Overactive Bladder
Conditions
Brief summary
This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.
Interventions
DRUGFesoterodine 8mg
Oral, 1 tablet per day, 12 weeks duration, 8mg/day
DRUGFesoterodine 4mg
Oral, 1 tablet per day, 12 weeks duration, 4mg/day
DRUGPlacebo
Oral, 1 tablet per day, 12 weeks duration
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence episodes per 24 hours and minimum of 8 micturitions per 24 hours.
Exclusion criteria
* Other concurrent and concomitant medication or disease that could put the subjects at additional risk or interfere with the study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | Week 12 | UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4. | Week 4 | Micturitions include episodes of voluntary micturition and episodes of UUI. |
| Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12. | Week 12 | Micturitions include episodes of voluntary micturition and episodes of UUI. |
| Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4. | Week 4 | UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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. |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4. | Week 4 | Micturitions include episodes of voluntary micturition and episodes of UUI. |
| Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4. | Week 4 | UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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. |
| Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12. | Week 12 | UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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. |
| Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. | Week 4 | 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 total range 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. |
| Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. | Week 12 | 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 total range 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. |
| Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. | Week 4 | 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 total range 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. |
| Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. | Week 12 | 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 total range 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. |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | Week 12 | Micturitions include episodes of voluntary micturition and episodes of UUI. |
| Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12. | Week 12 | 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). |
| Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12. | Week 12 | 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 From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Week 12 | 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. |
| Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Week 12 | 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. |
| Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Week 12 | 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. |
| Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Week 12 | 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. |
| Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Week 12 | 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. |
| Percentage of Participants Who Became Dry at Week 4. | Week 4 | Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI\>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary |
| Percentage of Participants Who Became Dry at Week 12. | Week 12 | Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI \>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. |
| Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. | Week 12 | PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline. |
Countries
Argentina, Canada, Chile, Colombia, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Mexico, Norway, Philippines, Poland, Russia, Slovakia, South Africa, South Korea, Sweden, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
This report presents results of a 12-week study conducted at 241 centers across 27 countries.
Pre-assignment details
Participants ≥18 years of age with overactive bladder (OAB) symptoms for ≥6 months prior to screening were enrolled. After screening eligible participants were enrolled into the run-in period and received placebo for 2 weeks in a single-blind manner. Participants completed a 3-day bladder diary for 3 days in the week prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Fesoterodine 4 Milligram (mg) Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks. | 790 |
| Placebo Participants received one tablet of placebo per day for 12 weeks. | 386 |
| Fesoterodine 8 mg Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks. | 779 |
| Total | 1,955 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 27 | 14 | 45 |
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 8 | 4 | 2 |
| Overall Study | Lost to Follow-up | 9 | 4 | 15 |
| Overall Study | Other | 1 | 1 | 3 |
| Overall Study | Physician Decision | 9 | 5 | 14 |
| Overall Study | Protocol Violation | 11 | 0 | 8 |
| Overall Study | Withdrawal by Subject | 13 | 6 | 10 |
Baseline characteristics
| Characteristic | Fesoterodine 4 Milligram (mg) | Placebo | Fesoterodine 8 mg | Total |
|---|---|---|---|---|
| Age, Customized <18 | 0 Years | 0 Years | 0 Years | 0 Years |
| Age, Customized 18 to 44 | 114 Years | 49 Years | 99 Years | 262 Years |
| Age, Customized 45 to 64 | 380 Years | 193 Years | 377 Years | 950 Years |
| Age, Customized >= 65 | 296 Years | 144 Years | 303 Years | 743 Years |
| Sex: Female, Male Female | 647 Participants | 316 Participants | 627 Participants | 1590 Participants |
| Sex: Female, Male Male | 143 Participants | 70 Participants | 152 Participants | 365 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 297 / 790 | 103 / 386 | 349 / 779 |
| serious Total, serious adverse events | 10 / 790 | 11 / 386 | 10 / 779 |
Outcome results
Primary
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.
UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 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 12
Population: Full Analysis Set (FAS)included participants receiving 1 dose of assigned study drug and with 1 baseline (BL) or post-BL efficacy assessment. Last observation carried forward (LOCF) was used to impute missing data at Week 12. Participants with baseline UUI \>0 per 24 hours \& non-missing change from BL to Week 12 were included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | -2.85 Episodes per 24 hours | Standard Error 0.09 |
| Placebo | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | -2.22 Episodes per 24 hours | Standard Error 0.12 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | -3.12 Episodes per 24 hours | Standard Error 0.09 |
Comparison: Comparisons were done with 2-sided test at 5% significance level. Null hypothesis: mean change from BL in the number of UUI episodes per 24 hours in the 8mg group was same as 4mg group at Week 12. ANCOVA was used to compare 8mg and 4mg arms for numeric change from BL - Week 12. This included terms for treatment, country, centered BL value and centered BL by treatment interaction, in which centered BL (BL - mean BL) was used to ensure that treatment effect was estimated at mean covariate value.p-value: <0.000195% CI: [-1.16, -0.66]ANCOVA
Comparison: Treatment comparisons were performed with a two-sided test at the 5% significance level.p-value: 0.010995% CI: [-0.48, -0.06]ANCOVA
Comparison: Treatment comparisons were performed with a two-sided test at the 5% significance level.p-value: <0.000195% CI: [-0.89, -0.39]ANCOVA
Secondary
Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
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: Week 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 26.82 Scores on a scale | Standard Error 1.15 |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 20.27 Scores on a scale | Standard Error 1.51 |
| Fesoterodine 8 mg | Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 31.18 Scores on a scale | Standard Error 1.16 |
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: <0.000195% CI: [7.73, 14.09]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: 0.00195% CI: [1.76, 6.96]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: <0.000195% CI: [3.39, 9.72]ANCOVA
Secondary
Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
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: Week 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 26.69 Scores on a scale | Standard Error 1.18 |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 20.91 Scores on a scale | Standard Error 1.55 |
| Fesoterodine 8 mg | Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 31.38 Scores on a scale | Standard Error 1.19 |
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: <0.000195% CI: [7.2, 13.73]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: 0.000695% CI: [2.01, 7.36]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: 0.000595% CI: [2.53, 9.03]ANCOVA
Secondary
Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
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: Week 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 21.97 Scores on a scale | Standard Error 1.1 |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 18.25 Scores on a scale | Standard Error 1.45 |
| Fesoterodine 8 mg | Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 25.71 Scores on a scale | Standard Error 1.12 |
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: <0.000195% CI: [4.4, 10.51]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: 0.003495% CI: [1.24, 6.23]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: 0.016495% CI: [0.68, 6.76]ANCOVA
Secondary
Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
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: Week 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 16.43 Scores on a scale | Standard Error 0.89 |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 12.61 Scores on a scale | Standard Error 1.17 |
| Fesoterodine 8 mg | Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 20.11 Scores on a scale | Standard Error 0.9 |
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: <0.000195% CI: [5.03, 9.97]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: 0.000495% CI: [1.65, 5.7]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: 0.002395% CI: [1.36, 6.28]ANCOVA
Secondary
Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
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: Week 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 23.70 Scores on a scale | Standard Error 1.02 |
| Placebo | Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 18.57 Scores on a scale | Standard Error 1.33 |
| Fesoterodine 8 mg | Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. | 27.94 Scores on a scale | Standard Error 1.03 |
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: <0.000195% CI: [6.56, 12.18]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: 0.000395% CI: [1.93, 6.53]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: 0.000395% CI: [2.34, 7.94]ANCOVA
Secondary
Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.
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 total range 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 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes \>0 per 24 hours and non-missing change from BL to Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. | -4.23 Episodes per 24 hours | Standard Error 0.19 |
| Placebo | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. | -2.99 Episodes per 24 hours | Standard Error 0.25 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. | -5.01 Episodes per 24 hours | Standard Error 0.19 |
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.p-value: <0.000195% CI: [-2.55, -1.49]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.p-value: 0.000595% CI: [-1.22, -0.34]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.p-value: <0.000195% CI: [-1.77, -0.71]ANCOVA
Secondary
Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.
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 total range 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
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-related urgency episodes \>0 per 24 hours and non-missing change from BL to Week 4.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. | -2.89 Episodes per 24 hours | Standard Error 0.18 |
| Placebo | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. | -1.85 Episodes per 24 hours | Standard Error 0.23 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. | -3.40 Episodes per 24 hours | Standard Error 0.18 |
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.p-value: <0.000195% CI: [-2.04, -1.06]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.p-value: 0.012195% CI: [-0.92, -0.11]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.p-value: <0.000195% CI: [-1.52, -0.55]ANCOVA
Secondary
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.
Micturitions include episodes of voluntary micturition and episodes of UUI.
Time frame: Week 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency \>0 per 24 hours and non-missing change from BL to Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | -2.45 Episodes per 24 hours | Standard Error 0.13 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | -1.58 Episodes per 24 hours | Standard Error 0.17 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | -2.97 Episodes per 24 hours | Standard Error 0.13 |
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.p-value: <0.000195% CI: [-1.76, -1.03]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.p-value: 0.000695% CI: [-0.83, -0.23]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.p-value: <0.000195% CI: [-1.23, -0.51]ANCOVA
Secondary
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.
Micturitions include episodes of voluntary micturition and episodes of UUI.
Time frame: Week 4
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency \>0 per 24 hours and non-missing change from BL to Week 4.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4. | -1.95 Episodes per 24 hours | Standard Error 0.13 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4. | -1.19 Episodes per 24 hours | Standard Error 0.16 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4. | -2.33 Episodes per 24 hours | Standard Error 0.13 |
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.p-value: <0.000195% CI: [-1.48, -0.79]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.p-value: 0.008295% CI: [-0.67, -0.1]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.p-value: <0.000195% CI: [-1.1, -0.41]ANCOVA
Secondary
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI \>0 per 24 hours and non-missing change from BL to Week 4.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4. | -2.55 Episodes per 24 hours | Standard Error 0.09 |
| Placebo | Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4. | -1.99 Episodes per 24 hours | Standard Error 0.12 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4. | -2.75 Episodes per 24 hours | Standard Error 0.09 |
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: 0.066295% CI: [-0.41, 0.01]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: <0.000195% CI: [-1.02, -0.5]ANCOVA
Comparison: P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.p-value: <0.000195% CI: [-0.82, -0.3]ANCOVA
Secondary
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12.
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.
Time frame: Week 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12. | -30.19 Scores on a scale | Standard Error 1.09 |
| Placebo | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12. | -22.41 Scores on a scale | Standard Error 1.43 |
| Fesoterodine 8 mg | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12. | -34.88 Scores on a scale | Standard Error 1.1 |
Comparison: Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.p-value: <0.000195% CI: [-15.49, -9.45]ANCOVA
Comparison: Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.p-value: 0.000295% CI: [-7.15, -2.22]ANCOVA
Comparison: Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.p-value: <0.000195% CI: [-10.78, -4.78]ANCOVA
Secondary
Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.
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 total range 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 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes \>0 per 24 hours and non-missing change from BL to Week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. | -34.88 Participant |
| Placebo | Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. | -22.73 Participant |
| Fesoterodine 8 mg | Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. | -44.29 Participant |
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: <0.0001ANCOVA
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: 0.0002ANCOVA
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.
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 total range 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
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-Related Urgency Episodes \>0 per 24 hours and non-missing change from BL to Week 4.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. | -23.26 Participant |
| Placebo | Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. | -14.70 Participant |
| Fesoterodine 8 mg | Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. | -27.27 Participant |
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: <0.0001ANCOVA
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: 0.0348ANCOVA
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: 0.0003ANCOVA
Secondary
Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.
Micturitions include episodes of voluntary micturition and episodes of UUI.
Time frame: Week 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency \>0 per 24 hours and non-missing change from BL to Week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12. | -19.74 Episodes per 24 hours |
| Placebo | Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12. | -12.16 Episodes per 24 hours |
| Fesoterodine 8 mg | Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12. | -24.14 Episodes per 24 hours |
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: <0.0001ANCOVA
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: <0.0001ANCOVA
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.
Micturitions include episodes of voluntary micturition and episodes of UUI.
Time frame: Week 4
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency \>0 per 24 hours and non-missing change from BL to Week 4.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4. | -14.58 Episodes per 24 hours |
| Placebo | Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4. | -9.01 Episodes per 24 hours |
| Fesoterodine 8 mg | Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4. | -17.24 Episodes per 24 hours |
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: <0.0001ANCOVA
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: 0.004ANCOVA
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12.
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL UUI \>0 per 24 hours and non-missing change from BL to Week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12. | -93.75 Episodes per 24 hours |
| Placebo | Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12. | -78.89 Episodes per 24 hours |
| Fesoterodine 8 mg | Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12. | -100.00 Episodes per 24 hours |
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: <0.0001ANCOVA
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: 0.0006ANCOVA
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: 0.0001ANCOVA
Secondary
Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4.
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI \>0 per 24 hours and non-missing change from BL to Week 4.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fesoterodine 4 Milligram (mg) | Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4. | -77.78 Episodes per 24 hours |
| Placebo | Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4. | -60.50 Episodes per 24 hours |
| Fesoterodine 8 mg | Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4. | -82.48 Episodes per 24 hours |
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: <0.0001ANCOVA
Comparison: P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.p-value: <0.0001ANCOVA
Secondary
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12.
PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.
Time frame: Week 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. | Deterioration | 38 Participants |
| Fesoterodine 4 Milligram (mg) | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. | No Change | 172 Participants |
| Fesoterodine 4 Milligram (mg) | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. | Minor improvement | 210 Participants |
| Fesoterodine 4 Milligram (mg) | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. | Major improvement | 280 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. | Major improvement | 96 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. | Deterioration | 25 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. | Minor improvement | 105 Participants |
| Placebo | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. | No Change | 122 Participants |
| Fesoterodine 8 mg | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. | Major improvement | 329 Participants |
| Fesoterodine 8 mg | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. | No Change | 151 Participants |
| Fesoterodine 8 mg | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. | Minor improvement | 170 Participants |
| Fesoterodine 8 mg | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. | Deterioration | 27 Participants |
Comparison: Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.p-value: 0.0057Cochran-Mantel-Haenszel
Comparison: Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.p-value: 0.0008Cochran-Mantel-Haenszel
Secondary
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12.
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: Week 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fesoterodine 4 Milligram (mg) | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12. | No change | 361 Participants |
| Fesoterodine 4 Milligram (mg) | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12. | Deterioration | 37 Participants |
| Fesoterodine 4 Milligram (mg) | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12. | Improvement | 302 Participants |
| Placebo | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12. | No change | 193 Participants |
| Placebo | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12. | Deterioration | 23 Participants |
| Placebo | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12. | Improvement | 132 Participants |
| Fesoterodine 8 mg | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12. | Deterioration | 30 Participants |
| Fesoterodine 8 mg | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12. | Improvement | 342 Participants |
| Fesoterodine 8 mg | Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12. | No change | 305 Participants |
Comparison: Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.p-value: 0.0007Cochran-Mantel-Haenszel
Comparison: Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.p-value: 0.0091Cochran-Mantel-Haenszel
Comparison: Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.p-value: 0.3901Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Became Dry at Week 12.
Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI \>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.
Time frame: Week 12
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. Number of participants with Baseline UUI \>0 per 24 hours and non-missing change from baseline to Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fesoterodine 4 Milligram (mg) | Percentage of Participants Who Became Dry at Week 12. | 49.2 Percentage of participants |
| Placebo | Percentage of Participants Who Became Dry at Week 12. | 39.5 Percentage of participants |
| Fesoterodine 8 mg | Percentage of Participants Who Became Dry at Week 12. | 57.8 Percentage of participants |
Comparison: P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.p-value: 0.0006Cochran-Mantel-Haenszel
Comparison: P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.p-value: 0.0027Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Became Dry at Week 4.
Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI\>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary
Time frame: Week 4
Population: The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with baseline UUI \>0 per 24 hours and non-missing change from baseline to Week 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fesoterodine 4 Milligram (mg) | Percentage of Participants Who Became Dry at Week 4. | 35.5 Percentage of participants |
| Placebo | Percentage of Participants Who Became Dry at Week 4. | 26.4 Percentage of participants |
| Fesoterodine 8 mg | Percentage of Participants Who Became Dry at Week 4. | 36.2 Percentage of participants |
Comparison: P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.p-value: 0.0016Cochran-Mantel-Haenszel
Comparison: P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.p-value: 0.8121Cochran-Mantel-Haenszel
Comparison: P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.p-value: 0.0015Cochran-Mantel-Haenszel