Trial Outcomes & Findings for Fesoterodine "add-on" Male Overactive Bladder Study (NCT NCT00546637)

NCT ID: NCT00546637

Last Updated: 2011-02-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 947 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2011-02-18

Participant Flow

Participant milestones

Measure	Fesoterodine 4mg or 8mg Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Overall Study STARTED	474	473
Overall Study Received Treatment	471	472
Overall Study COMPLETED	401	424
Overall Study NOT COMPLETED	73	49

Reasons for withdrawal

Measure	Fesoterodine 4mg or 8mg Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Overall Study Adverse Event	46	20
Overall Study Lack of Efficacy	5	5
Overall Study Lost to Follow-up	2	2
Overall Study Other	10	12
Overall Study Withdrawal by Subject	7	9
Overall Study Randomized, but not treated	3	1

Baseline Characteristics

Fesoterodine "add-on" Male Overactive Bladder Study

Baseline characteristics by cohort

Measure	Fesoterodine 4mg or 8mg n=471 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=472 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.	Total n=943 Participants Total of all reporting groups
Age, Customized 18 - 44 years	7 participants n=5 Participants	9 participants n=7 Participants	16 participants n=5 Participants
Age, Customized 45- 64 years	211 participants n=5 Participants	189 participants n=7 Participants	400 participants n=5 Participants
Age, Customized >=65 years	253 participants n=5 Participants	274 participants n=7 Participants	527 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	471 Participants n=5 Participants	472 Participants n=7 Participants	943 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The full analysis set (FAS) included all subjects who took at least one dose of assigned study drug and had at least one baseline or post-baseline efficacy assessment. Only FAS subjects with non-zero micturition-related urgency episodes at Baseline and non-missing change from Baseline to Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=446 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=451 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12	-3.2 number of episodes Standard Error 0.2	-2.9 number of episodes Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=445 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=450 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4	-2.3 number of episodes Standard Error 0.2	-1.9 number of episodes Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=446 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=451 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 Week 4 (n=445, 450)	-30.8 percent change Full Range 56.9 • Interval -100.0 to 363.3	-20.7 percent change Full Range 49.1 • Interval -100.0 to 158.8
Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 Week 12 (n=446, n=451)	-43.8 percent change Full Range 60.8 • Interval -100.0 to 363.6	-35.7 percent change Full Range 58.0 • Interval -100.0 to 600.0

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=446 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=452 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 Week 4 (n=445, n=451)	-1.3 number of micturitions Standard Error 0.1	-0.8 number of micturitions Standard Error 0.1
Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 Week 12 (n=446, n=452)	-1.9 number of micturitions Standard Error 0.1	-1.5 number of micturitions Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=446 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=452 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 Week 4 (n=445, n=451)	-12.0 percent change Full Range 18.8 • Interval -71.6 to 96.2	-7.3 percent change Full Range 18.9 • Interval -53.7 to 66.7
Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 Week 12 (n=446, n=452)	-14.9 percent change Full Range 19.3 • Interval -81.8 to 96.2	-12.5 percent change Full Range 19.2 • Interval -58.3 to 51.4

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=439 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=442 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 Week 4 (n=438, n=441)	-0.4 number of micturitions Standard Error 0.1	-0.3 number of micturitions Standard Error 1.0
Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 Week 12 (n=439, n=442)	-0.6 number of micturitions Standard Error 0.1	-0.5 number of micturitions Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=439 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=442 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 Week 4 (n=438, n=441)	-16.7 percent change Full Range 60.4 • Interval -100.0 to 700.0	-11.1 percent change Full Range 44.8 • Interval -100.0 to 300.0
Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 Week 12 (n=439, n=442)	-25.0 percent change Full Range 66.1 • Interval -100.0 to 600.0	-16.7 percent change Full Range 58.2 • Interval -100.0 to 700.0

SECONDARY outcome

Timeframe: Baseline, Week 4 and Week 12

Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=103 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=104 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 Week 4 (n=103, n=104)	-0.3 number of episodes Full Range 1.9 • Interval -11.3 to 5.7	-0.7 number of episodes Full Range 1.7 • Interval -6.7 to 9.7
Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12 Week 12 (n=103, n=104)	-0.7 number of episodes Full Range 2.3 • Interval -16.7 to 5.7	-0.7 number of episodes Full Range 1.4 • Interval -6.7 to 4.0

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=103 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=104 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12 Week 4 (n=103, n=104)	-100.0 percent change Full Range 85.3 • Interval -100.0 to 425.0	-100.0 percent change Full Range 136.7 • Interval -100.0 to 966.7
Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12 Week 12 (n=103, n=104)	-100.0 percent change Full Range 77.2 • Interval -100.0 to 425.0	-100.0 percent change Full Range 79.0 • Interval -100.0 to 300.0

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=311 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=340 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 Week 4 (n=310, n=339)	-1.0 number of episodes Full Range 2.7 • Interval -13.0 to 10.7	-1.0 number of episodes Full Range 2.6 • Interval -11.0 to 13.7
Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 Week 12 (n=311, n=340)	-1.3 number of episodes Full Range 3.1 • Interval -18.0 to 10.7	-1.0 number of episodes Full Range 2.8 • Interval -16.7 to 9.0

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=311 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=340 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 Week 4 (n=310, n=339)	-78.6 percent change Full Range 79.4 • Interval -100.0 to 500.0	-60.0 percent change Full Range 130.7 • Interval -100.0 to 1366.7
Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 Week 12 (n=311, n=340)	-100.0 percent change Full Range 100.7 • Interval -100.0 to 600.0	-88.4 percent change Full Range 90.1 • Interval -100.0 to 600.0

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=425 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=434 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 Week 4 (n= 424, n=433)	-0.7 number of episodes Standard Error 0.1	-0.6 number of episodes Standard Error 0.1
Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 Week 12 (n=425, n=434)	-0.9 number of episodes Standard Error 0.1	-0.9 number of episodes Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=425 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=434 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 Week 4 (n=424, n=433)	-33.3 percent change Full Range 87.1 • Interval -100.0 to 800.0	-25.0 percent change Full Range 68.9 • Interval -100.0 to 400.0
Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12 Week 12 (n=425, n=434)	-50.0 percent change Full Range 104.2 • Interval -100.0 to 800.0	-40.0 percent change Full Range 70.4 • Interval -100.0 to 400.0

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-missing change from Baseline (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=446 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=452 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12 Week 12 (n=446, n=452)	-8.9 USS Sum rating per 24 hours Standard Error 0.6	-7.8 USS Sum rating per 24 hours Standard Error 0.6
Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12 Week 4 (n=445, n=451)	-6.4 USS Sum rating per 24 hours Standard Error 0.5	-4.7 USS Sum rating per 24 hours Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=454 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=456 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
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 Week 4 (n=453, n=454)	-3.4 scores on a scale Standard Error 0.3	-3.1 scores on a scale Standard Error 0.3
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 Week 12 (n=454, n=456)	-4.4 scores on a scale Standard Error 0.3	-4.4 scores on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=456 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=458 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12 Week 4 (n=456, n=457)	-1.8 scores on scale Standard Error 0.1	-1.4 scores on scale Standard Error 0.1
Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12 Week 12 (n=456, n=458)	-2.4 scores on scale Standard Error 0.2	-2.1 scores on scale Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=455 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=457 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12 Week 4 (n=454, n=455)	-1.6 scores on scale Standard Error 0.2	-1.7 scores on scale Standard Error 0.2
Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12 Week 12 (n=455, n=457)	-2.1 scores on scale Standard Error 0.2	-2.3 scores on scale Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=455 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=457 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12 Week 4 (n=455, n=455)	-0.6 scores on scale Standard Error 0.1	-0.5 scores on scale Standard Error 0.1
Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12 Week 12 (n=455, 457)	-1.0 scores on scale Standard Error 0.1	-1.0 scores on scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: FAS subjects with non-missing change from Baseline to Week 4 were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=445 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=451 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 Q1 (sensation of not emptying bladder?)	-0.6 scores on scale Standard Error 0.1	-0.6 scores on scale Standard Error 0.1
Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 Q2 (urinate less than two hours after urination?)	-0.8 scores on scale Standard Error 0.1	-0.5 scores on scale Standard Error 0.1
Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 Q3 (stop and start several times during urination?	-0.4 scores on scale Standard Error 0.1	-0.4 scores on scale Standard Error 0.1
Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 Q4 (difficulty postponing urination?)	-0.7 scores on scale Standard Error 0.1	-0.6 scores on scale Standard Error 0.1
Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 Q5 (weak urinary stream?)	-0.5 scores on scale Standard Error 0.1	-0.4 scores on scale Standard Error 0.1
Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 Q6 (strain to begin urination?)	-0.2 scores on scale Standard Error 0.1	-0.3 scores on scale Standard Error 0.1
Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4 Q7 (urinate at night?)	-0.3 scores on scale Standard Error 0.1	-0.3 scores on scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS subjects with non-missing change from Baseline to Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=445 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=451 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 Q4 (difficulty postponing urination?)	-0.9 scores on scale Standard Error 0.1	-0.8 scores on scale Standard Error 0.1
Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 Q1 (sensation of not emptying bladder?)	-0.7 scores on scale Standard Error 0.1	-0.8 scores on scale Standard Error 0.1
Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 Q2 (urinate less than two hours after urination?)	-0.9 scores on scale Standard Error 0.1	-0.8 scores on scale Standard Error 0.1
Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 Q3 (stop and start several times during urination?	-0.5 scores on scale Standard Error 0.1	-0.6 scores on scale Standard Error 0.1
Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 Q5 (weak urinary stream?)	-0.6 scores on scale Standard Error 0.1	-0.6 scores on scale Standard Error 0.1
Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 Q6 (strain to begin urination?)	-0.3 scores on scale Standard Error 0.1	-0.3 scores on scale Standard Error 0.1
Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12 Q7 (urinate at night?)	-0.5 scores on scale Standard Error 0.1	-0.6 scores on scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: FAS subjects with non-missing Baseline and Week 4 values.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=459 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=457 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 Major Improvement	83 participants	63 participants
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 Minor Improvement	171 participants	160 participants
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 No Change	180 participants	212 participants
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4 Deterioration	25 participants	22 participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS subjects with non-missing Baseline and Week 12 values (LOCF).

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=459 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=459 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 Minor Improvement	166 participants	138 participants
Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 Major Improvement	124 participants	130 participants
Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 No Change	148 participants	170 participants
Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12 Deterioration	21 participants	21 participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: FAS subjects with non-missing Baseline and Week 4 values.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=458 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=458 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4 Improvement	111 participants	98 participants
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4 No Change	306 participants	326 participants
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4 Deterioration	41 participants	34 participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS subjects with non-missing Baseline and Week 12 values (LOCF).

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=459 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=459 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12. Improvement	132 participants	129 participants
Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12. No Change	290 participants	299 participants
Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12. Deterioration	37 participants	31 participants

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=459 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=459 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12 Week 4 (n=459, n=458)	-11.6 scores on scale Standard Error 0.8	-8.9 scores on scale Standard Error 0.8
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12 Week 12 (n=459, n=459)	-15.2 scores on scale Standard Error 0.9	-12.4 scores on scale Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=459 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=459 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 Week 4 (n=459, n=458)	8.7 scores on scale Standard Error 0.8	6.9 scores on scale Standard Error 0.8
Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 Week 12 (n=459, n=459)	11.5 scores on scale Standard Error 0.8	10.0 scores on scale Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline, Week 4 and 12

Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=459 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=459 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
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) Week 12 (n=459, n=459)	12.4 scores on scale Standard Error 0.9	11.1 scores on scale Standard Error 0.9
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) Week 4 (n=459, n=458)	9.7 scores on scale Standard Error 0.9	8.0 scores on scale Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline, Week 4 and Week 12

Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=459 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=459 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
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) Week 4 (n=459, n=458)	9.6 scores on a scale Standard Error 0.9	7.5 scores on a scale Standard Error 0.9
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) Week 12 (n=459, n=459)	12.5 scores on a scale Standard Error 1.0	10.6 scores on a scale Standard Error 1.0

SECONDARY outcome

Timeframe: Baseline, Week 4 and Week 12

Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=459 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=459 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
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) Week 4 (n=459, n=458)	9.6 scores on a scale Standard Error 1.0	7.6 scores on a scale Standard Error 1.0
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) Week 12 (n=459, n=459)	13.8 scores on a scale Standard Error 1.0	11.5 scores on a scale Standard Error 1.1

SECONDARY outcome

Timeframe: Baseline, Week 4 and Week 12

Population: FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.

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.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=459 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=459 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
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) Week 4 (n=459, n=458)	5.2 scores on a scale Standard Error 0.8	3.7 scores on a scale Standard Error 0.8
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) Week 12 (n=459, n=459)	6.3 scores on a scale Standard Error 0.8	6.0 scores on a scale Standard Error 0.8

SECONDARY outcome

Timeframe: Baseline, Week 4, 8 and 12

Population: The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 4, Week 8 (LOCF), or Week 12 (LOCF) were included in the analysis.

Post-void residual volume measurement was measured by an ultrasound at Baseline, and at Weeks 4, 8 and 12.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=454 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=453 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12 Week 4	0.0 ml Interval -174.0 to 274.0	0.0 ml Interval -251.0 to 193.0
Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12 Week 8	0.0 ml Interval -180.0 to 275.0	0.0 ml Interval -180.0 to 255.0
Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12 Week 12	3.5 ml Interval -156.0 to 392.0	0.0 ml Interval -172.0 to 405.0

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 12 (LOCF) were included in the analysis.

Maximum urinary flow rate (Qmax) was recorded at Baseline and Week 12 visit.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=425 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=427 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12	0.0 ml/sec Interval -46.9 to 47.4	0.0 ml/sec Interval -25.9 to 43.0

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The safety analysis set included all subjects who took at least one dose of study drug.

Number of participants experiencing serious and non-serious adverse events of acute urinary retention requiring catheterization.

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=471 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=472 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities)	1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The safety analysis set included all subjects who took at least one dose of study drug.

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)

Outcome measures

Measure	Fesoterodine 4mg or 8mg n=471 Participants Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=472 Participants Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) Dysuria	16 participants	4 participants
Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) Urinary retention (Regardless of catheterization)	11 participants	2 participants
Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) Urine flow decreased	4 participants	0 participants
Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) Residual urine volume	1 participants	0 participants
Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) Residual urine volume increased	1 participants	0 participants
Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) Residual urine	1 participants	0 participants
Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities) Urinary hesitation	0 participants	2 participants

Adverse Events

Fesoterodine 4mg or 8mg

Serious events: 11 serious events

Other events: 176 other events

Deaths: 0 deaths

Placebo

Serious events: 11 serious events

Other events: 72 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fesoterodine 4mg or 8mg n=471 participants at risk Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=472 participants at risk Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/471	0.21% 1/472
Cardiac disorders Angina unstable	0.00% 0/471	0.21% 1/472
Cardiac disorders Atrial fibrillation	0.21% 1/471	0.21% 1/472
Cardiac disorders Cardiac failure	0.00% 0/471	0.21% 1/472
Cardiac disorders Myocardial infarction	0.21% 1/471	0.00% 0/472
Gastrointestinal disorders Colitis ulcerative	0.21% 1/471	0.00% 0/472
Gastrointestinal disorders Diarrhoea	0.00% 0/471	0.21% 1/472
Gastrointestinal disorders Nausea	0.00% 0/471	0.21% 1/472
Gastrointestinal disorders Vomiting	0.00% 0/471	0.42% 2/472
Infections and infestations Cellulitis	0.00% 0/471	0.21% 1/472
Infections and infestations Cellulitis staphylococcal	0.21% 1/471	0.00% 0/472
Infections and infestations Genitourinary tract infection	0.21% 1/471	0.00% 0/472
Infections and infestations Pneumonia	0.00% 0/471	0.21% 1/472
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/471	0.21% 1/472
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.21% 1/471	0.00% 0/472
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.21% 1/471	0.00% 0/472
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.21% 1/471	0.00% 0/472
Nervous system disorders Cerebrovascular insufficiency	0.00% 0/471	0.21% 1/472
Renal and urinary disorders Dysuria	0.21% 1/471	0.00% 0/472
Renal and urinary disorders Haematuria	0.00% 0/471	0.21% 1/472
Renal and urinary disorders Renal colic	0.21% 1/471	0.00% 0/472
Renal and urinary disorders Renal failure acute	0.00% 0/471	0.21% 1/472
Renal and urinary disorders Urinary retention	0.00% 0/471	0.21% 1/472
Reproductive system and breast disorders Prostatitis	0.00% 0/471	0.21% 1/472
Reproductive system and breast disorders Testicular torsion	0.21% 1/471	0.00% 0/472
Vascular disorders Hypertension	0.00% 0/471	0.21% 1/472
Vascular disorders Hypertensive crisis	0.00% 0/471	0.21% 1/472
Vascular disorders Orthostatic hypotension	0.21% 1/471	0.00% 0/472

Other adverse events

Measure	Fesoterodine 4mg or 8mg n=471 participants at risk Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.	Placebo n=472 participants at risk Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
Gastrointestinal disorders Abdominal pain	1.3% 6/471	0.42% 2/472
Gastrointestinal disorders Constipation	6.6% 31/471	2.1% 10/472
Gastrointestinal disorders Diarrhoea	1.9% 9/471	1.3% 6/472
Gastrointestinal disorders Dry mouth	21.2% 100/471	6.1% 29/472
Gastrointestinal disorders Dyspepsia	1.9% 9/471	0.21% 1/472
Gastrointestinal disorders Gastritis	1.1% 5/471	0.21% 1/472
Gastrointestinal disorders Nausea	1.3% 6/471	0.64% 3/472
Infections and infestations Influenza	1.3% 6/471	0.64% 3/472
Infections and infestations Nasopharyngitis	1.1% 5/471	0.42% 2/472
Infections and infestations Sinusitis	1.1% 5/471	0.42% 2/472
Musculoskeletal and connective tissue disorders Back pain	1.5% 7/471	1.9% 9/472
Nervous system disorders Dizziness	1.3% 6/471	1.7% 8/472
Nervous system disorders Headache	3.2% 15/471	1.7% 8/472
Psychiatric disorders Insomnia	1.9% 9/471	1.1% 5/472
Renal and urinary disorders Dysuria	3.2% 15/471	0.85% 4/472
Renal and urinary disorders Urinary retention	2.3% 11/471	0.21% 1/472
Reproductive system and breast disorders Erectile dysfunction	1.1% 5/471	0.21% 1/472

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.govCallCenter@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER