Fesoterodine "add-on" Male Overactive Bladder Study

Overactive Bladder Syndrome Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Fesoterodine As An "Add-On" Therapy In Men With Persistent Overactive Bladder Symptoms Under Monotherapy Of Alpha Blocker For Lower Urinary Tract Symptoms.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546637
• Other study ID #: A0221009
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2007
• Last updated: February 15, 2011
• Start date: November 2007
• Est. completion date: February 2009

Study information

• Verified date: February 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 on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 947
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Men aged 40 years and above.

• On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).

• Persistent symptoms of OAB with urinary frequency >=8 times/24 hours and micturition-related urgency episodes >=3 episode/24 hours.

Exclusion Criteria:

• Contraindication to fesoterodine (antimuscarinics).

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

• Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Study Design

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

Drug:
• Fesoterodine
Fesoterodine 4mg or 8mg
• Placebo
Placebo

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Antwerpen
Belgium	Pfizer Investigational Site	Edegem
Belgium	Pfizer Investigational Site	Leuven
Brazil	Pfizer Investigational Site	Campos do Jordão	São Paulo
Brazil	Pfizer Investigational Site	Curitiba	PR
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	São Paulo	SP
Canada	Pfizer Investigational Site	Barrie	Ontario
Canada	Pfizer Investigational Site	Chicoutimi	Quebec
Canada	Pfizer Investigational Site	North Bay	Ontario
Canada	Pfizer Investigational Site	Pointe-Claire	Quebec
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Victoria	British Columbia
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Colombia	Pfizer Investigational Site	Medellin	Antioquia
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Goettingen
Germany	Pfizer Investigational Site	Hagenow
Germany	Pfizer Investigational Site	Lauenburg
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Oberursel
Germany	Pfizer Investigational Site	Wiesbaden
Greece	Pfizer Investigational Site	Ioannina	Ipiros
Greece	Pfizer Investigational Site	Patras
Greece	Pfizer Investigational Site	Thessaloniki
India	Pfizer Investigational Site	Lucknow	Uttar Pradesh
India	Pfizer Investigational Site	Lucknow	Uttar Pradesh
India	Pfizer Investigational Site	Ludhiana	Punjab
India	Pfizer Investigational Site	New Delhi
Korea, Republic of	Pfizer Investigational Site	Bucheon-si	Gyunggi-do
Korea, Republic of	Pfizer Investigational Site	Pusan
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Malaysia	Pfizer Investigational Site	Kuching	Sarawak
Malaysia	Pfizer Investigational Site	Kuching	Sarawak
Netherlands	Pfizer Investigational Site	Roermond
Netherlands	Pfizer Investigational Site	Tilburg
Netherlands	Pfizer Investigational Site	Zutphen
Norway	Pfizer Investigational Site	Bodø
Norway	Pfizer Investigational Site	Oslo
Philippines	Pfizer Investigational Site	Bacolod City
Philippines	Pfizer Investigational Site	Cebu City	Cebu
Philippines	Pfizer Investigational Site	Makati City
Philippines	Pfizer Investigational Site	Manila
Philippines	Pfizer Investigational Site	Manila
Philippines	Pfizer Investigational Site	Quezon City
Poland	Pfizer Investigational Site	Bialystok
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Myslowice
Poland	Pfizer Investigational Site	Wroclaw
Singapore	Pfizer Investigational Site	Singapore
Singapore	Pfizer Investigational Site	Singapore
Slovakia	Pfizer Investigational Site	Banska Bystrica
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Martin
Slovakia	Pfizer Investigational Site	Piestany
Slovakia	Pfizer Investigational Site	Skalica
Spain	Pfizer Investigational Site	Getafe	Madrid
Spain	Pfizer Investigational Site	Manacor	Palma de Mallorca
Spain	Pfizer Investigational Site	Martorell	Barcelona
Sweden	Pfizer Investigational Site	Boras
Sweden	Pfizer Investigational Site	Jonkoping
Sweden	Pfizer Investigational Site	Skovde
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Stockholm
Thailand	Pfizer Investigational Site	Amphoe Mueang	Chiang Mai
Thailand	Pfizer Investigational Site	Ratchathewi	Bangkok
United States	Pfizer Investigational Site	Albany	New York
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Bala Cynwyd	Pennsylvania
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bethany	Oklahoma
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Camp Hill	Pennsylvania
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Des Moines	Iowa
United States	Pfizer Investigational Site	Dunwoody	Georgia
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Fargo	North Dakota
United States	Pfizer Investigational Site	Fargo	North Dakota
United States	Pfizer Investigational Site	Flint	Michigan
United States	Pfizer Investigational Site	Garden City	New York
United States	Pfizer Investigational Site	Gilbert	Arizona
United States	Pfizer Investigational Site	Gilbert	Arizona
United States	Pfizer Investigational Site	Greensboro	North Carolina
United States	Pfizer Investigational Site	Greer	South Carolina
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Iowa City	Iowa
United States	Pfizer Investigational Site	Jeffersonville	Indiana
United States	Pfizer Investigational Site	Jupiter	Florida
United States	Pfizer Investigational Site	Kingston	New York
United States	Pfizer Investigational Site	La Mesa	California
United States	Pfizer Investigational Site	Litchfield Park	Arizona
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	Mesa	Arizona
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Newburgh	Indiana
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Orange City	Florida
United States	Pfizer Investigational Site	Owings Mills	Maryland
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Poughkeepsie	New York
United States	Pfizer Investigational Site	San Bernardino	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Sewell	New Jersey
United States	Pfizer Investigational Site	St. Clair Shores	Michigan
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Tacoma	Washington
United States	Pfizer Investigational Site	Troy	Michigan
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Utica	Michigan
United States	Pfizer Investigational Site	Watertown	Massachusetts
United States	Pfizer Investigational Site	West Bloomfield	Michigan
United States	Pfizer Investigational Site	West Bloomfield	Michigan
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  Colombia,  Germany,  Greece,  India,  Korea, Republic of,  Malaysia,  Netherlands,  Norway,  Philippines,  Poland,  Singapore,  Slovakia,  Spain,  Sweden,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Change From Baseline in 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 Scale >= 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.	Baseline, Week 12	No
Secondary	Numerical Change From Baseline in 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 Scale >= 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.	Baseline, Week 4	No
Secondary	Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	Micturition-related urgency episodes per 24 hours were defined as those with USS Scale rating of >= 3 marked for the corresponding micturition 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. The percentage change at Week 4 or 12 was calculated as: 100* (Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline	Baseline, Week 4 and 12	No
Secondary	Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12	All micturitions with USS rating 1 to 5. USS rating: 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. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Numeric change of micturitions per 24 hours at Week 4 and 12 relative to Baseline.	Baseline, Week 4 and 12	No
Secondary	Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12	All micturitions with USS rating 1 to 5. USS rating: 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. The percentage change at Week 4 or 12 was calculated as: 100* (Micturitions at Week 4 or 12 - Baseline)/Baseline	Baseline, Week 4 and 12	No
Secondary	Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12	Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 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. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.	Baseline, Week 4 and 12	No
Secondary	Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12	Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 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. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal micturitions at Week 4 or 12 - Baseline)/Baseline	Baseline, Week 4 and 12	No
Secondary	Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12	UUI episodes were defined as those micturitions with USS rating of 5 in the diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine.	Baseline, Week 4 and Week 12	No
Secondary	Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12	UUI episodes are defined as those micturitions with a USS rating of 5 in the bladder diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (UUI Episodes at Week 4 or 12 - Baseline)/Baseline	Baseline, Week 4 and 12	No
Secondary	Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	Severe micturition related urgency episodes were defined as those micturitions with USS rating >=4 marked for the corresponding micturition in the diary. USS: 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 4 and 12	No
Secondary	Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	Severe micturition-related urgency episodes are defined as those with a USS rating =4 marked for the corresponding micturition in the bladder diary. USS rating: 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. The percentage change at Week 4 or 12 was calculated as: 100* (Severe Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline	Baseline, Week 4 and 12	No
Secondary	Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 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 4 and 12	No
Secondary	Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 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. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal Micturition-Related Urgency Episodes at Week 4 or 12 - Baseline)/Baseline	Baseline, Week 4 and 12	No
Secondary	Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12	The USS sum rating was defined as the total of USS ratings recorded for all micturitions over the course of a day in the bladder diary. USS rating: 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. USS Sum rating per 24 hours was calculated as the mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit.	Baseline, Week 4 and 12	No
Secondary	Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12	The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.	Baseline, Week 4 and 12	No
Secondary	Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12	The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q2, Q4, and Q7 range = 0-15 points.	Baseline, Week 4 and 12	No
Secondary	Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12	The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q1, Q3, Q5, and Q6 range = 0-20 points.	Baseline, Week 4 and 12	No
Secondary	Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12	The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Score of Q8 range = 0-5 points.	Baseline, Week 4 and 12	No
Secondary	Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4	The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.	Baseline, Week 4	No
Secondary	Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12	The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.	Baseline, Week 12	No
Secondary	Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4	PPBC: self-administered, single-item, validated questionnaire. Rated on a 6-point scale: subject was asked: "Which of the following statements describes your bladder condition best at the moment?" 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. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was = 2.	Baseline, Week 4	No
Secondary	Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12	PPBC: self-administered, single-item, validated questionnaire. Rated on a 6-point scale: subject was asked: "Which of the following statements describes your bladder condition best at the moment?" 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. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was = 2.	Baseline, Week 12	No
Secondary	Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4	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 4	No
Secondary	Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12.	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 12	No
Secondary	Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12	OAB-q is a self-administered, 33-item, validated questionnaire that assesses how much the subject has been bothered by selected bladder symptoms during the previous week. Each item rated by subject on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0-100. Once transformed, higher scores represent less favorable outcome.	Baseline, Week 4 and 12	No
Secondary	Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 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 range 0 to 100 (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.	Baseline, Week 4 and 12	No
Secondary	Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain)	The HRQL concern domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.	Baseline, Week 4 and 12	No
Secondary	Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain)	The HRQL coping domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.	Baseline, Week 4 and Week 12	No
Secondary	Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain)	The HRQL sleep domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.	Baseline, Week 4 and Week 12	No
Secondary	Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain)	The HRQL social interaction domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score - Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.	Baseline, Week 4 and Week 12	No
Secondary	Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12	Post-void residual volume measurement was measured by an ultrasound at Baseline, and at Weeks 4, 8 and 12.	Baseline, Week 4, 8 and 12	Yes
Secondary	Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12	Maximum urinary flow rate (Qmax) was recorded at Baseline and Week 12 visit.	Baseline, Week 12	Yes
Secondary	Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities)	Number of participants experiencing serious and non-serious adverse events of acute urinary retention requiring catheterization.	Baseline, Week 12	Yes
Secondary	Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities)	Number of participants experiencing serious and non-serious adverse events related to increased voiding difficulty (ie, Dysuria, Urinary retention regardless of catheterization, Urine flow decreased, Residual urine volume, Residual urine volume increased, Residual urine, and Urinary hesitation)	Baseline, Week 12	Yes

External Links

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