A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).
1 other identifier
interventional
990
15 countries
176
Brief Summary
Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2011
Shorter than P25 for phase_4
176 active sites
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
CompletedFirst Posted
Study publicly available on registry
February 23, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
March 12, 2013
CompletedDecember 4, 2018
November 1, 2018
1 year
February 18, 2011
February 7, 2013
November 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 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.
Baseline, Week 12
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 range from 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.
Baseline, Week 12
Secondary Outcomes (9)
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
Baseline, Week 12
Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12
Baseline, Week 12
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Baseline, Week 12
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12
Baseline, Week 12
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12
Baseline, Week 12
- +4 more secondary outcomes
Study Arms (2)
Fesoterodine
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength.
Eligibility Criteria
You may qualify if:
- Diagnosis of overactive bladder with symptoms for at least 6 months.
- Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine
- Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception
You may not qualify if:
- Conditions or prior treatment that may also affect bladder function
- Clinically significant urinary tract infection (UTI)
- Ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (176)
Radiant Research, Inc.
Birmingham, Alabama, 35209, United States
Alabama Internal Medicine, PC
Birmingham, Alabama, 35235, United States
Brown and McCool Gynecology
Fairhope, Alabama, 36532, United States
Radiant Research, Inc.
Chandler, Arizona, 85225, United States
Eclipse Clinical Research
Green Valley, Arizona, 85614, United States
Radiant Research, Inc.
Tucson, Arizona, 85710, United States
Urological Associates of Southern Arizona, PC
Tucson, Arizona, 85715, United States
American Institute of Research
Los Angeles, California, 90017, United States
Moaz Khorsandi, DO
Los Angeles, California, 90017, United States
Urology Group of Southern California
Los Angeles, California, 90017, United States
Institute for Advanced Urology
Los Angeles, California, 90048, United States
Center for Clinical Trials, LLC
Paramount, California, 90723, United States
Sierra Clinical Research
Roseville, California, 95661, United States
Superior Research LLC
Sacramento, California, 95825, United States
California Research Foundation
San Diego, California, 92103, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Advanced Urology, PC
Parker, Colorado, 80134, United States
Thameside Obstetrics/Gynecological Center
Groton, Connecticut, 06340, United States
S.H.E. Medical Associates
Hartford, Connecticut, 06105, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Manatee Medical Research Institute, LLC
Bradenton, Florida, 34205, United States
Atlantic Institute of Clinical Research
Daytona Beach, Florida, 32114, United States
SJS Clinical Research
Destin, Florida, 32541, United States
Ocala Urology Specialists
Ocala, Florida, 34471, United States
Renstar Medical Research, Inc.
Ocala, Florida, 34471, United States
Accord Clinical Research, LLC
Port Orange, Florida, 32129, United States
Pinellas Urology, Inc.
St. Petersburg, Florida, 33710, United States
Florida Urology Partners
Tampa, Florida, 33607, United States
The Office of Georgis Patsias, MD, PA
Wellington, Florida, 33449, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Atlanta Medical Research Institute, LLC
Alpharetta, Georgia, 30005, United States
Radiant Research, Inc.
Atlanta, Georgia, 30342, United States
In-Quest Medical Research, LLC
Duluth, Georgia, 30096, United States
Prism Research Group
Rome, Georgia, 30165, United States
Valley Health Care
Rome, Georgia, 30165, United States
Fox Valley Clinical Research Center, LLC
Aurora, Illinois, 60504, United States
Radiant Research, Inc.
Chicago, Illinois, 60654, United States
Urology of Indiana, LLC
Noblesville, Indiana, 46062, United States
Radiant Research, Inc.
Overland Park, Kansas, 66202, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
New England Center for Clinical Research Fall River, LLC
Fall River, Massachusetts, 02720, United States
New England Center for Clinical Research of Massachusetts, LLC
New Bedford, Massachusetts, 02740, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472, United States
Beyer Research
Kalamazoo, Michigan, 49009, United States
Medical Research Associates, Inc.
Traverse City, Michigan, 49684, United States
Radiant Research, Inc.
Edina, Minnesota, 55435, United States
Adult and Pediatric Urology
Sartell, Minnesota, 56377, United States
CRC of Jackson
Jackson, Mississippi, 39202, United States
Women's Specialty Center
Jackson, Mississippi, 39202, United States
The Urology Group
Southaven, Mississippi, 38671, United States
Radiant Research, Inc.
St Louis, Missouri, 63141, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Francis Jimenez, MD
Las Vegas, Nevada, 89102, United States
Impact Clinical Trials
Las Vegas, Nevada, 89106, United States
Richard M. Groom, MD
Las Vegas, Nevada, 89106, United States
Northeast Urogynecology
Albany, New York, 12205, United States
The Urologic Institute of Northeastern New York - Community Care Physicians, PC
Albany, New York, 12208, United States
University Urology Associates
New York, New York, 10016, United States
Associated Medical Professionals of New York, PLLC
Oneida, New York, 13421, United States
Associated Medical Professionals of NY
Syracuse, New York, 13210, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, 27518, United States
PMG Research of Charlotte
Charlotte, North Carolina, 28209, United States
Urology Specialists of the Carolinas
Charlotte, North Carolina, 28210, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, 28144, United States
Salibury Urological Clinic
Salisbury, North Carolina, 28144, United States
Carolina Urological Associates
Winston-Salem, North Carolina, 27103, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Lillestol Research LLC
Fargo, North Dakota, 58103, United States
Radiant Research, Inc.
Akron, Ohio, 44311, United States
Radiant Research, Inc.
Cincinnati, Ohio, 45249, United States
Radiant Research, Inc.
Columbus, Ohio, 43212, United States
Providence Health Partners - Center for Clinical Research
Dayton, Ohio, 45439, United States
Central Sooner Research
Norman, Oklahoma, 73071, United States
Pacific Women's Center, LLC
Eugene, Oregon, 97401, United States
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004, United States
OB/GYN Associates of Erie
Erie, Pennsylvania, 16507, United States
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, 15243, United States
Gilbert Teixeira, DO
East Providence, Rhode Island, 02914, United States
Pharma Resource
East Providence, Rhode Island, 02915, United States
Memorial Hospital of Rhode Island - Clinical Studies Center
Pawtucket, Rhode Island, 02860, United States
Radiant Research, Inc.
Anderson, South Carolina, 29621, United States
Columbia Women's Healthcare, LLC
Columbia, South Carolina, 29201, United States
SC Clinical Research Center, LLC
Columbia, South Carolina, 29201, United States
Radiant Research, Inc.
Greer, South Carolina, 29651, United States
PMG Research of Charleston, LLC
Mt. Pleasant, South Carolina, 29464, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404, United States
OB-GYN Centre of Excellence
Chattanooga, Tennessee, 37404, United States
Advanced Therapeutics, Inc.
Johnson City, Tennessee, 37601, United States
Johnson City Internal Medicine
Johnson City, Tennessee, 37604, United States
Adult Care of Austin
Austin, Texas, 78745, United States
Senior Adults Specialty Research
Austin, Texas, 78757, United States
DiscoveResearch, Inc.
Beaumont, Texas, 77701, United States
Beaumont Internal Medicine & Geriatric Associates
Beaumont, Texas, 77702, United States
DiscoveResearch, Inc.
Bryan, Texas, 77802, United States
DiscoveResearch, Incorporated
Bryan, Texas, 77802, United States
Radiant Research, Inc.
Dallas, Texas, 75231, United States
Advances In Health, Inc.
Houston, Texas, 77030, United States
Centex Research, Inc. - Pineloch Medical Clinic
Houston, Texas, 77062, United States
The Office of Dr. Steven Maislos, MD
Houston, Texas, 77074, United States
Village Health Partners
Plano, Texas, 75024, United States
Paragon Research Center, LLC
San Antonio, Texas, 78205, United States
Radiant Research, Inc.
Murray, Utah, 84123, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Integra Trials, LLC
Arlington, Virginia, 22205, United States
Washington Urology
Arlington, Virginia, 22205, United States
Integrity Medical Research, LLC
Mountlake Terrace, Washington, 98043, United States
Urology Northwest, PA
Mountlake Terrace, Washington, 98043, United States
North Spokane Women's Clinic
Spokane, Washington, 99207, United States
MBAL Trimontsium OOD
Plovdiv, 4000, Bulgaria
MBAL Ruse AD, Urologichno otdelenie,
Rousse, 7002, Bulgaria
UMBAL Aleksandrovska EAD
Sofia, 1431, Bulgaria
MBALSM N.I.Pirogov EAD
Sofia, 1606, Bulgaria
MBAL Doverie AD, Otdelenie po urologia
Sofia, 1632, Bulgaria
The Prostate Cancer Centre
Calgary, Alberta, T2V 1P9, Canada
Lois Hole Hospital for Women, Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
Maritime Research Center
Bathurst, New Brunswick, E2A 4X7, Canada
Maritime Research Center
Bathurst, New Brunswick, E2A 4Z9, Canada
The Male/Female Health and Research Centre, Royal Court Medical Centre
Barrie, Ontario, L4M 7G1, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Centre for Applied Urological Research, Queen's University, Kingston General Hospital
Kingston, Ontario, K7L 3J7, Canada
URLX Corporation
Ottawa, Ontario, K1H 1A2, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Diex Research Montreal Inc.
Montreal, Quebec, H4N 3C5, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 1Z1, Canada
Prvni privatni chirurgicke centrum spol. s .r.o. - SANUS
Hradec Králové, 500 02, Czechia
Nemocnice Jindrichuv Hradec
Jindřichův Hradec, 377 38, Czechia
Oblastni nemocnice Kolin, a.s.
Kolin III, 28000, Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, 401 13, Czechia
Ain Shams University Hospital
Cairo, Egypt
Suomen Terveystalo Turku
Turku, 20100, Finland
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
Klinische Forschung Berlin
Berlin, 10787, Germany
Praxis fuer Urologie
Berlin, 14052, Germany
Duisburger Fachaerztegemeinschaft
Duisburg, 47179, Germany
ZKS Suedbrandenburg GmbH
Elsterwerda, 04910, Germany
Facharzt für Frauenheilkunde und Geburtshilfe
Frankfurt am Main, 60322, Germany
Urologische Praxis
Hagenow, 19230, Germany
Klinische Forschung Hamburg GmbH
Hamburg, 20253, Germany
Arztpraxis Dr. von Keitz
Marburg, 35039, Germany
Pharmakologisches Studienzentrum Chemnitz GmbH
Mittweida, 09648, Germany
Frauenarzt Praxis
München, 81241, Germany
Semmelweis Egyetem Altalanos Orvostudomanyi Kar Urologiai Klinika
Budapest, 1082, Hungary
Soproni Erzsebet Oktato Korhaz, Urologiai Osztaly
Sopron, 9400, Hungary
Donatella 99 Bt.
Szentes, 6600, Hungary
MAV Korhaz es Rendelointezet, Urologia
Szolnok, 5000, Hungary
Phylasis Clinicas Research S de RL de CV
Cuautitlán Izcalli, State of Mexico, 54740, Mexico
Unidad de Diagnostico Integral
Colima, 28000, Mexico
NZOZ VIP - MED, Poradnia Urologiczna
Gdynia, 81-366, Poland
SP ZOZ Wojewodzki Szpital Specjalistyczny im. J. Koraczaka
Słupsk, 76-200, Poland
Specjalistyczny Gabinet Lekarski
Warsaw, 02-926, Poland
Kemerovо Regional Perinatal Center
Kemerovo, 650066, Russia
Moscow State Healthcare Institution City Clinical Hospital #12
Moscow, 115516, Russia
Saint-Petersburg State Budgetary Healthcare Institution City Hospital #26
Saint Petersburg, 196247, Russia
Saint-Petersburg State Medical University I.P.Pavlov
Saint Petersburg, 197022, Russia
Saint-Petersburg State Healthcare Institution City Hospital # 15
Saint Petersburg, 198205, Russia
St. Petersburg State Healthcare Institution
Saint Petersburg, 199106, Russia
Siberian State Medical University
Tomsk, 634050, Russia
Parklands Hospital
Durban, KwaZulu-Natal, South Africa
Department of Urology, Pusan National University Hospital
Pusan, 602-739, South Korea
Department of Urology, Konkuk University Medical Center
Seoul, 143-729, South Korea
Department of Urology, Ajou University Hospital
Suwon, 443-721, South Korea
Kvinnohalsan Soder
Bandhagen, 124 54, Sweden
Specialistmottagningen i urologi
Gothenburg, 405 45, Sweden
Partus Kvinnohalsa
Gothenburg, 412 54, Sweden
Me3plus Clinical Trials
Gothenburg, 41263, Sweden
Tudorkliniken, Specialistmottagningen i Urologi
Halmstad, 302 46, Sweden
Vrinnevisjukhuset
Norrköping, 601 82, Sweden
Regional Clinical Hospital, Department of Urology of Dnipropetrovsk State Medical Academy
Dnipropetrovsk, 49005, Ukraine
Regional Clinical Center of Urology and Nephrology
Kharkiv, 61037, Ukraine
Institute of Urology of AMS of Ukraine
Kyiv, 04053, Ukraine
Lugansk City Multi-Discipline Hospital #2, department of Urology
Luhansk, Ukraine
5Th City Clinical Hospital, Urology Department
Lviv, 79059, Ukraine
LTD Out-patient clinic of General practice and Family medicine
Odesa, 65009, Ukraine
Poltava Regional Clinical Hospital, Department of Urology
Poltava, Ukraine
Municipal Institution of Ternopil Regional Council, Ternopil University Hospital
Ternopil, 46002, Ukraine
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.
PMID: 37160401DERIVEDWagg 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.
PMID: 35881009DERIVEDKaplan SA, Cardozo L, Herschorn S, Grenabo L, Carlsson M, Arumi D, Crook TJ, Whelan L, Scholfield D, Ntanios F; Assessment of Fesoterodine after Tolterodine ER (AFTER) Study Group. Efficacy and safety of fesoterodine 8 mg in subjects with overactive bladder after a suboptimal response to tolterodine ER. Int J Clin Pract. 2014 Sep;68(9):1065-73. doi: 10.1111/ijcp.12464. Epub 2014 Jun 4.
PMID: 24898471DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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
May 1, 2012
Study Completion
May 1, 2012
Last Updated
December 4, 2018
Results First Posted
March 12, 2013
Record last verified: 2018-11