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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00611026
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : January 12, 2011
Last Update Posted : February 2, 2011
Sponsor:
Information provided by:
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: Tolterodine ER
Drug: Placebo
Drug: Fesoterodine
Enrollment 2417
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 3867 participants entered the single-blind placebo run-in period; 2417 participants completed single-blind placebo run-in and progressed to randomization in the double-blind treatment period.
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 matching to treatment. 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: Randomized to Double-blind Treatment
Started 480 974 963
Completed 478 973 960
Not Completed 2 1 3
Reason Not Completed
Not treated             2             1             3
Period Title: Double-blind Treatment Period
Started 478 973 960
Completed 431 885 862
Not Completed 47 88 98
Reason Not Completed
Death             1             0             0
Adverse Event             9             28             46
Lack of Efficacy             11             10             4
Lost to Follow-up             6             11             14
Withdrawal by Subject             7             19             16
Other             13             20             18
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 matching to treatment. 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 478 973 960 2411
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 478 participants 973 participants 960 participants 2411 participants
Between 18 and 44 years 70 157 156 383
Between 45 and 64 years 214 462 474 1150
≥65 years 194 354 330 878
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 478 participants 973 participants 960 participants 2411 participants
Female
410
  85.8%
818
  84.1%
816
  85.0%
2044
  84.8%
Male
68
  14.2%
155
  15.9%
144
  15.0%
367
  15.2%
1.Primary Outcome
Title Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
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).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): at least 1 dose of assigned treatment, data for at least 1 baseline or post-baseline efficacy assessment, and excluded 77 participants from 3 study sites with Good Clinical Practices (GCP) deviations (Fesoterodine N=30, Tolterodine ER N=31, Placebo N=16). Decision to exclude that data was made while the study was 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 matching to treatment.
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 448 926 908
Mean (Standard Error)
Unit of Measure: episodes per 24 hours
-1.62  (0.07) -1.74  (0.06) -1.95  (0.05)
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).

If normality assumptions were severely violated (proportion of non normal observations > 5%) a non-parametric analysis was to be conducted using Van Elteren’s test stratified by baseline quartile of the diary variable analyzed.

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 0.0228
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 0.0072
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 Voided Volume Per Micturition
Hide Description Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [Last Observation Carried Forward (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 matching to treatment.
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 452 930 912
Mean (Standard Error)
Unit of Measure: mL
Week 1 (n=447, 917, 895) 9.80  (1.92) 15.65  (1.43) 18.63  (1.55)
Week 4 [LOCF] (n=452, 927, 909) 14.27  (2.28) 26.43  (1.76) 32.26  (1.94)
Week 12 [LOCF] (n=452, 930, 912) 17.34  (2.40) 28.43  (1.82) 34.47  (2.06)
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. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).

If normality assumptions were severely violated (proportion of non normal observations > 5%) a non-parametric analysis was to be conducted using Van Elteren’s test stratified by baseline quartile of the diary variable analyzed.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.
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. 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 0.0519
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.
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. 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 0.1503
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.
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. 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 <0.0001
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.
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. 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 0.0002
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.
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. 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 0.0130
Comments [Not Specified]
Method Van Elteren's
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.
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. 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 <0.0001
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.
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. 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 0.0021
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.
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. 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 0.0525
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.
3.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 total number of micturitions divided by the total number of diary days collected at that visit.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants 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 matching to treatment.
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 454 935 916
Least Squares Mean (Standard Error)
Unit of Measure: micturitions per 24 hours
Week 1 (n=448, 921, 908) -0.8  (0.1) -1.0  (0.1) -1.0  (0.1)
Week 4 [LOCF] (n=454, 931, 916) -1.5  (0.1) -1.8  (0.1) -2.1  (0.1)
Week 12 [LOCF] (n=454, 935, 916) -2.0  (0.1) -2.3  (0.1) -2.6  (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 0.0161
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.5 to -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 0.0944
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.4 to 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 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 0.3613
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.3 to 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 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 terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-0.9 to -0.4
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 0.0043
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.6 to -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 0.0186
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.5 to -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 <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-0.9 to -0.4
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 0.0407
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.6 to -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 0.0016
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.6 to -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.

4.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 1 or 4 or 12 - baseline)/baseline).
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants 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 matching to treatment.
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 454 935 916
Median (Full Range)
Unit of Measure: percent change
Week 1 (n=448, 921, 908)
-7.1
(-70.6 to 53.6)
-9.4
(-64.3 to 74.2)
-9.0
(-61.9 to 89.3)
Week 4 [LOCF] (n=454, 931, 916)
-13.4
(-64.4 to 118.8)
-16.7
(-67.9 to 64.0)
-18.9
(-68.8 to 96.2)
Week 12 [LOCF] (n=454, 935, 916)
-18.2
(-66.7 to 118.8)
-20.8
(-67.5 to 70.8)
-23.5
(-75.3 to 64.3)
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 0.0217
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, 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 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, 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 0.0020
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 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 0.0217
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 0.0421
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 0.0023
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.
5.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 total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants with baseline nocturnal micturitions >0 per 24 hours and 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 matching to treatment.
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 445 899 892
Least Squares Mean (Standard Error)
Unit of Measure: nocturnal micturitions per 24 hours
Week 1 (n=432, 879, 871) -0.2  (0.1) -0.3  (0.0) -0.3  (0.0)
Week 4 [LOCF] (n=437, 888, 879) -0.4  (0.1) -0.5  (0.0) -0.5  (0.0)
Week 12 [LOCF] (n=437, 892, 879) -0.5  (0.1) -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 0.3823
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.1 to 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 0.4802
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.1 to 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 0.8355
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.1 to 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 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 0.0286
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.12 to -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 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 0.0794
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.2 to 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 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 0.5906
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.1 to 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 0.0134
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.3 to -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 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 0.1759
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.2 to 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 0.1661
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.2 to 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.

6.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 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants with baseline nocturnal micturitions >0 per 24 hours and 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 matching to treatment.
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 445 899 892
Median (Full Range)
Unit of Measure: percent change
Week 1 (n=432, 879, 871)
-7.7
(-100.0 to 500.0)
-14.3
(-100.0 to 500.0)
-12.5
(-100.0 to 800.0)
Week 4 [LOCF] (n=437, 888, 879)
-20.0
(-100.0 to 600.0)
-25.0
(-100.0 to 400.0)
-25.0
(-100.0 to 1600.0)
Week 12 [LOCF] (n=437, 892, 879)
-27.3
(-100.0 to 800.0)
-33.3
(-100.0 to 350.0)
-33.3
(-100.0 to 500.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment difference fesoterodine vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0021
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 terms for country and treatment and ranked baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.0200
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 terms for country and treatment and ranked baseline value as a covariate.
7.Secondary Outcome
Title Change From Baseline in Mean Number of Urgency Urinary Incontinence (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).
Time Frame Baseline, Week 1, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants with baseline UUI >0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 [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 matching to treatment.
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 456 932 920
Mean (Standard Error)
Unit of Measure: episodes per 24 hours
Week 1 (n=442, 911, 899) -0.80  (0.06) -0.95  (0.05) -1.03  (0.05)
Week 4 [LOCF] (n=448, 922, 908) -1.31  (0.07) -1.52  (0.05) -1.68  (0.05)
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).

If normality assumptions were severely violated (proportion of non normal observations > 5%) a non-parametric analysis was to be conducted using Van Elteren’s test stratified by baseline quartile of the diary variable analyzed.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
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 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 0.0202
Comments [Not Specified]
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 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 0.2126
Comments [Not Specified]
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 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 (a stratified Wilcoxon-Mann Whitney 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 0.0019
Comments [Not Specified]
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 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 0.0148
Comments [Not Specified]
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.
8.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; (n)=number of participants with baseline UUI >0 per 24 hours and 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 matching to treatment.
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 456 932 920
Median (Full Range)
Unit of Measure: percent change
Week 1 (n=442, 911, 899)
-40.8
(-100.0 to 966.7)
-50.0
(-100.0 to 366.7)
-50.0
(-100.0 to 633.3)
Week 4 [LOCF] (n=448, 922, 908)
-75.0
(-100.0 to 1000.0)
-88.9
(-100.0 to 900.0)
-100.0
(-100.0 to 666.7)
Week 12 [LOCF] (n=448, 926, 908)
-100.0
(-100.0 to 612.5)
-100.0
(-100.0 to 687.5)
-100.0
(-100.0 to 500.0)
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 0.0012
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 terms for country and treatment 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0205
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 terms for country and treatment 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.
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 terms for country and treatment 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
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 terms for country and treatment and ranked baseline value as a covariate.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0219
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 terms for country and treatment and ranked baseline value as a covariate.
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 terms for country and treatment and ranked baseline value as a covariate.
Show Statistical Analysis 7 Hide Statistical Analysis 7
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 0.0805
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 terms for country and treatment and ranked baseline value as a covariate.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0093
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 terms for country and treatment and ranked baseline value as a covariate.
9.Secondary Outcome
Title Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)
Hide Description Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants with baseline urgency episodes >0 per 24 hours and 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 matching to treatment.
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 461 940 928
Least Squares Mean (Standard Error)
Unit of Measure: episodes per 24 hours
Week 1 (n=447, 918, 906) -0.8  (0.2) -1.0  (0.1) -1.2  (0.2)
Week 4 [LOCF] (n=453, 929, 915) -1.9  (0.2) -2.5  (0.2) -3.1  (0.2)
Week 12 [LOCF] (n=453, 933, 915) -3.2  (0.2) -3.5  (0.2) -4.2  (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 0.0374
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.7 to -0.0
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 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 0.3161
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.5 to 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 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1817
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.5 to 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 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 terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-1.6 to -0.8
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 0.0054
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.0 to -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 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
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 terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-0.9 to -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 terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.5 to -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 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 0.1467
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.7 to 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 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine 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 terms for country and treatment and with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.1 to -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 in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)
Hide Description Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants with baseline urgency episodes >0 per 24 hours and 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 matching to treatment.
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 461 940 928
Median (Full Range)
Unit of Measure: percent change
Week 1 (n=447, 918, 906)
-9.4
(-100.0 to 385.7)
-12.0
(-100.0 to 325.0)
-11.8
(-100.0 to 433.3)
Week 4 [LOCF] (n=453, 929, 915)
-17.2
(-100.0 to 457.1)
-26.3
(-100.0 to 350.0)
-32.1
(-100.0 to 433.3)
Week 12 [LOCF] (n=453, 933, 915)
-31.0
(-100.0 to 385.7)
-37.5
(-100.0 to 475.0)
-45.5
(-100.0 to 266.7)
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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0828
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 terms for country and treatment and ranked baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 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 terms for country and treatment and ranked baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 0.0008
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 terms for country and treatment and ranked baseline value as a covariate.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
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 terms for country and treatment 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 terms for country and treatment and ranked baseline value as a covariate.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
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 terms for country and treatment 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 ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants with baseline severe urgency episodes >0 per 24 hours and 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 matching to treatment.
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 460 937 924
Mean (Standard Error)
Unit of Measure: severe urgency episodes per 24 hours
Week 1 (n=446, 915, 902) -1.14  (0.13) -1.34  (0.10) -1.58  (0.11)
Week 4 [LOCF] (n=452, 926, 911) -2.14  (0.16) -2.71  (0.12) -3.21  (0.12)
Week 12 [LOCF] (n=452, 930, 911) -3.01  (0.17) -3.39  (0.13) -4.08  (0.13)
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. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).

If normality assumptions were severely violated (proportion of non normal observations > 5%) a non-parametric analysis was to be conducted using Van Elteren’s test stratified by baseline quartile of the diary variable analyzed.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0576
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.
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. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2230
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.
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. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3555
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.
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. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 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 (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.
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. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.
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. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0071
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.
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. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 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 (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.
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. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1764
Comments [Not Specified]
Method Van Elteren's Test
Comments P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.
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. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 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 (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.
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 ≥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; (n)=number of participants with baseline severe urgency episodes >0 per 24 hours and 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 matching to treatment.
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 460 937 924
Median (Full Range)
Unit of Measure: percent change
Week 1 (n=446, 915, 902)
-19.7
(-100.0 to 575.0)
-24.1
(-100.0 to 500.0)
-25.0
(-100.0 to 475.0)
Week 4 [LOCF] (n=452, 926, 911)
-41.7
(-100.0 to 533.3)
-55.6
(-100.0 to 800.0)
-61.1
(-100.0 to 433.3)
Week 12 [LOCF] (n=452, 930, 911)
-61.0
(-100.0 to 1850.0)
-69.2
(-100.0 to 600.0)
-79.3
(-100.0 to 440.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment difference fesoterodine vs placebo at Week 4.
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 terms for country and treatment 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 4.
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 terms for country and treatment and ranked baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0302
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 terms for country and treatment and ranked baseline value as a covariate.
Show Statistical Analysis 4 Hide Statistical Analysis 4
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 terms for country and treatment and ranked baseline value as a covariate.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
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 terms for country and treatment and ranked baseline value as a covariate.
13.Secondary Outcome
Title Change From Baseline in Mean Urinary Sensation Scale (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 total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants 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 matching to treatment.
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 453 933 915
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=447, 918, 906) -0.2  (0.0) -0.2  (0.0) -0.2  (0.0)
Week 4 [LOCF] (n=453, 929, 915) -0.3  (0.0) -0.4  (0.0) -0.5  (0.0)
Week 12 [LOCF] (n=453, 933, 915) -0.6  (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 0.0701
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.1 to 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 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 0.4823
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.1 to 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 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1702
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.1 to 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 terms for country and treatment with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.3 to -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 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 0.0059
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.2 to -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 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.2 to -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 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 terms for country and treatment with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.3 to -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 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 0.3110
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.1 to 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 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine 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 ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.2 to -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 (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)
Hide Description Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants 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 matching to treatment.
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 453 933 915
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=447, 918, 906) -4.0  (0.6) -4.8  (0.5) -5.5  (0.5)
Week 4 [LOCF] (n=453, 929, 915) -8.1  (0.7) -10.1  (0.6) -12.0  (0.6)
Week 12 [LOCF] (n=453, 933, 915) -12.0  (0.7) -13.2  (0.6) -15.6  (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 0.0136
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-2.7 to -0.3
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 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 0.1918
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-2.0 to 0.4
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 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1505
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.7 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.5
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 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 terms for country and treatment and baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-5.2 to -2.6
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 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 0.0034
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-3.3 to -0.7
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 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
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 terms for country and treatment and baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-3.0 to -0.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.5
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 terms for country and treatment and baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-5.0 to -2.3
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 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 0.0859
Comments [Not Specified]
Method ANCOVA
Comments Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-2.5 to 0.2
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 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine 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 terms for country and treatment and baseline value as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-3.6 to -1.4
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.
15.Secondary Outcome
Title Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary
Hide Description Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Time Frame Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants with non-missing baseline and 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 matching to treatment.
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 448 926 908
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 (n=422, 911, 899) 17.6 24.5 25.1
Week 4 [LOCF] (n=448, 922, 908) 39.5 46.7 51.1
Week 12 [LOCF] (n=448, 926, 908) 53.8 58.1 63.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment difference in continent rate for 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 Cochran-Mantel-Haenszel
Comments P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment difference in continent rate for Tolterodine ER vs placebo at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6514
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment difference in continent rate for 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 P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment difference in continent rate for Tolterodine ER vs placebo at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0494
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine
Comments Treatment difference in continent rate for fesoterodine vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tolterodine ER
Comments Treatment difference in continent rate for Tolterodine ER vs placebo at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0991
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0169
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.
16.Secondary Outcome
Title Change From Baseline in Patient Perception of Bladder Condition (PPBC)
Hide Description Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.
Time Frame Baseline, Week 1, Week, 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants 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 matching to treatment.
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 455 937 918
Measure Type: Number
Unit of Measure: participants
Week 1 (n=452, 931, 913) ≥2 points improvement 43 138 144
Week 1: 1-point improvement 144 278 280
Week 1: no change 210 434 428
Week 1: deterioration 55 81 61
Week 4 (n=455, 937, 918) ≥2 points improvement 111 290 334
Week 4: 1-point improvement 124 298 280
Week 4: no change 172 285 250
Week 4: deterioration 48 64 54
Week 12 (n=455, 937, 918) ≥2 points improvement 166 379 440
Week 12: 1-point improvement 106 250 236
Week 12: no change 133 249 189
Week 12: deterioration 50 59 53
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 0.0009
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
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 0.0279
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2817
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
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 P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
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 P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine at Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0177
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
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 P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
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 0.0107
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tolterodine ER, Fesoterodine
Comments Treatment difference Tolterodine ER vs Fesoterodine 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 Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
17.Secondary Outcome
Title Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.
Hide Description Number of participants in 3-point category: improvement [≥1-point improvement]; no change; deterioration [≥1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.
Time Frame Baseline, Week 1, Week, 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants 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 matching to treatment.
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 455 938 918
Measure Type: Number
Unit of Measure: participants
Week 1 (n=452, 932, 913) improvement 97 264 267
Week 1: no change 326 619 609
Week 1: deterioration 29 49 37
Week 4 (n=455, 938, 918) improvement 161 376 421
Week 4: no change 271 511 467
Week 4: deterioration 23 51 30
Week 12 (n=455, 938, 918) improvement 183 440 495
Week 12: no change 239 455 393
Week 12: deterioration 33 43 30
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 0.0011
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
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 0.0072
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
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 0.3713
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
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 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
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 0.1485
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
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 0.0040
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
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 P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
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 0.0060
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
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 0.0016
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.
18.Secondary Outcome
Title Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12
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)/range]*100. Higher scores values indicative of greater symptom bother. Negative change in Symptom Bother Score indicates improvement.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (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 matching to treatment.
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 436 897 876
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-21.8  (1.3) -24.3  (1.0) -28.9  (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