NCT01302067

Brief 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. The study also assesses the side effects and safety of the two doses.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
2,012

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2011

Geographic Reach
27 countries

293 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 24, 2013

Completed
Last Updated

March 26, 2014

Status Verified

February 1, 2014

Enrollment Period

1.5 years

First QC Date

February 18, 2011

Results QC Date

November 1, 2013

Last Update Submit

February 25, 2014

Conditions

Outcome Measures

Primary Outcomes (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.

    Week 12

Secondary Outcomes (21)

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

    Week 4

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

    Week 12

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

    Week 4

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

    Week 12

  • Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.

    Week 4

  • +16 more secondary outcomes

Study Arms (3)

Fesoterodine 8mg

EXPERIMENTAL
Drug: Fesoterodine 8mg

Fesoterodine 4mg

EXPERIMENTAL
Drug: Fesoterodine 4mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

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

Fesoterodine 8mg

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

Fesoterodine 4mg

Oral, 1 tablet per day, 12 weeks duration

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (293)

Urology Centers of Alabama

Birmingham, Alabama, 35209, United States

Location

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States

Location

James Gordon McMurray, MD

Huntsville, Alabama, 35801, United States

Location

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, 35801, United States

Location

Mobile Ob-Gyn, P.C.

Mobile, Alabama, 36608, United States

Location

Montgomery Women's Health Associates, P.C.

Montgomery, Alabama, 36117, United States

Location

Scottsboro Quick Care Clinic

Scottsboro, Alabama, 35768, United States

Location

Dedicated Clinical Research

Phoenix, Arizona, 85020, United States

Location

Genova Clinical Research

Tucson, Arizona, 85704, United States

Location

NEA Baptist Women's Clinic

Jonesboro, Arkansas, 72401, United States

Location

A Clinic For Women

Little Rock, Arkansas, 72205, United States

Location

Larry S. Watkins, MD

Little Rock, Arkansas, 72205, United States

Location

Lynn Institute of the Ozarks

Little Rock, Arkansas, 72205, United States

Location

May Women's Health Clinic

Little Rock, Arkansas, 72205, United States

Location

The Office of Dr. Simon Yassear, MD

Carmichael, California, 95608, United States

Location

Citrus Valley Medical Research, Inc.

Glendora, California, 91741, United States

Location

Grossmont Center for Clinical Research

La Mesa, California, 91942, United States

Location

Sockolov and Sockolov APC

Sacramento, California, 95825, United States

Location

Genesis Center for Clinical Research

San Diego, California, 92103, United States

Location

San Diego Clinical Trials

San Diego, California, 92120, United States

Location

Clinical Innovations, Inc.

Santa Ana, California, 92705, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Urology Associates, PC

Denver, Colorado, 80113, United States

Location

Genitourinary Surgical Consultants

Denver, Colorado, 80220, United States

Location

The Women's Clinic of Northern Colorado

Fort Collins, Colorado, 80524, United States

Location

Women's Health Specialty Care

Farmington, Connecticut, 06032, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Uromedix

Aventura, Florida, 33180, United States

Location

Meridien Research

Bradenton, Florida, 34208, United States

Location

Florida Sleep Disorder Center of Brandon

Brandon, Florida, 33511, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Pulmonary Associates of Brandon

Brandon, Florida, 33511, United States

Location

Meridien Research

Brooksville, Florida, 34601, United States

Location

Nature Coast Clinical Research

Crystal River, Florida, 34429, United States

Location

Doctors Medical Center of Walton County

DeFuniak Springs, Florida, 32435, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

SJS Clinical Research, Inc.

Destin, Florida, 32541, United States

Location

Fleming Island Center for Clinical Research

Fleming Island, Florida, 32003, United States

Location

M & O Clinical Research, LLC

Fort Lauderdale, Florida, 33316, United States

Location

Florida Urology Physicians

Fort Myers, Florida, 33908, United States

Location

Urological Research Network, LLC

Hialeah, Florida, 33016, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

OB-GYN Associates of Mid-Florida, PA

Leesburg, Florida, 34748, United States

Location

New Horizon Research Center

Miami, Florida, 33175, United States

Location

Urology Health Team, PLLC

Ocala, Florida, 34474, United States

Location

Broward Research Group

Pembroke Pines, Florida, 33026, United States

Location

Clinical Research of Central Florida

Plant City, Florida, 33563, United States

Location

Southeastern Research Group, Inc.

Tallahassee, Florida, 32308, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

Advanced OBGYN Associates

West Palm Beach, Florida, 33409, United States

Location

Clinical Research of Central Florida

Winter Haven, Florida, 33880, United States

Location

North Fulton Urology, PC

Roswell, Georgia, 30076, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

Location

North Georgia Internal Medicine

Woodstock, Georgia, 30189, United States

Location

Women's Healthcare Associates dba Rosemark WomenCare Specialists

Idaho Falls, Idaho, 83404, United States

Location

Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

Women's Health Practice

Champaign, Illinois, 61820, United States

Location

Center for Women's Research

Chicago, Illinois, 60612, United States

Location

Medical and Surgical Specialists

Galesburg, Illinois, 61401, United States

Location

Clinical Investigation Specialists, Inc.

Gurnee, Illinois, 60031, United States

Location

American Health Network of Indiana, LLC

Avon, Indiana, 46123, United States

Location

Summit Research Institute

Bloomington, Indiana, 47403, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

American Health Network of Indiana, LLC

Greenfield, Indiana, 46140, United States

Location

Metropolitan Urology

Jeffersonville, Indiana, 47130, United States

Location

Deaconess Clinic Gateway Health Center

Newburgh, Indiana, 47630, United States

Location

University of Iowa Healthcare

Iowa City, Iowa, 52242, United States

Location

Health Science Research Center

Pratt, Kansas, 67124, United States

Location

Women's and Family Care dba GTC Research

Shawnee, Kansas, 66218, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Kentucky Medical Research Center

Lexington, Kentucky, 40504, United States

Location

Commonwealth Biomedical Research

Madisonville, Kentucky, 42431, United States

Location

Central Kentucky Research Associates, Inc.

Mount Sterling, Kentucky, 40353, United States

Location

Mount Sterling Clinic

Mount Sterling, Kentucky, 40353, United States

Location

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

Greenbelt, Maryland, 20770, United States

Location

Boston Clinical Trials, Inc.

Boston, Massachusetts, 02135, United States

Location

Beacon Clinical Research, LLC

Brockton, Massachusetts, 02301, United States

Location

Clinical Research Center of Cape Cod, Inc.

Hyannis, Massachusetts, 02601, United States

Location

Infinity Medical Research

North Dartmouth, Massachusetts, 02747, United States

Location

DM Clinical Research

Springfield, Massachusetts, 01103, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

CRC of Jackson

Jackson, Mississippi, 39202, United States

Location

Mississippi Urology Clinic

Jackson, Mississippi, 39202, United States

Location

Midwest Pharmaceutical Research

City of Saint Peters, Missouri, 63376, United States

Location

Mercy Health Research

St Louis, Missouri, 63141, United States

Location

Family Health Care Center

Lincoln, Nebraska, 68506, United States

Location

Women's Clinic of Lincoln, P.C.

Lincoln, Nebraska, 68510, United States

Location

Lincoln Internal Medicine Associates

Lincoln, Nebraska, 68516, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89123, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89130, United States

Location

Virtua Phoenix Ob-Gyn

Moorestown, New Jersey, 08057, United States

Location

Premier Research, Inc.

Trenton, New Jersey, 08611, United States

Location

United Medical Associates

Binghamton, New York, 13901, United States

Location

Brooklyn Urology Research Group

Brooklyn, New York, 11215, United States

Location

Urological Surgeons of Long Island

Garden City, New York, 11530, United States

Location

Premier Medical Group of the Hudson Valley

Kingston, New York, 12401, United States

Location

Mid Hudson Medical Research, PLLC

New Windsor, New York, 12553, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12601, United States

Location

Upstate Clinical Research Associates

Williamsville, New York, 14221, United States

Location

Kernodle Clinic, Inc.

Burlington, North Carolina, 27215, United States

Location

American Health Research

Charlotte, North Carolina, 28207, United States

Location

Carolina Clinical Trials

Concord, North Carolina, 28025, United States

Location

Carolina Urology Partners, PLLC

Concord, North Carolina, 28025, United States

Location

Carolinas Research Associates

Harrisburg, North Carolina, 28075, United States

Location

University Medical Associates

Huntersville, North Carolina, 28078, United States

Location

Wake Internal Medicine Consultants, Inc.

Raleigh, North Carolina, 27612, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

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

Winston-Salem, North Carolina, 27103, United States

Location

Hawthorne Medical Research, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Patient Priority Clinical Sites, LLC

Cincinnati, Ohio, 45215, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Columbus Center for Women's Health Research

Columbus, Ohio, 43213, United States

Location

Columbus Clinical Research

Columbus, Ohio, 43213, United States

Location

Hometown Urgent Care and Research

Dayton, Ohio, 45432, United States

Location

HWC Women's Research Center

Englewood, Ohio, 45322, United States

Location

Ohio Clinical Research, LLC

Willoughby Hills, Ohio, 44094, United States

Location

The Office of Johnny B. Roy, MD

Edmond, Oklahoma, 73034, United States

Location

Legacy Clinical Research, LLC

Oklahoma City, Oklahoma, 73109, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Institute for Female Pelvic Medicine

Allentown, Pennsylvania, 18103, United States

Location

Laurel Highlands OB/GYN

Hopwood, Pennsylvania, 15445, United States

Location

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, 19046, United States

Location

Richard Kastelic and Associates

Johnstown, Pennsylvania, 15405, United States

Location

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, 15206, United States

Location

Triangle Urological Group

Pittsburgh, Pennsylvania, 15212, United States

Location

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

State College, Pennsylvania, 16801, United States

Location

Pish Medical Associates

Uniontown, Pennsylvania, 15401, United States

Location

Advanced Clinical Concepts

West Reading, Pennsylvania, 19611, United States

Location

Woman's Clinic Ltd.

West Reading, Pennsylvania, 19611, United States

Location

Coastal Medical

East Greenwich, Rhode Island, 02818, United States

Location

Safe Harbor Clinical Research

East Providence, Rhode Island, 02914, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

TLM Medical Services, LLC

Columbia, South Carolina, 29204, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Southern Urogynecology

West Columbia, South Carolina, 29169, United States

Location

Internal Medicine and Pediatric Associates of Bristol, PC

Bristol, Tennessee, 37620, United States

Location

PMG Research of Bristol, LLC

Bristol, Tennessee, 37620, United States

Location

Adams Patterson Gynocology and Obstetrics, PLLC

Memphis, Tennessee, 38120, United States

Location

Heartland Medical PC

New Tazewell, Tennessee, 37825, United States

Location

Austin Center for Clinical Research

Austin, Texas, 78756, United States

Location

RJE Clinical Research

Dallas, Texas, 75224, United States

Location

Memorial Clinical Associates dba MCA Research

Houston, Texas, 77079, United States

Location

ACRC Trials (Administrative/Mailing Site)

Plano, Texas, 75024, United States

Location

North Texas Family Medicine

Plano, Texas, 75093, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Institute for Women's Health

San Antonio, Texas, 78229, United States

Location

Seven Oaks Women's Center

San Antonio, Texas, 78229, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78299, United States

Location

Scott and White Healthcare

Temple, Texas, 76502, United States

Location

Scott and White Healthcare

Temple, Texas, 76508, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

National Clinical Research - Richmond

Richmond, Virginia, 23294, United States

Location

Independence Family Medicine

Virginia Beach, Virginia, 23455, United States

Location

Seattle Urology Research Center

Burien, Washington, 98166, United States

Location

CAMC Clinical Trials Center

Charleston, West Virginia, 25304, United States

Location

CAMC Physicians Group

Charleston, West Virginia, 25304, United States

Location

Charleston Internal Medicine, Inc.

Charleston, West Virginia, 25304, United States

Location

Urologic Surgical Center

Charleston, West Virginia, 25304, United States

Location

Clinical Investigation Specialists, Inc.

Kenosha, Wisconsin, 53142, United States

Location

Dean Oregon Clinic

Oregon, Wisconsin, 53575, United States

Location

Allegiance Research Specialists

Wauwatosa, Wisconsin, 53226, United States

Location

Instituto Urologico Buenos Aires

Buenos Aires, C1060AAA, Argentina

Location

Centro de Urología (CDU)

Buenos Aires, C1120AAS, Argentina

Location

Instituto Medico Especializado (IME)

Buenos Aires, C1405BCH, Argentina

Location

Office of Dr. Peter Pommerville

Victoria, British Columbia, V6T 5G1, Canada

Location

Can-Med Clinical Research

Victoria, British Columbia, V8R 6T9, Canada

Location

Office of Dr. Nazmuddin Merali

Victoria, British Columbia, V8R 6T9, Canada

Location

Can-Med Clinical Research Incorporated

Victoria, British Columbia, V8T 5G1, Canada

Location

Pharos Medical Research Ltd.

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

Location

Queen Elizabeth Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

McMaster Institute of Urology, St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Office of Dr. Bernard Goldfarb

North Bay, Ontario, P1B 7K8, Canada

Location

Stanley Flax Medical Professional Corporation

North York, Ontario, M2J 1V1, Canada

Location

Urotec

Oshawa, Ontario, L1H 7K4, Canada

Location

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Toronto Urology Clinical Study Group

Toronto, Ontario, M6A 3B5, Canada

Location

Urology South Shore Research

Greenfield Park, Quebec, J4V 2H3, Canada

Location

UroLaval

Laval, Quebec, H7G 2E6, Canada

Location

Ultra-Med Inc.

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Clinica Uromed

Santiago, RM, 7500787, Chile

Location

Hospital Clinico Universidad de Chile

Santiago, RM, 8380456, Chile

Location

Fundacion Centro de Investigacion Clinica CIC

Medellín, Antioquia, 0000, Colombia

Location

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

Bogota, Cundinamarca, 0000, Colombia

Location

Urologicka ambulance

Benešov, 25601, Czechia

Location

FN a LFUK Hradec Kralove/Urologicka klinika

Hradec Králové, 500 05, Czechia

Location

Nemocnice Jablonec nad Nisou

Jablonec nad Nisou, 466 60, Czechia

Location

Fakultni nemocnice v Motole

Prague, 15006, Czechia

Location

Urologicka klinika

Praha 1 - Nove Mesto, 110 00, Czechia

Location

Androgeos spol. s.r.o.

Praha 6 - Hradcany, 160 00, Czechia

Location

Urologicka ambulance

Znojmo, 66902, Czechia

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Roskilde sygehus, Gynaekologisk/obstetrisk afdeling

Roskilde, 4000, Denmark

Location

Al-Azhar University hospital

Cairo, Egypt

Location

Kouvolan Lääkäriasema

Kouvola, 45200, Finland

Location

Lääkäriasema Cantti Oy

Kuopio, 70110, Finland

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

CHU de Nantes - Hôtel Dieu

Nantes, 44093, France

Location

Hôpital CAREMEAU - Service Urologie/Andrologie

Nîmes, 30029, France

Location

Hôpital Tenon - Service d'Urologie

Paris, 75020, France

Location

Arztpraxis

Alzey, 55232, Germany

Location

Synexus Clinical Research GmbH

Berlin, 12627, Germany

Location

Klinische Forschung Berlin-Buch GmbH

Berlin, 13125, Germany

Location

Synexus Clinical Research GmbH

Bochum, 44787, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Synexus Clinical Research GmbH

Frankfurt am Main, 60596, Germany

Location

Synexus Clinical Research GmbH

Görlitz, 02826, Germany

Location

Clinical Research Hamburg

Hamburg, 22143, Germany

Location

Klinische Forschung Hannover - Mitte GmbH

Hanover, 30159, Germany

Location

Allgemeinmedizin Praktische Aerzte

Karlsruhe, 76199, Germany

Location

Arztpraxis

Lauenburg, 21481, Germany

Location

Synexus Clinical Research GmbH

Leipzig, 04103, Germany

Location

SMO MD GmbH

Magdeburg, 39112, Germany

Location

CRS Clinical Research Service Moenchengladbach GmbH

Mönchengladbach, 41061, Germany

Location

Praxisklinik Urologie Rhein-Ruhr

Muelheim A.d. Ruhr, 45468, Germany

Location

Facharzt fuer Urologie

Reutlingen, 72764, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

University General Hospital of Larisa/ Urology Department

Larissa, 41110, Greece

Location

General Hospital Papageorgiou

Thessaloniki, 56429, Greece

Location

Synexus Magyarorszag Kft.

Budapest, 1036, Hungary

Location

Jahn Ferenc Del-pesti Korhaz, Urologiai Osztaly

Budapest, 1204, Hungary

Location

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Urologiai Klinika

Debrecen, 4032, Hungary

Location

Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Urologiai osztaly

Nyíregyháza, 4400, Hungary

Location

Università Magna Graecia di Catanzaro

Catanzaro, Italy, 88100, Italy

Location

Clinica Urologica Centro Trapianti di rene

Foggia, 71122, Italy

Location

Saules Seimos Medicinos Centras, JSC

Kaunas, 49449, Lithuania

Location

Mano Seimos Gydytojas, JSC

Klaipėda, 94231, Lithuania

Location

Seimos Gydytojas, JSC

Vilnius, 01118, Lithuania

Location

Hospital Lomas de San Luis Internacional

San Luis Potosí City, San Luis Potosí, 78218, Mexico

Location

Medi 3 Elverum AS

Elverum, 2408, Norway

Location

Medi 3 Innlandet

Hamar, 2317, Norway

Location

Norsk Helseklinikk AS, c/o Heiaklinikken

Lierskogen, 3420, Norway

Location

Forusakutten AS, Avdeling for oppdragsforskning

Stavanger, 4005, Norway

Location

Perpetual Succour Hospital of Cebu Inc.

Cebu City, Cebu, 6000, Philippines

Location

Dr. Pablo O. Torre Memorial Hospital

Bacolod City, 6100, Philippines

Location

St. Paul's Hospital

Iloilo City, 5000, Philippines

Location

Klinika Urologii Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdansku

Gdansk, 80-402, Poland

Location

NZOZ Centrum Medyczne

Lodz, 90-302, Poland

Location

Centrum Urologiczne Sp. z o. o.

Mysłowice, 41-400, Poland

Location

Nzoz "Nasz Lekarz"

Torun, 87-100, Poland

Location

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

Barnaul, 656038, Russia

Location

Rostov State Medical University, Chair of Urology

Rostov-on-Don, 344022, Russia

Location

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

Saint Petersburg, 199034, Russia

Location

URO CLINIC, s.r.o.

Bratislava, 811 06, Slovakia

Location

Ruzinovska poliklinika, a.s.

Bratislava, 820 07, Slovakia

Location

Nemocnica s Poliklinikou Svateho Lukasa Galanta

Galanta, 924 22, Slovakia

Location

UROX s.r.o.

Piešťany, 921 01, Slovakia

Location

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

Považská Bystrica, 017 01, Slovakia

Location

Fakultna nemocnica Trencin

Trenčín, 911 71, Slovakia

Location

GYNPOR SK, s.r.o. Urogynekologicka ambulancia

Zvolen, 960 01, Slovakia

Location

UROGYN,s.r.o.

Žilina, 010 01, Slovakia

Location

Fakultna nemocnica s poliklinikou Zilina

Žilina, 012 07, Slovakia

Location

Clinical Research Unit

Pretoria, Gauteng, 0001, South Africa

Location

Clinix Private Clinic

Vosloorus, Gauteng, 1475, South Africa

Location

Mayo Centre

Roodepoort, 1715, South Africa

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

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

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Department of Urology, Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

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

Seoul, 137-701, South Korea

Location

Asan Medical Center, Department of Urology

Seoul, 138-736, South Korea

Location

Carema Specialistvard Eslov

Eslöv, 241 23, Sweden

Location

Hagakliniken

Gothenburg, 413 28, Sweden

Location

CTC, Sahlgrenska sjukhuset/SU

Gothenburg, 413 45, Sweden

Location

Probare

Lund, 222 22, Sweden

Location

Center for Lakemedelsstudier

Malmo, 211 52, Sweden

Location

Ladulaas kliniska studier

Skene, 511 62, Sweden

Location

Verksamhet Urologi

Skövde, 541 85, Sweden

Location

Kvinnokliniken Karolinska Universitetssjukhuset Huddinge

Stockholm, 141 86, Sweden

Location

S3 Clinical Research Centers

Vällingby, 162 68, Sweden

Location

Vasterviks sjukhus, Kvinnokliniken

Västervik, 593 81, Sweden

Location

Chang Gung Medical Foundation. Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

National Taiwan University Hospital, Department of Urology

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital/Division of Urology

Taipei, 112, Taiwan

Location

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

Chernivtsi, 58002, Ukraine

Location

City Hospital #4 of Donetsk, Woman Consultative Department

Donetsk, 83002, Ukraine

Location

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

Donetsk, Ukraine

Location

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

Donetsk, Ukraine

Location

Uzhorod City Outpatient Clinic, Prophylaxis Department

Uzhhorod, 88000, Ukraine

Location

Vinnitsa Regional Clinical Dispensary of Endocrinology

Vinnitsa, 21010, Ukraine

Location

Urology Dept of Zaporizhzhia Medical Academy of Postgraduate Education

Zaporizhzhia, 69600, Ukraine

Location

Fowey River Practice

Fowey, Cornwall, PL23 1DT, United Kingdom

Location

Knowle House Surgery

Plymouth, Devon, PL5 3JB, United Kingdom

Location

Ormeau Health Centre

Belfast, Northern Ireland, BT7 2EB, United Kingdom

Location

Cambridge University Hospital Trials NHS Trust

Cambridge, CB2 2QQ, United Kingdom

Location

Southern General Hospital

Glasgow, G51 4TF, United Kingdom

Location

Baillieston Health Centre

Glasgow, G69 7AD, United Kingdom

Location

Sheepcot Medical Centre

Hertfordshire, WD2 6EB, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

Related Publications (3)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 23, 2011

Study Start

May 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

March 26, 2014

Results First Posted

December 24, 2013

Record last verified: 2014-02

Locations