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

Overactive Bladder Clinical Trial

Official title:

A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302067
• Other study ID #: A0221095
• Secondary ID: EIGHT
• Status: Completed
• Phase: Phase 4
• First received: February 18, 2011
• Last updated: February 25, 2014
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: February 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2012
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Fesoterodine 8mg
Oral, 1 tablet per day, 12 weeks duration, 8mg/day
• Fesoterodine 4mg
Oral, 1 tablet per day, 12 weeks duration, 4mg/day
• Placebo
Oral, 1 tablet per day, 12 weeks duration

Locations

Country	Name	City	State
Argentina	Centro de Urología (CDU)	Buenos Aires
Argentina	Instituto Medico Especializado (IME)	Buenos Aires
Argentina	Instituto Urologico Buenos Aires	Buenos Aires
Canada	Pharos Medical Research Ltd.	Grand Falls-Windsor	Newfoundland and Labrador
Canada	Urology South Shore Research	Greenfield Park	Quebec
Canada	Queen Elizabeth Health Sciences Centre	Halifax	Nova Scotia
Canada	McMaster Institute of Urology, St Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	UroLaval	Laval	Quebec
Canada	Office of Dr. Bernard Goldfarb	North Bay	Ontario
Canada	Stanley Flax Medical Professional Corporation	North York	Ontario
Canada	Urotec	Oshawa	Ontario
Canada	Ultra-Med Inc.	Pointe-Claire	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Toronto Urology Clinical Study Group	Toronto	Ontario
Canada	Toronto Western Hospital, University Health Network	Toronto	Ontario
Canada	Can-Med Clinical Research	Victoria	British Columbia
Canada	Can-Med Clinical Research Incorporated	Victoria	British Columbia
Canada	Office of Dr. Nazmuddin Merali	Victoria	British Columbia
Canada	Office of Dr. Peter Pommerville	Victoria	British Columbia
Chile	Clinica Uromed	Santiago	RM
Chile	Hospital Clinico Universidad de Chile	Santiago	RM
Colombia	Solano Y Terront Servicios Medicos Ltda / Unidad Integral de Endocrinologia Uniendo	Bogota	Cundinamarca
Colombia	Fundacion Centro de Investigacion Clinica CIC	Medellin	Antioquia
Czech Republic	Urologicka ambulance	Benesov
Czech Republic	FN a LFUK Hradec Kralove/Urologicka klinika	Hradec Kralove
Czech Republic	Nemocnice Jablonec nad Nisou	Jablonec nad Nisou
Czech Republic	Urologicka klinika	Praha 1 - Nove Mesto
Czech Republic	Fakultni nemocnice v Motole	Praha 5
Czech Republic	Androgeos spol. s.r.o.	Praha 6 - Hradcany
Czech Republic	Urologicka ambulance	Znojmo
Denmark	Herlev Hospital	Herlev
Denmark	Roskilde sygehus, Gynaekologisk/obstetrisk afdeling	Roskilde
Egypt	Al-Azhar University hospital	Cairo
Finland	Kouvolan Lääkäriasema	Kouvola
Finland	Lääkäriasema Cantti Oy	Kuopio
France	Hôpital Edouard Herriot	Lyon Cedex 03
France	CHU de Nantes - Hôtel Dieu	Nantes
France	Hôpital CAREMEAU - Service Urologie/Andrologie	Nimes Cedex 9
France	Hôpital Tenon - Service d'Urologie	Paris
Germany	Arztpraxis	Alzey
Germany	Klinische Forschung Berlin-Buch GmbH	Berlin
Germany	Synexus Clinical Research GmbH	Berlin
Germany	Synexus Clinical Research GmbH	Bochum
Germany	Klinische Forschung Dresden GmbH	Dresden
Germany	Synexus Clinical Research GmbH	Frankfurt am Main
Germany	Synexus Clinical Research GmbH	Goerlitz
Germany	Clinical Research Hamburg	Hamburg
Germany	Klinische Forschung Hannover - Mitte GmbH	Hannover
Germany	Allgemeinmedizin Praktische Aerzte	Karlsruhe
Germany	Arztpraxis	Lauenburg
Germany	Synexus Clinical Research GmbH	Leipzig
Germany	SMO MD GmbH	Magdeburg
Germany	CRS Clinical Research Service Moenchengladbach GmbH	Moenchengladbach
Germany	Praxisklinik Urologie Rhein-Ruhr	Muelheim a.d. Ruhr
Germany	Facharzt fuer Urologie	Reutlingen
Germany	Klinische Forschung Schwerin GmbH	Schwerin
Greece	University General Hospital of Larisa/ Urology Department	Larisa
Greece	General Hospital Papageorgiou	Thessaloniki
Hungary	Jahn Ferenc Del-pesti Korhaz, Urologiai Osztaly	Budapest
Hungary	Synexus Magyarorszag Kft.	Budapest
Hungary	Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Urologiai Klinika	Debrecen
Hungary	Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Urologiai osztaly	Nyiregyhaza
Italy	Università Magna Graecia di Catanzaro	Catanzaro
Italy	Clinica Urologica Centro Trapianti di rene	Foggia
Korea, Republic of	Asan Medical Center, Department of Urology	Seoul
Korea, Republic of	Department of Urology, Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University College of Medicine, Department of Urology	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital, Department of Urology	Seoul
Lithuania	Saules Seimos Medicinos Centras, JSC	Kaunas
Lithuania	Mano Seimos Gydytojas, JSC	Klaipeda
Lithuania	Seimos Gydytojas, JSC	Vilnius
Mexico	Hospital Lomas de San Luis Internacional	San Luis Potosi
Norway	Medi 3 Elverum AS	Elverum
Norway	Medi 3 Innlandet	Hamar
Norway	Norsk Helseklinikk AS, c/o Heiaklinikken	Lierskogen
Norway	Forusakutten AS, Avdeling for oppdragsforskning	Stavanger
Philippines	Dr. Pablo O. Torre Memorial Hospital	Bacolod City
Philippines	Perpetual Succour Hospital of Cebu Inc.	Cebu City	Cebu
Philippines	St. Paul's Hospital	Iloilo City
Poland	Klinika Urologii Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdansku	Gdansk
Poland	NZOZ Centrum Medyczne	Lodz
Poland	Centrum Urologiczne Sp. z o. o.	Myslowice
Poland	Nzoz "Nasz Lekarz"	Torun
Russian Federation	Non-governmental Healthcare Institution Departmental Clinical Hospital at Barnaul station OAO RZD	Barnaul
Russian Federation	Rostov State Medical University, Chair of Urology	Rostov-on-Don
Russian Federation	Research Institute of Obstetrics and Gynaecology D.O. Otta of North-west Department of RAMS	Saint-Petersburg
Slovakia	Ruzinovska poliklinika, a.s.	Bratislava
Slovakia	URO CLINIC, s.r.o.	Bratislava
Slovakia	Nemocnica s Poliklinikou Svateho Lukasa Galanta	Galanta
Slovakia	UROX s.r.o.	Piestany
Slovakia	Centrum urologie Povazska Bystrica, s.r.o. urologicka ambulancia	Povazska Bystrica
Slovakia	Fakultna nemocnica Trencin	Trencin
Slovakia	Fakultna nemocnica s poliklinikou Zilina	Zilina
Slovakia	UROGYN,s.r.o.	Zilina
Slovakia	GYNPOR SK, s.r.o. Urogynekologicka ambulancia	Zvolen
South Africa	Clinical Research Unit	Pretoria	Gauteng
South Africa	Mayo Centre	Roodepoort
South Africa	Clinix Private Clinic	Vosloorus	Gauteng
Sweden	Carema Specialistvard Eslov	Eslov
Sweden	CTC, Sahlgrenska sjukhuset/SU	Goteborg
Sweden	Hagakliniken	Goteborg
Sweden	Probare	Lund
Sweden	Center for Lakemedelsstudier	Malmo
Sweden	Ladulaas kliniska studier	Skene
Sweden	Verksamhet Urologi	Skovde
Sweden	Kvinnokliniken Karolinska Universitetssjukhuset Huddinge	Stockholm
Sweden	S3 Clinical Research Centers	Vallingby
Sweden	Vasterviks sjukhus, Kvinnokliniken	Vastervik
Taiwan	Chang Gung Medical Foundation. Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital, Department of Urology	Taipei
Taiwan	Taipei Veterans General Hospital/Division of Urology	Taipei
Ukraine	RMI "Chernivtsi Regional Clinical Hosp.", Dep. of Urology, BSMU, Chair of Surgery and Urology	Chernivtsi
Ukraine	City Hospital #4 of Donetsk, Woman Consultative Department	Donetsk
Ukraine	Department of Urology of Donetsk National Medical University at Central City Clinical Hospital #1	Donetsk
Ukraine	MTPI "Central City Clinical Hospital #1"/Donetsk National Medical University n.a. M. Gorkiy,	Donetsk
Ukraine	Uzhorod City Outpatient Clinic, Prophylaxis Department	Uzhorod
Ukraine	Vinnitsa Regional Clinical Dispensary of Endocrinology	Vinnitsa
Ukraine	Urology Dept of Zaporizhzhia Medical Academy of Postgraduate Education	Zaporizhzhia
United Kingdom	Ormeau Health Centre	Belfast	Northern Ireland
United Kingdom	Cambridge University Hospital Trials NHS Trust	Cambridge
United Kingdom	Fowey River Practice	Fowey	Cornwall
United Kingdom	Baillieston Health Centre	Glasgow
United Kingdom	Southern General Hospital	Glasgow
United Kingdom	Sheepcot Medical Centre	Hertfordshire
United Kingdom	Knowle House Surgery	Plymouth	Devon
United Kingdom	Royal Hallamshire Hospital	Sheffield
United States	Institute for Female Pelvic Medicine	Allentown	Pennsylvania
United States	Austin Center for Clinical Research	Austin	Texas
United States	South Florida Medical Research	Aventura	Florida
United States	Uromedix	Aventura	Florida
United States	American Health Network of Indiana, LLC	Avon	Indiana
United States	United Medical Associates	Binghamton	New York
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Urology Centers of Alabama	Birmingham	Alabama
United States	Summit Research Institute	Bloomington	Indiana
United States	Boston Clinical Trials, Inc.	Boston	Massachusetts
United States	Meridien Research	Bradenton	Florida
United States	Florida Sleep Disorder Center of Brandon	Brandon	Florida
United States	PAB Clinical Research	Brandon	Florida
United States	Pulmonary Associates of Brandon	Brandon	Florida
United States	Internal Medicine and Pediatric Associates of Bristol, PC	Bristol	Tennessee
United States	PMG Research of Bristol, LLC	Bristol	Tennessee
United States	Beacon Clinical Research, LLC	Brockton	Massachusetts
United States	Brooklyn Urology Research Group	Brooklyn	New York
United States	Meridien Research	Brooksville	Florida
United States	Seattle Urology Research Center	Burien	Washington
United States	Kernodle Clinic, Inc.	Burlington	North Carolina
United States	The Office of Dr. Simon Yassear, MD	Carmichael	California
United States	Women's Health Practice	Champaign	Illinois
United States	CAMC Clinical Trials Center	Charleston	West Virginia
United States	CAMC Physicians Group	Charleston	West Virginia
United States	Charleston Internal Medicine, Inc.	Charleston	West Virginia
United States	Urologic Surgical Center	Charleston	West Virginia
United States	American Health Research	Charlotte	North Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Center for Women's Research	Chicago	Illinois
United States	Patient Priority Clinical Sites, LLC	Cincinnati	Ohio
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	TLM Medical Services, LLC	Columbia	South Carolina
United States	Columbus Center for Women's Health Research	Columbus	Ohio
United States	Columbus Clinical Research	Columbus	Ohio
United States	Carolina Clinical Trials	Concord	North Carolina
United States	Carolina Urology Partners, PLLC	Concord	North Carolina
United States	Nature Coast Clinical Research	Crystal River	Florida
United States	RJE Clinical Research	Dallas	Texas
United States	Hometown Urgent Care and Research	Dayton	Ohio
United States	Doctors Medical Center of Walton County	DeFuniak Springs	Florida
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Genitourinary Surgical Consultants	Denver	Colorado
United States	Urology Associates, PC	Denver	Colorado
United States	SJS Clinical Research, Inc.	Destin	Florida
United States	Coastal Medical	East Greenwich	Rhode Island
United States	Safe Harbor Clinical Research	East Providence	Rhode Island
United States	The Office of Johnny B. Roy, MD	Edmond	Oklahoma
United States	HWC Women's Research Center	Englewood	Ohio
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Women's Health Specialty Care	Farmington	Connecticut
United States	Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	The Women's Clinic of Northern Colorado	Fort Collins	Colorado
United States	M & O Clinical Research, LLC	Fort Lauderdale	Florida
United States	Florida Urology Physicians	Fort Myers	Florida
United States	Medical and Surgical Specialists	Galesburg	Illinois
United States	Urological Surgeons of Long Island	Garden City	New York
United States	Citrus Valley Medical Research, Inc.	Glendora	California
United States	The Office of Dr. Myron I. Murdock, MD, LLC	Greenbelt	Maryland
United States	American Health Network of Indiana, LLC	Greenfield	Indiana
United States	Clinical Investigation Specialists, Inc.	Gurnee	Illinois
United States	Carolinas Research Associates	Harrisburg	North Carolina
United States	Urological Research Network, LLC	Hialeah	Florida
United States	Laurel Highlands OB/GYN	Hopwood	Pennsylvania
United States	Memorial Clinical Associates dba MCA Research	Houston	Texas
United States	University Medical Associates	Huntersville	North Carolina
United States	James Gordon McMurray, MD	Huntsville	Alabama
United States	Medical Affiliated Research Center, Inc.	Huntsville	Alabama
United States	Clinical Research Center of Cape Cod, Inc.	Hyannis	Massachusetts
United States	Women's Healthcare Associates dba Rosemark WomenCare Specialists	Idaho Falls	Idaho
United States	Nature Coast Clinical Research	Inverness	Florida
United States	University of Iowa Healthcare	Iowa City	Iowa
United States	CRC of Jackson	Jackson	Mississippi
United States	Mississippi Urology Clinic	Jackson	Mississippi
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Metropolitan Urology	Jeffersonville	Indiana
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	Richard Kastelic and Associates	Johnstown	Pennsylvania
United States	NEA Baptist Women's Clinic	Jonesboro	Arkansas
United States	Clinical Investigation Specialists, Inc.	Kenosha	Wisconsin
United States	Premier Medical Group of the Hudson Valley	Kingston	New York
United States	Grossmont Center for Clinical Research	La Mesa	California
United States	Altus Research	Lake Worth	Florida
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	OB-GYN Associates of Mid-Florida, PA	Leesburg	Florida
United States	Kentucky Medical Research Center	Lexington	Kentucky
United States	Family Health Care Center	Lincoln	Nebraska
United States	Lincoln Internal Medicine Associates	Lincoln	Nebraska
United States	Women's Clinic of Lincoln, P.C.	Lincoln	Nebraska
United States	A Clinic For Women	Little Rock	Arkansas
United States	Larry S. Watkins, MD	Little Rock	Arkansas
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	May Women's Health Clinic	Little Rock	Arkansas
United States	Commonwealth Biomedical Research	Madisonville	Kentucky
United States	Adams Patterson Gynocology and Obstetrics, PLLC	Memphis	Tennessee
United States	Advanced Clinical Research	Meridian	Idaho
United States	New Horizon Research Center	Miami	Florida
United States	Mobile Ob-Gyn, P.C.	Mobile	Alabama
United States	Montgomery Women's Health Associates, P.C.	Montgomery	Alabama
United States	Virtua Phoenix Ob-Gyn	Moorestown	New Jersey
United States	Central Kentucky Research Associates, Inc.	Mount Sterling	Kentucky
United States	Mount Sterling Clinic	Mount Sterling	Kentucky
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Heartland Medical PC	New Tazewell	Tennessee
United States	Mid Hudson Medical Research, PLLC	New Windsor	New York
United States	Deaconess Clinic Gateway Health Center	Newburgh	Indiana
United States	Infinity Medical Research	North Dartmouth	Massachusetts
United States	Urology Health Team, PLLC	Ocala	Florida
United States	Legacy Clinical Research, LLC	Oklahoma City	Oklahoma
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Dean Oregon Clinic	Oregon	Wisconsin
United States	Broward Research Group	Pembroke Pines	Florida
United States	Dedicated Clinical Research	Phoenix	Arizona
United States	Clinical Trials Research Services, LLC	Pittsburgh	Pennsylvania
United States	Triangle Urological Group	Pittsburgh	Pennsylvania
United States	ACRC Trials (Administrative/Mailing Site)	Plano	Texas
United States	North Texas Family Medicine	Plano	Texas
United States	Clinical Research of Central Florida	Plant City	Florida
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	Health Science Research Center	Pratt	Kansas
United States	Wake Internal Medicine Consultants, Inc.	Raleigh	North Carolina
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	National Clinical Research - Richmond	Richmond	Virginia
United States	North Fulton Urology, PC	Roswell	Georgia
United States	Sockolov and Sockolov APC	Sacramento	California
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Institute for Women's Health	San Antonio	Texas
United States	Seven Oaks Women's Center	San Antonio	Texas
United States	Genesis Center for Clinical Research	San Diego	California
United States	San Diego Clinical Trials	San Diego	California
United States	Clinical Innovations, Inc.	Santa Ana	California
United States	Scottsboro Quick Care Clinic	Scottsboro	Alabama
United States	Women's and Family Care dba GTC Research	Shawnee	Kansas
United States	DM Clinical Research	Springfield	Massachusetts
United States	Mercy Health Research	St. Louis	Missouri
United States	Midwest Pharmaceutical Research	St. Peters	Missouri
United States	Mount Nittany Medical Center Health Services Inc. dba Mount Nittany Physician Group	State College	Pennsylvania
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Southeastern Research Group, Inc.	Tallahassee	Florida
United States	Meridien Research	Tampa	Florida
United States	Scott and White Healthcare	Temple	Texas
United States	Scott and White Healthcare	Temple	Texas
United States	Premier Research, Inc.	Trenton	New Jersey
United States	Genova Clinical Research	Tucson	Arizona
United States	Pish Medical Associates	Uniontown	Pennsylvania
United States	Independence Family Medicine	Virginia Beach	Virginia
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	Allegiance Research Specialists	Wauwatosa	Wisconsin
United States	Southern Urogynecology	West Columbia	South Carolina
United States	Advanced OBGYN Associates	West Palm Beach	Florida
United States	Advanced Clinical Concepts	West Reading	Pennsylvania
United States	Woman's Clinic Ltd.	West Reading	Pennsylvania
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	Ohio Clinical Research, LLC	Willoughby Hills	Ohio
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	Hawthorne Medical Research, Inc.	Winston-Salem	North Carolina
United States	Hawthorne Medical Research, Inc. - Hawthorne OB/GYN Associates	Winston-Salem	North Carolina
United States	Clinical Research of Central Florida	Winter Haven	Florida
United States	North Georgia Clinical Research	Woodstock	Georgia
United States	North Georgia Internal Medicine	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  Colombia,  Czech Republic,  Denmark,  Egypt,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Lithuania,  Mexico,  Norway,  Philippines,  Poland,  Russian Federation,  Slovakia,  South Africa,  Sweden,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.	Micturitions include episodes of voluntary micturition and episodes of UUI.	Week 4	No
Secondary	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.	Micturitions include episodes of voluntary micturition and episodes of UUI.	Week 12	No
Secondary	Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.	Micturitions include episodes of voluntary micturition and episodes of UUI.	Week 4	No
Secondary	Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.	Micturitions include episodes of voluntary micturition and episodes of UUI.	Week 12	No
Secondary	Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Week 4	No
Secondary	Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4.	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Week 4	No
Secondary	Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12.	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Week 12	No
Secondary	Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Week 4	No
Secondary	Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Week 12	No
Secondary	Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Week 4	No
Secondary	Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.	The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.	Week 12	No
Secondary	Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12.	PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.	Week 12	No
Secondary	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).	Week 12	No
Secondary	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.	Week 12	No
Secondary	Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.	OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.	Week 12	No
Secondary	Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.	OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.	Week 12	No
Secondary	Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.	OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.	Week 12	No
Secondary	Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.	OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.	Week 12	No
Secondary	Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.	OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.	Week 12	No
Secondary	Percentage of Participants Who Became Dry at Week 4.	Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary	Week 4	No
Secondary	Percentage of Participants Who Became Dry at Week 12.	Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI >0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.	Week 12	No

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