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Trial record 1 of 1 for:    NCT00561951
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Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Overactive Bladder
Interventions Drug: fesoterodine fumarate
Drug: Placebo
Enrollment 951
Recruitment Details  
Pre-assignment Details Eligible subjects who underwent screening were enrolled into the run-in period at visit 1 and received single-blind placebo for 2 weeks. At Visit 2, Only subjects with overactive bladder who met the criteria were randomized to one of three treatment arms (fesoterodine 4 mg, fesoterodine 8 mg or placebo) in a 1:1:1 ratio.
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description Subjects were treated with placebo once daily for 12 weeks. Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Period Title: Overall Study
Started 318 320 313
Completed 285 286 281
Not Completed 33 34 32
Reason Not Completed
Adverse Event             11             14             14
Lack of Efficacy             5             3             2
Lost to Follow-up             1             1             0
Withdrawal by Subject             10             9             10
Protocol Violation             4             3             4
Physician Decision             1             0             0
Pregnancy             0             1             0
Meet Withdrawal Criterion             0             1             1
Adverse Event Occured Before Treatment             1             2             1
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg Total
Hide Arm/Group Description Subjects were treated with placebo once daily for 12 weeks. Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 318 320 313 951
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 318 participants 320 participants 313 participants 951 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
227
  71.4%
217
  67.8%
196
  62.6%
640
  67.3%
>=65 years
91
  28.6%
103
  32.2%
117
  37.4%
311
  32.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 318 participants 320 participants 313 participants 951 participants
56.7  (13.5) 57.2  (14.2) 58.8  (13.4) 57.6  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 318 participants 320 participants 313 participants 951 participants
Female
251
  78.9%
251
  78.4%
255
  81.5%
757
  79.6%
Male
67
  21.1%
69
  21.6%
58
  18.5%
194
  20.4%
1.Primary Outcome
Title Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.
Hide Description

Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.

Change: mean at Week 12 minus mean at Baseline.

Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Last observation carried forward.
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 309 314 306
Least Squares Mean (95% Confidence Interval)
Unit of Measure: UUI Episodes
-1.01
(-1.31 to -0.71)
-1.35
(-1.65 to -1.05)
-1.40
(-1.70 to -1.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine 4 mg
Comments The significance level was 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The closed testing procedure was used in order to control the probability of a type 1 error.
Method ANCOVA
Comments Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Confidence Interval 95%
-0.56 to -0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine 8 mg
Comments The significance level was 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The closed testing procedure was used in order to control the probability of a type 1 error.
Method ANCOVA
Comments Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval 95%
-0.60 to -0.17
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Hide Description

Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.

Change: mean at each visit minus mean at Baseline.

Time Frame Baseline to Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. No imputation was used for missing data.
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 309 314 306
Mean (Standard Deviation)
Unit of Measure: UUI Episodes
Week 2 (n=308, 314, 305) -0.79  (1.465) -1.10  (1.681) -1.12  (1.736)
Week 4 (n=301, 303, 296) -1.15  (1.532) -1.48  (1.688) -1.49  (1.643)
Week 8 (n=289, 289, 287) -1.45  (1.518) -1.61  (1.680) -1.65  (1.690)
Week 12 (n=284, 284, 281) -1.49  (1.717) -1.76  (1.618) -1.87  (1.814)
3.Secondary Outcome
Title Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.
Hide Description

Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

Change: mean at Week 12 minus mean at Baseline.

Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Last observation carried forward.
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 309 314 306
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Micturitions
-0.59
(-1.08 to -0.10)
-1.15
(-1.64 to -0.67)
-1.25
(-1.75 to -0.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine 4 mg
Comments The significance level was 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.56
Confidence Interval 95%
-0.91 to -0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine 8 mg
Comments The significance level was 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.66
Confidence Interval 95%
-1.01 to -0.32
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Hide Description

Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

Change: mean at each visit minus mean at Baseline.

Time Frame Baseline to Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. No imputation was used for missing data.
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 309 314 306
Mean (Standard Deviation)
Unit of Measure: Micturitions
Week 2 (n=308, 314, 305) -0.47  (1.786) -0.94  (1.987) -1.06  (2.076)
Week 4 (n=301, 303, 296) -0.85  (1.960) -1.33  (2.146) -1.60  (2.246)
Week 8 (n=289, 289, 287) -1.36  (2.215) -1.81  (2.277) -2.15  (2.402)
Week 12 (n=284, 284, 281) -1.36  (2.415) -2.13  (2.214) -2.17  (2.515)
5.Secondary Outcome
Title Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.
Hide Description

Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.

Change: mean at Week 12 minus mean at Baseline.

Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Last observation carried forward.
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 309 314 306
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Urgency Episodes
-1.00
(-1.60 to -0.40)
-1.65
(-2.25 to -1.05)
-1.66
(-2.27 to -1.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine 4 mg
Comments The significance level was 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.65
Confidence Interval 95%
-1.07 to -0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine 8 mg
Comments The significance level was 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.66
Confidence Interval 95%
-1.09 to -0.23
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Hide Description

Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.

Change: mean at each visit minus mean at Baseline.

Time Frame Baseline to Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. No imputation was used for missing data.
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 309 314 306
Mean (Standard Deviation)
Unit of Measure: Urgency Episodes
Week 2 (n=308, 314, 305) -0.79  (2.640) -1.37  (2.722) -1.59  (2.816)
Week 4 (n=301, 303, 296) -1.60  (2.780) -2.16  (2.906) -2.16  (3.065)
Week 8 (n=289, 289, 287) -2.34  (2.835) -2.50  (3.080) -2.71  (3.139)
Week 12 (n=284, 284, 281) -2.37  (2.975) -2.89  (2.838) -3.05  (3.462)
7.Secondary Outcome
Title Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.
Hide Description

Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

Incontinence is the complaint of any involuntary leakage of urine.

Change: mean at Week 12 minus mean at Baseline.

Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Last observation carried forward
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 309 314 306
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Incontinence Episodes
-0.88
(-1.22 to -0.54)
-1.27
(-1.61 to -0.93)
-1.15
(-1.50 to -0.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine 4 mg
Comments The significance level was 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval 95%
-0.63 to -0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine 8 mg
Comments The significance level was 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.27
Confidence Interval 95%
-0.52 to -0.03
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Hide Description

Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

Incontinence is the complaint of any involuntary leakage of urine.

Change: mean at each visit minus mean at Baseline.

Time Frame Baseline to Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. No imputation was used for missing data.
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 309 314 306
Mean (Standard Deviation)
Unit of Measure: Incontinence Episodes
Week 2 (n=308, 314, 305) -0.80  (1.573) -1.11  (1.725) -1.06  (1.887)
Week 4 (n=301, 303, 296) -1.22  (1.598) -1.61  (1.755) -1.50  (1.707)
Week 8 (n=289, 289, 287) -1.56  (1.727) -1.76  (1.795) -1.73  (1.760)
Week 12 (n=284, 284, 281) -1.59  (1.869) -1.97  (1.843) -1.86  (2.000)
9.Secondary Outcome
Title Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.
Hide Description

Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

Change: mean at Week 12 minus mean at Baseline.

Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

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

Last observation carried forward.

Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 243 256 257
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Night-Time Micturitions
-0.18
(-0.41 to 0.06)
-0.21
(-0.44 to 0.02)
-0.29
(-0.52 to -0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine 4 mg
Comments The significance level was 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.624
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval 95%
-0.18 to 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fesoterodine 8 mg
Comments The significance level was 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.129
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval 95%
-0.26 to 0.03
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Hide Description

Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

Change: mean at each visit minus mean at Baseline.

Time Frame Baseline to Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description

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

No imputation was used for missing data.

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

Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day.

Change: mean at Week 12 minus mean at Baseline.

Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Last observation carried forward.
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 309 314 306
Mean (Standard Deviation)
Unit of Measure: mL
13.07  (46.207) 22.80  (47.590) 32.77  (52.893)
12.Secondary Outcome
Title Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.
Hide Description

Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.

Change: mean at each visit minus mean at Baseline.

Time Frame Baseline to Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. No imputation was used for missing data.
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 309 314 306
Mean (Standard Deviation)
Unit of Measure: mL
Week 2 (n=308, 314, 304) 5.06  (37.875) 13.63  (35.350) 21.52  (42.946)
Week 4 (n=301, 303, 296) 9.23  (43.639) 21.62  (44.623) 27.41  (45.803)
Week 8 (n=289, 289, 287) 10.75  (45.628) 22.05  (44.949) 30.94  (51.258)
Week 12 (n=284, 284, 281) 13.28  (46.317) 24.52  (48.620) 33.40  (53.379)
13.Secondary Outcome
Title Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
Hide Description

King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response.

Change: mean at Week 12 minus mean at Baseline.

Time Frame Baseline to Week12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. No imputation was used for missing data.
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 285 283 283
Mean (Standard Deviation)
Unit of Measure: score on scale
General Health Perceptions (n=285, 283, 283) -7.02  (22.573) -9.36  (25.190) -6.10  (25.272)
Impact on Life (n=285, 283, 283) -22.46  (28.018) -27.33  (29.960) -25.09  (32.172)
Role Limitations (n=285, 283, 283) -20.47  (27.730) -27.92  (26.373) -25.97  (28.590)
Physical Limitations (n=285, 283, 283) -18.65  (28.250) -23.50  (28.807) -25.97  (28.278)
Social Limitations (n=285, 283, 283) -14.44  (25.541) -17.92  (24.029) -18.53  (25.765)
Personal Relationships (n=214, 210, 202) -8.33  (21.773) -16.11  (25.798) -9.98  (24.335)
Emotions (n=285, 283, 283) -18.01  (26.365) -24.70  (27.192) -24.89  (27.310)
Sleep/Energy (n=285, 283, 283) -12.51  (24.967) -19.08  (23.800) -18.02  (25.287)
Incontinence Severity Measures (n=285, 283, 283) -13.75  (20.763) -17.67  (21.038) -18.59  (21.814)
14.Secondary Outcome
Title Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Hide Description

The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL).

The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain.

Change: mean at Week 12 minus mean at Baseline.

Time Frame Baseline to Week 12
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Hide Analysis Population Description
Full analysis set. Half scale rule (domain scores were calculated if a respondent had answered at least half of the items in a multi-item scale. Missing items were then replaced by the mean of non-missing items in that scale, for that participant.)
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 285 283 283
Mean (Standard Deviation)
Unit of Measure: score on scale
Symptom Bother Score -18.25  (23.618) -26.61  (22.592) -26.35  (23.849)
Total Score of HRQL domain 12.88  (18.868) 17.84  (17.880) 17.29  (19.670)
Coping Score of HRQL domain 16.54  (23.633) 21.01  (22.109) 21.48  (25.336)
Concern Score of HRQL domain 13.25  (21.182) 20.05  (20.526) 19.10  (21.868)
Sleep Score of HRQL domain 12.03  (22.215) 16.16  (21.886) 15.35  (24.654)
Social Score of HRQL domain 7.37  (17.211) 11.35  (16.504) 9.98  (16.706)
15.Secondary Outcome
Title Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.
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Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:

  1. No problems at all
  2. Some very minor problems
  3. Some minor problems
  4. Some moderate problems
  5. Severe problems
  6. Many severe problems

Change: mean at Week 12 minus mean at Baseline.

Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. No imputation was used for missing data.
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 285 283 283
Mean (Standard Deviation)
Unit of Measure: score on scale
-1.57  (1.236) -1.83  (1.157) -1.76  (1.182)
16.Secondary Outcome
Title The Number of Patients With “Severe Problems, Score 5” or “Many Severe Problems, Score 6” in Patient Perception of Bladder Condition (PPBC) at Week 12.
Hide Description

Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:

  1. No problems at all
  2. Some very minor problems
  3. Some minor problems
  4. Some moderate problems
  5. Severe problems
  6. Many severe problems
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. No imputation was used for missing data
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description:
Subjects were treated with placebo once daily for 12 weeks.
Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
Overall Number of Participants Analyzed 285 283 283
Measure Type: Number
Unit of Measure: participants
Baseline 82 97 83
Week 12 28 12 19
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Hide Arm/Group Description Subjects were treated with placebo once daily for 12 weeks. Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
All-Cause Mortality
Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/318 (1.57%)   3/320 (0.94%)   0/313 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  1/318 (0.31%)  0/320 (0.00%)  0/313 (0.00%) 
Diarrhoea   1/318 (0.31%)  0/320 (0.00%)  0/313 (0.00%) 
Vomiting   1/318 (0.31%)  0/320 (0.00%)  0/313 (0.00%) 
General disorders       
Pyrexia   1/318 (0.31%)  0/320 (0.00%)  0/313 (0.00%) 
Infections and infestations       
Abscess   1/318 (0.31%)  0/320 (0.00%)  0/313 (0.00%) 
Cellulitis   1/318 (0.31%)  0/320 (0.00%)  0/313 (0.00%) 
Urinary tract infection   0/318 (0.00%)  1/320 (0.31%)  0/313 (0.00%) 
Injury, poisoning and procedural complications       
Pelvic fracture   0/318 (0.00%)  1/320 (0.31%)  0/313 (0.00%) 
Road traffic accident   0/318 (0.00%)  1/320 (0.31%)  0/313 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cervix carcinoma   1/318 (0.31%)  0/320 (0.00%)  0/313 (0.00%) 
Nervous system disorders       
Cerebral infarction   1/318 (0.31%)  0/320 (0.00%)  0/313 (0.00%) 
Reproductive system and breast disorders       
Pelvic pain   0/318 (0.00%)  1/320 (0.31%)  0/313 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Fesoterodine 4 mg Fesoterodine 8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   68/318 (21.38%)   138/320 (43.13%)   185/313 (59.11%) 
Gastrointestinal disorders       
Constipation  1  15/318 (4.72%)  17/320 (5.31%)  33/313 (10.54%) 
Diarrhoea   2/318 (0.63%)  7/320 (2.19%)  3/313 (0.96%) 
Dry mouth   31/318 (9.75%)  93/320 (29.06%)  158/313 (50.48%) 
Infections and infestations       
Cystitis   4/318 (1.26%)  12/320 (3.75%)  7/313 (2.24%) 
Nasopharyngitis   21/318 (6.60%)  19/320 (5.94%)  22/313 (7.03%) 
Nervous system disorders       
Dizziness   1/318 (0.31%)  7/320 (2.19%)  2/313 (0.64%) 
Headache   5/318 (1.57%)  10/320 (3.13%)  4/313 (1.28%) 
Renal and urinary disorders       
Dysuria   0/318 (0.00%)  2/320 (0.63%)  14/313 (4.47%) 
Residual urine   5/318 (1.57%)  7/320 (2.19%)  2/313 (0.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00561951     History of Changes
Other Study ID Numbers: A0221005
First Submitted: November 19, 2007
First Posted: November 21, 2007
Results First Submitted: January 11, 2010
Results First Posted: September 9, 2010
Last Update Posted: July 14, 2011