| Primary | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | 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. | Full analysis set. Last observation carried forward. | Posted | | Least Squares Mean | 95% Confidence Interval | UUI Episodes | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.01(-1.31 to -0.71)
- OG001-1.35(-1.65 to -1.05)
- OG002-1.40(-1.70 to -1.09)
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The significance level was 0.05 (2-sided). | ANCOVA | Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used. | 0.002 | The closed testing procedure was used in order to control the probability of a type 1 error. | Mean Difference (Final Values) | -0.34 | | | | 95 | -0.56 | -0.13 | | | | No | Superiority or Other | | | |
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| Secondary | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | 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. | Full analysis set. No imputation was used for missing data. | Posted | | Mean | Standard Deviation | UUI Episodes | | Baseline to Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
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| Secondary | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | 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. | Full analysis set. Last observation carried forward. | Posted | | Least Squares Mean | 95% Confidence Interval | Micturitions | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
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| Secondary | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | 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. | Full analysis set. No imputation was used for missing data. | Posted | | Mean | Standard Deviation | Micturitions | | Baseline to Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
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| Secondary | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12. | 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. | Full analysis set. Last observation carried forward. | Posted | | Least Squares Mean | 95% Confidence Interval | Urgency Episodes | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
| |
| Secondary | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | 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. | Full analysis set. No imputation was used for missing data. | Posted | | Mean | Standard Deviation | Urgency Episodes | | Baseline to Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
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| Secondary | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12. | 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. | Full analysis set. Last observation carried forward | Posted | | Least Squares Mean | 95% Confidence Interval | Incontinence Episodes | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
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| Secondary | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | 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. | Full analysis set. No imputation was used for missing data. | Posted | | Mean | Standard Deviation | Incontinence Episodes | | Baseline to Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
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| Secondary | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12. | 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Night-Time Micturitions | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
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| Secondary | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | 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. | 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. | Posted | | Mean | Standard Deviation | Night-Time Micturitions | | Baseline to Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
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| Secondary | Change From Baseline in Mean Voided Volume Per Micturition at Week 12. | 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. | Full analysis set. Last observation carried forward. | Posted | | Mean | Standard Deviation | mL | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
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| Secondary | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | 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. | Full analysis set. No imputation was used for missing data. | Posted | | Mean | Standard Deviation | mL | | Baseline to Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
| |
| Secondary | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | 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. | Full analysis set. No imputation was used for missing data. | Posted | | Mean | Standard Deviation | score on scale | | Baseline to Week12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
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| Secondary | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 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. | 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.) | Posted | | Mean | Standard Deviation | score on scale | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
|
| Secondary | Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12. | Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:
- No problems at all
- Some very minor problems
- Some minor problems
- Some moderate problems
- Severe problems
- Many severe problems
Change: mean at Week 12 minus mean at Baseline. | Full analysis set. No imputation was used for missing data. | Posted | | Mean | Standard Deviation | score on scale | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
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| Secondary | 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. | Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:
- No problems at all
- Some very minor problems
- Some minor problems
- Some moderate problems
- Severe problems
- Many severe problems
| Full analysis set. No imputation was used for missing data | Posted | | Number | | participants | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects were treated with placebo once daily for 12 weeks. | | OG001 | Fesoterodine 4 mg | Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | | OG002 | Fesoterodine 8 mg | Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. |
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