Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.

• ClinicalTrials.gov Identifier: NCT00561951
• Recruitment Status: Completed
• First Posted: November 21, 2007
• Results First Posted: September 9, 2010
• Last Update Posted: July 14, 2011
• Sponsor: Pfizer
• Information provided by: Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Overactive Bladder
• Interventions: Drug: fesoterodine fumarate; Drug: Placebo
• Enrollment: 951

Participant Flow

Recruitment Details
Pre-assignment Details	Eligible subjects who underwent screening were enrolled into the run-in period at visit 1 and received single-blind placebo for 2 weeks. At Visit 2, Only subjects with overactive bladder who met the criteria were randomized to one of three treatment arms (fesoterodine 4 mg, fesoterodine 8 mg or placebo) in a 1:1:1 ratio.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Period Title: Overall Study
Started	318	320	313
Completed	285	286	281
Not Completed	33	34	32
Reason Not Completed
Adverse Event	11	14	14
Lack of Efficacy	5	3	2
Lost to Follow-up	1	1	0
Withdrawal by Subject	10	9	10
Protocol Violation	4	3	4
Physician Decision	1	0	0
Pregnancy	0	1	0
Meet Withdrawal Criterion	0	1	1
Adverse Event Occured Before Treatment	1	2	1

Baseline Characteristics

Arm/Group Title		Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg	Total
Arm/Group Description		Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		318	320	313	951
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	318 participants	320 participants	313 participants	951 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	227 71.4%	217 67.8%	196 62.6%	640 67.3%
	>=65 years	91 28.6%	103 32.2%	117 37.4%	311 32.7%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	318 participants	320 participants	313 participants	951 participants
		56.7 (13.5)	57.2 (14.2)	58.8 (13.4)	57.6 (13.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	318 participants	320 participants	313 participants	951 participants
	Female	251 78.9%	251 78.4%	255 81.5%	757 79.6%
	Male	67 21.1%	69 21.6%	58 18.5%	194 20.4%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.
Description	Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. Last observation carried forward.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	309	314	306
Least Squares Mean (95% Confidence Interval); Unit of Measure: UUI Episodes
	-1.01; (-1.31 to -0.71)	-1.35; (-1.65 to -1.05)	-1.40; (-1.70 to -1.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 4 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	The closed testing procedure was used in order to control the probability of a type 1 error.
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.34
	Confidence Interval	95%; -0.56 to -0.13
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The closed testing procedure was used in order to control the probability of a type 1 error.
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.39
	Confidence Interval	95%; -0.60 to -0.17
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Description	Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.
Time Frame	Baseline to Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	309	314	306
Mean (Standard Deviation); Unit of Measure: UUI Episodes
Week 2 (n=308, 314, 305)	-0.79 (1.465)	-1.10 (1.681)	-1.12 (1.736)
Week 4 (n=301, 303, 296)	-1.15 (1.532)	-1.48 (1.688)	-1.49 (1.643)
Week 8 (n=289, 289, 287)	-1.45 (1.518)	-1.61 (1.680)	-1.65 (1.690)
Week 12 (n=284, 284, 281)	-1.49 (1.717)	-1.76 (1.618)	-1.87 (1.814)

3. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.
Description	Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. Last observation carried forward.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	309	314	306
Least Squares Mean (95% Confidence Interval); Unit of Measure: Micturitions
	-0.59; (-1.08 to -0.10)	-1.15; (-1.64 to -0.67)	-1.25; (-1.75 to -0.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 4 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.56
	Confidence Interval	95%; -0.91 to -0.22
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.66
	Confidence Interval	95%; -1.01 to -0.32
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Description	Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Time Frame	Baseline to Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	309	314	306
Mean (Standard Deviation); Unit of Measure: Micturitions
Week 2 (n=308, 314, 305)	-0.47 (1.786)	-0.94 (1.987)	-1.06 (2.076)
Week 4 (n=301, 303, 296)	-0.85 (1.960)	-1.33 (2.146)	-1.60 (2.246)
Week 8 (n=289, 289, 287)	-1.36 (2.215)	-1.81 (2.277)	-2.15 (2.402)
Week 12 (n=284, 284, 281)	-1.36 (2.415)	-2.13 (2.214)	-2.17 (2.515)

5. Secondary Outcome

Title	Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.
Description	Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. Last observation carried forward.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	309	314	306
Least Squares Mean (95% Confidence Interval); Unit of Measure: Urgency Episodes
	-1.00; (-1.60 to -0.40)	-1.65; (-2.25 to -1.05)	-1.66; (-2.27 to -1.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 4 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.65
	Confidence Interval	95%; -1.07 to -0.22
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.66
	Confidence Interval	95%; -1.09 to -0.23
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Description	Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at each visit minus mean at Baseline.
Time Frame	Baseline to Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	309	314	306
Mean (Standard Deviation); Unit of Measure: Urgency Episodes
Week 2 (n=308, 314, 305)	-0.79 (2.640)	-1.37 (2.722)	-1.59 (2.816)
Week 4 (n=301, 303, 296)	-1.60 (2.780)	-2.16 (2.906)	-2.16 (3.065)
Week 8 (n=289, 289, 287)	-2.34 (2.835)	-2.50 (3.080)	-2.71 (3.139)
Week 12 (n=284, 284, 281)	-2.37 (2.975)	-2.89 (2.838)	-3.05 (3.462)

7. Secondary Outcome

Title	Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.
Description	Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. Last observation carried forward

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	309	314	306
Least Squares Mean (95% Confidence Interval); Unit of Measure: Incontinence Episodes
	-0.88; (-1.22 to -0.54)	-1.27; (-1.61 to -0.93)	-1.15; (-1.50 to -0.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 4 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.39
	Confidence Interval	95%; -0.63 to -0.14
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.030
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.27
	Confidence Interval	95%; -0.52 to -0.03
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Description	Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Incontinence is the complaint of any involuntary leakage of urine. Change: mean at each visit minus mean at Baseline.
Time Frame	Baseline to Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	309	314	306
Mean (Standard Deviation); Unit of Measure: Incontinence Episodes
Week 2 (n=308, 314, 305)	-0.80 (1.573)	-1.11 (1.725)	-1.06 (1.887)
Week 4 (n=301, 303, 296)	-1.22 (1.598)	-1.61 (1.755)	-1.50 (1.707)
Week 8 (n=289, 289, 287)	-1.56 (1.727)	-1.76 (1.795)	-1.73 (1.760)
Week 12 (n=284, 284, 281)	-1.59 (1.869)	-1.97 (1.843)	-1.86 (2.000)

9. Secondary Outcome

Title	Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.
Description	Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Among the full analysis set, participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline .

Last observation carried forward.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	243	256	257
Least Squares Mean (95% Confidence Interval); Unit of Measure: Night-Time Micturitions
	-0.18; (-0.41 to 0.06)	-0.21; (-0.44 to 0.02)	-0.29; (-0.52 to -0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 4 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.624
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	95%; -0.18 to 0.11
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	The significance level was 0.05 (2-sided).
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.129
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.11
	Confidence Interval	95%; -0.26 to 0.03
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Description	Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Time Frame	Baseline to Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline within the full analysis set.

No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	243	256	257
Mean (Standard Deviation); Unit of Measure: Night-Time Micturitions
Week 2 (n=242, 256, 256)	-0.25 (0.696)	-0.24 (0.796)	-0.34 (0.809)
Week 4 (n=236, 246, 248)	-0.30 (0.835)	-0.30 (0.830)	-0.46 (0.780)
Week 8 (n=224, 232, 241)	-0.41 (0.820)	-0.45 (0.815)	-0.58 (0.903)
Week 12 (n=220, 229, 236)	-0.44 (0.945)	-0.48 (0.882)	-0.63 (0.945)

11. Secondary Outcome

Title	Change From Baseline in Mean Voided Volume Per Micturition at Week 12.
Description	Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. Last observation carried forward.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	309	314	306
Mean (Standard Deviation); Unit of Measure: mL
	13.07 (46.207)	22.80 (47.590)	32.77 (52.893)

12. Secondary Outcome

Title	Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.
Description	Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Change: mean at each visit minus mean at Baseline.
Time Frame	Baseline to Weeks 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	309	314	306
Mean (Standard Deviation); Unit of Measure: mL
Week 2 (n=308, 314, 304)	5.06 (37.875)	13.63 (35.350)	21.52 (42.946)
Week 4 (n=301, 303, 296)	9.23 (43.639)	21.62 (44.623)	27.41 (45.803)
Week 8 (n=289, 289, 287)	10.75 (45.628)	22.05 (44.949)	30.94 (51.258)
Week 12 (n=284, 284, 281)	13.28 (46.317)	24.52 (48.620)	33.40 (53.379)

13. Secondary Outcome

Title	Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
Description	King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	285	283	283
Mean (Standard Deviation); Unit of Measure: score on scale
General Health Perceptions (n=285, 283, 283)	-7.02 (22.573)	-9.36 (25.190)	-6.10 (25.272)
Impact on Life (n=285, 283, 283)	-22.46 (28.018)	-27.33 (29.960)	-25.09 (32.172)
Role Limitations (n=285, 283, 283)	-20.47 (27.730)	-27.92 (26.373)	-25.97 (28.590)
Physical Limitations (n=285, 283, 283)	-18.65 (28.250)	-23.50 (28.807)	-25.97 (28.278)
Social Limitations (n=285, 283, 283)	-14.44 (25.541)	-17.92 (24.029)	-18.53 (25.765)
Personal Relationships (n=214, 210, 202)	-8.33 (21.773)	-16.11 (25.798)	-9.98 (24.335)
Emotions (n=285, 283, 283)	-18.01 (26.365)	-24.70 (27.192)	-24.89 (27.310)
Sleep/Energy (n=285, 283, 283)	-12.51 (24.967)	-19.08 (23.800)	-18.02 (25.287)
Incontinence Severity Measures (n=285, 283, 283)	-13.75 (20.763)	-17.67 (21.038)	-18.59 (21.814)

14. Secondary Outcome

Title	Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Description	The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain. Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. Half scale rule (domain scores were calculated if a respondent had answered at least half of the items in a multi-item scale. Missing items were then replaced by the mean of non-missing items in that scale, for that participant.)

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	285	283	283
Mean (Standard Deviation); Unit of Measure: score on scale
Symptom Bother Score	-18.25 (23.618)	-26.61 (22.592)	-26.35 (23.849)
Total Score of HRQL domain	12.88 (18.868)	17.84 (17.880)	17.29 (19.670)
Coping Score of HRQL domain	16.54 (23.633)	21.01 (22.109)	21.48 (25.336)
Concern Score of HRQL domain	13.25 (21.182)	20.05 (20.526)	19.10 (21.868)
Sleep Score of HRQL domain	12.03 (22.215)	16.16 (21.886)	15.35 (24.654)
Social Score of HRQL domain	7.37 (17.211)	11.35 (16.504)	9.98 (16.706)

15. Secondary Outcome

Title	Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.
Description	Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: No problems at all; Some very minor problems; Some minor problems; Some moderate problems; Severe problems; Many severe problems Change: mean at Week 12 minus mean at Baseline.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data.

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	285	283	283
Mean (Standard Deviation); Unit of Measure: score on scale
	-1.57 (1.236)	-1.83 (1.157)	-1.76 (1.182)

16. Secondary Outcome

Title	The Number of Patients With "Severe Problems, Score 5" or "Many Severe Problems, Score 6" in Patient Perception of Bladder Condition (PPBC) at Week 12.
Description	Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: No problems at all; Some very minor problems; Some minor problems; Some moderate problems; Severe problems; Many severe problems
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set. No imputation was used for missing data

Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description:	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed	285	283	283
Measure Type: Number; Unit of Measure: participants
Baseline	82	97	83
Week 12	28	12	19

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
Arm/Group Description	Subjects were treated with placebo once daily for 12 weeks.	Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.	Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
All-Cause Mortality
	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	5/318 (1.57%)	3/320 (0.94%)	0/313 (0.00%)
Gastrointestinal disorders
Abdominal pain † 1	1/318 (0.31%)	0/320 (0.00%)	0/313 (0.00%)
Diarrhoea †	1/318 (0.31%)	0/320 (0.00%)	0/313 (0.00%)
Vomiting †	1/318 (0.31%)	0/320 (0.00%)	0/313 (0.00%)
General disorders
Pyrexia †	1/318 (0.31%)	0/320 (0.00%)	0/313 (0.00%)
Infections and infestations
Abscess †	1/318 (0.31%)	0/320 (0.00%)	0/313 (0.00%)
Cellulitis †	1/318 (0.31%)	0/320 (0.00%)	0/313 (0.00%)
Urinary tract infection †	0/318 (0.00%)	1/320 (0.31%)	0/313 (0.00%)
Injury, poisoning and procedural complications
Pelvic fracture †	0/318 (0.00%)	1/320 (0.31%)	0/313 (0.00%)
Road traffic accident †	0/318 (0.00%)	1/320 (0.31%)	0/313 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma †	1/318 (0.31%)	0/320 (0.00%)	0/313 (0.00%)
Nervous system disorders
Cerebral infarction †	1/318 (0.31%)	0/320 (0.00%)	0/313 (0.00%)
Reproductive system and breast disorders
Pelvic pain †	0/318 (0.00%)	1/320 (0.31%)	0/313 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 11.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Placebo	Fesoterodine 4 mg	Fesoterodine 8 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	68/318 (21.38%)	138/320 (43.13%)	185/313 (59.11%)
Gastrointestinal disorders
Constipation † 1	15/318 (4.72%)	17/320 (5.31%)	33/313 (10.54%)
Diarrhoea †	2/318 (0.63%)	7/320 (2.19%)	3/313 (0.96%)
Dry mouth †	31/318 (9.75%)	93/320 (29.06%)	158/313 (50.48%)
Infections and infestations
Cystitis †	4/318 (1.26%)	12/320 (3.75%)	7/313 (2.24%)
Nasopharyngitis †	21/318 (6.60%)	19/320 (5.94%)	22/313 (7.03%)
Nervous system disorders
Dizziness †	1/318 (0.31%)	7/320 (2.19%)	2/313 (0.64%)
Headache †	5/318 (1.57%)	10/320 (3.13%)	4/313 (1.28%)
Renal and urinary disorders
Dysuria †	0/318 (0.00%)	2/320 (0.63%)	14/313 (4.47%)
Residual urine †	5/318 (1.57%)	7/320 (2.19%)	2/313 (0.64%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 11.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.govCallCenter@pfizer.com

• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
• ClinicalTrials.gov Identifier: NCT00561951
• Other Study ID Numbers: A0221005
• First Submitted: November 19, 2007
• First Posted: November 21, 2007
• Results First Submitted: January 11, 2010
• Results First Posted: September 9, 2010
• Last Update Posted: July 14, 2011