Urinary Bladder, Overactive
Conditions
Keywords
Micturition, Urinary incontinence, Urinary urge incontinence, Overactive bladder (OAB), Urgency, YM178, Frequency
Brief summary
The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.
Interventions
DRUGMirabegron
Tablets
DRUGTolterodine
Capsules
Matching mirabegron placebo tablets.
Matching tolterodine placebo capsules.
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is willing and able to complete the micturition diary and questionnaires correctly * Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months * Subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period * Subject must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period
Exclusion criteria
* Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control * Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor * Subject has an indwelling catheter or practices intermittent self-catheterization * Subject has diabetic neuropathy * Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs * Subject receives non-drug treatment including electro-stimulation therapy * Subject has severe hypertension * Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients * Subject has been treated with any investigational drug or device within 30 days (90 days in the UK) * Subject had an average total daily urine volume \> 3000 mL as recorded in the 3-day micturition diary period * Subject has serum creatinine \>150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2x upper limit of normal range (ULN), or gamma glutamyl transferase (γ-GT) \> 3x ULN * Subject has a clinically significant abnormal electrocardiogram (ECG)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Week 12 (final visit) | The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours | Baseline and Week 12 | The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours | Baseline and Week 4 | The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Weeks 8 and 12 | The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours | Baseline and Weeks 8 and 12 | The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Baseline and Weeks 4, 8 and 12 | The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and Weeks 4, 8 and 12 | The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Baseline and Weeks 4, 8 and 12 | The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Baseline and Weeks 4, 8 and 12 | Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Baseline and Weeks 4, 8 and 12 | Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Baseline and Weeks 4, 8 and 12 | The average number of times a patient records a new pad used per day during the 3-day micturition diary period. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Weeks 4, 8 and 12 | The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient. |
| Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Baseline and Weeks 4, 8 and 12 | The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary. |
| Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Baseline and Weeks 4, 8 and 12 | Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Baseline and Weeks 4, 8 and 12 | Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Change From Baseline to Final Visit in Mean Volume Voided Per Micturition | Baseline and Week 12 | The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
| Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Baseline and Week 12 | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. |
| Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Baseline and Week 12 | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement. |
| Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Baseline and Week 12 | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement. |
| Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Baseline and Week 12 | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit. |
| Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Baseline and Week 12 | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit. |
| Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Baseline and Week 12 | The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit. |
| Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Baseline and Week 12 | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit. |
| Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Baseline and Week 12 | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit. |
| Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline and Weeks 4, 8 and 12 | The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement. |
| Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Baseline and Week 12 | The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement. |
| Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | Baseline and Week 12 | The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement. |
| Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Baseline and Weeks 4, 8 and 12 | The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition. |
| Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Baseline and Week 12 | The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score. |
| Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Baseline and Week 12 | The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement. |
| Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Week 4 | The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate. |
Countries
Australia, Austria, Belarus, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom
Participant flow
Pre-assignment details
After screening, 2336 patients took placebo run-in study drug in a 2-week, single-blind, placebo run-in period. On completion of the run-in period, 1987 eligible patients were randomly assigned to receive placebo, mirabegron 50 mg, mirabegron 100 mg or tolterodine 4 mg for 12 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks. | 494 |
| Mirabegron 50 mg Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks. | 493 |
| Mirabegron 100 mg Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks. | 496 |
| Tolterodine SR 4 mg Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks. | 495 |
| Total | 1,978 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 13 | 25 | 16 | 24 |
| Overall Study | Eligibility criterion not met | 5 | 8 | 0 | 4 |
| Overall Study | Lack of Efficacy | 5 | 6 | 2 | 3 |
| Overall Study | Lost to Follow-up | 4 | 3 | 2 | 5 |
| Overall Study | Non-compliance with study procedures | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 2 | 3 | 5 | 3 |
| Overall Study | Randomized but never received study drug | 2 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 12 | 11 | 18 | 11 |
Baseline characteristics
| Characteristic | Placebo | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine SR 4 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 12.3 | 59.1 years STANDARD_DEVIATION 12.36 | 59.0 years STANDARD_DEVIATION 12.71 | 59.1 years STANDARD_DEVIATION 12.89 | 59.1 years STANDARD_DEVIATION 12.56 |
| Duration of OAB symptoms | 76.0 months STANDARD_DEVIATION 91.38 | 79.6 months STANDARD_DEVIATION 87.14 | 84.8 months STANDARD_DEVIATION 94.12 | 75.5 months STANDARD_DEVIATION 92.2 | 79.0 months STANDARD_DEVIATION 91.25 |
| Mean level of urgency | 2.36 scores on a scale STANDARD_DEVIATION 0.563 | 2.40 scores on a scale STANDARD_DEVIATION 0.547 | 2.46 scores on a scale STANDARD_DEVIATION 0.528 | 2.41 scores on a scale STANDARD_DEVIATION 0.561 | 2.41 scores on a scale STANDARD_DEVIATION 0.551 |
| Mean number of micturitions per 24 Hours | 11.72 micturitions STANDARD_DEVIATION 3.122 | 11.64 micturitions STANDARD_DEVIATION 2.967 | 11.49 micturitions STANDARD_DEVIATION 2.72 | 11.53 micturitions STANDARD_DEVIATION 2.773 | 11.59 micturitions STANDARD_DEVIATION 2.899 |
| Mean number of nocturia episodes per 24 hours | 1.98 nocturia episodes STANDARD_DEVIATION 1.405 | 1.87 nocturia episodes STANDARD_DEVIATION 1.294 | 1.91 nocturia episodes STANDARD_DEVIATION 1.374 | 1.93 nocturia episodes STANDARD_DEVIATION 1.417 | 1.92 nocturia episodes STANDARD_DEVIATION 1.373 |
| Mean number of pads used per 24 hours | 1.12 pads STANDARD_DEVIATION 1.812 | 1.12 pads STANDARD_DEVIATION 1.941 | 1.25 pads STANDARD_DEVIATION 2.02 | 1.04 pads STANDARD_DEVIATION 1.752 | 1.13 pads STANDARD_DEVIATION 1.884 |
| Mean number of urgency episodes (grade 3 or 4) per 24 hours | 5.72 urgency episodes STANDARD_DEVIATION 3.972 | 5.68 urgency episodes STANDARD_DEVIATION 3.679 | 5.95 urgency episodes STANDARD_DEVIATION 3.699 | 5.79 urgency episodes STANDARD_DEVIATION 3.494 | 5.79 urgency episodes STANDARD_DEVIATION 3.713 |
| Mean volume voided per micturition | 156.8 mL STANDARD_DEVIATION 52.73 | 160.3 mL STANDARD_DEVIATION 57.85 | 158.9 mL STANDARD_DEVIATION 53.95 | 157.4 mL STANDARD_DEVIATION 54.23 | 158.3 mL STANDARD_DEVIATION 54.69 |
| Race/Ethnicity, Customized Asian | 0 participants | 2 participants | 2 participants | 2 participants | 6 participants |
| Race/Ethnicity, Customized Black or African American | 2 participants | 1 participants | 1 participants | 3 participants | 7 participants |
| Race/Ethnicity, Customized Other | 2 participants | 2 participants | 1 participants | 0 participants | 5 participants |
| Race/Ethnicity, Customized White | 490 participants | 488 participants | 492 participants | 490 participants | 1960 participants |
| Sex: Female, Male Female | 356 Participants | 357 Participants | 355 Participants | 361 Participants | 1429 Participants |
| Sex: Female, Male Male | 138 Participants | 136 Participants | 141 Participants | 134 Participants | 549 Participants |
| Type of overactive bladder (OAB) Frequency | 184 participants | 180 participants | 189 participants | 194 participants | 747 participants |
| Type of overactive bladder (OAB) Mixed | 106 participants | 113 participants | 119 participants | 111 participants | 449 participants |
| Type of overactive bladder (OAB) Urge Incontinence | 204 participants | 200 participants | 188 participants | 190 participants | 782 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 49 / 494 | 42 / 493 | 41 / 496 | 86 / 495 |
| serious Total, serious adverse events | 8 / 494 | 14 / 493 | 12 / 496 | 11 / 495 |
Outcome results
Primary
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Week 12 (final visit)
Population: The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours | -1.17 Incontinence episodes | Standard Error 0.113 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours | -1.57 Incontinence episodes | Standard Error 0.113 |
| Mirabegron 100 mg | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours | -1.46 Incontinence episodes | Standard Error 0.115 |
| Tolterodine SR 4 mg | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours | -1.27 Incontinence episodes | Standard Error 0.112 |
Comparison: Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.p-value: 0.00395% CI: [-0.72, -0.09]Stratified rank ANCOVA
Comparison: Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.p-value: 0.0195% CI: [-0.61, 0.03]Stratified rank ANCOVA
Comparison: Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.p-value: 0.1195% CI: [-0.42, 0.21]Stratified rank ANCOVA
Primary
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Week 12
Population: The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours | -1.34 micturitions | Standard Error 0.11 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours | -1.93 micturitions | Standard Error 0.111 |
| Mirabegron 100 mg | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours | -1.77 micturitions | Standard Error 0.11 |
| Tolterodine SR 4 mg | Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours | -1.59 micturitions | Standard Error 0.111 |
Comparison: Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.p-value: <0.00195% CI: [-0.9, -0.29]ANCOVA
Comparison: Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.p-value: 0.00595% CI: [-0.74, -0.13]ANCOVA
Comparison: Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.p-value: 0.1195% CI: [-0.55, 0.06]ANCOVA
Secondary
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Time frame: Baseline and Week 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Not anxious | 76 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Moderately anxious | 37 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Extremely anxious | 2 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Missing data | 1 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Not anxious | 219 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Moderately anxious | 108 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Extremely anxious | 9 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Missing data | 1 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Not anxious | 3 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Moderately anxious | 12 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Extremely anxious | 9 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Missing data | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Not anxious | 2 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Moderately anxious | 1 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Extremely anxious | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Moderately anxious | 111 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Not anxious | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Missing data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Extremely anxious | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Moderately anxious | 12 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Extremely anxious | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Extremely anxious | 9 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Not anxious | 74 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Extremely anxious | 5 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Moderately anxious | 30 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Not anxious | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Missing data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Moderately anxious | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Not anxious | 224 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Moderately anxious | 105 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Not anxious | 88 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Moderately anxious | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Extremely anxious | 10 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Missing data | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Missing data | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Not anxious | 1 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Moderately anxious | 11 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Extremely anxious | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Extremely anxious | 8 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Missing data | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Not anxious | 232 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Moderately anxious | 19 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Not anxious | 1 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Extremely anxious | 1 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Missing data | 2 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Missing data | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Missing data | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Extremely anxious | 3 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Not anxious | 217 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Moderately anxious | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Extremely anxious | 12 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Not anxious | 3 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Moderately anxious | 21 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Not anxious | 71 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Moderately anxious | 18 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Moderately anxious -> Moderately anxious | 122 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Extremely anxious | 2 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Missing data -> Extremely anxious | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Not anxious | 4 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Not anxious -> Missing data | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score | Extremely anxious -> Missing data | 0 participants |
Secondary
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Time frame: Baseline and Week 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> No problems | 37 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Some problems | 27 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Confined to bed | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Missing data | 2 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> No problem | 334 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Some problems | 78 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Confined to bed | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Missing data | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> No problems | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> Some problems | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> Confined to bed | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> Missing data | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> No problem | 2 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> Some problems | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> Confined to bed | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Some problems | 59 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> No problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> Confined to bed | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> Some problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Confined to bed | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> Confined to bed | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> No problems | 44 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Confined to bed | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Missing data | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Some problems | 26 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> No problem | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> Some problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> No problem | 340 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Some problems | 82 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> No problems | 40 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> Some problems | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Confined to bed | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Missing data | 1 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> Missing data | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> No problems | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> Some problems | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> Confined to bed | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> Confined to bed | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> Missing data | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> No problem | 334 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Some problems | 18 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> No problem | 2 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Confined to bed | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Missing data | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> Missing data | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Missing data | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Confined to bed | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> No problem | 330 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> Some problems | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Confined to bed | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> No problem | 3 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Some problems | 28 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> No problems | 38 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> Some problems | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Some problems | 73 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> Confined to bed | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> Confined to bed | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> No problems | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Missing data | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined -> Missing data | 0 participants |
Secondary
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Time frame: Baseline and Week 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> No pain | 70 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Moderate pain | 36 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Extreme pain | 4 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Missing data | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> No pain | 210 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> Moderate pain | 129 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> Extreme pain | 2 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain ->Missing data | 2 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> No pain | 3 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Moderate pain | 13 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Extreme pain | 10 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Missing data | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> No pain | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> Moderate pain | 1 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> Extreme pain | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> Moderate pain | 128 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> No pain | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> Extreme pain | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Moderate pain | 12 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Extreme pain | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Extreme pain | 4 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> No pain | 71 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> Extreme pain | 8 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Missing data | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Moderate pain | 32 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> No pain | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain ->Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> Moderate pain | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> No pain | 211 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> Moderate pain | 114 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> No pain | 76 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> Moderate pain | 1 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> Extreme pain | 5 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain ->Missing data | 1 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> Missing data | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> No pain | 1 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Moderate pain | 12 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> Extreme pain | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Extreme pain | 5 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Missing data | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> No pain | 209 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Moderate pain | 50 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> No pain | 1 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Extreme pain | 2 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Missing data | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> Missing data | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain ->Missing data | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Extreme pain | 2 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> No pain | 197 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> Moderate pain | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> Extreme pain | 7 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> No pain | 3 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Moderate pain | 37 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> No pain | 69 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Moderate pain | 12 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> Moderate pain | 132 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Extreme pain | 9 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data -> Extreme pain | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> No pain | 4 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Missing data | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Missing data | 0 participants |
Secondary
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit.
Time frame: Baseline and Week 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress myself -> No problems | 1 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> Unable to wash or dress myself | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> No problems | 18 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> Missing data | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress -> Unable to wash or dress | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> Some problems | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> Some problems | 14 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress myself -> Missing data | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> No problem | 437 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> Unable to wash or dress myself | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> Unable to wash or dress myself | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> Missing data | 2 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> Some problems | 7 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> No problem | 1 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> Missing data | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress myself -> Some problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress myself -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress myself -> No problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress myself -> Some problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress -> Unable to wash or dress | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> Unable to wash or dress myself | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> Missing data | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> No problem | 445 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> Some problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> No problems | 9 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> Some problems | 6 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> Unable to wash or dress myself | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> No problem | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> Unable to wash or dress myself | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> Some problems | 9 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> Some problems | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> No problem | 439 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> Some problems | 17 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> Unable to wash or dress myself | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> Missing data | 2 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> No problems | 8 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> Some problems | 10 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> Unable to wash or dress myself | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> Missing data | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress myself -> No problems | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress myself -> Some problems | 1 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress -> Unable to wash or dress | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress myself -> Missing data | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> No problem | 1 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> Unable to wash or dress myself | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> Missing data | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> Some problems | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> Unable to wash or dress myself | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> Some problems | 15 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress myself -> Missing data | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> No problem | 4 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> No problems | 9 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> Missing data | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> Some problems | 12 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> Unable to wash or dress myself | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem -> No problem | 432 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> Missing data | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress myself -> Some problems | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data -> Unable to wash or dress myself | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress -> Unable to wash or dress | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable to wash or dress myself -> No problems | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems -> Missing data | 0 participants |
Secondary
Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.
Time frame: Baseline and Week 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> No problems | 73 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> Some problems | 25 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> Unable to perform usual activities | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> Missing data | 2 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> No problem | 298 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> Some problems | 75 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems-> Unable to perform usual activities | 2 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> Missing data | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform usual activities -> No problems | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform usual activities-> Some problems | 2 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform -> Unable to perform | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform usual activities -> Missing data | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> No problem | 2 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> Some problems | 1 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> Unable to perform usual activities | 0 participants |
| Placebo | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> Some problems | 48 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform usual activities -> No problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform usual activities -> Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> Unable to perform usual activities | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform usual activities-> Some problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> Unable to perform usual activities | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform -> Unable to perform | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> No problems | 82 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems-> Unable to perform usual activities | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> Missing data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> Some problems | 18 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> No problem | 2 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> Missing data | 1 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> Some problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> No problem | 316 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> Some problems | 63 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> No problems | 51 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> Some problems | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems-> Unable to perform usual activities | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> Missing data | 1 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> Missing data | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform usual activities -> No problems | 1 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform usual activities-> Some problems | 3 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> Unable to perform usual activities | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform -> Unable to perform | 2 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform usual activities -> Missing data | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> No problem | 327 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> Some problems | 25 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> No problem | 1 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> Unable to perform usual activities | 3 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> Missing data | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> Missing data | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> Missing data | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> Unable to perform usual activities | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> No problem | 283 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> Some problems | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems-> Unable to perform usual activities | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> No problem | 4 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> Some problems | 39 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> No problems | 68 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform usual activities-> Some problems | 3 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> Some problems | 73 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform -> Unable to perform | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data -> Unable to perform usual activities | 0 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform usual activities -> No problems | 2 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> Missing data | 1 participants |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable to perform usual activities -> Missing data | 0 participants |
Secondary
Change From Baseline to Final Visit in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Week 12
Population: The Full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Final Visit in Mean Volume Voided Per Micturition | 12.3 mL | Standard Error 1.99 |
| Mirabegron 50 mg | Change From Baseline to Final Visit in Mean Volume Voided Per Micturition | 24.2 mL | Standard Error 2.01 |
| Mirabegron 100 mg | Change From Baseline to Final Visit in Mean Volume Voided Per Micturition | 25.6 mL | Standard Error 2 |
| Tolterodine SR 4 mg | Change From Baseline to Final Visit in Mean Volume Voided Per Micturition | 25.0 mL | Standard Error 2 |
Comparison: Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.p-value: <0.00195% CI: [6.3, 17.4]ANCOVA
Comparison: Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.p-value: <0.00195% CI: [7.7, 18.7]ANCOVA
Comparison: Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.p-value: <0.00195% CI: [7.1, 18.2]ANCOVA
Secondary
Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.
Time frame: Baseline and Week 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Week 12 [N=425; 410; 421; 417] | -0.8 Scores on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Final Visit (LOCF) [N=433; 416; 429; 426] | -0.8 Scores on a scale | Standard Error 0.05 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Final Visit (LOCF) [N=433; 416; 429; 426] | -1.0 Scores on a scale | Standard Error 0.06 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Week 12 [N=425; 410; 421; 417] | -1.1 Scores on a scale | Standard Error 0.06 |
| Mirabegron 100 mg | Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Week 12 [N=425; 410; 421; 417] | -0.1 Scores on a scale | Standard Error 0.06 |
| Mirabegron 100 mg | Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Final Visit (LOCF) [N=433; 416; 429; 426] | -1.1 Scores on a scale | Standard Error 0.05 |
| Tolterodine SR 4 mg | Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Week 12 [N=425; 410; 421; 417] | -1.0 Scores on a scale | Standard Error 0.06 |
| Tolterodine SR 4 mg | Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Final Visit (LOCF) [N=433; 416; 429; 426] | -1.0 Scores on a scale | Standard Error 0.06 |
Secondary
Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.
Time frame: Baseline and Week 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | Week 12 [N=421; 410; 420; 416] | 1.92 Scores on a scale | Standard Error 0.147 |
| Placebo | Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | Final Visit (LOCF) [N=428; 414; 427; 425] | 1.89 Scores on a scale | Standard Error 0.146 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | Final Visit (LOCF) [N=428; 414; 427; 425] | 2.55 Scores on a scale | Standard Error 0.149 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | Week 12 [N=421; 410; 420; 416] | 2.57 Scores on a scale | Standard Error 0.149 |
| Mirabegron 100 mg | Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | Week 12 [N=421; 410; 420; 416] | 2.67 Scores on a scale | Standard Error 0.147 |
| Mirabegron 100 mg | Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | Final Visit (LOCF) [N=428; 414; 427; 425] | 2.66 Scores on a scale | Standard Error 0.146 |
| Tolterodine SR 4 mg | Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | Week 12 [N=421; 410; 420; 416] | 2.44 Scores on a scale | Standard Error 0.148 |
| Tolterodine SR 4 mg | Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | Final Visit (LOCF) [N=428; 414; 427; 425] | 2.44 Scores on a scale | Standard Error 0.147 |
Secondary
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Week 12 [N=409; 395; 409; 400] | -11.2 percent activity impairment | Standard Deviation 27.73 |
| Placebo | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Final Visit (LOCF) [N=419; 400; 417; 409] | -11.0 percent activity impairment | Standard Deviation 27.78 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Final Visit (LOCF) [N=419; 400; 417; 409] | -14.9 percent activity impairment | Standard Deviation 27.84 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Week 12 [N=409; 395; 409; 400] | -15.0 percent activity impairment | Standard Deviation 27.93 |
| Mirabegron 100 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Week 12 [N=409; 395; 409; 400] | -14.5 percent activity impairment | Standard Deviation 28.67 |
| Mirabegron 100 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Final Visit (LOCF) [N=419; 400; 417; 409] | -14.4 percent activity impairment | Standard Deviation 28.7 |
| Tolterodine SR 4 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Week 12 [N=409; 395; 409; 400] | -14.7 percent activity impairment | Standard Deviation 29.5 |
| Tolterodine SR 4 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Final Visit (LOCF) [N=419; 400; 417; 409] | -14.3 percent activity impairment | Standard Deviation 29.7 |
Secondary
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Final Visit (LOCF) [N=118; 130; 106; 115] | -8.1 percent impairment while working | Standard Deviation 24.43 |
| Placebo | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Week 12 [N=116; 128; 104; 114] | -8.3 percent impairment while working | Standard Deviation 24.5 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Final Visit (LOCF) [N=118; 130; 106; 115] | -12.8 percent impairment while working | Standard Deviation 23.24 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Week 12 [N=116; 128; 104; 114] | -12.5 percent impairment while working | Standard Deviation 23.24 |
| Mirabegron 100 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Week 12 [N=116; 128; 104; 114] | -10.8 percent impairment while working | Standard Deviation 25.19 |
| Mirabegron 100 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Final Visit (LOCF) [N=118; 130; 106; 115] | -10.8 percent impairment while working | Standard Deviation 25.04 |
| Tolterodine SR 4 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Week 12 [N=116; 128; 104; 114] | -6.7 percent impairment while working | Standard Deviation 28.4 |
| Tolterodine SR 4 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Final Visit (LOCF) [N=118; 130; 106; 115] | -6.6 percent impairment while working | Standard Deviation 28.28 |
Secondary
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient's assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Final Visit (LOCF) [N=106; 119; 99; 105] | -7.7 percent overall work impairment | Standard Deviation 23.79 |
| Placebo | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Week 12 [N=104; 117; 98; 104] | -7.9 percent overall work impairment | Standard Deviation 23.86 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Week 12 [N=104; 117; 98; 104] | -13.2 percent overall work impairment | Standard Deviation 25.7 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Final Visit (LOCF) [N=106; 119; 99; 105] | -13.6 percent overall work impairment | Standard Deviation 25.64 |
| Mirabegron 100 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Week 12 [N=104; 117; 98; 104] | -11.6 percent overall work impairment | Standard Deviation 27.09 |
| Mirabegron 100 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Final Visit (LOCF) [N=106; 119; 99; 105] | -11.5 percent overall work impairment | Standard Deviation 26.97 |
| Tolterodine SR 4 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Final Visit (LOCF) [N=106; 119; 99; 105] | -5.8 percent overall work impairment | Standard Deviation 28.19 |
| Tolterodine SR 4 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Week 12 [N=104; 117; 98; 104] | -5.8 percent overall work impairment | Standard Deviation 28.32 |
Secondary
Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Week 12 [N=111; 120; 109; 113] | -0.2 percent work time missed | Standard Deviation 7.31 |
| Placebo | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Final Visit (LOCF) [N=113; 122; 110; 114] | -0.2 percent work time missed | Standard Deviation 7.24 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Week 12 [N=111; 120; 109; 113] | -1.9 percent work time missed | Standard Deviation 13.42 |
| Mirabegron 50 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Final Visit (LOCF) [N=113; 122; 110; 114] | -1.8 percent work time missed | Standard Deviation 13.31 |
| Mirabegron 100 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Final Visit (LOCF) [N=113; 122; 110; 114] | -1.7 percent work time missed | Standard Deviation 18.74 |
| Mirabegron 100 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Week 12 [N=111; 120; 109; 113] | -1.7 percent work time missed | Standard Deviation 18.83 |
| Tolterodine SR 4 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Week 12 [N=111; 120; 109; 113] | -1.2 percent work time missed | Standard Deviation 12.68 |
| Tolterodine SR 4 mg | Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Final Visit (LOCF) [N=113; 122; 110; 114] | -1.2 percent work time missed | Standard Deviation 12.62 |
Secondary
Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Week 4
Population: The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward was not utilized in this analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours | -0.65 Incontinence episodes | Standard Error 0.118 |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours | -1.04 Incontinence episodes | Standard Error 0.118 |
| Mirabegron 100 mg | Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours | -1.03 Incontinence episodes | Standard Error 0.12 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours | -1.00 Incontinence episodes | Standard Error 0.117 |
Comparison: Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.p-value: 0.00295% CI: [-0.71, -0.06]Stratified rank ANCOVA
Comparison: Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.p-value: 0.00295% CI: [-0.71, -0.05]Stratified rank ANCOVA
Comparison: Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.p-value: 0.01995% CI: [-0.68, -0.03]Stratified rank ANCOVA
Secondary
Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Week 4
Population: The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not utilized in this analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours | -0.77 micturitions | Standard Error 0.096 |
| Mirabegron 50 mg | Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours | -1.16 micturitions | Standard Error 0.097 |
| Mirabegron 100 mg | Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours | -1.29 micturitions | Standard Error 0.096 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours | -1.10 micturitions | Standard Error 0.096 |
Comparison: Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.p-value: 0.00495% CI: [-0.66, -0.13]ANCOVA
Comparison: Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.p-value: <0.00195% CI: [-0.79, -0.26]ANCOVA
Comparison: Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.p-value: 0.01695% CI: [-0.6, -0.06]ANCOVA
Secondary
Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Weeks 4, 8 and 12
Population: The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as N.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Week 12 [N=452; 437; 447; 438] | 11.9 mL | Standard Error 2.07 |
| Placebo | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Week 4 [N=479; 470; 477; 474] | 9.8 mL | Standard Error 1.73 |
| Placebo | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Week 8 [N=463; 449; 455; 461] | 11.7 mL | Standard Error 1.97 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Week 8 [N=463; 449; 455; 461] | 20.7 mL | Standard Error 2 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Week 4 [N=479; 470; 477; 474] | 20.1 mL | Standard Error 1.75 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Week 12 [N=452; 437; 447; 438] | 25.3 mL | Standard Error 2.11 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Week 12 [N=452; 437; 447; 438] | 25.7 mL | Standard Error 2.08 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Week 4 [N=479; 470; 477; 474] | 20.3 mL | Standard Error 1.74 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Week 8 [N=463; 449; 455; 461] | 25.3 mL | Standard Error 1.99 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Week 8 [N=463; 449; 455; 461] | 25.9 mL | Standard Error 1.97 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Week 4 [N=479; 470; 477; 474] | 21.4 mL | Standard Error 1.74 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition | Week 12 [N=452; 437; 447; 438] | 25.8 mL | Standard Error 2.1 |
Secondary
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Weeks 4, 8 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was utilized for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Week 4 [N=471; 463; 469; 467] | 8.8 Scores on a scale | Standard Error 0.68 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Week 8 [N=454; 446; 450; 453] | 11.9 Scores on a scale | Standard Error 0.76 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Week 12 [N=445; 426; 435; 432] | 14.1 Scores on a scale | Standard Error 0.79 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Final Visit (LOCF) [N=473; 468; 472; 470] | 13.7 Scores on a scale | Standard Error 0.76 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Week 8 [N=454; 446; 450; 453] | 13.7 Scores on a scale | Standard Error 0.76 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Week 12 [N=445; 426; 435; 432] | 16.6 Scores on a scale | Standard Error 0.8 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Final Visit (LOCF) [N=473; 468; 472; 470] | 16.1 Scores on a scale | Standard Error 0.77 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Week 4 [N=471; 463; 469; 467] | 9.5 Scores on a scale | Standard Error 0.68 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Week 12 [N=445; 426; 435; 432] | 17.2 Scores on a scale | Standard Error 0.8 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Week 8 [N=454; 446; 450; 453] | 14.8 Scores on a scale | Standard Error 0.76 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Final Visit (LOCF) [N=473; 468; 472; 470] | 17.0 Scores on a scale | Standard Error 0.77 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Week 4 [N=471; 463; 469; 467] | 11.2 Scores on a scale | Standard Error 0.68 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Final Visit (LOCF) [N=473; 468; 472; 470] | 14.8 Scores on a scale | Standard Error 0.77 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Week 8 [N=454; 446; 450; 453] | 13.2 Scores on a scale | Standard Error 0.76 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Week 4 [N=471; 463; 469; 467] | 9.4 Scores on a scale | Standard Error 0.68 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Week 12 [N=445; 426; 435; 432] | 15.1 Scores on a scale | Standard Error 0.8 |
Secondary
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency
Average of patients' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Weeks 4, 8 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Week 4 [N=476; 469; 472; 471] | -0.08 Scores on a scale | Standard Error 0.023 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Week 8 [N=460; 447; 451; 456] | -0.16 Scores on a scale | Standard Error 0.027 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Week 12 [N=450; 434; 442; 434] | -0.22 Scores on a scale | Standard Error 0.029 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Final Visit (LOCF) [N=480; 472; 475; 473] | -0.22 Scores on a scale | Standard Error 0.028 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Week 8 [N=460; 447; 451; 456] | -0.26 Scores on a scale | Standard Error 0.027 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Week 12 [N=450; 434; 442; 434] | -0.33 Scores on a scale | Standard Error 0.029 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Final Visit (LOCF) [N=480; 472; 475; 473] | -0.31 Scores on a scale | Standard Error 0.028 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Week 4 [N=476; 469; 472; 471] | -0.19 Scores on a scale | Standard Error 0.023 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Week 12 [N=450; 434; 442; 434] | -0.31 Scores on a scale | Standard Error 0.029 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Week 8 [N=460; 447; 451; 456] | -0.27 Scores on a scale | Standard Error 0.027 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Final Visit (LOCF) [N=480; 472; 475; 473] | -0.30 Scores on a scale | Standard Error 0.028 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Week 4 [N=476; 469; 472; 471] | -0.21 Scores on a scale | Standard Error 0.023 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Final Visit (LOCF) [N=480; 472; 475; 473] | -0.29 Scores on a scale | Standard Error 0.028 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Week 8 [N=460; 447; 451; 456] | -0.25 Scores on a scale | Standard Error 0.027 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Week 4 [N=476; 469; 472; 471] | -0.21 Scores on a scale | Standard Error 0.023 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency | Week 12 [N=450; 434; 442; 434] | -0.30 Scores on a scale | Standard Error 0.029 |
Secondary
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours
Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Weeks 4, 8 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Week 4 [N=428; 422; 422; 432] | -0.25 nocturia episodes | Standard Error 0.045 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Week 8 [N=414; 404; 403; 419] | -0.30 nocturia episodes | Standard Error 0.047 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Week 12 [N=404; 393; 395; 399] | -0.41 nocturia episodes | Standard Error 0.048 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Final Visit (LOCF) [N=428; 423; 422; 433] | -0.41 nocturia episodes | Standard Error 0.047 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Week 8 [N=414; 404; 403; 419] | -0.41 nocturia episodes | Standard Error 0.048 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Week 12 [N=404; 393; 395; 399] | -0.57 nocturia episodes | Standard Error 0.049 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Final Visit (LOCF) [N=428; 423; 422; 433] | -0.56 nocturia episodes | Standard Error 0.047 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Week 4 [N=428; 422; 422; 432] | -0.27 nocturia episodes | Standard Error 0.045 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Week 12 [N=404; 393; 395; 399] | -0.47 nocturia episodes | Standard Error 0.049 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Week 8 [N=414; 404; 403; 419] | -0.48 nocturia episodes | Standard Error 0.048 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Final Visit (LOCF) [N=428; 423; 422; 433] | -0.50 nocturia episodes | Standard Error 0.047 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Week 4 [N=428; 422; 422; 432] | -0.34 nocturia episodes | Standard Error 0.045 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Final Visit (LOCF) [N=428; 423; 422; 433] | -0.45 nocturia episodes | Standard Error 0.047 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Week 8 [N=414; 404; 403; 419] | -0.39 nocturia episodes | Standard Error 0.047 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Week 4 [N=428; 422; 422; 432] | -0.29 nocturia episodes | Standard Error 0.045 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Week 12 [N=404; 393; 395; 399] | -0.44 nocturia episodes | Standard Error 0.048 |
Secondary
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours
The average number of times a patient records a new pad used per day during the 3-day micturition diary period. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Weeks 4, 8 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Week 4 [N=209; 183; 195; 181] | -0.45 pads | Standard Error 0.103 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Week 8 [N=204; 176; 183; 177] | -0.72 pads | Standard Error 0.116 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Week 12 [N=200; 172; 181; 165] | -0.99 pads | Standard Error 0.117 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Final Visit (LOCF) [N=209; 183; 195; 181] | -0.95 pads | Standard Error 0.115 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Week 8 [N=204; 176; 183; 177] | -1.02 pads | Standard Error 0.125 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Week 12 [N=200; 172; 181; 165] | -1.26 pads | Standard Error 0.126 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Final Visit (LOCF) [N=209; 183; 195; 181] | -1.17 pads | Standard Error 0.123 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Week 4 [N=209; 183; 195; 181] | -0.73 pads | Standard Error 0.11 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Week 12 [N=200; 172; 181; 165] | -1.11 pads | Standard Error 0.123 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Week 8 [N=204; 176; 183; 177] | -1.03 pads | Standard Error 0.122 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Final Visit (LOCF) [N=209; 183; 195; 181] | -1.12 pads | Standard Error 0.119 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Week 4 [N=209; 183; 195; 181] | -0.81 pads | Standard Error 0.107 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Final Visit (LOCF) [N=209; 183; 195; 181] | -0.95 pads | Standard Error 0.123 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Week 8 [N=204; 176; 183; 177] | -0.77 pads | Standard Error 0.124 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Week 4 [N=209; 183; 195; 181] | -0.67 pads | Standard Error 0.111 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours | Week 12 [N=200; 172; 181; 165] | -0.95 pads | Standard Error 0.128 |
Secondary
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Weeks 4, 8 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Week 4 [N=475; 469; 471; 470] | -0.89 Urgency episodes | Standard Error 0.138 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Week 8 [N=460; 446; 450; 456] | -1.28 Urgency episodes | Standard Error 0.152 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Week 12 [N=450; 433; 441; 434] | -1.65 Urgency episodes | Standard Error 0.154 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Final Visit (LOCF) [N=479; 470; 474; 472] | -1.65 Urgency episodes | Standard Error 0.151 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Week 8 [N=460; 446; 450; 456] | -1.90 Urgency episodes | Standard Error 0.155 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Week 12 [N=450; 433; 441; 434] | -2.35 Urgency episodes | Standard Error 0.157 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Final Visit (LOCF) [N=479; 470; 474; 472] | -2.25 Urgency episodes | Standard Error 0.152 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Week 4 [N=475; 469; 471; 470] | -1.39 Urgency episodes | Standard Error 0.139 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Week 12 [N=450; 433; 441; 434] | -2.00 Urgency episodes | Standard Error 0.155 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Week 8 [N=460; 446; 450; 456] | -1.90 Urgency episodes | Standard Error 0.154 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Final Visit (LOCF) [N=479; 470; 474; 472] | -1.96 Urgency episodes | Standard Error 0.151 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Week 4 [N=475; 469; 471; 470] | -1.54 Urgency episodes | Standard Error 0.138 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Final Visit (LOCF) [N=479; 470; 474; 472] | -2.07 Urgency episodes | Standard Error 0.152 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Week 8 [N=460; 446; 450; 456] | -1.91 Urgency episodes | Standard Error 0.153 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Week 4 [N=475; 469; 471; 470] | -1.63 Urgency episodes | Standard Error 0.139 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours | Week 12 [N=450; 433; 441; 434] | -2.16 Urgency episodes | Standard Error 0.156 |
Secondary
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Weeks 4, 8 and 12
Population: The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 post baseline micturition measurement in the visit diary \& at least 1 urgency incontinence episode at baseline. LOCF was used for the Final Visit analysis. N = the number of patients included at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Final Visit (LOCF) [N=283; 286; 276; 289] | -1.11 Urgency incontinence episodes | Standard Error 0.11 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12 [N=269; 267; 257; 265] | -1.12 Urgency incontinence episodes | Standard Error 0.111 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4 [N=283; 286; 276; 288] | -0.63 Urgency incontinence episodes | Standard Error 0.108 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8 [N=273; 272; 263; 281] | -0.94 Urgency incontinence episodes | Standard Error 0.118 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8 [N=273; 272; 263; 281] | -1.27 Urgency incontinence episodes | Standard Error 0.118 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4 [N=283; 286; 276; 288] | -0.98 Urgency incontinence episodes | Standard Error 0.107 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12 [N=269; 267; 257; 265] | -1.52 Urgency incontinence episodes | Standard Error 0.112 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Final Visit (LOCF) [N=283; 286; 276; 289] | -1.46 Urgency incontinence episodes | Standard Error 0.109 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12 [N=269; 267; 257; 265] | -1.32 Urgency incontinence episodes | Standard Error 0.114 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Final Visit (LOCF) [N=283; 286; 276; 289] | -1.33 Urgency incontinence episodes | Standard Error 0.111 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8 [N=273; 272; 263; 281] | -1.32 Urgency incontinence episodes | Standard Error 0.12 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4 [N=283; 286; 276; 288] | -1.00 Urgency incontinence episodes | Standard Error 0.109 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Final Visit (LOCF) [N=283; 286; 276; 289] | -1.18 Urgency incontinence episodes | Standard Error 0.109 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4 [N=283; 286; 276; 288] | -1.01 Urgency incontinence episodes | Standard Error 0.107 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8 [N=273; 272; 263; 281] | -0.99 Urgency incontinence episodes | Standard Error 0.116 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12 [N=269; 267; 257; 265] | -1.19 Urgency incontinence episodes | Standard Error 0.122 |
Secondary
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician
The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.
Time frame: Baseline and Weeks 4, 8 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Week 4 [N=477; 467; 473; 474] | -0.0 Physician visits | Standard Deviation 0.2 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Week 8 [N=462; 448; 453; 460] | -0.0 Physician visits | Standard Deviation 0.17 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Week 12 [N=451; 435; 443; 439] | -0.0 Physician visits | Standard Deviation 0.16 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Final Visit (LOCF) [N=478; 469; 475; 474] | -0.0 Physician visits | Standard Deviation 0.19 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Week 8 [N=462; 448; 453; 460] | 0.0 Physician visits | Standard Deviation 0.18 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Week 12 [N=451; 435; 443; 439] | -0.0 Physician visits | Standard Deviation 0.16 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Final Visit (LOCF) [N=478; 469; 475; 474] | -0.0 Physician visits | Standard Deviation 0.17 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Week 4 [N=477; 467; 473; 474] | -0.0 Physician visits | Standard Deviation 0.14 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Week 12 [N=451; 435; 443; 439] | -0.0 Physician visits | Standard Deviation 0.18 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Week 8 [N=462; 448; 453; 460] | -0.0 Physician visits | Standard Deviation 0.21 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Final Visit (LOCF) [N=478; 469; 475; 474] | -0.0 Physician visits | Standard Deviation 0.18 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Week 4 [N=477; 467; 473; 474] | -0.0 Physician visits | Standard Deviation 0.19 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Final Visit (LOCF) [N=478; 469; 475; 474] | -0.0 Physician visits | Standard Deviation 0.19 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Week 8 [N=462; 448; 453; 460] | -0.0 Physician visits | Standard Deviation 0.15 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Week 4 [N=477; 467; 473; 474] | 0.0 Physician visits | Standard Deviation 0.23 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician | Week 12 [N=451; 435; 443; 439] | -0.0 Physician visits | Standard Deviation 0.18 |
Secondary
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Weeks 4, 8 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Week 4 [N=472; 460; 470; 467] | -9.7 Scores on a scale | Standard Error 0.75 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Week 8 [N=455; 441; 450; 451] | -13.3 Scores on a scale | Standard Error 0.84 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Week 12 [N=445; 424; 435; 433] | -15.3 Scores on a scale | Standard Error 0.87 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Final Visit (LOCF) [N=475; 465; 473; 469] | -14.9 Scores on a scale | Standard Error 0.84 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Week 8 [N=455; 441; 450; 451] | -17.8 Scores on a scale | Standard Error 0.85 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Week 12 [N=445; 424; 435; 433] | -20.3 Scores on a scale | Standard Error 0.89 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Final Visit (LOCF) [N=475; 465; 473; 469] | -19.6 Scores on a scale | Standard Error 0.85 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Week 4 [N=472; 460; 470; 467] | -13.0 Scores on a scale | Standard Error 0.76 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Week 12 [N=445; 424; 435; 433] | -20.0 Scores on a scale | Standard Error 0.88 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Week 8 [N=455; 441; 450; 451] | -17.6 Scores on a scale | Standard Error 0.84 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Final Visit (LOCF) [N=475; 465; 473; 469] | -19.9 Scores on a scale | Standard Error 0.84 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Week 4 [N=472; 460; 470; 467] | -13.8 Scores on a scale | Standard Error 0.75 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Final Visit (LOCF) [N=475; 465; 473; 469] | -18.4 Scores on a scale | Standard Error 0.85 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Week 8 [N=455; 441; 450; 451] | -17.1 Scores on a scale | Standard Error 0.84 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Week 4 [N=472; 460; 470; 467] | -13.8 Scores on a scale | Standard Error 0.76 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score | Week 12 [N=445; 424; 435; 433] | -18.5 Scores on a scale | Standard Error 0.88 |
Secondary
Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.
Time frame: Baseline and Weeks 4, 8 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Week 4 [N=466; 459; 468; 461] | 3.1 Scores on a scale | Standard Deviation 15.64 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Week 8 [N=451; 443; 447; 447] | 4.5 Scores on a scale | Standard Deviation 16.81 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Week 12 [N=443; 423; 437; 429] | 6.7 Scores on a scale | Standard Deviation 19.01 |
| Placebo | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Final Visit (LOCF) [N=470; 466; 472; 467] | 6.4 Scores on a scale | Standard Deviation 19.03 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Week 8 [N=451; 443; 447; 447] | 5.5 Scores on a scale | Standard Deviation 16.79 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Week 12 [N=443; 423; 437; 429] | 7.1 Scores on a scale | Standard Deviation 18.89 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Final Visit (LOCF) [N=470; 466; 472; 467] | 6.5 Scores on a scale | Standard Deviation 18.67 |
| Mirabegron 50 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Week 4 [N=466; 459; 468; 461] | 3.3 Scores on a scale | Standard Deviation 15.74 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Week 12 [N=443; 423; 437; 429] | 8.2 Scores on a scale | Standard Deviation 17.56 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Week 8 [N=451; 443; 447; 447] | 6.8 Scores on a scale | Standard Deviation 17.42 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Final Visit (LOCF) [N=470; 466; 472; 467] | 8.1 Scores on a scale | Standard Deviation 17.74 |
| Mirabegron 100 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Week 4 [N=466; 459; 468; 461] | 4.4 Scores on a scale | Standard Deviation 16.75 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Final Visit (LOCF) [N=470; 466; 472; 467] | 6.4 Scores on a scale | Standard Deviation 18.23 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Week 8 [N=451; 443; 447; 447] | 6.0 Scores on a scale | Standard Deviation 17.31 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Week 4 [N=466; 459; 468; 461] | 3.2 Scores on a scale | Standard Deviation 17.68 |
| Tolterodine SR 4 mg | Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Week 12 [N=443; 423; 437; 429] | 6.9 Scores on a scale | Standard Deviation 17.62 |
Secondary
Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Weeks 8 and 12
Population: The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as N. LOCF was not utilized.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 8 [N=280; 277; 268; 292] | -1.00 Incontinence episodes | Standard Error 0.127 |
| Placebo | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 12 [N=275; 272; 262; 276] | -1.18 Incontinence episodes | Standard Error 0.116 |
| Mirabegron 50 mg | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 12 [N=275; 272; 262; 276] | -1.62 Incontinence episodes | Standard Error 0.117 |
| Mirabegron 50 mg | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 8 [N=280; 277; 268; 292] | -1.29 Incontinence episodes | Standard Error 0.128 |
| Mirabegron 100 mg | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 8 [N=280; 277; 268; 292] | -1.40 Incontinence episodes | Standard Error 0.13 |
| Mirabegron 100 mg | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 12 [N=275; 272; 262; 276] | -1.45 Incontinence episodes | Standard Error 0.119 |
| Tolterodine SR 4 mg | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 8 [N=280; 277; 268; 292] | -1.02 Incontinence episodes | Standard Error 0.125 |
| Tolterodine SR 4 mg | Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours | Week 12 [N=275; 272; 262; 276] | -1.27 Incontinence episodes | Standard Error 0.116 |
Secondary
Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.
Time frame: Baseline and Weeks 8 and 12
Population: The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. The number of patients included in the calculation for each time point is noted as N. LOCF was not used in this analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours | Week 8 [N=463; 450; 455; 461] | -1.15 micturitions | Standard Error 0.106 |
| Placebo | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours | Week 12 [N=452; 437; 447; 438] | -1.33 micturitions | Standard Error 0.113 |
| Mirabegron 50 mg | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours | Week 12 [N=452; 437; 447; 438] | -2.02 micturitions | Standard Error 0.115 |
| Mirabegron 50 mg | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours | Week 8 [N=463; 450; 455; 461] | -1.64 micturitions | Standard Error 0.107 |
| Mirabegron 100 mg | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours | Week 8 [N=463; 450; 455; 461] | -1.66 micturitions | Standard Error 0.106 |
| Mirabegron 100 mg | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours | Week 12 [N=452; 437; 447; 438] | -1.78 micturitions | Standard Error 0.113 |
| Tolterodine SR 4 mg | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours | Week 8 [N=463; 450; 455; 461] | -1.43 micturitions | Standard Error 0.106 |
| Tolterodine SR 4 mg | Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours | Week 12 [N=452; 437; 447; 438] | -1.60 micturitions | Standard Error 0.114 |
Secondary
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit
The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.
Time frame: Baseline and Weeks 4, 8 and 12
Population: The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary \& who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Week 4 [N=291; 293; 281; 299] | 46.0 percentage of participants |
| Placebo | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Week 8 [N=280; 277; 268; 292] | 53.9 percentage of participants |
| Placebo | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Week 12 [N=275; 272; 262; 276] | 61.5 percentage of participants |
| Placebo | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Final Visit (LOCF) [N=291; 293; 281; 300] | 60.1 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Week 8 [N=280; 277; 268; 292] | 67.9 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Week 12 [N=275; 272; 262; 276] | 73.5 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Final Visit (LOCF) [N=291; 293; 281; 300] | 72.2 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Week 4 [N=291; 293; 281; 299] | 57.3 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Week 12 [N=275; 272; 262; 276] | 67.9 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Week 8 [N=280; 277; 268; 292] | 68.3 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Final Visit (LOCF) [N=291; 293; 281; 300] | 67.6 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Week 4 [N=291; 293; 281; 299] | 54.4 percentage of participants |
| Tolterodine SR 4 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Final Visit (LOCF) [N=291; 293; 281; 300] | 68.3 percentage of participants |
| Tolterodine SR 4 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Week 8 [N=280; 277; 268; 292] | 64.4 percentage of participants |
| Tolterodine SR 4 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Week 4 [N=291; 293; 281; 299] | 56.5 percentage of participants |
| Tolterodine SR 4 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit | Week 12 [N=275; 272; 262; 276] | 69.6 percentage of participants |
Secondary
Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.
Time frame: Baseline and Week 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Improvement: Week 12 [N=425; 410;421; 417] | 56.9 percentage of participants |
| Placebo | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Improvement: Final Visit [N=433; 416; 429; 426] | 56.6 percentage of participants |
| Placebo | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Major Improvement: Week 12 [N=425; 410; 421; 417] | 28.5 percentage of participants |
| Placebo | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Major Improvement: Final Visit [N=433;416;429;426] | 28.2 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Improvement: Final Visit [N=433; 416; 429; 426] | 61.3 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Major Improvement: Week 12 [N=425; 410; 421; 417] | 29.5 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Major Improvement: Final Visit [N=433;416;429;426] | 29.1 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Improvement: Week 12 [N=425; 410;421; 417] | 61.5 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Major Improvement: Week 12 [N=425; 410; 421; 417] | 34.0 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Improvement: Final Visit [N=433; 416; 429; 426] | 62.2 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Major Improvement: Final Visit [N=433;416;429;426] | 33.6 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Improvement: Week 12 [N=425; 410;421; 417] | 62.7 percentage of participants |
| Tolterodine SR 4 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Major Improvement: Final Visit [N=433;416;429;426] | 31.5 percentage of participants |
| Tolterodine SR 4 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Improvement: Final Visit [N=433; 416; 429; 426] | 65.0 percentage of participants |
| Tolterodine SR 4 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Improvement: Week 12 [N=425; 410;421; 417] | 65.2 percentage of participants |
| Tolterodine SR 4 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit | Major Improvement: Week 12 [N=425; 410; 421; 417] | 31.7 percentage of participants |
Secondary
Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.
Time frame: Weeks 4, 8 and 12
Population: The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug \& had a baseline \& at least 1 postbaseline micturition measurement in the visit diary \& who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Week 4 [N=291; 293; 281; 299] | 28.9 percentage of participants |
| Placebo | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Week 8 [N=280; 277; 268; 292] | 34.3 percentage of participants |
| Placebo | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Final Visit (LOCF) [N=291; 293; 281; 300] | 40.5 percentage of participants |
| Placebo | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Week 12 [N=275; 272; 262; 276] | 41.1 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Week 8 [N=280; 277; 268; 292] | 42.6 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Final Visit (LOCF) [N=291; 293; 281; 300] | 45.1 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Week 4 [N=291; 293; 281; 299] | 32.1 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Week 12 [N=275; 272; 262; 276] | 46.3 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Week 12 [N=275; 272; 262; 276] | 43.9 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Week 4 [N=291; 293; 281; 299] | 32.0 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Final Visit (LOCF) [N=291; 293; 281; 300] | 43.8 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Week 8 [N=280; 277; 268; 292] | 45.1 percentage of participants |
| Tolterodine SR 4 mg | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Final Visit (LOCF) [N=291; 293; 281; 300] | 47.3 percentage of participants |
| Tolterodine SR 4 mg | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Week 4 [N=291; 293; 281; 299] | 33.4 percentage of participants |
| Tolterodine SR 4 mg | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Week 8 [N=280; 277; 268; 292] | 41.8 percentage of participants |
| Tolterodine SR 4 mg | Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit | Week 12 [N=275; 272; 262; 276] | 48.6 percentage of participants |