Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

Overactive Bladder Clinical Trial

Official title:

12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611026
• Other study ID #: A0221046
• Status: Completed
• Phase: Phase 3
• First received: January 28, 2008
• Last updated: January 28, 2011
• Start date: February 2008
• Est. completion date: October 2009

Study information

• Verified date: January 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2417
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.

• Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit

• Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Exclusion Criteria:

• Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.

• Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.

• OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

• Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.

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:
• Tolterodine ER
The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.
• Placebo
Placebo treatment will be once daily(QD) for 12 weeks.
• Fesoterodine
The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Curitiba	PR
Brazil	Pfizer Investigational Site	Goiania	GO
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Salvador	BA
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Bulgaria	Pfizer Investigational Site	Pernik
Bulgaria	Pfizer Investigational Site	Pleven
Bulgaria	Pfizer Investigational Site	Plovdiv
Bulgaria	Pfizer Investigational Site	Plovdiv
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Veliko Tarnovo
Canada	Pfizer Investigational Site	Chicoutimi	Quebec
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Oshawa	Ontario
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
Canada	Pfizer Investigational Site	Surrey	British Columbia
Canada	Pfizer Investigational Site	Trois-Rivieres	Quebec
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Colombia	Pfizer Investigational Site	Barranquilla	Atlantico
Colombia	Pfizer Investigational Site	Bogota
Costa Rica	Pfizer Investigational Site	Alajuela
Costa Rica	Pfizer Investigational Site	Cartago
Costa Rica	Pfizer Investigational Site	San Jose
Estonia	Pfizer Investigational Site	Tallinn
Estonia	Pfizer Investigational Site	Tallinn
Estonia	Pfizer Investigational Site	Tartu
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Gruenstadt
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Krumbach
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Marburg
Germany	Pfizer Investigational Site	Muelheim a.d. Ruhr
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Muenchen
Greece	Pfizer Investigational Site	Alexandroupolis
Greece	Pfizer Investigational Site	Athens, Maroussi
Greece	Pfizer Investigational Site	Heraklion/Voutes	Crete
Greece	Pfizer Investigational Site	Larisa
Greece	Pfizer Investigational Site	Thessaloniki
Hungary	Pfizer Investigational Site	Debrecen
Hungary	Pfizer Investigational Site	Gyor
Hungary	Pfizer Investigational Site	Nyiregyhaza
Hungary	Pfizer Investigational Site	Salgotarjan
Hungary	Pfizer Investigational Site	Szentes
India	Pfizer Investigational Site	Ahmedabad	Gujarat
India	Pfizer Investigational Site	Bengaluru	Karnataka
India	Pfizer Investigational Site	Hyderabad	Andhra Pradesh
India	Pfizer Investigational Site	Nadiad	Gujarat
India	Pfizer Investigational Site	New Delhi
India	Pfizer Investigational Site	Pune	Maharashtra
Ireland	Pfizer Investigational Site	Beaumont	Dublin
Ireland	Pfizer Investigational Site	Dublin
Korea, Republic of	Pfizer Investigational Site	Busan
Korea, Republic of	Pfizer Investigational Site	Chonju	Chonbuk
Korea, Republic of	Pfizer Investigational Site	Daegu
Korea, Republic of	Pfizer Investigational Site	Incheon
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Suwon
Latvia	Pfizer Investigational Site	Riga
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Klaipeda
Lithuania	Pfizer Investigational Site	Vilnius
Lithuania	Pfizer Investigational Site	Vilnius
Malaysia	Pfizer Investigational Site	Kuala Lumpur
Malaysia	Pfizer Investigational Site	Kuala Lumpur
Poland	Pfizer Investigational Site	Bialystok
Poland	Pfizer Investigational Site	Bydgoszcz
Poland	Pfizer Investigational Site	Gdynia
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Lublin
Poland	Pfizer Investigational Site	Poznan
Poland	Pfizer Investigational Site	Slupsk
Romania	Pfizer Investigational Site	Arad
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Bucuresti	Sector 5,
Romania	Pfizer Investigational Site	Sibiu
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Rostov-on-Don
Russian Federation	Pfizer Investigational Site	Saint-Petersburg
Russian Federation	Pfizer Investigational Site	Saint-Petersburg
Russian Federation	Pfizer Investigational Site	Saint-Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Singapore	Pfizer Investigational Site	Singapore
Slovakia	Pfizer Investigational Site	Nitra
Slovakia	Pfizer Investigational Site	Povazska Bystrica
Slovakia	Pfizer Investigational Site	Presov
Slovakia	Pfizer Investigational Site	Trencin
Slovakia	Pfizer Investigational Site	Zvolen
South Africa	Pfizer Investigational Site	Bloemfontein	Free State
South Africa	Pfizer Investigational Site	Claremont	Cape Town
South Africa	Pfizer Investigational Site	Durban	Kwa Zulu Natal
South Africa	Pfizer Investigational Site	Durban	Kwa Zulu Natal
South Africa	Pfizer Investigational Site	Pietermaritzburg	Kwa Zulu Natal
South Africa	Pfizer Investigational Site	Pretoria
South Africa	Pfizer Investigational Site	Roodepoort
South Africa	Pfizer Investigational Site	Vosloorus	Gauteng
Spain	Pfizer Investigational Site	La Laguna	Santa Cruz de Tenerife
Spain	Pfizer Investigational Site	Las Palmas de Gran Canaria
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Santander	Cantabria
Spain	Pfizer Investigational Site	Valencia
Spain	Pfizer Investigational Site	Valencia
Sweden	Pfizer Investigational Site	Karlskoga
Sweden	Pfizer Investigational Site	Malmo
Sweden	Pfizer Investigational Site	Norrkoping
Sweden	Pfizer Investigational Site	Orebro
Sweden	Pfizer Investigational Site	Skovde
Sweden	Pfizer Investigational Site	Stockholm
Ukraine	Pfizer Investigational Site	Chernivtsi
Ukraine	Pfizer Investigational Site	Dnipropetrovsk
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Uzhorod
Ukraine	Pfizer Investigational Site	Zaporizhzhia
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Anderson	South Carolina
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Arlington	Virginia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Avon	Indiana
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Bel Air	Maryland
United States	Pfizer Investigational Site	Bensalem	Pennsylvania
United States	Pfizer Investigational Site	Bonita Spring	Florida
United States	Pfizer Investigational Site	Bryan	Texas
United States	Pfizer Investigational Site	Cary	North Carolina
United States	Pfizer Investigational Site	Chandler	Arizona
United States	Pfizer Investigational Site	Charlottesville	Virginia
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Clovis	California
United States	Pfizer Investigational Site	Cumberland	Rhode Island
United States	Pfizer Investigational Site	Edina	Minnesota
United States	Pfizer Investigational Site	Englewood	Colorado
United States	Pfizer Investigational Site	Enterprise	Alabama
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Greer	South Carolina
United States	Pfizer Investigational Site	Hamilton	New Jersey
United States	Pfizer Investigational Site	Hollywood	Florida
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Johnson City	Tennessee
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Lake Worth	Florida
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Leesburg	Florida
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Longwood	Florida
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Loxahatchee	Florida
United States	Pfizer Investigational Site	Meridian	Idaho
United States	Pfizer Investigational Site	Metairie	Louisiana
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Midvale	Utah
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Montgomery	Alabama
United States	Pfizer Investigational Site	Naples	Florida
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New London	Connecticut
United States	Pfizer Investigational Site	New Tazewell	Tennessee
United States	Pfizer Investigational Site	Noblesville	Indiana
United States	Pfizer Investigational Site	North Dartmouth	Massachusetts
United States	Pfizer Investigational Site	Olive Branch	Mississippi
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Pawtucket	Rhode Island
United States	Pfizer Investigational Site	Pembroke Pines	Florida
United States	Pfizer Investigational Site	Peoria	Arizona
United States	Pfizer Investigational Site	Peoria	Illinois
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Picayune	Mississippi
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Plano	Texas
United States	Pfizer Investigational Site	Plano	Texas
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Royal Oak	Michigan
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Sartell	Minnesota
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Stuart	Florida
United States	Pfizer Investigational Site	Sugar Land	Texas
United States	Pfizer Investigational Site	Summerville	South Carolina
United States	Pfizer Investigational Site	Tallahassee	Florida
United States	Pfizer Investigational Site	Torrance	California
United States	Pfizer Investigational Site	Troy	Michigan
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Uniontown	Pennsylvania
United States	Pfizer Investigational Site	Upland	California
United States	Pfizer Investigational Site	Virginia Beach	Virginia
United States	Pfizer Investigational Site	Virginia Beach	Virginia
United States	Pfizer Investigational Site	Vista	California
United States	Pfizer Investigational Site	Weber City	Virginia
United States	Pfizer Investigational Site	West Jordan	Utah
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	Westlake Village	California
United States	Pfizer Investigational Site	Williamsville	New York
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Brazil,  Bulgaria,  Canada,  Colombia,  Costa Rica,  Estonia,  Germany,  Greece,  Hungary,  India,  Ireland,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Poland,  Romania,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Ukraine, 

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 per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).	Baseline, Week 12	No
Secondary	Change From Baseline in Mean Voided Volume Per Micturition	Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.	Baseline, Week 1, Week 4, Week 12	No
Secondary	Change From Baseline in Mean Number of Micturitions Per 24 Hours	The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.	Baseline, Week 1, Week 4, Week 12	No
Secondary	Percent Change From Baseline of Micturitions Per 24 Hours	Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline).	Baseline, Week 1, Week 4, Week 12	No
Secondary	Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours	Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.	Baseline, Week 1, Week 4, Week 12	No
Secondary	Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours	Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.	Baseline, Week 1, Week 4, Week 12	No
Secondary	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4	UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).	Baseline, Week 1, Week 4	No
Secondary	Percent Change From Baseline of UUI Episodes Per 24 Hours	UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is; 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.	Baseline, Week 1, Week 4, Week 12	No
Secondary	Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale =3 in the Diary)	Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of =3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).	Baseline, Week 1, Week 4, Week 12	No
Secondary	Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale =3 in the Diary)	Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale =3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.	Baseline, Week 1, Week 4, Week 12	No
Secondary	Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours	Mean number of severe urgency episodes (USS rating =4 in diary ) per 24 hours calculated as the total number of micturitions with USS =4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).	Baseline, Week 1, Week 4, Week 12	No
Secondary	Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours	Percent change calculated as change in severe urgency episodes (USS rating =4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).	Baseline, Week 1, Week 4, Week 12	No
Secondary	Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.	Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).	Baseline, Week 1, Week 4, Week 12	No
Secondary	Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)	Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).	Baseline, Week 1, Week 4, Week 12	No
Secondary	Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary	Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).	Week 1, Week 4, Week 12	No
Secondary	Change From Baseline in Patient Perception of Bladder Condition (PPBC)	Number of participants in 4-point category: =2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.	Baseline, Week 1, Week, 4, Week 12	No
Secondary	Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.	Number of participants in 3-point category: improvement [=1-point improvement]; no change; deterioration [=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.	Baseline, Week 1, Week, 4, Week 12	No
Secondary	Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12	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. Negative change in Symptom Bother Score indicates improvement.	Baseline, Week 12	No
Secondary	Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12	HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score- Actual total raw score)/Raw score range] * 100. Higher transformed scores indicative of better HRQL. Positive change in HRQL Score indicates improvement.	Baseline, Week 12	No

External Links

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