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).

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.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Overactive
• Intervention / Treatment: Drug: Fesoterodine 8 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 990
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • MBAL Trimontsium OOD
  • Ruse, Bulgaria, 7002
    • MBAL Ruse AD, Urologichno otdelenie,
  • Sofia, Bulgaria, 1431
    • UMBAL Aleksandrovska EAD
  • Sofia, Bulgaria, 1606
    • MBALSM N.I.Pirogov EAD
  • Sofia, Bulgaria, 1632
    • MBAL Doverie AD, Otdelenie po urologia
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2V 1P9
      • The Prostate Cancer Centre
    • Edmonton, Alberta, Canada, T5H 3V9
      • Lois Hole Hospital for Women, Royal Alexandra Hospital
  • New Brunswick
    • Bathurst, New Brunswick, Canada, E2A 4X7
      • Maritime Research Center
    • Bathurst, New Brunswick, Canada, E2A 4Z9
      • Maritime Research Center
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • The Male/Female Health and Research Centre, Royal Court Medical Centre
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital
    • Kingston, Ontario, Canada, K7L 3J7
      • Centre for Applied Urological Research, Queen's University, Kingston General Hospital
    • Ottawa, Ontario, Canada, K1H 1A2
      • URLX Corporation
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H4N 3C5
      • Diex Research Montreal Inc.
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Diex Research Sherbrooke Inc.
• Czechia
  • Hradec Kralove, Czechia, 500 02
    • Prvni privatni chirurgicke centrum spol. s .r.o. - SANUS
  • Jindrichuv Hradec, Czechia, 377 38
    • Nemocnice Jindrichuv Hradec
  • Kolin III, Czechia, 28000
    • Oblastni nemocnice Kolin, a.s.
  • Usti nad Labem, Czechia, 401 13
    • Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.
• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospital
• Finland
  • Turku, Finland, 20100
    • Suomen Terveystalo Turku
• Germany
  • Berlin, Germany, 10787
    • Klinische Forschung Berlin
  • Berlin, Germany, 10117
    • Klinische Forschung Berlin-Mitte GmbH
  • Berlin, Germany, 14052
    • Praxis fuer Urologie
  • Duisburg, Germany, 47179
    • Duisburger Fachaerztegemeinschaft
  • Elsterwerda, Germany, 04910
    • ZKS Suedbrandenburg GmbH
  • Frankfurt am Main, Germany, 60322
    • Facharzt für Frauenheilkunde und Geburtshilfe
  • Hagenow, Germany, 19230
    • Urologische Praxis
  • Hamburg, Germany, 20253
    • Klinische Forschung Hamburg GmbH
  • Marburg, Germany, 35039
    • Arztpraxis Dr. von Keitz
  • Mittweida, Germany, 09648
    • Pharmakologisches Studienzentrum Chemnitz GmbH
  • Muenchen, Germany, 81241
    • Frauenarzt Praxis
• Hungary
  • Budapest, Hungary, 1082
    • Semmelweis Egyetem Altalanos Orvostudomanyi Kar Urologiai Klinika
  • Sopron, Hungary, 9400
    • Soproni Erzsebet Oktato Korhaz, Urologiai Osztaly
  • Szentes, Hungary, 6600
    • Donatella 99 Bt.
  • Szolnok, Hungary, 5000
    • MAV Korhaz es Rendelointezet, Urologia
• Korea, Republic of
  • Pusan, Korea, Republic of, 602-739
    • Department of Urology, Pusan National University Hospital
  • Seoul, Korea, Republic of, 143-729
    • Department of Urology, Konkuk University Medical Center
  • Suwon, Korea, Republic of, 443-721
    • Department of Urology, Ajou University Hospital
• Mexico
  • Colima, Mexico, 28000
    • Unidad de Diagnostico Integral
  • Estado De Mexico
    • Cuautitlan Izcalli, Estado De Mexico, Mexico, 54740
      • Phylasis Clinicas Research S de RL de CV
• Poland
  • Gdynia, Poland, 81-366
    • NZOZ VIP - MED, Poradnia Urologiczna
  • Slupsk, Poland, 76-200
    • SP ZOZ Wojewodzki Szpital Specjalistyczny im. J. Koraczaka
  • Warszawa, Poland, 02-926
    • Specjalistyczny Gabinet Lekarski
• Russian Federation
  • Kemerovo, Russian Federation, 650066
    • Kemerovо Regional Perinatal Center
  • Moscow, Russian Federation, 115516
    • Moscow State Healthcare Institution City Clinical Hospital #12
  • Saint-Petersburg, Russian Federation, 196247
    • Saint-Petersburg State Budgetary Healthcare Institution City Hospital #26
  • Saint-Petersburg, Russian Federation, 197022
    • Saint-Petersburg State Medical University I.P.Pavlov
  • Saint-Petersburg, Russian Federation, 198205
    • Saint-Petersburg State Healthcare Institution City Hospital # 15
  • St. Petersburg, Russian Federation, 199106
    • St. Petersburg State Healthcare Institution
  • Tomsk, Russian Federation, 634050
    • Siberian State Medical University
• South Africa
  • Kwa Zulu Natal
    • Durban, Kwa Zulu Natal, South Africa
      • Parklands Hospital
• Sweden
  • Bandhagen, Sweden, 124 54
    • Kvinnohalsan Soder
  • Goteborg, Sweden, 405 45
    • Specialistmottagningen i urologi
  • Goteborg, Sweden, 412 54
    • Partus Kvinnohalsa
  • Goteborg, Sweden, 41263
    • ME3PLUS Clinical Trials
  • Halmstad, Sweden, 302 46
    • Tudorkliniken, Specialistmottagningen i Urologi
  • Norrkoping, Sweden, 601 82
    • Vrinnevisjukhuset
• Ukraine
  • Dnipropetrovsk, Ukraine, 49005
    • Regional Clinical Hospital, Department of Urology of Dnipropetrovsk State Medical Academy
  • Kharkiv, Ukraine, 61037
    • Regional Clinical Center of Urology and Nephrology
  • Kyiv, Ukraine, 04053
    • Institute of Urology of AMS of Ukraine
  • Lugansk, Ukraine
    • Lugansk City Multi-Discipline Hospital #2, department of Urology
  • Lviv, Ukraine, 79059
    • 5Th City Clinical Hospital, Urology Department
  • Odesa, Ukraine, 65009
    • LTD Out-patient clinic of General practice and Family medicine
  • Poltava, Ukraine
    • Poltava Regional Clinical Hospital, Department of Urology
  • Ternopil, Ukraine, 46002
    • Municipal Institution of Ternopil Regional Council, Ternopil University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Radiant Research, Inc.
    • Birmingham, Alabama, United States, 35235
      • Alabama Internal Medicine, PC
    • Fairhope, Alabama, United States, 36532
      • Brown and McCool Gynecology
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Radiant Research, Inc.
    • Green Valley, Arizona, United States, 85614
      • Eclipse Clinical Research
    • Tucson, Arizona, United States, 85710
      • Radiant Research, Inc.
    • Tucson, Arizona, United States, 85715
      • Urological Associates of Southern Arizona, PC
  • California
    • Los Angeles, California, United States, 90017
      • American Institute of Research
    • Los Angeles, California, United States, 90017
      • Urology Group of Southern California
    • Los Angeles, California, United States, 90048
      • Institute for Advanced Urology
    • Los Angeles, California, United States, 90017
      • Moaz Khorsandi, DO
    • Paramount, California, United States, 90723
      • Center for Clinical Trials, LLC
    • Roseville, California, United States, 95661
      • Sierra Clinical Research
    • Sacramento, California, United States, 95825
      • Superior Research LLC
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92103
      • California Research Foundation
  • Colorado
    • Parker, Colorado, United States, 80134
      • Advanced Urology, PC
  • Connecticut
    • Groton, Connecticut, United States, 06340
      • Thameside Obstetrics/Gynecological Center
    • Hartford, Connecticut, United States, 06105
      • S.H.E. Medical Associates
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Bradenton, Florida, United States, 34205
      • Manatee Medical Research Institute, LLC
    • Daytona Beach, Florida, United States, 32114
      • Atlantic Institute of Clinical Research
    • Destin, Florida, United States, 32541
      • Sjs Clinical Research
    • Ocala, Florida, United States, 34471
      • Ocala Urology Specialists
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research, Inc.
    • Port Orange, Florida, United States, 32129
      • Accord Clinical Research, LLC
    • Saint Petersburg, Florida, United States, 33710
      • Pinellas Urology, Inc.
    • Tampa, Florida, United States, 33607
      • Florida Urology Partners
    • Wellington, Florida, United States, 33449
      • The Office of Georgis Patsias, MD, PA
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Atlanta Medical Research Institute, LLC
    • Atlanta, Georgia, United States, 30342
      • Radiant Research, Inc.
    • Duluth, Georgia, United States, 30096
      • In-Quest Medical Research, LLC
    • Rome, Georgia, United States, 30165
      • Valley Health Care
    • Rome, Georgia, United States, 30165
      • Prism Research Group
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Fox Valley Clinical Research Center, LLC
    • Chicago, Illinois, United States, 60654
      • Radiant Research, Inc.
  • Indiana
    • Noblesville, Indiana, United States, 46062
      • Urology of Indiana, LLC
  • Kansas
    • Overland Park, Kansas, United States, 66202
      • Radiant Research, Inc.
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research Fall River, LLC
    • New Bedford, Massachusetts, United States, 02740
      • New England Center for Clinical Research of Massachusetts, LLC
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials, Inc.
  • Michigan
    • Kalamazoo, Michigan, United States, 49009
      • Beyer Research
    • Traverse City, Michigan, United States, 49684
      • Medical Research Associates, Inc.
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Radiant Research, Inc.
    • Sartell, Minnesota, United States, 56377
      • Adult and Pediatric Urology
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • CRC of Jackson
    • Jackson, Mississippi, United States, 39202
      • Women's Specialty Center
    • Southaven, Mississippi, United States, 38671
      • The Urology Group
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Radiant Research, Inc.
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Impact Clinical Trials
    • Las Vegas, Nevada, United States, 89102
      • Francis Jimenez, MD
    • Las Vegas, Nevada, United States, 89106
      • Richard M. Groom, MD
  • New York
    • Albany, New York, United States, 12205
      • Northeast Urogynecology
    • Albany, New York, United States, 12208
      • The Urologic Institute of Northeastern New York - Community Care Physicians, PC
    • New York, New York, United States, 10016
      • University Urology Associates
    • Oneida, New York, United States, 13421
      • Associated Medical Professionals of New York, PLLC
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals of Ny
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
    • Charlotte, North Carolina, United States, 28209
      • PMG Research of Charlotte
    • Charlotte, North Carolina, United States, 28210
      • Urology Specialists of The Carolinas
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh, LLC
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury, LLC
    • Salisbury, North Carolina, United States, 28144
      • Salibury Urological Clinic
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • Carolina Urological Associates
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Lillestol Research LLC
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research, Inc.
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research, Inc.
    • Columbus, Ohio, United States, 43212
      • Radiant Research, Inc.
    • Dayton, Ohio, United States, 45439
      • Providence Health Partners - Center For Clinical Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pacific Women's Center, LLC
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Urologic Consultants of Southeastern Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • OB/GYN Associates of Erie
    • Pittsburgh, Pennsylvania, United States, 15243
      • Research Protocol Management Specialists
  • Rhode Island
    • East Providence, Rhode Island, United States, 02915
      • Pharma Resource
    • East Providence, Rhode Island, United States, 02914
      • Gilbert Teixeira, DO
    • Pawtucket, Rhode Island, United States, 02860
      • Memorial Hospital of Rhode Island - Clinical Studies Center
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research, Inc.
    • Columbia, South Carolina, United States, 29201
      • Columbia Women's Healthcare, LLC
    • Columbia, South Carolina, United States, 29201
      • SC Clinical Research Center, LLC
    • Greer, South Carolina, United States, 29651
      • Radiant Research, Inc.
    • Mount Pleasant, South Carolina, United States, 29464
      • PMG Research of Charleston, LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research, Llc
    • Chattanooga, Tennessee, United States, 37404
      • OB-GYN Centre of Excellence
    • Johnson City, Tennessee, United States, 37601
      • Advanced Therapeutics, Inc.
    • Johnson City, Tennessee, United States, 37604
      • Johnson City Internal Medicine
  • Texas
    • Austin, Texas, United States, 78757
      • Senior Adults Specialty Research
    • Austin, Texas, United States, 78745
      • Adult Care of Austin
    • Beaumont, Texas, United States, 77701
      • DiscoveResearch, Inc.
    • Beaumont, Texas, United States, 77702
      • Beaumont Internal Medicine & Geriatric Associates
    • Bryan, Texas, United States, 77802
      • DiscoveResearch, Inc.
    • Bryan, Texas, United States, 77802
      • DiscoveResearch, Incorporated
    • Dallas, Texas, United States, 75231
      • Radiant Research, Inc.
    • Houston, Texas, United States, 77030
      • Advances in Health, Inc.
    • Houston, Texas, United States, 77062
      • Centex Research, Inc. - Pineloch Medical Clinic
    • Houston, Texas, United States, 77074
      • The Office of Dr. Steven Maislos, MD
    • Plano, Texas, United States, 75024
      • Village Health Partners
    • San Antonio, Texas, United States, 78205
      • Paragon Research Center, LLC
  • Utah
    • Murray, Utah, United States, 84123
      • Radiant Research, Inc.
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Integra Trials, LLC
    • Arlington, Virginia, United States, 22205
      • Washington Urology
  • Washington
    • Mountlake Terrace, Washington, United States, 98043
      • Integrity Medical Research, LLC
    • Mountlake Terrace, Washington, United States, 98043
      • Urology Northwest, PA
    • Spokane, Washington, United States, 99207
      • North Spokane Women's Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo for fesoterodine 4 and 8 mg for a total of 12 weeks.
Experimental: Fesoterodine	Drug: Fesoterodine 8 mg; Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength.; Other Names: Toviaz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12	Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.	Baseline, Week 12
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 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
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12	PPBC: single-item, self-administered validated questionnaire. Participant answered: "Which of the following statements describes your bladder condition best at the moment?" on a 6-point scale, 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of >=2).	Baseline, Week 12
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).	Baseline, Week 12
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. Change=observation minus baseline.	Baseline, Week 12
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL 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.	Baseline, Week 12
Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2	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.	Week -2, Week 12
Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline	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
Percentage of Participants With No UUI Episodes (Diary Dry Rate)	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.	Week 4, Week 12

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.
• Kaplan 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 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 (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: November 7, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Overactive Bladder; Overactive urinary bladder; Bladder Overactive
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Fesoterodine
• Other Study ID Numbers: A0221094