Oral, 1 tablet per day, 12 weeks duration, 8mg/day
Experimental: Fesoterodine 4mg
Drug: Fesoterodine 4mg
Oral, 1 tablet per day, 12 weeks duration, 4mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.
Time Frame: Week 12
UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.
Time Frame: Week 4
Micturitions include episodes of voluntary micturition and episodes of UUI.
Week 4
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.
Time Frame: Week 12
Micturitions include episodes of voluntary micturition and episodes of UUI.
Week 12
Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.
Time Frame: Week 4
Micturitions include episodes of voluntary micturition and episodes of UUI.
Week 4
Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.
Time Frame: Week 12
Micturitions include episodes of voluntary micturition and episodes of UUI.
Week 12
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.
Time Frame: Week 4
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Week 4
Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4.
Time Frame: Week 4
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Week 4
Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12.
Time Frame: Week 12
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Week 12
Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.
Time Frame: Week 4
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Week 4
Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.
Time Frame: Week 12
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Week 12
Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.
Time Frame: Week 4
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Week 4
Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.
Time Frame: Week 12
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Week 12
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12.
Time Frame: Week 12
PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.
Week 12
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12.
Time Frame: Week 12
UPS: single-item, self-administered validated questionnaire. Participant answered: "Which of the following would typically describe your experience when you have a desire to urinate?" on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).
Week 12
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12.
Time Frame: Week 12
OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.
Week 12
Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Time Frame: Week 12
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Week 12
Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Time Frame: Week 12
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Week 12
Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Time Frame: Week 12
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Week 12
Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Time Frame: Week 12
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Week 12
Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Time Frame: Week 12
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Week 12
Percentage of Participants Who Became Dry at Week 4.
Time Frame: Week 4
Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary
Week 4
Percentage of Participants Who Became Dry at Week 12.
Time Frame: Week 12
Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI >0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

February 25, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0221095
  • EIGHT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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