Clinical trial NCT01302054: 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.
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Keywords: Bladder Overactive
Overactive urinary bladder
Overactive Bladder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 990
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2
timeFrame: Week -2, Week 12
measure: Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline
timeFrame: Baseline, Week 12
measure: Percentage of Participants With No UUI Episodes (Diary Dry Rate)
timeFrame: Week 4, Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research, Inc.
state: Alabama
city: Birmingham
country: United States
facility: Alabama Internal Medicine, PC
state: Alabama
city: Fairhope
country: United States
facility: Brown and McCool Gynecology
state: Alabama
city: Chandler
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Green Valley
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona, PC
state: Arizona
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Los Angeles
country: United States
facility: Moaz Khorsandi, DO
state: California
city: Los Angeles
country: United States
facility: Urology Group of Southern California
state: California
city: Los Angeles
country: United States
facility: Institute for Advanced Urology
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Roseville
country: United States
facility: Sierra Clinical Research
state: California
city: Sacramento
country: United States
facility: Superior Research LLC
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Parker
country: United States
facility: Advanced Urology, PC
state: Colorado
city: Groton
country: United States
facility: Thameside Obstetrics/Gynecological Center
state: Connecticut
city: Hartford
country: United States
facility: S.H.E. Medical Associates
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Bradenton
country: United States
facility: Manatee Medical Research Institute, LLC
state: Florida
city: Daytona Beach
country: United States
facility: Atlantic Institute of Clinical Research
state: Florida
city: Destin
country: United States
facility: SJS Clinical Research
state: Florida
city: Ocala
country: United States
facility: Ocala Urology Specialists
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research, Inc.
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Pinellas Urology, Inc.
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Wellington
country: United States
facility: The Office of Georgis Patsias, MD, PA
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Medical Research Institute, LLC
state: Georgia
city: Atlanta
country: United States
facility: Radiant Research, Inc.
state: Georgia
city: Duluth
country: United States
facility: In-Quest Medical Research, LLC
state: Georgia
city: Rome
country: United States
facility: Prism Research Group
state: Georgia
city: Rome
country: United States
facility: Valley Health Care
state: Georgia
city: Aurora
country: United States
facility: Fox Valley Clinical Research Center, LLC
state: Illinois
city: Chicago
country: United States
facility: Radiant Research, Inc.
state: Illinois
city: Noblesville
country: United States
facility: Urology of Indiana, LLC
state: Indiana
city: Overland Park
country: United States
facility: Radiant Research, Inc.
state: Kansas
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Fall River
country: United States
facility: New England Center for Clinical Research Fall River, LLC
state: Massachusetts
city: New Bedford
country: United States
facility: New England Center for Clinical Research of Massachusetts, LLC
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Traverse City
country: United States
facility: Medical Research Associates, Inc.
state: Michigan
city: Edina
country: United States
facility: Radiant Research, Inc.
state: Minnesota
city: Sartell
country: United States
facility: Adult and Pediatric Urology
state: Minnesota
city: Jackson
country: United States
facility: CRC of Jackson
state: Mississippi
city: Jackson
country: United States
facility: Women's Specialty Center
state: Mississippi
city: Southaven
country: United States
facility: The Urology Group
state: Mississippi
city: Saint Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: Francis Jimenez, MD
state: Nevada
city: Las Vegas
country: United States
facility: Impact Clinical Trials
state: Nevada
city: Las Vegas
country: United States
facility: Richard M. Groom, MD
state: Nevada
city: Albany
country: United States
facility: Northeast Urogynecology
state: New York
city: Albany
country: United States
facility: The Urologic Institute of Northeastern New York - Community Care Physicians, PC
state: New York
city: New York
country: United States
facility: University Urology Associates
state: New York
city: Oneida
country: United States
facility: Associated Medical Professionals of New York, PLLC
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY
state: New York
city: Cary
country: United States
facility: PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
state: North Carolina
city: Charlotte
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: Charlotte
country: United States
facility: Urology Specialists of the Carolinas
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury, LLC
state: North Carolina
city: Salisbury
country: United States
facility: Salibury Urological Clinic
state: North Carolina
city: Winston-Salem
country: United States
facility: Carolina Urological Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Akron
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners - Center for Clinical Research
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Eugene
country: United States
facility: Pacific Women's Center, LLC
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southeastern Pennsylvania
state: Pennsylvania
city: Erie
country: United States
facility: OB/GYN Associates of Erie
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Protocol Management Specialists
state: Pennsylvania
city: East Providence
country: United States
facility: Gilbert Teixeira, DO
state: Rhode Island
city: East Providence
country: United States
facility: Pharma Resource
state: Rhode Island
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island - Clinical Studies Center
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Columbia
country: United States
facility: Columbia Women's Healthcare, LLC
state: South Carolina
city: Columbia
country: United States
facility: SC Clinical Research Center, LLC
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Chattanooga
country: United States
facility: OB-GYN Centre of Excellence
state: Tennessee
city: Johnson City
country: United States
facility: Advanced Therapeutics, Inc.
state: Tennessee
city: Johnson City
country: United States
facility: Johnson City Internal Medicine
state: Tennessee
city: Austin
country: United States
facility: Adult Care of Austin
state: Texas
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Beaumont
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Beaumont
country: United States
facility: Beaumont Internal Medicine & Geriatric Associates
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Incorporated
state: Texas
city: Dallas
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Houston
country: United States
facility: Advances In Health, Inc.
state: Texas
city: Houston
country: United States
facility: Centex Research, Inc. - Pineloch Medical Clinic
state: Texas
city: Houston
country: United States
facility: The Office of Dr. Steven Maislos, MD
state: Texas
city: Plano
country: United States
facility: Village Health Partners
state: Texas
city: San Antonio
country: United States
facility: Paragon Research Center, LLC
state: Texas
city: Murray
country: United States
facility: Radiant Research, Inc.
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Arlington
country: United States
facility: Integra Trials, LLC
state: Virginia
city: Arlington
country: United States
facility: Washington Urology
state: Virginia
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research, LLC
state: Washington
city: Mountlake Terrace
country: United States
facility: Urology Northwest, PA
state: Washington
city: Spokane
country: United States
facility: North Spokane Women's Clinic
state: Washington
city: Plovdiv
country: Bulgaria
facility: MBAL Trimontsium OOD
city: Ruse
country: Bulgaria
facility: MBAL Ruse AD, Urologichno otdelenie,
city: Sofia
country: Bulgaria
facility: UMBAL Aleksandrovska EAD
city: Sofia
country: Bulgaria
facility: MBALSM N.I.Pirogov EAD
city: Sofia
country: Bulgaria
facility: MBAL Doverie AD, Otdelenie po urologia
city: Calgary
country: Canada
facility: The Prostate Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Lois Hole Hospital for Women, Royal Alexandra Hospital
state: Alberta
city: Bathurst
country: Canada
facility: Maritime Research Center
state: New Brunswick
city: Bathurst
country: Canada
facility: Maritime Research Center
state: New Brunswick
city: Barrie
country: Canada
facility: The Male/Female Health and Research Centre, Royal Court Medical Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Kingston
country: Canada
facility: Centre for Applied Urological Research, Queen's University, Kingston General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: URLX Corporation
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Diex Research Montreal Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Hradec Kralove
country: Czechia
facility: Prvni privatni chirurgicke centrum spol. s .r.o. - SANUS
city: Jindrichuv Hradec
country: Czechia
facility: Nemocnice Jindrichuv Hradec
city: Kolin III
country: Czechia
facility: Oblastni nemocnice Kolin, a.s.
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
city: Turku
country: Finland
facility: Suomen Terveystalo Turku
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: Klinische Forschung Berlin
city: Berlin
country: Germany
facility: Praxis fuer Urologie
city: Duisburg
country: Germany
facility: Duisburger Fachaerztegemeinschaft
city: Elsterwerda
country: Germany
facility: ZKS Suedbrandenburg GmbH
city: Frankfurt am Main
country: Germany
facility: Facharzt für Frauenheilkunde und Geburtshilfe
city: Hagenow
country: Germany
facility: Urologische Praxis
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Marburg
country: Germany
facility: Arztpraxis Dr. von Keitz
city: Mittweida
country: Germany
facility: Pharmakologisches Studienzentrum Chemnitz GmbH
city: Muenchen
country: Germany
facility: Frauenarzt Praxis
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar Urologiai Klinika
city: Sopron
country: Hungary
facility: Soproni Erzsebet Oktato Korhaz, Urologiai Osztaly
city: Szentes
country: Hungary
facility: Donatella 99 Bt.
city: Szolnok
country: Hungary
facility: MAV Korhaz es Rendelointezet, Urologia
city: Pusan
country: Korea, Republic of
facility: Department of Urology, Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Konkuk University Medical Center
city: Suwon
country: Korea, Republic of
facility: Department of Urology, Ajou University Hospital
city: Cuautitlan Izcalli
country: Mexico
facility: Phylasis Clinicas Research S de RL de CV
state: Estado De Mexico
city: Colima
country: Mexico
facility: Unidad de Diagnostico Integral
city: Gdynia
country: Poland
facility: NZOZ VIP - MED, Poradnia Urologiczna
city: Slupsk
country: Poland
facility: SP ZOZ Wojewodzki Szpital Specjalistyczny im. J. Koraczaka
city: Warszawa
country: Poland
facility: Specjalistyczny Gabinet Lekarski
city: Kemerovo
country: Russian Federation
facility: Kemerovо Regional Perinatal Center
city: Moscow
country: Russian Federation
facility: Moscow State Healthcare Institution City Clinical Hospital #12
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Healthcare Institution City Hospital #26
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Medical University I.P.Pavlov
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Healthcare Institution City Hospital # 15
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Durban
country: South Africa
facility: Parklands Hospital
state: Kwa Zulu Natal
city: Bandhagen
country: Sweden
facility: Kvinnohalsan Soder
city: Goteborg
country: Sweden
facility: Specialistmottagningen i urologi
city: Goteborg
country: Sweden
facility: Partus Kvinnohalsa
city: Goteborg
country: Sweden
facility: Me3plus Clinical Trials
city: Halmstad
country: Sweden
facility: Tudorkliniken, Specialistmottagningen i Urologi
city: Norrkoping
country: Sweden
facility: Vrinnevisjukhuset
city: Dnipropetrovsk
country: Ukraine
facility: Regional Clinical Hospital, Department of Urology of Dnipropetrovsk State Medical Academy
city: Kharkiv
country: Ukraine
facility: Regional Clinical Center of Urology and Nephrology
city: Kyiv
country: Ukraine
facility: Institute of Urology of AMS of Ukraine
city: Lugansk
country: Ukraine
facility: Lugansk City Multi-Discipline Hospital #2, department of Urology
city: Lviv
country: Ukraine
facility: 5Th City Clinical Hospital, Urology Department
city: Odesa
country: Ukraine
facility: LTD Out-patient clinic of General practice and Family medicine
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Hospital, Department of Urology
city: Ternopil
country: Ukraine
facility: Municipal Institution of Ternopil Regional Council, Ternopil University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.