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Trial record 6 of 638 for:    Russian Federation | Chile

Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)

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ClinicalTrials.gov Identifier: NCT00444925
Recruitment Status : Completed
First Posted : March 8, 2007
Results First Posted : September 3, 2009
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Overactive Bladder
Interventions Drug: fesoterodine fumarate
Drug: placebo
Drug: tolterodine tartrate
Enrollment 1712
Recruitment Details Participants with urgency incontinence Overactive Bladder (OAB) symptoms who met all entrance criteria were randomized to the double-blind treatment period.
Pre-assignment Details  
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER) Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Period Title: Single-blind Placebo Run-In Period
Started 2446 0 0
Completed 1712 [1] 0 0
Not Completed 734 0 0
[1]
progressed to randomization in double-blind treatment period
Period Title: Randomized to Double-blind Treatment
Started 337 690 685
Completed 334 684 679
Not Completed 3 6 6
Reason Not Completed
Never returned after randomization             3             6             6
Period Title: Double-blind Treatment Period
Started 334 684 679
Completed 304 628 598
Not Completed 30 56 81
Reason Not Completed
Death             2             0             0
Adverse Event             6             28             44
Lack of Efficacy             5             5             13
Lost to Follow-up             4             8             5
Withdrawal by Subject             6             8             7
Other             7             7             12
Arm/Group Title Placebo Tolterodine ER Fesoterodine Total
Hide Arm/Group Description Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER) Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) Total of all reporting groups
Overall Number of Baseline Participants 334 684 679 1697
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 334 participants 684 participants 679 participants 1697 participants
18 - 44 years 55 103 96 254
45 - 64 years 167 349 367 883
>= 65 years 112 232 216 560
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 334 participants 684 participants 679 participants 1697 participants
Female
269
  80.5%
564
  82.5%
558
  82.2%
1391
  82.0%
Male
65
  19.5%
120
  17.5%
121
  17.8%
306
  18.0%
1.Primary Outcome
Title Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
Hide Description UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): took at least 1 dose of assigned treatment, contributed data to at least 1 baseline or post-baseline efficacy assessment, and excluded 107 subjects from two study sites with significant Good Clinical Practices (GCP) deviations. The decision to exclude that data was made while the study was still blinded.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 307 626 619
Mean (Standard Error)
Unit of Measure: number of episodes per 24 hours
-1.46  (0.10) -1.61  (0.06) -1.72  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0107
Comments Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0172
Comments Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.
2.Secondary Outcome
Title Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.
Hide Description UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Time Frame Baseline, Week 1, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI>0 per 24 hours, non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 [Last Observation Carried Forward (LOCF)]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Mean (Standard Error)
Unit of Measure: number of episodes per 24 hours
Week 1 (n=302, 614, 612) -0.54  (0.09) -0.92  (0.06) -0.95  (0.06)
Week 4 [LOCF] (n=307, 626, 618) -1.06  (0.10) -1.40  (0.06) -1.52  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test adjusted by baseline UUI quartile.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test adjusted by baseline UUI quartile.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8460
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test adjusted by baseline UUI quartile.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test adjusted by baseline UUI quartile.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test adjusted by baseline UUI quartile.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1937
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test adjusted by baseline UUI quartile.
3.Secondary Outcome
Title Percent Change From Baseline of UUI Episodes Per 24 Hours.
Hide Description UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI>0 per 24 hours, non-missing change from baseline to respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Median (Full Range)
Unit of Measure: percent change
Week 1 (n=302, 614, 612)
-28.6
(-100.0 to 300.0)
-55.1
(-100.0 to 537.5)
-53.6
(-100.0 to 525.0)
Week 4 [LOCF] (n=307, 626, 618)
-60.0
(-100.0 to 300.0)
-85.7
(-100.0 to 650.0)
-93.2
(-100.0 to 450.0)
Week 12 [LOCF] (n=307, 626, 619)
-82.1
(-100.0 to 300.0)
-100.0
(-100.0 to 450.0)
-100.0
(-100.0 to 400.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0220
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
4.Secondary Outcome
Title Change From Baseline in Mean Voided Volume Per Micturition.
Hide Description Mean voided volume calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Least Squares Mean (Standard Error)
Unit of Measure: voided volume per micturition
Week 1 (n=306, 622, 623) 11.0  (3.2) 19.2  (2.5) 18.7  (2.5)
Week 4 [LOCF] (n=313, 633, 625) 14.0  (3.8) 25.7  (3.0) 30.5  (3.0)
Week 12 [LOCF] (n=313, 633, 626) 16.8  (3.9) 23.5  (3.0) 32.9  (3.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0214
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.4
Estimation Comments Treatment Difference Least Squares Mean (LSMean) Difference Standard Error (SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0149
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.4
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8659
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.7
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.0
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0036
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.0
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1484
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.3
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1029
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.3
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
5.Secondary Outcome
Title Change From Baseline in Mean Number of Micturitions Per 24 Hours.
Hide Description The mean number of micturitions was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change calculated as mean at observation minus mean at baseline.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Least Squares Mean (Standard Error)
Unit of Measure: number of micturitions per 24 hours
Week 1 (n=307, 622, 623) -0.5  (0.1) -1.0  (0.1) -1.0  (0.1)
Week 4 [LOCF] (n= 313, 634, 627) -1.2  (0.2) -1.8  (0.1) -1.9  (0.1)
Week 12 [LOCF] (n= 313, 634, 628) -1.5  (0.2) -2.1  (0.1) -2.2  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7395
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4185
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3798
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
6.Secondary Outcome
Title Percent Change From Baseline of Micturitions Per 24 Hours.
Hide Description Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline).
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of subjects with non-missing percent change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Median (Full Range)
Unit of Measure: percent change
Week 1 (n=307, 622, 623)
-2.7
(-48.5 to 68.3)
-7.7
(-68.2 to 70.0)
-7.9
(-66.0 to 184.0)
Week 4 [LOCF] (n=313, 634, 627)
-10.3
(-67.4 to 75.0)
-15.0
(-66.2 to 82.9)
-14.8
(-67.6 to 135.7)
Week 12 [LOCF] (n=313, 634, 628)
-12.1
(-69.6 to 73.0)
-16.2
(-69.6 to 55.6)
-18.9
(-66.7 to 185.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
7.Secondary Outcome
Title Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.
Hide Description Mean number of nocturnal micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline nocturnal micturitions >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Least Squares Mean (Standard Error)
Unit of Measure: nocturnal micturitions per 24 hours
Week 1 (n=288, 584, 596) -0.1  (0.1) -0.3  (0.0) -0.2  (0.0)
Week 4 [LOCF] (n=293, 596, 600) -0.4  (0.1) -0.5  (0.0) -0.5  (0.1)
Week 12 [LOCF] (n=293, 596, 601) -0.5  (0.1) -0.6  (0.1) -0.6  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2730
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0652
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3503
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2667
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1643
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7264
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3269
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5059
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6990
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
8.Secondary Outcome
Title Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.
Hide Description Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline nocturnal micturitions >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Median (Full Range)
Unit of Measure: percent change
Week 1 (n=288, 584, 596)
-10.0
(-100.0 to 500.0)
-12.5
(-100.0 to 350.0)
0.0
(-100.0 to 800.0)
Week 4 [LOCF] (n=293, 596, 600)
-22.2
(-100.0 to 600.0)
-25.0
(-100.0 to 400.0)
-20.0
(-100.0 to 900.0)
Week 12 [LOCF] (n=293, 596, 601)
-25.0
(-100.0 to 600.0)
-27.9
(-100.0 to 500.0)
-28.6
(-100.0 to 400.0)
9.Secondary Outcome
Title Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.
Hide Description Mean number urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Least Squares Mean (Standard Error)
Unit of Measure: urgency episodes per 24 hours
Week 1 (n=306, 619, 621) -0.4  (0.2) -1.3  (0.2) -1.1  (0.2)
Week 4 [LOCF] (n=311, 631, 627) -1.2  (0.2) -2.4  (0.2) -2.6  (0.2)
Week 12 [LOCF] (n=311, 631, 628) -2.0  (0.3) -3.1  (0.2) -3.5  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3820
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3498
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0542
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
10.Secondary Outcome
Title Percent Change From Baseline of Urgency Episodes Per 24 Hours.
Hide Description Percent change of urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Median (Full Range)
Unit of Measure: percent change
Week 1 (n=306, 619, 621)
-5.6
(-100.0 to 271.4)
-12.5
(-100.0 to 400.0)
-9.7
(-100.0 to 485.7)
Week 4 [LOCF] (n=311,631, 627)
-11.4
(-100.0 to 560.0)
-23.1
(-100.0 to 233.3)
-26.9
(-100.0 to 385.7)
Week 12 [LOCF] (n=311, 631, 628)
-17.6
(-100.0 to 560.0)
-30.8
(-100.0 to 372.7)
-37.9
(-100.0 to 385.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
11.Secondary Outcome
Title Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.
Hide Description Mean number of severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours: sum of all micturitions divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline severe urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Least Squares Mean (Standard Error)
Unit of Measure: severe urgency episodes per 24 hours
Week 1 (n=306, 618, 618) -0.4  (0.2) -1.3  (0.2) -1.2  (0.2)
Week 4 [LOCF] (n=311, 630, 624) -1.2  (0.2) -2.2  (0.2) -2.4  (0.2)
Week 12 [LOCF] (n=311, 630, 625) -1.9  (0.2) -2.8  (0.2) -3.0  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5581
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1510
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1391
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
12.Secondary Outcome
Title Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.
Hide Description Percent change calculated as change in severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline severe urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Median (Full Range)
Unit of Measure: percent change
Week 1 (n=306, 618, 618)
-9.4
(-100.0 to 500.0)
-25.0
(-100.0 to 775.0)
-25.0
(-100.0 to 680.0)
Week 4 [LOCF] (n=311, 630, 624)
-25.0
(-100.0 to 866.7)
-45.8
(-100.0 to 460.0)
-54.5
(-100.0 to 550.0)
Week 12 [LOCF] (n=311, 630, 625)
-48.0
(-100.0 to 733.3)
-63.4
(-100.0 to 412.5)
-71.4
(-100.0 to 585.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).
Method ANCOVA
Comments Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.
13.Secondary Outcome
Title Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.
Hide Description Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 1 (n=306, 619, 621) -0.1  (0.0) -0.2  (0.0) -0.2  (0.0)
Week 4 [LOCF] (n=311, 631, 627) -0.2  (0.0) -0.4  (0.0) -0.5  (0.0)
Week 12 [LOCF] (n=311, 631, 628) -0.4  (0.0) -0.6  (0.0) -0.7  (0.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5972
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1267
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0289
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
14.Secondary Outcome
Title Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.
Hide Description Frequency-Urgency Sum rating per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
Week 1 (n=306, 619, 621) -2.4  (0.7) -5.7  (0.5) -5.5  (0.5)
Week 4 [LOCF] (n=311,631, 627) -5.7  (0.8) -9.7  (0.6) -10.5  (0.6)
Week 12 [LOCF] (n=311, 631, 628) -8.2  (0.8) -12.1  (0.6) -13.2  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7288
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2473
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1047
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
15.Secondary Outcome
Title Change From Baseline in Patient Perception of Bladder Condition (PPBC).
Hide Description Number of subjects in 4-point category: >= to 2 points improvement [major improvement]; 1 point improvement [minor improvement]; no change; deterioration, based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.
Time Frame Baseline, Week 1, Week, 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Measure Type: Number
Unit of Measure: participants
Week 1 (n=309, 625, 623), >=2 points improvement 32 79 102
Week 1, 1-point improvement 94 181 186
Week 1, no change 147 306 286
Week 1, deterioration 36 59 49
Week 4 (n=313, 632, 629), >=2 points improvement 57 169 196
Week 4, 1-point improvement 95 201 224
Week 4, no change 127 203 176
Week 4, deterioration 34 59 33
Week 12 (n=313, 632, 630), >=2 points improvement 67 210 254
Week 12, 1-point improvement 102 189 198
Week 12, no change 111 171 148
Week 12, deterioration 33 62 30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Fesoterodine vs placebo at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0143
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments With modified ridit scoring and stratified by country.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Fesoterodine vs placebo at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments With modified ridit scoring and stratified by country.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Fesoterodine vs placebo at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments With modified ridit scoring and stratified by country.
16.Secondary Outcome
Title Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.
Hide Description Number of subjects 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.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Measure Type: Number
Unit of Measure: participants
Week 1 (n=309, 627, 624), improvement 68 162 171
Week 1, no change 218 438 413
Week 1, deterioration 23 27 40
Week 4 (n=313, 633, 629), improvement 98 238 256
Week 4, no change 194 362 348
Week 4, deterioration 21 33 25
Week 12 (n=313, 633, 630), improvement 112 254 291
Week 12, no change 181 344 314
Week 12, deterioration 20 35 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Fesoterodine vs placebo at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0773
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments With modified ridit scoring and stratified by country.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Fesoterodine vs placebo at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments With modified ridit scoring and stratified by country.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Fesoterodine vs placebo at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments With modified ridit scoring and stratified by country.
17.Secondary Outcome
Title Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).
Hide Description Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/by raw score range * 100]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 for placebo n=289; Tolterodine ER n=589; Fesoterodine n=571.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
-16.3  (1.4) -22.5  (1.1) -27.1  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment difference Fesoterodine vs placebo at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.5
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
18.Secondary Outcome
Title Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).
Hide Description HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 for placebo, Tolterodine ER, and Fesoterodine, respectively.
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Least Squares Mean (Standard Error)
Unit of Measure: score on scale
HRQL concern domain (n=289, 589, 572) 13.4  (1.5) 19.3  (1.1) 22.6  (1.2)
HRQL coping domain (n=289, 589, 572) 14.0  (1.5) 18.5  (1.2) 22.6  (1.2)
HRQL sleep domain (n=289, 589, 572) 12.2  (1.4) 15.1  (1.1) 17.3  (1.1)
HRQL social interaction domain (n=289, 588, 572) 6.8  (1.1) 9.4  (0.9) 11.6  (0.9)
HRQL scale score total (n=289, 588, 572) 12.0  (1.3) 16.3  (1.0) 19.3  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo: HRQL concern domain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.6
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo: HRQL coping domain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.6
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.0
Parameter Dispersion
Type: Standard Deviation
Value: 1.5
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo: HRQL scale score total.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.3
Estimation Comments Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.
19.Post-Hoc Outcome
Title Diary Dry Rates
Hide Description Diary dry rate: number of subjects with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only subjects with baseline urgency urinary incontinence >0 per 24 hours are included; n=number of subjects in the respective category at observation (Week 1, Week 4, Week 12).
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description:
Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Overall Number of Participants Analyzed 334 684 679
Measure Type: Number
Unit of Measure: participants
Week 1 54 153 159
Week 4 97 290 306
Week 12 138 358 396
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0072
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline urgency urinary incontinence quartile.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0116
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline urgency urinary incontinence quartile.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7828
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline urgency urinary incontinence quartile.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline urgency urinary incontinence quartile.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline urgency urinary incontinence quartile.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3104
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline urgency urinary incontinence quartile.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment Difference Fesoterodine vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline urgency urinary incontinence quartile.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment Difference Tolterodine ER vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline urgency urinary incontinence quartile.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0153
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline urgency urinary incontinence quartile.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Tolterodine ER Fesoterodine
Hide Arm/Group Description Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER) Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
All-Cause Mortality
Placebo Tolterodine ER Fesoterodine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Tolterodine ER Fesoterodine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8   9   15