Overactive Bladder
Conditions
Brief summary
To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.
Interventions
8mg tablets OD for 12 weeks
DRUGPlacebo
Corresponding placebo tablets OD for 12 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult OAB patients who present with OAB symptoms, including micturitions \>= 8 per day and urgency urinary incontinence \>= 1 per day.
Exclusion criteria
* Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients. * Patient has a known neurological disease influencing bladder function. * Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
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. | Baseline to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | Baseline to 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. |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Baseline to 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. |
| Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Baseline to 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. |
| Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12. | Baseline to 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. |
| Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Baseline to 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. |
| Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12. | Baseline to 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. |
| Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12. | Baseline to 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. |
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Baseline to 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. |
| Change From Baseline in Mean Voided Volume Per Micturition at Week 12. | Baseline to 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. |
| Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Baseline to 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. |
| Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Baseline to Week12 | 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. |
| Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Baseline to 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. |
| Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12. | Baseline to Week 12 | Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: 1. No problems at all 2. Some very minor problems 3. Some minor problems 4. Some moderate problems 5. Severe problems 6. Many severe problems Change: mean at Week 12 minus mean at Baseline. |
| 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. | Baseline to Week 12 | Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows: 1. No problems at all 2. Some very minor problems 3. Some minor problems 4. Some moderate problems 5. Severe problems 6. Many severe problems |
| Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Baseline to 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. |
Countries
Hong Kong, Japan, South Korea, Taiwan
Participant flow
Pre-assignment details
Eligible subjects who underwent screening were enrolled into the run-in period at visit 1 and received single-blind placebo for 2 weeks. At Visit 2, Only subjects with overactive bladder who met the criteria were randomized to one of three treatment arms (fesoterodine 4 mg, fesoterodine 8 mg or placebo) in a 1:1:1 ratio.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Subjects were treated with placebo once daily for 12 weeks. | 318 |
| Fesoterodine 4 mg Subjects were treated with Fesoterodine 4 mg/day for 12 weeks. | 320 |
| Fesoterodine 8 mg Subjects were treated with Fesoterodine 8 mg/day for 12 weeks. | 313 |
| Total | 951 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 11 | 14 | 14 |
| Overall Study | Adverse Event Occured Before Treatment | 1 | 2 | 1 |
| Overall Study | Lack of Efficacy | 5 | 3 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Meet Withdrawal Criterion | 0 | 1 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Pregnancy | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 4 | 3 | 4 |
| Overall Study | Withdrawal by Subject | 10 | 9 | 10 |
Baseline characteristics
| Characteristic | Placebo | Fesoterodine 4 mg | Fesoterodine 8 mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 91 Participants | 103 Participants | 117 Participants | 311 Participants |
| Age, Categorical Between 18 and 65 years | 227 Participants | 217 Participants | 196 Participants | 640 Participants |
| Age Continuous | 56.7 years STANDARD_DEVIATION 13.5 | 57.2 years STANDARD_DEVIATION 14.2 | 58.8 years STANDARD_DEVIATION 13.4 | 57.6 years STANDARD_DEVIATION 13.7 |
| Sex: Female, Male Female | 251 Participants | 251 Participants | 255 Participants | 757 Participants |
| Sex: Female, Male Male | 67 Participants | 69 Participants | 58 Participants | 194 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 | 68 / 318 | 138 / 320 | 185 / 313 |
| serious Total, serious adverse events | 5 / 318 | 3 / 320 | 0 / 313 |
Outcome results
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.
Time frame: Baseline to Week 12
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | -1.01 UUI Episodes |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | -1.35 UUI Episodes |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. | -1.40 UUI Episodes |
Comparison: The significance level was 0.05 (2-sided).p-value: 0.00295% CI: [-0.56, -0.13]ANCOVA
Comparison: The significance level was 0.05 (2-sided).p-value: <0.00195% CI: [-0.6, -0.17]ANCOVA
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: 1. No problems at all 2. Some very minor problems 3. Some minor problems 4. Some moderate problems 5. Severe problems 6. Many severe problems Change: mean at Week 12 minus mean at Baseline.
Time frame: Baseline to Week 12
Population: Full analysis set. No imputation was used for missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12. | -1.57 score on scale | Standard Deviation 1.236 |
| Fesoterodine 4 mg | Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12. | -1.83 score on scale | Standard Deviation 1.157 |
| Fesoterodine 8 mg | Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12. | -1.76 score on scale | Standard Deviation 1.182 |
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.
Time frame: Baseline to Week12
Population: Full analysis set. No imputation was used for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Role Limitations (n=285, 283, 283) | -20.47 score on scale | Standard Deviation 27.73 |
| Placebo | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Sleep/Energy (n=285, 283, 283) | -12.51 score on scale | Standard Deviation 24.967 |
| Placebo | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Impact on Life (n=285, 283, 283) | -22.46 score on scale | Standard Deviation 28.018 |
| Placebo | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Incontinence Severity Measures (n=285, 283, 283) | -13.75 score on scale | Standard Deviation 20.763 |
| Placebo | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | General Health Perceptions (n=285, 283, 283) | -7.02 score on scale | Standard Deviation 22.573 |
| Placebo | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Physical Limitations (n=285, 283, 283) | -18.65 score on scale | Standard Deviation 28.25 |
| Placebo | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Personal Relationships (n=214, 210, 202) | -8.33 score on scale | Standard Deviation 21.773 |
| Placebo | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Social Limitations (n=285, 283, 283) | -14.44 score on scale | Standard Deviation 25.541 |
| Placebo | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Emotions (n=285, 283, 283) | -18.01 score on scale | Standard Deviation 26.365 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Personal Relationships (n=214, 210, 202) | -16.11 score on scale | Standard Deviation 25.798 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Emotions (n=285, 283, 283) | -24.70 score on scale | Standard Deviation 27.192 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Role Limitations (n=285, 283, 283) | -27.92 score on scale | Standard Deviation 26.373 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Physical Limitations (n=285, 283, 283) | -23.50 score on scale | Standard Deviation 28.807 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Sleep/Energy (n=285, 283, 283) | -19.08 score on scale | Standard Deviation 23.8 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Impact on Life (n=285, 283, 283) | -27.33 score on scale | Standard Deviation 29.96 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Social Limitations (n=285, 283, 283) | -17.92 score on scale | Standard Deviation 24.029 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Incontinence Severity Measures (n=285, 283, 283) | -17.67 score on scale | Standard Deviation 21.038 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | General Health Perceptions (n=285, 283, 283) | -9.36 score on scale | Standard Deviation 25.19 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Incontinence Severity Measures (n=285, 283, 283) | -18.59 score on scale | Standard Deviation 21.814 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | General Health Perceptions (n=285, 283, 283) | -6.10 score on scale | Standard Deviation 25.272 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Impact on Life (n=285, 283, 283) | -25.09 score on scale | Standard Deviation 32.172 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Role Limitations (n=285, 283, 283) | -25.97 score on scale | Standard Deviation 28.59 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Physical Limitations (n=285, 283, 283) | -25.97 score on scale | Standard Deviation 28.278 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Social Limitations (n=285, 283, 283) | -18.53 score on scale | Standard Deviation 25.765 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Personal Relationships (n=214, 210, 202) | -9.98 score on scale | Standard Deviation 24.335 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Emotions (n=285, 283, 283) | -24.89 score on scale | Standard Deviation 27.31 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). | Sleep/Energy (n=285, 283, 283) | -18.02 score on scale | Standard Deviation 25.287 |
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.
Time frame: Baseline to Week 12
Population: Full analysis set. Half scale rule (domain scores were calculated if a respondent had answered at least half of the items in a multi-item scale. Missing items were then replaced by the mean of non-missing items in that scale, for that participant.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Symptom Bother Score | -18.25 score on scale | Standard Deviation 23.618 |
| Placebo | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Total Score of HRQL domain | 12.88 score on scale | Standard Deviation 18.868 |
| Placebo | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Social Score of HRQL domain | 7.37 score on scale | Standard Deviation 17.211 |
| Placebo | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Coping Score of HRQL domain | 16.54 score on scale | Standard Deviation 23.633 |
| Placebo | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Concern Score of HRQL domain | 13.25 score on scale | Standard Deviation 21.182 |
| Placebo | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Sleep Score of HRQL domain | 12.03 score on scale | Standard Deviation 22.215 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Concern Score of HRQL domain | 20.05 score on scale | Standard Deviation 20.526 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Sleep Score of HRQL domain | 16.16 score on scale | Standard Deviation 21.886 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Coping Score of HRQL domain | 21.01 score on scale | Standard Deviation 22.109 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Symptom Bother Score | -26.61 score on scale | Standard Deviation 22.592 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Social Score of HRQL domain | 11.35 score on scale | Standard Deviation 16.504 |
| Fesoterodine 4 mg | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Total Score of HRQL domain | 17.84 score on scale | Standard Deviation 17.88 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Social Score of HRQL domain | 9.98 score on scale | Standard Deviation 16.706 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Symptom Bother Score | -26.35 score on scale | Standard Deviation 23.849 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Coping Score of HRQL domain | 21.48 score on scale | Standard Deviation 25.336 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Concern Score of HRQL domain | 19.10 score on scale | Standard Deviation 21.868 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Sleep Score of HRQL domain | 15.35 score on scale | Standard Deviation 24.654 |
| Fesoterodine 8 mg | Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. | Total Score of HRQL domain | 17.29 score on scale | Standard Deviation 19.67 |
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.
Time frame: Baseline to Week 12
Population: Full analysis set. Last observation carried forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12. | -0.88 Incontinence Episodes |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12. | -1.27 Incontinence Episodes |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12. | -1.15 Incontinence Episodes |
Comparison: The significance level was 0.05 (2-sided).p-value: 0.00295% CI: [-0.63, -0.14]ANCOVA
Comparison: The significance level was 0.05 (2-sided).p-value: 0.0395% CI: [-0.52, -0.03]ANCOVA
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.
Time frame: Baseline to Weeks 2, 4, 8, and 12
Population: Full analysis set. No imputation was used for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 305) | -0.80 Incontinence Episodes | Standard Deviation 1.573 |
| Placebo | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | -1.22 Incontinence Episodes | Standard Deviation 1.598 |
| Placebo | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | -1.56 Incontinence Episodes | Standard Deviation 1.727 |
| Placebo | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | -1.59 Incontinence Episodes | Standard Deviation 1.869 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | -1.97 Incontinence Episodes | Standard Deviation 1.843 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 305) | -1.11 Incontinence Episodes | Standard Deviation 1.725 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | -1.76 Incontinence Episodes | Standard Deviation 1.795 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | -1.61 Incontinence Episodes | Standard Deviation 1.755 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | -1.86 Incontinence Episodes | Standard Deviation 2 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | -1.50 Incontinence Episodes | Standard Deviation 1.707 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | -1.73 Incontinence Episodes | Standard Deviation 1.76 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 305) | -1.06 Incontinence Episodes | Standard Deviation 1.887 |
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.
Time frame: Baseline to Week 12
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | -0.59 Micturitions |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | -1.15 Micturitions |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. | -1.25 Micturitions |
Comparison: The significance level was 0.05 (2-sided).p-value: 0.00295% CI: [-0.91, -0.22]ANCOVA
Comparison: The significance level was 0.05 (2-sided).p-value: <0.00195% CI: [-1.01, -0.32]ANCOVA
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.
Time frame: Baseline to Weeks 2, 4, 8, and 12
Population: Full analysis set. No imputation was used for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 305) | -0.47 Micturitions | Standard Deviation 1.786 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | -0.85 Micturitions | Standard Deviation 1.96 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | -1.36 Micturitions | Standard Deviation 2.215 |
| Placebo | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | -1.36 Micturitions | Standard Deviation 2.415 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | -2.13 Micturitions | Standard Deviation 2.214 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 305) | -0.94 Micturitions | Standard Deviation 1.987 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | -1.81 Micturitions | Standard Deviation 2.277 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | -1.33 Micturitions | Standard Deviation 2.146 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | -2.17 Micturitions | Standard Deviation 2.515 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | -1.60 Micturitions | Standard Deviation 2.246 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | -2.15 Micturitions | Standard Deviation 2.402 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 305) | -1.06 Micturitions | Standard Deviation 2.076 |
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.
Time frame: Baseline to Week 12
Population: Among the full analysis set, participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline .~Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12. | -0.18 Night-Time Micturitions |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12. | -0.21 Night-Time Micturitions |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12. | -0.29 Night-Time Micturitions |
Comparison: The significance level was 0.05 (2-sided).p-value: 0.62495% CI: [-0.18, 0.11]ANCOVA
Comparison: The significance level was 0.05 (2-sided).p-value: 0.12995% CI: [-0.26, 0.03]ANCOVA
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.
Time frame: Baseline to Weeks 2, 4, 8, and 12
Population: Participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline within the full analysis set.~No imputation was used for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=242, 256, 256) | -0.25 Night-Time Micturitions | Standard Deviation 0.696 |
| Placebo | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=236, 246, 248) | -0.30 Night-Time Micturitions | Standard Deviation 0.835 |
| Placebo | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=224, 232, 241) | -0.41 Night-Time Micturitions | Standard Deviation 0.82 |
| Placebo | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=220, 229, 236) | -0.44 Night-Time Micturitions | Standard Deviation 0.945 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=220, 229, 236) | -0.48 Night-Time Micturitions | Standard Deviation 0.882 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=242, 256, 256) | -0.24 Night-Time Micturitions | Standard Deviation 0.796 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=224, 232, 241) | -0.45 Night-Time Micturitions | Standard Deviation 0.815 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=236, 246, 248) | -0.30 Night-Time Micturitions | Standard Deviation 0.83 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=220, 229, 236) | -0.63 Night-Time Micturitions | Standard Deviation 0.945 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=236, 246, 248) | -0.46 Night-Time Micturitions | Standard Deviation 0.78 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=224, 232, 241) | -0.58 Night-Time Micturitions | Standard Deviation 0.903 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=242, 256, 256) | -0.34 Night-Time Micturitions | Standard Deviation 0.809 |
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.
Time frame: Baseline to Week 12
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12. | -1.00 Urgency Episodes |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12. | -1.65 Urgency Episodes |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12. | -1.66 Urgency Episodes |
Comparison: The significance level was 0.05 (2-sided).p-value: 0.00395% CI: [-1.07, -0.22]ANCOVA
Comparison: The significance level was 0.05 (2-sided).p-value: 0.00295% CI: [-1.09, -0.23]ANCOVA
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.
Time frame: Baseline to Weeks 2, 4, 8, and 12
Population: Full analysis set. No imputation was used for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 305) | -0.79 Urgency Episodes | Standard Deviation 2.64 |
| Placebo | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | -1.60 Urgency Episodes | Standard Deviation 2.78 |
| Placebo | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | -2.34 Urgency Episodes | Standard Deviation 2.835 |
| Placebo | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | -2.37 Urgency Episodes | Standard Deviation 2.975 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | -2.89 Urgency Episodes | Standard Deviation 2.838 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 305) | -1.37 Urgency Episodes | Standard Deviation 2.722 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | -2.50 Urgency Episodes | Standard Deviation 3.08 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | -2.16 Urgency Episodes | Standard Deviation 2.906 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | -3.05 Urgency Episodes | Standard Deviation 3.462 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | -2.16 Urgency Episodes | Standard Deviation 3.065 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | -2.71 Urgency Episodes | Standard Deviation 3.139 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 305) | -1.59 Urgency Episodes | Standard Deviation 2.816 |
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.
Time frame: Baseline to Weeks 2, 4, 8, and 12
Population: Full analysis set. No imputation was used for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 305) | -0.79 UUI Episodes | Standard Deviation 1.465 |
| Placebo | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | -1.15 UUI Episodes | Standard Deviation 1.532 |
| Placebo | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | -1.45 UUI Episodes | Standard Deviation 1.518 |
| Placebo | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | -1.49 UUI Episodes | Standard Deviation 1.717 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | -1.76 UUI Episodes | Standard Deviation 1.618 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 305) | -1.10 UUI Episodes | Standard Deviation 1.681 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | -1.61 UUI Episodes | Standard Deviation 1.68 |
| Fesoterodine 4 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | -1.48 UUI Episodes | Standard Deviation 1.688 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | -1.87 UUI Episodes | Standard Deviation 1.814 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | -1.49 UUI Episodes | Standard Deviation 1.643 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | -1.65 UUI Episodes | Standard Deviation 1.69 |
| Fesoterodine 8 mg | Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 305) | -1.12 UUI Episodes | Standard Deviation 1.736 |
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.
Time frame: Baseline to Week 12
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Mean Voided Volume Per Micturition at Week 12. | 13.07 mL | Standard Deviation 46.207 |
| Fesoterodine 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 12. | 22.80 mL | Standard Deviation 47.59 |
| Fesoterodine 8 mg | Change From Baseline in Mean Voided Volume Per Micturition at Week 12. | 32.77 mL | Standard Deviation 52.893 |
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.
Time frame: Baseline to Weeks 2, 4, 8, and 12
Population: Full analysis set. No imputation was used for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 304) | 5.06 mL | Standard Deviation 37.875 |
| Placebo | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | 10.75 mL | Standard Deviation 45.628 |
| Placebo | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | 9.23 mL | Standard Deviation 43.639 |
| Placebo | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | 13.28 mL | Standard Deviation 46.317 |
| Fesoterodine 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 304) | 13.63 mL | Standard Deviation 35.35 |
| Fesoterodine 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | 24.52 mL | Standard Deviation 48.62 |
| Fesoterodine 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | 22.05 mL | Standard Deviation 44.949 |
| Fesoterodine 4 mg | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | 21.62 mL | Standard Deviation 44.623 |
| Fesoterodine 8 mg | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Week 12 (n=284, 284, 281) | 33.40 mL | Standard Deviation 53.379 |
| Fesoterodine 8 mg | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Week 8 (n=289, 289, 287) | 30.94 mL | Standard Deviation 51.258 |
| Fesoterodine 8 mg | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Week 4 (n=301, 303, 296) | 27.41 mL | Standard Deviation 45.803 |
| Fesoterodine 8 mg | Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. | Week 2 (n=308, 314, 304) | 21.52 mL | Standard Deviation 42.946 |
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: 1. No problems at all 2. Some very minor problems 3. Some minor problems 4. Some moderate problems 5. Severe problems 6. Many severe problems
Time frame: Baseline to Week 12
Population: Full analysis set. No imputation was used for missing data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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. | Baseline | 82 participants |
| Placebo | 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. | Week 12 | 28 participants |
| Fesoterodine 4 mg | 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. | Week 12 | 12 participants |
| Fesoterodine 4 mg | 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. | Baseline | 97 participants |
| Fesoterodine 8 mg | 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. | Week 12 | 19 participants |
| Fesoterodine 8 mg | 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. | Baseline | 83 participants |