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A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.

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ClinicalTrials.gov Identifier: NCT01302054
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : March 12, 2013
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Urinary Bladder, Overactive
Interventions Drug: Fesoterodine 8 mg
Drug: Placebo
Enrollment 990
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tolterodine Fesoterodine Placebo
Hide Arm/Group Description Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase. Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase. Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Period Title: Tolterodine Open-Label Run-In Phase
Started 990 0 0
Completed 611 0 0
Not Completed 379 0 0
Reason Not Completed
Lack of Efficacy             4             0             0
Lost to Follow-up             17             0             0
Withdrawal by Subject             16             0             0
Protocol Violation             8             0             0
Adverse Event             13             0             0
Did Not Meet Entrance Criteria             314             0             0
Other             7             0             0
Period Title: Between Open-Label and Double Blind
Started 611 0 0
Completed 609 0 0
Not Completed 2 0 0
Reason Not Completed
Did Not Enter Double-Blind Phase             2             0             0
Period Title: Double-Blind Treatment Phase
Started 0 308 301
Completed 0 281 255
Not Completed 0 27 46
Reason Not Completed
Lack of Efficacy             0             2             4
Lost to Follow-up             0             2             1
Withdrawal by Subject             0             6             14
Protocol Violation             0             3             6
Adverse Event             0             10             10
Did Not Meet Entrance Criteria             0             0             2
Other             0             4             9
Arm/Group Title Entire Study Population
Hide Arm/Group Description Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had <= 50 percent change in UUI episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
Overall Number of Baseline Participants 990
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 990 participants
57.1  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 990 participants
Female
810
  81.8%
Male
180
  18.2%
1.Primary Outcome
Title Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Hide Description UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set:all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Last Observation Carried Forward(LOCF) was used. N(number of participants analyzed):participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12(LOCF).
Arm/Group Title Fesoterodine: Double-Blind Baseline Fesoterodine: Double-Blind Week 12
Hide Arm/Group Description:
Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Overall Number of Participants Analyzed 292 292
Mean (Standard Deviation)
Unit of Measure: episodes per 24 hours
3.93  (2.53) 1.60  (2.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine: Double-Blind Baseline, Fesoterodine: Double-Blind Week 12
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical testing: one-sided, at alpha = 0.025.
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.37
Confidence Interval (2-Sided) 95%
-2.63 to -2.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.17
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
Hide Description UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (FAS): all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
Arm/Group Title Fesoterodine Placebo
Hide Arm/Group Description:
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Overall Number of Participants Analyzed 292 279
Mean (Standard Deviation)
Unit of Measure: episodes per 24 hours
Baseline 3.93  (2.53) 3.83  (2.52)
Change at Week 12 -2.32  (2.67) -1.76  (2.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments Multiple hypothesis testing was carried out in a hierarchical sequentially rejective manner. Statistical testing between fesoterodine and placebo (Analysis of covariance [ANCOVA]) was carried out only if the change from baseline at Week 12 in UUI episodes for fesoterodine group was found statistically significant (paired t-test).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0079
Comments Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used. Statistical testing: one-sided, at alpha = 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.87 to -0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
Hide Description Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here ‘N’ (number of participants analyzed): participants with baseline micturitions >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
Arm/Group Title Fesoterodine Placebo
Hide Arm/Group Description:
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Overall Number of Participants Analyzed 292 279
Mean (Standard Deviation)
Unit of Measure: micturitions per 24 hours
Baseline 12.44  (3.57) 12.48  (3.75)
Change at Week 12 -1.94  (3.15) -1.57  (3.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0931
Comments Statistical testing: one-sided, at alpha = 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.86 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.24
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12
Hide Description The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here ‘N’ (number of participants analyzed): participants with baseline urgency episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
Arm/Group Title Fesoterodine Placebo
Hide Arm/Group Description:
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Overall Number of Participants Analyzed 292 279
Mean (Standard Deviation)
Unit of Measure: episodes per 24 hours
Baseline 11.38  (3.98) 11.26  (4.01)
Change at Week 12 -3.33  (4.47) -2.52  (4.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0438
Comments Statistical testing: one-sided, at alpha = 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-1.37 to -0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.34
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Hide Description PPBC: single-item, self-administered validated questionnaire. Participant answered: “Which of the following statements describes your bladder condition best at the moment?" on a 6-point scale, 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=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of >=2).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.
Arm/Group Title Fesoterodine Placebo
Hide Arm/Group Description:
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Overall Number of Participants Analyzed 291 267
Measure Type: Number
Unit of Measure: participants
Baseline: No Problems at all 0 0
Baseline: Some Very Minor Problems 4 6
Baseline: Some Minor Problems 15 9
Baseline: Some Moderate Problems 60 75
Baseline: Severe Problems 147 141
Baseline: Many Severe Problems 65 36
Change at Week 12: Deterioration 17 32
Change at Week 12: No Change 80 95
Change at Week 12: Minor Improvement 84 83
Change at Week 12: Major Improvement 110 57
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12
Hide Description UPS: single-item, self-administered validated questionnaire. Participant answered: “Which of the following would typically describe your experience when you have a desire to urinate?” on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.
Arm/Group Title Fesoterodine Placebo
Hide Arm/Group Description:
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Overall Number of Participants Analyzed 291 267
Measure Type: Number
Unit of Measure: participants
Baseline: Not able to hold urine 126 99
Baseline:Able to hold urine until I reach a toilet 158 157
Baseline:Able to finish what I am doing 7 11
Change at Week 12: Deterioration 17 31
Change at Week 12: No Change 167 158
Change at Week 12: Improvement 107 78
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0095
Comments Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12
Hide Description OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). 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. Change=observation minus baseline.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.
Arm/Group Title Fesoterodine Placebo
Hide Arm/Group Description:
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Overall Number of Participants Analyzed 286 267
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 66.67  (20.28) 64.74  (19.69)
Change at Week 12 -24.61  (25.57) -15.99  (24.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Statistical testing: one-sided, at alpha = 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -7.34
Confidence Interval (2-Sided) 95%
-11.10 to -3.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.91
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
Hide Description OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.
Arm/Group Title Fesoterodine Placebo
Hide Arm/Group Description:
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Overall Number of Participants Analyzed 286 267
Mean (Standard Deviation)
Unit of Measure: units on a scale
Concern Subscale: Baseline 43.63  (26.00) 44.25  (25.58)
Concern Subscale: Change at Week 12 23.11  (27.77) 13.83  (25.03)
Coping Subscale: Baseline 38.74  (26.24) 41.15  (26.04)
Coping Subscale: Change at Week 12 23.70  (26.69) 15.07  (24.20)
Sleep Subscale: Baseline 41.38  (25.66) 40.69  (26.28)
Sleep Subscale: Change at Week 12 20.85  (27.42) 14.79  (25.74)
Social Interaction Subscale: Baseline 65.03  (28.34) 68.40  (26.29)
Social Interaction Subscale: Change at Week 12 14.47  (24.26) 8.85  (21.12)
Total HRQL Score: Baseline 45.90  (23.72) 47.38  (22.70)
Total HRQL Score: Change at Week 12 21.12  (24.62) 13.42  (21.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments Concern Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical testing: one-sided, at alpha = 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value 9.01
Confidence Interval (2-Sided) 95%
5.12 to 12.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.98
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments Coping Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical testing: one-sided, at alpha = 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 7.75
Confidence Interval (2-Sided) 95%
3.87 to 11.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.97
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments Sleep Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments Statistical testing: one-sided, at alpha = 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 6.52
Confidence Interval (2-Sided) 95%
2.60 to 10.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.00
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments Social Interaction Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0123
Comments Statistical testing: one-sided, at alpha = 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.13
Confidence Interval (2-Sided) 95%
0.90 to 7.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.64
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments Total HRQL - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical testing: one-sided, at alpha = 0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 7.10
Confidence Interval (2-Sided) 95%
3.63 to 10.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.77
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2
Hide Description UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame Week -2, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with Week -2 UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
Arm/Group Title Fesoterodine Placebo
Hide Arm/Group Description:
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Overall Number of Participants Analyzed 279 275
Measure Type: Number
Unit of Measure: percentage of participants
72.8 59.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline
Hide Description UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
Arm/Group Title Fesoterodine Placebo
Hide Arm/Group Description:
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Overall Number of Participants Analyzed 292 279
Measure Type: Number
Unit of Measure: percentage of participants
69.9 57.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With No UUI Episodes (Diary Dry Rate)
Hide Description UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Time Frame Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 4 and 12 (LOCF).
Arm/Group Title Fesoterodine Placebo
Hide Arm/Group Description:
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
Overall Number of Participants Analyzed 292 279
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 25.4 17.7
Week 12 39.0 32.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0427
Comments Treatment difference at Week 4: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fesoterodine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1461
Comments Treatment difference at Week 12: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Tolterodine Fesoterodine Placebo
Hide Arm/Group Description Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase. Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase. Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
All-Cause Mortality
Tolterodine Fesoterodine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tolterodine Fesoterodine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/990 (0.30%)   5/308 (1.62%)   7/301 (2.33%) 
Cardiac disorders       
Angina pectoris * 1  0/990 (0.00%)  1/308 (0.32%)  0/301 (0.00%) 
Atrial fibrillation * 1  0/990 (0.00%)  0/308 (0.00%)  1/301 (0.33%) 
Myocardial infarction * 1  0/990 (0.00%)  1/308 (0.32%)  0/301 (0.00%) 
Gastrointestinal disorders       
Dysphagia * 1  0/990 (0.00%)  0/308 (0.00%)  1/301 (0.33%) 
Hiatus hernia * 1  0/990 (0.00%)  0/308 (0.00%)  1/301 (0.33%) 
General disorders       
Chest pain * 1  1/990 (0.10%)  0/308 (0.00%)  0/301 (0.00%) 
Non-cardiac chest pain * 1  1/990 (0.10%)  0/308 (0.00%)  0/301 (0.00%) 
Hepatobiliary disorders       
Cholecystitis acute * 1  0/990 (0.00%)  0/308 (0.00%)  1/301 (0.33%) 
Injury, poisoning and procedural complications       
Femur fracture * 1  0/990 (0.00%)  0/308 (0.00%)  1/301 (0.33%) 
Musculoskeletal and connective tissue disorders       
Cervical spinal stenosis * 1  0/990 (0.00%)  0/308 (0.00%)  1/301 (0.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Gastric cancer * 1  0/990 (0.00%)  0/308 (0.00%)  1/301 (0.33%) 
Prostate cancer * 1  0/990 (0.00%)  1/308 (0.32%)  0/301 (0.00%) 
Psychiatric disorders       
Adjustment disorder * 1  0/990 (0.00%)  0/308 (0.00%)  1/301 (0.33%) 
Reproductive system and breast disorders       
Uterine haemorrhage * 1  0/990 (0.00%)  0/308 (0.00%)  1/301 (0.33%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease * 1  0/990 (0.00%)  1/308 (0.32%)  0/301 (0.00%) 
Pneumonia aspiration * 1  0/990 (0.00%)  0/308 (0.00%)  1/301 (0.33%) 
Vascular disorders       
Arterial occlusive disease * 1  1/990 (0.10%)  0/308 (0.00%)  0/301 (0.00%) 
Hypertension * 1  0/990 (0.00%)  1/308 (0.32%)  0/301 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Tolterodine Fesoterodine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   90/990 (9.09%)   76/308 (24.68%)   48/301 (15.95%) 
Eye disorders       
Vision blurred * 1  1/990 (0.10%)  3/308 (0.97%)  0/301 (0.00%) 
Gastrointestinal disorders       
Constipation * 1  11/990 (1.11%)  12/308 (3.90%)  4/301 (1.33%) 
Diarrhoea * 1  4/990 (0.40%)  2/308 (0.65%)  4/301 (1.33%) 
Dry mouth * 1  61/990 (6.16%)  51/308 (16.56%)  12/301 (3.99%) 
Dyspepsia * 1  2/990 (0.20%)  6/308 (1.95%)  0/301 (0.00%) 
Nausea * 1  7/990 (0.71%)  1/308 (0.32%)  3/301 (1.00%) 
Infections and infestations       
Bronchitis * 1  0/990 (0.00%)  0/308 (0.00%)  4/301 (1.33%) 
Influenza * 1  0/990 (0.00%)  1/308 (0.32%)  3/301 (1.00%) 
Nasopharyngitis * 1  6/990 (0.61%)  3/308 (0.97%)  4/301 (1.33%) 
Upper respiratory tract infection * 1  3/990 (0.30%)  2/308 (0.65%)  3/301 (1.00%) 
Urinary tract infection * 1  3/990 (0.30%)  4/308 (1.30%)  4/301 (1.33%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  3/990 (0.30%)  1/308 (0.32%)  3/301 (1.00%) 
Nervous system disorders       
Dizziness * 1  1/990 (0.10%)  1/308 (0.32%)  4/301 (1.33%) 
Headache * 1  4/990 (0.40%)  3/308 (0.97%)  4/301 (1.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01302054     History of Changes
Other Study ID Numbers: A0221094
First Submitted: February 18, 2011
First Posted: February 23, 2011
Results First Submitted: February 7, 2013
Results First Posted: March 12, 2013
Last Update Posted: December 4, 2018