AzTrials
AzTrials

Overactive BladderPhase 4NCT01302067

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

A Phase 4 study testing Fesoterodine 8mg and Fesoterodine 4mg in people with Overactive Bladder, run by Pfizer at 293 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overactive Bladder
What is being tested?
Fesoterodine 8mg and Fesoterodine 4mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,012 participants
Where
293 sitesin 27 countries
Study dates
May 2011to Nov 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

293 sites in 27 countries.

293 sites in 27 countries

United States165 sites

  • Institute for Female Pelvic Medicine

    Allentown, Pennsylvania, 18103

  • Austin Center for Clinical Research

    Austin, Texas, 78756

  • South Florida Medical Research

    Aventura, Florida, 33180

  • Uromedix

    Aventura, Florida, 33180

  • American Health Network of Indiana, LLC

    Avon, Indiana, 46123

  • United Medical Associates

    Binghamton, New York, 13901

  • Urology Centers of Alabama

    Birmingham, Alabama, 35209

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Summit Research Institute

    Bloomington, Indiana, 47403

  • Boston Clinical Trials, Inc.

    Boston, Massachusetts, 02135

  • Meridien Research

    Bradenton, Florida, 34208

  • Florida Sleep Disorder Center of Brandon

    Brandon, Florida, 33511

  • PAB Clinical Research

    Brandon, Florida, 33511

  • Pulmonary Associates of Brandon

    Brandon, Florida, 33511

  • Internal Medicine and Pediatric Associates of Bristol, PC

    Bristol, Tennessee, 37620

  • PMG Research of Bristol, LLC

    Bristol, Tennessee, 37620

  • Beacon Clinical Research, LLC

    Brockton, Massachusetts, 02301

  • Brooklyn Urology Research Group

    Brooklyn, New York, 11215

  • Meridien Research

    Brooksville, Florida, 34601

  • Seattle Urology Research Center

    Burien, Washington, 98166

  • Kernodle Clinic, Inc.

    Burlington, North Carolina, 27215

  • The Office of Dr. Simon Yassear, MD

    Carmichael, California, 95608

  • Women's Health Practice

    Champaign, Illinois, 61820

  • CAMC Clinical Trials Center

    Charleston, West Virginia, 25304

  • CAMC Physicians Group

    Charleston, West Virginia, 25304

  • Charleston Internal Medicine, Inc.

    Charleston, West Virginia, 25304

  • Urologic Surgical Center

    Charleston, West Virginia, 25304

  • American Health Research

    Charlotte, North Carolina, 28207

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Center for Women's Research

    Chicago, Illinois, 60612

  • Patient Priority Clinical Sites, LLC

    Cincinnati, Ohio, 45215

  • Midwest Pharmaceutical Research

    City of Saint Peters, Missouri, 63376

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • TLM Medical Services, LLC

    Columbia, South Carolina, 29204

  • Columbus Center for Women's Health Research

    Columbus, Ohio, 43213

  • Columbus Clinical Research

    Columbus, Ohio, 43213

  • Carolina Clinical Trials

    Concord, North Carolina, 28025

  • Carolina Urology Partners, PLLC

    Concord, North Carolina, 28025

  • Nature Coast Clinical Research

    Crystal River, Florida, 34429

  • RJE Clinical Research

    Dallas, Texas, 75224

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45432

  • Doctors Medical Center of Walton County

    DeFuniak Springs, Florida, 32435

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Urology Associates, PC

    Denver, Colorado, 80113

  • Genitourinary Surgical Consultants

    Denver, Colorado, 80220

  • SJS Clinical Research, Inc.

    Destin, Florida, 32541

  • Coastal Medical

    East Greenwich, Rhode Island, 02818

  • Safe Harbor Clinical Research

    East Providence, Rhode Island, 02914

  • The Office of Johnny B. Roy, MD

    Edmond, Oklahoma, 73034

  • HWC Women's Research Center

    Englewood, Ohio, 45322

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Women's Health Specialty Care

    Farmington, Connecticut, 06032

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32003

  • The Women's Clinic of Northern Colorado

    Fort Collins, Colorado, 80524

  • M & O Clinical Research, LLC

    Fort Lauderdale, Florida, 33316

  • Florida Urology Physicians

    Fort Myers, Florida, 33908

  • Medical and Surgical Specialists

    Galesburg, Illinois, 61401

  • Urological Surgeons of Long Island

    Garden City, New York, 11530

  • Citrus Valley Medical Research, Inc.

    Glendora, California, 91741

  • The Office of Dr. Myron I. Murdock, MD, LLC

    Greenbelt, Maryland, 20770

  • American Health Network of Indiana, LLC

    Greenfield, Indiana, 46140

  • Clinical Investigation Specialists, Inc.

    Gurnee, Illinois, 60031

  • Carolinas Research Associates

    Harrisburg, North Carolina, 28075

  • Urological Research Network, LLC

    Hialeah, Florida, 33016

  • Laurel Highlands OB/GYN

    Hopwood, Pennsylvania, 15445

  • Memorial Clinical Associates dba MCA Research

    Houston, Texas, 77079

  • University Medical Associates

    Huntersville, North Carolina, 28078

  • James Gordon McMurray, MD

    Huntsville, Alabama, 35801

  • Medical Affiliated Research Center, Inc.

    Huntsville, Alabama, 35801

  • Clinical Research Center of Cape Cod, Inc.

    Hyannis, Massachusetts, 02601

  • Women's Healthcare Associates dba Rosemark WomenCare Specialists

    Idaho Falls, Idaho, 83404

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • University of Iowa Healthcare

    Iowa City, Iowa, 52242

  • CRC of Jackson

    Jackson, Mississippi, 39202

  • Mississippi Urology Clinic

    Jackson, Mississippi, 39202

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Metropolitan Urology

    Jeffersonville, Indiana, 47130

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Richard Kastelic and Associates

    Johnstown, Pennsylvania, 15405

  • NEA Baptist Women's Clinic

    Jonesboro, Arkansas, 72401

  • Clinical Investigation Specialists, Inc.

    Kenosha, Wisconsin, 53142

  • Premier Medical Group of the Hudson Valley

    Kingston, New York, 12401

  • Grossmont Center for Clinical Research

    La Mesa, California, 91942

  • Altus Research

    Lake Worth, Florida, 33461

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89123

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89130

  • OB-GYN Associates of Mid-Florida, PA

    Leesburg, Florida, 34748

  • Kentucky Medical Research Center

    Lexington, Kentucky, 40504

  • Family Health Care Center

    Lincoln, Nebraska, 68506

  • Women's Clinic of Lincoln, P.C.

    Lincoln, Nebraska, 68510

  • Lincoln Internal Medicine Associates

    Lincoln, Nebraska, 68516

  • A Clinic For Women

    Little Rock, Arkansas, 72205

  • Larry S. Watkins, MD

    Little Rock, Arkansas, 72205

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72205

  • May Women's Health Clinic

    Little Rock, Arkansas, 72205

  • Commonwealth Biomedical Research

    Madisonville, Kentucky, 42431

  • Adams Patterson Gynocology and Obstetrics, PLLC

    Memphis, Tennessee, 38120

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • New Horizon Research Center

    Miami, Florida, 33175

  • Mobile Ob-Gyn, P.C.

    Mobile, Alabama, 36608

  • Montgomery Women's Health Associates, P.C.

    Montgomery, Alabama, 36117

  • Virtua Phoenix Ob-Gyn

    Moorestown, New Jersey, 08057

  • Central Kentucky Research Associates, Inc.

    Mount Sterling, Kentucky, 40353

  • Mount Sterling Clinic

    Mount Sterling, Kentucky, 40353

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Heartland Medical PC

    New Tazewell, Tennessee, 37825

  • Mid Hudson Medical Research, PLLC

    New Windsor, New York, 12553

  • Deaconess Clinic Gateway Health Center

    Newburgh, Indiana, 47630

  • Infinity Medical Research

    North Dartmouth, Massachusetts, 02747

  • Urology Health Team, PLLC

    Ocala, Florida, 34474

  • Legacy Clinical Research, LLC

    Oklahoma City, Oklahoma, 73109

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Dean Oregon Clinic

    Oregon, Wisconsin, 53575

  • Broward Research Group

    Pembroke Pines, Florida, 33026

  • Dedicated Clinical Research

    Phoenix, Arizona, 85020

  • Clinical Trials Research Services, LLC

    Pittsburgh, Pennsylvania, 15206

  • Triangle Urological Group

    Pittsburgh, Pennsylvania, 15212

  • ACRC Trials (Administrative/Mailing Site)

    Plano, Texas, 75024

  • North Texas Family Medicine

    Plano, Texas, 75093

  • Clinical Research of Central Florida

    Plant City, Florida, 33563

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601

  • Health Science Research Center

    Pratt, Kansas, 67124

  • Wake Internal Medicine Consultants, Inc.

    Raleigh, North Carolina, 27612

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • National Clinical Research - Richmond

    Richmond, Virginia, 23294

  • North Fulton Urology, PC

    Roswell, Georgia, 30076

  • Sockolov and Sockolov APC

    Sacramento, California, 95825

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Institute for Women's Health

    San Antonio, Texas, 78229

  • Seven Oaks Women's Center

    San Antonio, Texas, 78229

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78299

  • Genesis Center for Clinical Research

    San Diego, California, 92103

  • San Diego Clinical Trials

    San Diego, California, 92120

  • Clinical Innovations, Inc.

    Santa Ana, California, 92705

  • Scottsboro Quick Care Clinic

    Scottsboro, Alabama, 35768

  • Women's and Family Care dba GTC Research

    Shawnee, Kansas, 66218

  • DM Clinical Research

    Springfield, Massachusetts, 01103

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Mount Nittany Medical Center Health Services Inc. dba Mount Nittany Physician Group

    State College, Pennsylvania, 16801

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Southeastern Research Group, Inc.

    Tallahassee, Florida, 32308

  • Meridien Research

    Tampa, Florida, 33606

  • Scott and White Healthcare

    Temple, Texas, 76502

  • Scott and White Healthcare

    Temple, Texas, 76508

  • Premier Research, Inc.

    Trenton, New Jersey, 08611

  • Genova Clinical Research

    Tucson, Arizona, 85704

  • Pish Medical Associates

    Uniontown, Pennsylvania, 15401

  • Independence Family Medicine

    Virginia Beach, Virginia, 23455

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Allegiance Research Specialists

    Wauwatosa, Wisconsin, 53226

  • Southern Urogynecology

    West Columbia, South Carolina, 29169

  • Advanced OBGYN Associates

    West Palm Beach, Florida, 33409

  • Advanced Clinical Concepts

    West Reading, Pennsylvania, 19611

  • Woman's Clinic Ltd.

    West Reading, Pennsylvania, 19611

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

  • Ohio Clinical Research, LLC

    Willoughby Hills, Ohio, 44094

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Hawthorne Medical Research, Inc. - Hawthorne OB/GYN Associates

    Winston-Salem, North Carolina, 27103

  • Hawthorne Medical Research, Inc.

    Winston-Salem, North Carolina, 27103

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

  • North Georgia Internal Medicine

    Woodstock, Georgia, 30189

Other trials in United States

Germany17 sites

  • Arztpraxis

    Alzey, 55232

  • Synexus Clinical Research GmbH

    Berlin, 12627

  • Klinische Forschung Berlin-Buch GmbH

    Berlin, 13125

  • Synexus Clinical Research GmbH

    Bochum, 44787

  • Klinische Forschung Dresden GmbH

    Dresden, 01069

  • Synexus Clinical Research GmbH

    Frankfurt am Main, 60596

  • Synexus Clinical Research GmbH

    Görlitz, 02826

  • Clinical Research Hamburg

    Hamburg, 22143

  • Klinische Forschung Hannover - Mitte GmbH

    Hanover, 30159

  • Allgemeinmedizin Praktische Aerzte

    Karlsruhe, 76199

  • Arztpraxis

    Lauenburg, 21481

  • Synexus Clinical Research GmbH

    Leipzig, 04103

  • SMO MD GmbH

    Magdeburg, 39112

  • CRS Clinical Research Service Moenchengladbach GmbH

    Mönchengladbach, 41061

  • Praxisklinik Urologie Rhein-Ruhr

    Muelheim A.d. Ruhr, 45468

  • Facharzt fuer Urologie

    Reutlingen, 72764

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055

Other trials in Germany

Canada16 sites

  • Pharos Medical Research Ltd.

    Grand Falls-Windsor, Newfoundland and Labrador, A2A 2E2

  • Urology South Shore Research

    Greenfield Park, Quebec, J4V 2H3

  • Queen Elizabeth Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • McMaster Institute of Urology, St Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • UroLaval

    Laval, Quebec, H7G 2E6

  • Office of Dr. Bernard Goldfarb

    North Bay, Ontario, P1B 7K8

  • Stanley Flax Medical Professional Corporation

    North York, Ontario, M2J 1V1

  • Urotec

    Oshawa, Ontario, L1H 7K4

  • Ultra-Med Inc.

    Pointe-Claire, Quebec, H9R 4S3

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Toronto Western Hospital, University Health Network

    Toronto, Ontario, M5T 2S8

  • Toronto Urology Clinical Study Group

    Toronto, Ontario, M6A 3B5

  • Office of Dr. Peter Pommerville

    Victoria, British Columbia, V6T 5G1

  • Can-Med Clinical Research

    Victoria, British Columbia, V8R 6T9

  • Office of Dr. Nazmuddin Merali

    Victoria, British Columbia, V8R 6T9

  • Can-Med Clinical Research Incorporated

    Victoria, British Columbia, V8T 5G1

Other trials in Canada

Sweden10 sites

  • Carema Specialistvard Eslov

    Eslöv, 241 23

  • Hagakliniken

    Gothenburg, 413 28

  • CTC, Sahlgrenska sjukhuset/SU

    Gothenburg, 413 45

  • Probare

    Lund, 222 22

  • Center for Lakemedelsstudier

    Malmö, 211 52

  • Ladulaas kliniska studier

    Skene, 511 62

  • Verksamhet Urologi

    Skövde, 541 85

  • Kvinnokliniken Karolinska Universitetssjukhuset Huddinge

    Stockholm, 141 86

  • S3 Clinical Research Centers

    Vällingby, 162 68

  • Vasterviks sjukhus, Kvinnokliniken

    Västervik, 593 81

Other trials in Sweden

Slovakia9 sites

  • URO CLINIC, s.r.o.

    Bratislava, 811 06

  • Ruzinovska poliklinika, a.s.

    Bratislava, 820 07

  • Nemocnica s Poliklinikou Svateho Lukasa Galanta

    Galanta, 924 22

  • UROX s.r.o.

    Piešťany, 921 01

  • Centrum urologie Povazska Bystrica, s.r.o. urologicka ambulancia

    Považská Bystrica, 017 01

  • Fakultna nemocnica Trencin

    Trenčín, 911 71

  • UROGYN,s.r.o.

    Žilina, 010 01

  • Fakultna nemocnica s poliklinikou Zilina

    Žilina, 012 07

  • GYNPOR SK, s.r.o. Urogynekologicka ambulancia

    Zvolen, 960 01

Other trials in Slovakia

United Kingdom8 sites

  • Ormeau Health Centre

    Belfast, Northern Ireland, BT7 2EB

  • Cambridge University Hospital Trials NHS Trust

    Cambridge, CB2 2QQ

  • Fowey River Practice

    Fowey, Cornwall, PL23 1DT

  • Southern General Hospital

    Glasgow, G51 4TF

  • Baillieston Health Centre

    Glasgow, G69 7AD

  • Sheepcot Medical Centre

    Hertfordshire, WD2 6EB

  • Knowle House Surgery

    Plymouth, Devon, PL5 3JB

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

Other trials in United Kingdom

Czechia7 sites

  • Urologicka ambulance

    Benešov, 25601

  • FN a LFUK Hradec Kralove/Urologicka klinika

    Hradec Králové, 500 05

  • Nemocnice Jablonec nad Nisou

    Jablonec nad Nisou, 466 60

  • Fakultni nemocnice v Motole

    Prague, 15006

  • Urologicka klinika

    Praha 1 - Nove Mesto, 110 00

  • Androgeos spol. s.r.o.

    Praha 6 - Hradcany, 160 00

  • Urologicka ambulance

    Znojmo, 66902

Other trials in Czechia

Ukraine7 sites

  • RMI "Chernivtsi Regional Clinical Hosp.", Dep. of Urology, BSMU, Chair of Surgery and Urology

    Chernivtsi, 58002

  • City Hospital #4 of Donetsk, Woman Consultative Department

    Donetsk, 83002

  • Department of Urology of Donetsk National Medical University at Central City Clinical Hospital #1

    Donetsk

  • MTPI "Central City Clinical Hospital #1"/Donetsk National Medical University n.a. M. Gorkiy,

    Donetsk

  • Uzhorod City Outpatient Clinic, Prophylaxis Department

    Uzhhorod, 88000

  • Vinnitsa Regional Clinical Dispensary of Endocrinology

    Vinnitsa, 21010

  • Urology Dept of Zaporizhzhia Medical Academy of Postgraduate Education

    Zaporizhzhya, 69600

Other trials in Ukraine

South Korea6 sites

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital, Yonsei University College of Medicine, Department of Urology

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Department of Urology, Korea University Anam Hospital

    Seoul, 136-705

  • The Catholic University of Korea Seoul St. Mary's Hospital, Department of Urology

    Seoul, 137-701

  • Asan Medical Center, Department of Urology

    Seoul, 138-736

Other trials in South Korea

France4 sites

  • Hôpital Edouard Herriot

    Lyon, 69437

  • CHU de Nantes - Hôtel Dieu

    Nantes, 44093

  • Hôpital CAREMEAU - Service Urologie/Andrologie

    Nîmes, 30029

  • Hôpital Tenon - Service d'Urologie

    Paris, 75020

Other trials in France

Hungary4 sites

  • Synexus Magyarorszag Kft.

    Budapest, 1036

  • Jahn Ferenc Del-pesti Korhaz, Urologiai Osztaly

    Budapest, 1204

  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Urologiai Klinika

    Debrecen, 4032

  • Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Urologiai osztaly

    Nyíregyháza, 4400

Other trials in Hungary

Norway4 sites

  • Medi 3 Elverum AS

    Elverum, 2408

  • Medi 3 Innlandet

    Hamar, 2317

  • Norsk Helseklinikk AS, c/o Heiaklinikken

    Lierskogen, 3420

  • Forusakutten AS, Avdeling for oppdragsforskning

    Stavanger, 4005

Other trials in Norway

Poland4 sites

  • Klinika Urologii Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdansku

    Gdansk, 80-402

  • NZOZ Centrum Medyczne

    Lodz, 90-302

  • Centrum Urologiczne Sp. z o. o.

    Mysłowice, 41-400

  • Nzoz "Nasz Lekarz"

    Torun, 87-100

Other trials in Poland

Argentina3 sites

  • Instituto Urologico Buenos Aires

    Buenos Aires, C1060AAA

  • Centro de Urología (CDU)

    Buenos Aires, C1120AAS

  • Instituto Medico Especializado (IME)

    Buenos Aires, C1405BCH

Other trials in Argentina

Lithuania3 sites

  • Saules Seimos Medicinos Centras, JSC

    Kaunas, 49449

  • Mano Seimos Gydytojas, JSC

    Klaipėda, 94231

  • Seimos Gydytojas, JSC

    Vilnius, 01118

Other trials in Lithuania

Philippines3 sites

  • Dr. Pablo O. Torre Memorial Hospital

    Bacolod City, 6100

  • Perpetual Succour Hospital of Cebu Inc.

    Cebu City, Cebu, 6000

  • St. Paul's Hospital

    Iloilo City, 5000

Other trials in Philippines

Russia3 sites

  • Non-governmental Healthcare Institution Departmental Clinical Hospital at Barnaul station OAO RZD

    Barnaul, 656038

  • Rostov State Medical University, Chair of Urology

    Rostov-on-Don, 344022

  • Research Institute of Obstetrics and Gynaecology D.O. Otta of North-west Department of RAMS

    Saint Petersburg, 199034

Other trials in Russia

South Africa3 sites

  • Clinical Research Unit

    Pretoria, Gauteng, 0001

  • Mayo Centre

    Roodepoort, 1715

  • Clinix Private Clinic

    Vosloorus, Gauteng, 1475

Other trials in South Africa

Taiwan3 sites

  • Chang Gung Medical Foundation. Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • National Taiwan University Hospital, Department of Urology

    Taipei, 100

  • Taipei Veterans General Hospital/Division of Urology

    Taipei, 112

Other trials in Taiwan

Chile2 sites

  • Clinica Uromed

    Santiago, RM, 7500787

  • Hospital Clinico Universidad de Chile

    Santiago, RM, 8380456

Other trials in Chile

Colombia2 sites

  • Solano Y Terront Servicios Medicos Ltda / Unidad Integral de Endocrinologia Uniendo

    Bogota, Cundinamarca, 0000

  • Fundacion Centro de Investigacion Clinica CIC

    Medellín, Antioquia, 0000

Other trials in Colombia

Denmark2 sites

  • Herlev Hospital

    Herlev, 2730

  • Roskilde sygehus, Gynaekologisk/obstetrisk afdeling

    Roskilde, 4000

Other trials in Denmark

Finland2 sites

  • Kouvolan Lääkäriasema

    Kouvola, 45200

  • Lääkäriasema Cantti Oy

    Kuopio, 70110

Other trials in Finland

Greece2 sites

  • University General Hospital of Larisa/ Urology Department

    Larissa, 41110

  • General Hospital Papageorgiou

    Thessaloniki, 56429

Other trials in Greece

Italy2 sites

  • Università Magna Graecia di Catanzaro

    Catanzaro, Italy, 88100

  • Clinica Urologica Centro Trapianti di rene

    Foggia, 71122

Other trials in Italy

Egypt1 site

  • Al-Azhar University hospital

    Cairo

Other trials in Egypt

Mexico1 site

  • Hospital Lomas de San Luis Internacional

    San Luis Potosí City, San Luis Potosí, 78218

Other trials in Mexico

About this study

Official title: 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.

Being tested
Fesoterodine 8mg, Fesoterodine 4mg, Placebo
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fesoterodine 8mgDrug

    Oral, 1 tablet per day, 12 weeks duration, 8mg/day

  • Fesoterodine 4mgDrug

    Oral, 1 tablet per day, 12 weeks duration, 4mg/day

  • PlaceboDrug

    Oral, 1 tablet per day, 12 weeks duration

Study groups in NCT01302067
Study groupRoleWhat they receive
Fesoterodine 8mgExperimentalNot described
Receives: Drug: Fesoterodine 8mg
Fesoterodine 4mgExperimentalNot described
Receives: Drug: Fesoterodine 4mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at 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.

    Measured: Week 12

Secondary outcomes (21)

  1. Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.

    Micturitions include episodes of voluntary micturition and episodes of UUI.

    Measured: Week 4

  2. Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.

    Micturitions include episodes of voluntary micturition and episodes of UUI.

    Measured: Week 12

  3. Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.

    Micturitions include episodes of voluntary micturition and episodes of UUI.

    Measured: Week 4

  4. Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.

    Micturitions include episodes of voluntary micturition and episodes of UUI.

    Measured: Week 12

  5. Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at 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.

    Measured: Week 4

  6. Change From Baseline in Percentage of UUI Episodes Per 24 Hours at 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.

    Measured: Week 4

  7. Change From Baseline in Percentage of UUI Episodes Per 24 Hours at 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.

    Measured: Week 12

  8. Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at 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.

    Measured: Week 4

  9. Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at 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.

    Measured: Week 12

  10. Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at 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.

    Measured: Week 4

  11. Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at 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.

    Measured: Week 12

  12. Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at 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.

    Measured: Week 12

  13. Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at 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).

    Measured: Week 12

  14. Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at 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.

    Measured: Week 12

  15. Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at 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.

    Measured: Week 12

  16. Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at 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.

    Measured: Week 12

  17. Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at 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.

    Measured: Week 12

  18. 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.

    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.

    Measured: Week 12

  19. Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at 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.

    Measured: Week 12

  20. Percentage of Participants Who Became Dry at 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

    Measured: Week 4

  21. Percentage of Participants Who Became Dry at 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.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,012 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01302067
Sponsor's protocol ID
A0221095
Other IDs
EIGHT
Status last verified
Feb 2014
First submitted
18 Feb 2011
Last updated
26 Mar 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 37160401

  • 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.

    PubMed 35881009

  • Chapple C, Schneider T, Haab F, Sun F, Whelan L, Scholfield D, Dragon E, Mangan E. Superiority of fesoterodine 8 mg vs 4 mg in reducing urgency urinary incontinence episodes in patients with overactive bladder: results of the randomised, double-blind, placebo-controlled EIGHT trial. BJU Int. 2014 Sep;114(3):418-26. doi: 10.1111/bju.12678. Epub 2014 Jul 1.

    PubMed 24552358

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fesoterodine 8mg and Fesoterodine 4mg in people with Overactive Bladder, run by Pfizer at 293 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 293 sites in United States, Germany, Canada, Sweden, Slovakia and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01302067, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.

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