Urinary Bladder, Overactive
Conditions
Keywords
Frequency, Overactive Bladder, Urgency, Urinary urge incontinence, Urinary incontinence, Micturition
Brief summary
The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.
Detailed description
Patients who completed 178-CL-046 (NCT00689104) or 178-CL-047 (NCT00662909) or new patients could be enrolled in this study if eligible.
Interventions
DRUGMirabegron
Tablets
DRUGTolterodine
Extended release 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
* Patient is willing and able to complete the micturition diary and questionnaires correctly * Patient has symptoms of overactive bladder for ≥ 3 months * Patient experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period * Patient 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
* Patient 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 * Patient has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor * Patient has an indwelling catheter or practices intermittent self-catheterization * Patient has diabetic neuropathy * Patient 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 * Patient receives non-drug treatment including electro-stimulation therapy * Patient has severe hypertension * Patient 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 * Patient has been treated with any investigational drug or device within 30 days (90 days in the UK for all clinical studies except 178-CL-046) * Patient had an average total daily urine volume \> 3000 mL as recorded in the 3-day micturition diary period * Patient has serum creatinine \>150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2x upper limit of normal range (ULN), or gamma-glutamyl transpeptidase (γ-GT) \> 3x ULN * Patient has a clinically significant abnormal electrocardiogram (ECG)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months. | An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | 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 prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Baseline and Months 1, 3, 6, 9 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 prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | The involuntary leakage of urine accompanied 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 time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 12 | The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from 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 delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Baseline and Months 1, 3, 6, 9 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 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 generated from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Baseline and Months 1, 3, 6, 9 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Baseline and Months 1, 3, 6, 9 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. |
| Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Months 1, 3, 6, 9 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 Months 1, 3, 6, 9 and 12 and the Final Visit | Baseline and Months 1, 3, 6, 9 and 12 | The percentage of participants with at least a 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 Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Baseline and Months 1, 3, 6, 9 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 patient 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Baseline and Months 1, 3, 6, 9 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. |
| Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Baseline and Month 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'. A negative change from Baseline score indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. |
| Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS) | Baseline and Month 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). A positive change from baseline indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate. |
| Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Baseline and Months 1, 3, 6, 9 and 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 prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate. |
| Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Baseline and Months 3, 6 and 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 Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Baseline and Months 3, 6 and 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 Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Baseline and Months 3, 6 and 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 and less productivity. 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 Month 12 | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating 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 Month 12 | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating 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 Month 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 Month 12 | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating 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 Month 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 Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline and Months 1, 3, 6, 9 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 Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | Baseline and Months 3, 6 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) | Baseline and Month 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 one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score. |
| Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months. | An abnormality identified during a medical test was defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant. The Investigator assessed each AE for causal relationship (not related, possible or probable) to study drug. A serious AE (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, resulted in significant disability/incapacity or congenital anomaly/birth defect, required or prolonged hospitalization or was a medically important event. The data reported represent the number of participants with adverse events in each category. |
| Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Baseline and Months 3, 6 and 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. |
Countries
Australia, Austria, Belarus, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Patients who completed the 12-week treatment and safety follow-up periods of studies 178-CL-046 (NCT00689104) or 178-CL-047 (NCT00662909), as well as patients that did not participate in these studies were enrolled into this study if they met all inclusion criteria and none of the exclusion criteria.
Pre-assignment details
After screening, 2792 patients took placebo run-in study drug in a 2-week, single-blind, placebo run-in period. On completion of the run-in period, 2452 eligible patients were randomly assigned to receive mirabegron 50 mg, or mirabegron 100 mg or tolterodine ER 4 mg once daily for 12 months.
Participants by arm
| Arm | Count |
|---|---|
| Mirabegron 50 mg Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months. | 812 |
| Mirabegron 100 mg Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months. | 820 |
| Tolterodine ER 4 mg Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months. | 812 |
| Total | 2,444 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 52 | 51 | 50 |
| Overall Study | Eligibility criterion not met | 7 | 7 | 10 |
| Overall Study | Lack of Efficacy | 34 | 25 | 45 |
| Overall Study | Lost to Follow-up | 14 | 7 | 7 |
| Overall Study | Non-compliance with study procedures | 5 | 3 | 4 |
| Overall Study | Protocol Violation | 6 | 9 | 11 |
| Overall Study | Randomized but never received study drug | 1 | 0 | 0 |
| Overall Study | Site closure | 0 | 1 | 0 |
| Overall Study | Taking exclusionary medications | 1 | 0 | 0 |
| Overall Study | Violation of exclusion criterion | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 66 | 75 | 65 |
Baseline characteristics
| Characteristic | Tolterodine ER 4 mg | Mirabegron 50 mg | Mirabegron 100 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 12.47 | 59.2 years STANDARD_DEVIATION 12.56 | 60.1 years STANDARD_DEVIATION 11.92 | 59.6 years STANDARD_DEVIATION 12.32 |
| Duration of OAB symptoms | 83.8 months STANDARD_DEVIATION 87.34 | 87.4 months STANDARD_DEVIATION 96.28 | 87.9 months STANDARD_DEVIATION 91.52 | 86.4 months STANDARD_DEVIATION 91.77 |
| Mean level of urgency | 2.43 scores on a scale STANDARD_DEVIATION 0.519 | 2.45 scores on a scale STANDARD_DEVIATION 0.544 | 2.44 scores on a scale STANDARD_DEVIATION 0.525 | 2.44 scores on a scale STANDARD_DEVIATION 0.529 |
| Mean number of micturitions per 24 Hours | 10.94 micturitions STANDARD_DEVIATION 2.668 | 11.12 micturitions STANDARD_DEVIATION 2.809 | 11.16 micturitions STANDARD_DEVIATION 2.917 | 11.08 micturitions STANDARD_DEVIATION 2.801 |
| Mean number of nocturia episodes per 24 hours | 1.77 nocturia episodes STANDARD_DEVIATION 1.388 | 1.83 nocturia episodes STANDARD_DEVIATION 1.361 | 1.85 nocturia episodes STANDARD_DEVIATION 1.404 | 1.82 nocturia episodes STANDARD_DEVIATION 1.384 |
| Mean number of pads used per 24 hours | 0.98 pads STANDARD_DEVIATION 1.759 | 1.06 pads STANDARD_DEVIATION 1.872 | 0.98 pads STANDARD_DEVIATION 1.769 | 1.01 pads STANDARD_DEVIATION 1.8 |
| Mean number of urgency episodes (grade 3 or 4) per 24 hours | 5.44 urgency episodes STANDARD_DEVIATION 3.453 | 5.66 urgency episodes STANDARD_DEVIATION 3.601 | 5.61 urgency episodes STANDARD_DEVIATION 3.722 | 5.57 urgency episodes STANDARD_DEVIATION 3.594 |
| Mean volume voided per micturition | 160.8 mL STANDARD_DEVIATION 56.98 | 160.4 mL STANDARD_DEVIATION 58.8 | 164.6 mL STANDARD_DEVIATION 58.62 | 162.0 mL STANDARD_DEVIATION 58.15 |
| Sex: Female, Male Female | 600 Participants | 602 Participants | 608 Participants | 1810 Participants |
| Sex: Female, Male Male | 212 Participants | 210 Participants | 212 Participants | 634 Participants |
| Summary of previous treatment Mirabegron 100 mg | 197 participants | 183 participants | 198 participants | 578 participants |
| Summary of previous treatment Mirabegron 50 mg | 171 participants | 170 participants | 180 participants | 521 participants |
| Summary of previous treatment Naive | 156 participants | 139 participants | 161 participants | 456 participants |
| Summary of previous treatment Placebo | 180 participants | 190 participants | 174 participants | 544 participants |
| Summary of previous treatment Tolterodine ER 4 mg | 108 participants | 130 participants | 107 participants | 345 participants |
| Type of overactive bladder (OAB) Frequency | 285 participants | 284 participants | 287 participants | 856 participants |
| Type of overactive bladder (OAB) Mixed | 210 participants | 232 participants | 228 participants | 670 participants |
| Type of overactive bladder (OAB) Urge incontinence | 317 participants | 296 participants | 305 participants | 918 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 136 / 812 | 137 / 820 | 181 / 812 |
| serious Total, serious adverse events | 42 / 812 | 51 / 820 | 44 / 812 |
Outcome results
Primary
Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.
Time frame: From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.
Population: The number of participants analyzed represents the Safety Analysis Set (SAF), including all randomized patients who took at least one dose of double-blind study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Severe adverse events | 51 participants |
| Mirabegron 50 mg | Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Mild adverse events | 222 participants |
| Mirabegron 50 mg | Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Moderate adverse events | 212 participants |
| Mirabegron 100 mg | Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Moderate adverse events | 211 participants |
| Mirabegron 100 mg | Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Severe adverse events | 52 participants |
| Mirabegron 100 mg | Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Mild adverse events | 240 participants |
| Tolterodine ER 4 mg | Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Mild adverse events | 251 participants |
| Tolterodine ER 4 mg | Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Severe adverse events | 39 participants |
| Tolterodine ER 4 mg | Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs) | Moderate adverse events | 218 participants |
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 Month 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) |
|---|---|---|---|
| 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 | 15 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 | 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 -> Extremely anxious | 3 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 | 7 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 | 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 -> 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 | 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 | Not anxious -> Missing data | 3 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 | 108 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 | 413 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 | 174 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 | 7 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 | Extremely anxious -> Not anxious | 3 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 | 8 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 | 43 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 | 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 -> Extremely anxious | 5 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 | 34 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 | 99 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 | 5 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 | 2 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 | 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 | 453 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 | 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 | 3 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 | 181 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 -> 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 -> Moderately anxious | 9 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 | Moderately anxious -> Extremely anxious | 9 participants |
| Tolterodine ER 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 ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderately anxious -> Moderately anxious | 169 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderately anxious -> Extremely anxious | 11 participants |
| Tolterodine ER 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 ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Not anxious -> Not anxious | 429 participants |
| Tolterodine ER 4 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 |
| Tolterodine ER 4 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 ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderately anxious -> Not anxious | 105 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderately anxious -> Missing data | 2 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extremely anxious -> Not anxious | 3 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extremely anxious -> Moderately anxious | 14 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extremely anxious -> Extremely anxious | 6 participants |
| Tolterodine ER 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 |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data -> Moderately anxious | 2 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data -> Extremely anxious | 1 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Not anxious -> Moderately anxious | 43 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 evaluating 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 Month 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) |
|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined to bed -> 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 -> No problems | 64 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 | 567 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 | 36 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 | No problem -> Missing data | 4 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 | 105 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 | 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 | Confined to bed -> No problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined to bed -> Some problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined to bed -> 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 | Missing data -> No problem | 11 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 | 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 | 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 | 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 | Confined to bed -> 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 -> Some problems | 97 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 | 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 | 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 | Some problems -> No problems | 55 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined to bed -> No problems | 1 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 | 601 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 | 1 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 | No problem -> Some problems | 42 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined to bed -> Some problems | 0 participants |
| Mirabegron 100 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined to bed -> 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 -> Confined to bed | 1 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 | 3 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined to bed -> Missing data | 0 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> No problems | 62 participants |
| Tolterodine ER 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 ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Some problems | 106 participants |
| Tolterodine ER 4 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 |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> No problem | 7 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems -> Missing data | 2 participants |
| Tolterodine ER 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 ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined to bed -> No problems | 0 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data -> Some problems | 0 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined to bed -> Some problems | 0 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Missing data | 2 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined to bed -> Confined to bed | 0 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> No problem | 573 participants |
| Tolterodine ER 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 ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem -> Some problems | 39 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 evaluating 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 Month 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) |
|---|---|---|---|
| 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 | 3 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 | Moderate pain -> Moderate pain | 173 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 | 398 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 | 8 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 | 14 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 | 10 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 | 54 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 | 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 -> No pain | 104 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 -> No pain | 3 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 | 4 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 | 13 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 | 4 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 | 6 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 | 10 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 | 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 | 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 | Missing data-> No pain | 3 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 | 0 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 | No pain -> Missing data | 2 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 | 107 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 | 396 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 | 196 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 | 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 -> Moderate pain | 69 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 | 4 participants |
| Tolterodine ER 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 ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> No pain | 398 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Moderate pain | 63 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain -> Extreme pain | 4 participants |
| Tolterodine ER 4 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 |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> No pain | 105 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> Moderate pain | 182 participants |
| Tolterodine ER 4 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 |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain -> Missing data | 2 participants |
| Tolterodine ER 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 ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Moderate pain | 9 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain -> Extreme pain | 8 participants |
| Tolterodine ER 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 |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data-> No pain | 6 participants |
| Tolterodine ER 4 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 |
| Tolterodine ER 4 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 |
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 evaluating 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 Month 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) |
|---|---|---|---|
| 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 | 16 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 | Some problems -> Some problems | 18 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 | 718 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 | 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 | 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 | No problem -> Unable to wash or dress myself | 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 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 | 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 | Missing data -> No problem | 13 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 | 4 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 | 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 | Some problems -> No problems | 19 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 -> 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 | No problem -> No problem | 735 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 | 15 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 | 4 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 | 19 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 | 25 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 | 2 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 | 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 -> 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 | Missing data -> Unable to wash or dress myself | 0 participants |
| Tolterodine ER 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 ER 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 ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score | Some problems -> No problems | 13 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score | No problem -> Missing data | 4 participants |
| Tolterodine ER 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 ER 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 | 3 participants |
| Tolterodine ER 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 ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score | Missing data -> No problem | 8 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score | No problem -> Some problems | 23 participants |
| Tolterodine ER 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 ER 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 |
| Tolterodine ER 4 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 |
| Tolterodine ER 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 ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score | No problem -> No problem | 720 participants |
| Tolterodine ER 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 ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score | Some problems -> Some problems | 20 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 Month 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) |
|---|---|---|---|
| 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 | 3 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 | 536 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 | 40 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 | Some problems -> No problems | 97 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 | 94 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 | 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 -> 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 | Unable to perform usual activities -> No problems | 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 | 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 | 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 usual activities -> Missing data | 10 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 | 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 | 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 | 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 | Some problems -> Missing data | 2 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 | 2 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 | 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 | No problem -> No problem | 569 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 | 76 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 | 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 -> Some problems | 55 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 | 2 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 | 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 -> Unable to perform usual activities | 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 -> 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 usual activities -> Missing data | 2 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 |
| 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 | 4 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 | 88 participants |
| Tolterodine ER 4 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 |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> No problems | 96 participants |
| Tolterodine ER 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 | 7 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> Some problems | 79 participants |
| Tolterodine ER 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 ER 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 | 1 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems -> Missing data | 3 participants |
| Tolterodine ER 4 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 |
| Tolterodine ER 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 | 0 participants |
| Tolterodine ER 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 | 5 participants |
| Tolterodine ER 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 ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> No problem | 542 participants |
| Tolterodine ER 4 mg | Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem -> Some problems | 53 participants |
| Tolterodine ER 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 ER 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 | 2 participants |
| Tolterodine ER 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 |
Secondary
Change From Baseline to Month 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'. A negative change from Baseline score indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time frame: Baseline and Month 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline \& 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 is used for the Final Visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Month 12 [N=601; 616; 611] | -0.8 scores on a scale | Standard Error 0.04 |
| Mirabegron 50 mg | Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Final Visit (LOCF) [N=655; 673; 673] | -0.8 scores on a scale | Standard Error 0.04 |
| Mirabegron 100 mg | Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Final Visit (LOCF) [N=655; 673; 673] | -0.9 scores on a scale | Standard Error 0.04 |
| Mirabegron 100 mg | Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Month 12 [N=601; 616; 611] | -0.9 scores on a scale | Standard Error 0.04 |
| Tolterodine ER 4 mg | Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Month 12 [N=601; 616; 611] | -0.9 scores on a scale | Standard Error 0.04 |
| Tolterodine ER 4 mg | Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) | Final Visit (LOCF) [N=655; 673; 673] | -0.8 scores on a scale | Standard Error 0.04 |
Secondary
Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-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). A positive change from baseline indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time frame: Baseline and Month 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline \& 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 is used for the Final Visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS) | Month 12 [N=599; 620; 613] | 2.27 scores on a scale | Standard Error 0.175 |
| Mirabegron 50 mg | Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS) | Final Visit (LOCF) [N=654; 676; 676] | 2.08 scores on a scale | Standard Error 0.167 |
| Mirabegron 100 mg | Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS) | Month 12 [N=599; 620; 613] | 2.27 scores on a scale | Standard Error 0.172 |
| Mirabegron 100 mg | Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS) | Final Visit (LOCF) [N=654; 676; 676] | 2.11 scores on a scale | Standard Error 0.164 |
| Tolterodine ER 4 mg | Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS) | Month 12 [N=599; 620; 613] | 2.52 scores on a scale | Standard Error 0.173 |
| Tolterodine ER 4 mg | Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS) | Final Visit (LOCF) [N=654; 676; 676] | 2.27 scores on a scale | Standard Error 0.164 |
Secondary
Change From Baseline to Months 1, 3, 6, 9, 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time frame: Baseline and Months 1, 3, 6, 9 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 6 [N=681; 700; 686] | 11.7 scores on a scale | Standard Error 0.56 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 1 [N=774; 787; 773] | 7.7 scores on a scale | Standard Error 0.48 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 9 [N=650; 667; 644] | 11.3 scores on a scale | Standard Error 0.6 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Final Visit (LOCF) [N=779; 798; 783] | 10.7 scores on a scale | Standard Error 0.58 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 3 [N=736; 740; 739] | 9.9 scores on a scale | Standard Error 0.54 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 12 [N=619; 640; 613] | 11.7 scores on a scale | Standard Error 0.62 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 3 [N=736; 740; 739] | 11.9 scores on a scale | Standard Error 0.54 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 1 [N=774; 787; 773] | 8.9 scores on a scale | Standard Error 0.48 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 6 [N=681; 700; 686] | 12.9 scores on a scale | Standard Error 0.56 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 9 [N=650; 667; 644] | 12.2 scores on a scale | Standard Error 0.59 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 12 [N=619; 640; 613] | 12.6 scores on a scale | Standard Error 0.61 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Final Visit (LOCF) [N=779; 798; 783] | 11.7 scores on a scale | Standard Error 0.57 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 3 [N=736; 740; 739] | 10.6 scores on a scale | Standard Error 0.54 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Final Visit (LOCF) [N=779; 798; 783] | 11.4 scores on a scale | Standard Error 0.58 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 12 [N=619; 640; 613] | 13.2 scores on a scale | Standard Error 0.62 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 6 [N=681; 700; 686] | 11.6 scores on a scale | Standard Error 0.56 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 1 [N=774; 787; 773] | 8.9 scores on a scale | Standard Error 0.48 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score | Month 9 [N=650; 667; 644] | 12.4 scores on a scale | Standard Error 0.6 |
Secondary
Change From Baseline to Months 1, 3, 6, 9, 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 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 generated from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time frame: Baseline and Months 1, 3, 6, 9 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 9 [N=654; 666; 643] | -0.30 scores on a scale | Standard Error 0.022 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 1 [N=784; 793; 780] | -0.18 scores on a scale | Standard Error 0.016 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 6 [N=684; 702; 680] | -0.29 scores on a scale | Standard Error 0.021 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Final Visit (LOCF) [N=789; 801; 788] | -0.29 scores on a scale | Standard Error 0.02 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 12 [N=622; 638; 621] | -0.33 scores on a scale | Standard Error 0.023 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 3 [N=739; 738; 733] | -0.21 scores on a scale | Standard Error 0.019 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 6 [N=684; 702; 680] | -0.32 scores on a scale | Standard Error 0.021 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 1 [N=784; 793; 780] | -0.19 scores on a scale | Standard Error 0.016 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 3 [N=739; 738; 733] | -0.28 scores on a scale | Standard Error 0.019 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 9 [N=654; 666; 643] | -0.30 scores on a scale | Standard Error 0.022 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 12 [N=622; 638; 621] | -0.31 scores on a scale | Standard Error 0.023 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Final Visit (LOCF) [N=789; 801; 788] | -0.29 scores on a scale | Standard Error 0.02 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 1 [N=784; 793; 780] | -0.17 scores on a scale | Standard Error 0.016 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Final Visit (LOCF) [N=789; 801; 788] | -0.27 scores on a scale | Standard Error 0.02 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 12 [N=622; 638; 621] | -0.32 scores on a scale | Standard Error 0.023 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 3 [N=739; 738; 733] | -0.24 scores on a scale | Standard Error 0.019 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 6 [N=684; 702; 680] | -0.27 scores on a scale | Standard Error 0.021 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency | Month 9 [N=654; 666; 643] | -0.31 scores on a scale | Standard Error 0.022 |
Secondary
Change From Baseline to Months 1, 3, 6, 9, 12 and 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 prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.
Time frame: Baseline and Months 1, 3, 6, 9 and 12
Population: The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary \& who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 12 [N=370; 387; 379] | -1.14 incontinence episodes | Standard Error 0.094 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Final Visit (LOCF) [N=479; 483; 488] | -1.01 incontinence episodes | Standard Error 0.087 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 6 [N=409; 428; 418] | -1.11 incontinence episodes | Standard Error 0.088 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 1 [N=478; 479; 485] | -0.94 incontinence episodes | Standard Error 0.079 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 9 [N=387; 402; 391] | -1.17 incontinence episodes | Standard Error 0.083 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 3 [N=447; 443; 452] | -1.10 incontinence episodes | Standard Error 0.083 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 1 [N=478; 479; 485] | -1.03 incontinence episodes | Standard Error 0.079 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 12 [N=370; 387; 379] | -1.19 incontinence episodes | Standard Error 0.092 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 3 [N=447; 443; 452] | -1.28 incontinence episodes | Standard Error 0.084 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 6 [N=409; 428; 418] | -1.27 incontinence episodes | Standard Error 0.086 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Final Visit (LOCF) [N=479; 483; 488] | -1.24 incontinence episodes | Standard Error 0.086 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 9 [N=387; 402; 391] | -1.32 incontinence episodes | Standard Error 0.082 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Final Visit (LOCF) [N=479; 483; 488] | -1.26 incontinence episodes | Standard Error 0.086 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 1 [N=478; 479; 485] | -0.96 incontinence episodes | Standard Error 0.078 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 3 [N=447; 443; 452] | -1.09 incontinence episodes | Standard Error 0.083 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 6 [N=409; 428; 418] | -1.17 incontinence episodes | Standard Error 0.087 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 9 [N=387; 402; 391] | -1.26 incontinence episodes | Standard Error 0.083 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours | Month 12 [N=370; 387; 379] | -1.36 incontinence episodes | Standard Error 0.093 |
Secondary
Change From Baseline to Months 1, 3, 6, 9, 12 and 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 prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.
Time frame: Baseline and Months 1, 3, 6, 9 and 12
Population: The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 1 [N=786; 797; 786] | -0.94 micturitions | Standard Error 0.069 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 3 [N=742; 741; 735] | -1.13 micturitions | Standard Error 0.079 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 6 [N=684; 705; 684] | -1.25 micturitions | Standard Error 0.083 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 9 [N=656; 667; 645] | -1.33 micturitions | Standard Error 0.086 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 12 [N=627; 642; 623] | -1.30 micturitions | Standard Error 0.089 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Final Visit (LOCF) [N=789; 802; 791] | -1.27 micturitions | Standard Error 0.083 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Final Visit (LOCF) [N=789; 802; 791] | -1.41 micturitions | Standard Error 0.082 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 1 [N=786; 797; 786] | -1.10 micturitions | Standard Error 0.068 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 9 [N=656; 667; 645] | -1.37 micturitions | Standard Error 0.086 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 12 [N=627; 642; 623] | -1.46 micturitions | Standard Error 0.088 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 3 [N=742; 741; 735] | -1.46 micturitions | Standard Error 0.079 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 6 [N=684; 705; 684] | -1.43 micturitions | Standard Error 0.082 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 3 [N=742; 741; 735] | -1.27 micturitions | Standard Error 0.08 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 6 [N=684; 705; 684] | -1.30 micturitions | Standard Error 0.083 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Final Visit (LOCF) [N=789; 802; 791] | -1.39 micturitions | Standard Error 0.083 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 9 [N=656; 667; 645] | -1.38 micturitions | Standard Error 0.087 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 1 [N=786; 797; 786] | -1.02 micturitions | Standard Error 0.069 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours | Month 12 [N=627; 642; 623] | -1.50 micturitions | Standard Error 0.089 |
Secondary
Change From Baseline to Months 1, 3, 6, 9, 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time frame: Baseline and Months 1, 3, 6, 9 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 nocturia episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 12 [N=554; 562; 550] | -0.48 nocturia episodes | Standard Error 0.042 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 6 [N=604; 618; 602] | -0.42 nocturia episodes | Standard Error 0.041 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Final Visit (LOCF) [N=693; 703; 693] | -0.46 nocturia episodes | Standard Error 0.038 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 1 [N=690; 698; 690] | -0.26 nocturia episodes | Standard Error 0.034 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 9 [N=580; 583; 567] | -0.50 nocturia episodes | Standard Error 0.04 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 3 [N=654; 651; 643] | -0.41 nocturia episodes | Standard Error 0.037 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 9 [N=580; 583; 567] | -0.41 nocturia episodes | Standard Error 0.04 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 3 [N=654; 651; 643] | -0.45 nocturia episodes | Standard Error 0.037 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Final Visit (LOCF) [N=693; 703; 693] | -0.39 nocturia episodes | Standard Error 0.038 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 12 [N=554; 562; 550] | -0.40 nocturia episodes | Standard Error 0.041 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 1 [N=690; 698; 690] | -0.29 nocturia episodes | Standard Error 0.033 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 6 [N=604; 618; 602] | -0.38 nocturia episodes | Standard Error 0.04 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Final Visit (LOCF) [N=693; 703; 693] | -0.43 nocturia episodes | Standard Error 0.038 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 1 [N=690; 698; 690] | -0.29 nocturia episodes | Standard Error 0.034 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 3 [N=654; 651; 643] | -0.37 nocturia episodes | Standard Error 0.037 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 6 [N=604; 618; 602] | -0.35 nocturia episodes | Standard Error 0.041 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 9 [N=580; 583; 567] | -0.39 nocturia episodes | Standard Error 0.04 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours | Month 12 [N=554; 562; 550] | -0.46 nocturia episodes | Standard Error 0.042 |
Secondary
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from 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 delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time frame: Baseline and Months 1, 3, 6, 9 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 urgency episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 1 [N=783; 791; 780] | -1.30 urgency episodes | Standard Error 0.092 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 3 [N=738; 737; 733] | -1.37 urgency episodes | Standard Error 0.103 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 6 [N=683; 701; 680] | -1.75 urgency episodes | Standard Error 0.108 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 9 [N=653; 665; 643] | -1.77 urgency episodes | Standard Error 0.114 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 12 [N=621; 637; 621] | -1.81 urgency episodes | Standard Error 0.116 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Final Visit (LOCF) [N=788; 799; 788] | -1.62 urgency episodes | Standard Error 0.108 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Final Visit (LOCF) [N=788; 799; 788] | -1.80 urgency episodes | Standard Error 0.107 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 1 [N=783; 791; 780] | -1.31 urgency episodes | Standard Error 0.091 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 9 [N=653; 665; 643] | -1.71 urgency episodes | Standard Error 0.113 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 12 [N=621; 637; 621] | -1.79 urgency episodes | Standard Error 0.115 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 3 [N=738; 737; 733] | -1.83 urgency episodes | Standard Error 0.103 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 6 [N=683; 701; 680] | -1.95 urgency episodes | Standard Error 0.106 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 3 [N=738; 737; 733] | -1.55 urgency episodes | Standard Error 0.103 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 6 [N=683; 701; 680] | -1.63 urgency episodes | Standard Error 0.108 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Final Visit (LOCF) [N=788; 799; 788] | -1.63 urgency episodes | Standard Error 0.108 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 9 [N=653; 665; 643] | -1.78 urgency episodes | Standard Error 0.115 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 1 [N=783; 791; 780] | -1.11 urgency episodes | Standard Error 0.092 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Month 12 [N=621; 637; 621] | -1.89 urgency episodes | Standard Error 0.116 |
Secondary
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
The involuntary leakage of urine accompanied 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 time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.
Time frame: Baseline and Months 1, 3, 6, 9 and 12
Population: The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary \& who had at least 1 urgency incontinence episode at baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 12 [N=366; 377; 371] | -1.17 urgency incontinence episodes | Standard Error 0.087 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Final Visit (LOCF) [N=472; 471; 474] | -1.01 urgency incontinence episodes | Standard Error 0.082 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 6 [N=404; 417; 408] | -1.13 urgency incontinence episodes | Standard Error 0.08 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 1 [N=471; 467; 471] | -0.92 urgency incontinence episodes | Standard Error 0.072 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 9 [N=382; 392; 382] | -1.13 urgency incontinence episodes | Standard Error 0.077 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 3 [N=441; 432; 440] | -1.05 urgency incontinence episodes | Standard Error 0.077 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 1 [N=471; 467; 471] | -1.04 urgency incontinence episodes | Standard Error 0.073 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 12 [N=366; 377; 371] | -1.20 urgency incontinence episodes | Standard Error 0.085 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 3 [N=441; 432; 440] | -1.23 urgency incontinence episodes | Standard Error 0.078 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 6 [N=404; 417; 408] | -1.32 urgency incontinence episodes | Standard Error 0.079 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Final Visit (LOCF) [N=472; 471; 474] | -1.23 urgency incontinence episodes | Standard Error 0.082 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 9 [N=382; 392; 382] | -1.33 urgency incontinence episodes | Standard Error 0.076 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Final Visit (LOCF) [N=472; 471; 474] | -1.21 urgency incontinence episodes | Standard Error 0.081 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 1 [N=471; 467; 471] | -0.95 urgency incontinence episodes | Standard Error 0.072 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 3 [N=441; 432; 440] | -1.06 urgency incontinence episodes | Standard Error 0.077 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 6 [N=404; 417; 408] | -1.11 urgency incontinence episodes | Standard Error 0.08 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 9 [N=382; 392; 382] | -1.25 urgency incontinence episodes | Standard Error 0.077 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Month 12 [N=366; 377; 371] | -1.29 urgency incontinence episodes | Standard Error 0.086 |
Secondary
Change From Baseline to Months 1, 3, 6, 9, 12 and 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 prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.
Time frame: Baseline and Months 1, 3, 6, 9 and 12
Population: The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 12 [N=626; 642; 623] | 18.5 mL | Standard Error 1.86 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Final Visit (LOCF) [N=789; 802; 791] | 17.5 mL | Standard Error 1.65 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 6 [N=684; 705; 684] | 18.6 mL | Standard Error 1.69 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 1 [N=785; 797; 786] | 12.1 mL | Standard Error 1.31 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 9 [N=655; 667; 645] | 20.5 mL | Standard Error 1.78 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 3 [N=741; 741; 735] | 14.8 mL | Standard Error 1.5 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 1 [N=785; 797; 786] | 16.7 mL | Standard Error 1.3 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 12 [N=626; 642; 623] | 24.3 mL | Standard Error 1.83 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 3 [N=741; 741; 735] | 20.4 mL | Standard Error 1.5 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 6 [N=684; 705; 684] | 23.0 mL | Standard Error 1.66 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Final Visit (LOCF) [N=789; 802; 791] | 21.5 mL | Standard Error 1.63 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 9 [N=655; 667; 645] | 23.5 mL | Standard Error 1.77 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Final Visit (LOCF) [N=789; 802; 791] | 18.1 mL | Standard Error 1.64 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 1 [N=785; 797; 786] | 16.0 mL | Standard Error 1.31 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 3 [N=741; 741; 735] | 17.4 mL | Standard Error 1.51 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 6 [N=684; 705; 684] | 18.8 mL | Standard Error 1.69 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 9 [N=655; 667; 645] | 17.9 mL | Standard Error 1.8 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition | Month 12 [N=626; 642; 623] | 18.9 mL | Standard Error 1.86 |
Secondary
Change From Baseline to Months 1, 3, 6, 9, 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 patient 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time frame: Baseline and Months 1, 3, 6, 9 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 1 [N=775; 784; 771] | -10.5 scores on a scale | Standard Error 0.55 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 3 [N=736; 733; 739] | -13.4 scores on a scale | Standard Error 0.61 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 6 [N=680; 699; 682] | -14.5 scores on a scale | Standard Error 0.65 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 9 [N=649; 661; 639] | -14.2 scores on a scale | Standard Error 0.68 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 12 [N=622; 636; 612] | -14.1 scores on a scale | Standard Error 0.7 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Final Visit (LOCF) [N=779; 795; 781] | -13.1 scores on a scale | Standard Error 0.65 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Final Visit (LOCF) [N=779; 795; 781] | -14.8 scores on a scale | Standard Error 0.65 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 1 [N=775; 784; 771] | -12.5 scores on a scale | Standard Error 0.55 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 9 [N=649; 661; 639] | -15.6 scores on a scale | Standard Error 0.68 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 12 [N=622; 636; 612] | -15.7 scores on a scale | Standard Error 0.69 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 3 [N=736; 733; 739] | -16.1 scores on a scale | Standard Error 0.61 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 6 [N=680; 699; 682] | -16.5 scores on a scale | Standard Error 0.64 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 3 [N=736; 733; 739] | -13.5 scores on a scale | Standard Error 0.6 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 6 [N=680; 699; 682] | -14.6 scores on a scale | Standard Error 0.64 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Final Visit (LOCF) [N=779; 795; 781] | -14.3 scores on a scale | Standard Error 0.65 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 9 [N=649; 661; 639] | -14.3 scores on a scale | Standard Error 0.69 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 1 [N=775; 784; 771] | -11.5 scores on a scale | Standard Error 0.55 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score | Month 12 [N=622; 636; 612] | -16.3 scores on a scale | Standard Error 0.71 |
Secondary
Change From Baseline to Months 1, 3, 6, 9, 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 Months 1, 3, 6, 9 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 patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 6 [N=676; 697; 678] | 6.5 scores on a scale | Standard Deviation 16.97 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 1 [N=767; 787; 770] | 3.8 scores on a scale | Standard Deviation 12.85 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 3 [N=734; 740; 731] | 5.0 scores on a scale | Standard Deviation 15.33 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 9 [N=645; 665; 637] | 6.6 scores on a scale | Standard Deviation 17.52 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 12 [N=615; 637; 612] | 8.2 scores on a scale | Standard Deviation 17.39 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Final Visit (LOCF) [N=776; 797; 777] | 6.8 scores on a scale | Standard Deviation 17.47 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 3 [N=734; 740; 731] | 5.4 scores on a scale | Standard Deviation 15.27 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 6 [N=676; 697; 678] | 6.4 scores on a scale | Standard Deviation 16.54 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 9 [N=645; 665; 637] | 6.5 scores on a scale | Standard Deviation 16.55 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Final Visit (LOCF) [N=776; 797; 777] | 5.9 scores on a scale | Standard Deviation 17.35 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 12 [N=615; 637; 612] | 6.8 scores on a scale | Standard Deviation 17.56 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 1 [N=767; 787; 770] | 3.9 scores on a scale | Standard Deviation 13.64 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 1 [N=767; 787; 770] | 3.1 scores on a scale | Standard Deviation 12.78 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 12 [N=615; 637; 612] | 7.9 scores on a scale | Standard Deviation 16.48 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 6 [N=676; 697; 678] | 5.2 scores on a scale | Standard Deviation 15.4 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Final Visit (LOCF) [N=776; 797; 777] | 6.0 scores on a scale | Standard Deviation 16.64 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 3 [N=734; 740; 731] | 4.3 scores on a scale | Standard Deviation 13.48 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Month 9 [N=645; 665; 637] | 6.3 scores on a scale | Standard Deviation 15.91 |
Secondary
Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the 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 model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.
Time frame: Baseline and Months 1, 3, 6, 9 and 12
Population: The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients who had at least 1 use of a pad at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 1 [N=324; 305; 313] | -0.75 pads | Standard Error 0.084 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 3 [N=307; 280; 286] | -0.80 pads | Standard Error 0.093 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 6 [N=277; 271; 264] | -0.88 pads | Standard Error 0.097 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 9 [N=264; 255; 250] | -0.99 pads | Standard Error 0.092 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 12 [N=254; 247; 241] | -0.87 pads | Standard Error 0.1 |
| Mirabegron 50 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Final Visit (LOCF) [N=325; 307; 314] | -0.81 pads | Standard Error 0.089 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Final Visit (LOCF) [N=325; 307; 314] | -0.88 pads | Standard Error 0.092 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 1 [N=324; 305; 313] | -0.79 pads | Standard Error 0.086 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 9 [N=264; 255; 250] | -0.96 pads | Standard Error 0.094 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 12 [N=254; 247; 241] | -0.92 pads | Standard Error 0.101 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 3 [N=307; 280; 286] | -0.94 pads | Standard Error 0.097 |
| Mirabegron 100 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 6 [N=277; 271; 264] | -0.94 pads | Standard Error 0.098 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 3 [N=307; 280; 286] | -0.95 pads | Standard Error 0.096 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 6 [N=277; 271; 264] | -0.99 pads | Standard Error 0.099 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Final Visit (LOCF) [N=325; 307; 314] | -1.02 pads | Standard Error 0.09 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 9 [N=264; 255; 250] | -0.99 pads | Standard Error 0.094 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 1 [N=324; 305; 313] | -0.79 pads | Standard Error 0.085 |
| Tolterodine ER 4 mg | Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours | Month 12 [N=254; 247; 241] | -1.13 pads | Standard Error 0.102 |
Secondary
Change From Baseline to Months 3, 6, 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 Months 3, 6 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 patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | Month 12 [N=628; 640; 622] | 0.0 Physician visits | Standard Deviation 0.25 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | Month 6 [N=690; 705; 687] | 0.0 Physician visits | Standard Deviation 0.17 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | Month 3 [N=748; 750; 744] | 0.0 Physician visits | Standard Deviation 0.22 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | Final Visit (LOCF) [N=773; 769; 760] | 0.0 Physician visits | Standard Deviation 0.25 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | Month 6 [N=690; 705; 687] | 0.0 Physician visits | Standard Deviation 0.13 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | Month 12 [N=628; 640; 622] | 0.0 Physician visits | Standard Deviation 0.13 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | Month 3 [N=748; 750; 744] | 0.0 Physician visits | Standard Deviation 0.15 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | Final Visit (LOCF) [N=773; 769; 760] | 0.0 Physician visits | Standard Deviation 0.15 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | Month 3 [N=748; 750; 744] | 0.0 Physician visits | Standard Deviation 0.14 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | Month 12 [N=628; 640; 622] | 0.0 Physician visits | Standard Deviation 0.11 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | Final Visit (LOCF) [N=773; 769; 760] | 0.0 Physician visits | Standard Deviation 0.14 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician | Month 6 [N=690; 705; 687] | 0.0 Physician visits | Standard Deviation 0.18 |
Secondary
Change From Baseline to Months 3, 6, 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 and less productivity. A negative change from baseline indicates improvement.
Time frame: Baseline and Months 3, 6 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 patients at each time point (N) includes those with both baseline and post-baseline value. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Month 6 [N=640; 663; 651] | -14.0 Percent activity impairment | Standard Deviation 25.47 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Month 3 [N=691; 690; 692] | -12.0 Percent activity impairment | Standard Deviation 24.21 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Month 12 [N=582; 603; 598] | -13.3 Percent activity impairment | Standard Deviation 26.5 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Final Visit (LOCF) [N=728; 737; 733] | -12.5 Percent activity impairment | Standard Deviation 26.37 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Month 6 [N=640; 663; 651] | -15.6 Percent activity impairment | Standard Deviation 26.38 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Final Visit (LOCF) [N=728; 737; 733] | -13.9 Percent activity impairment | Standard Deviation 28.53 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Month 12 [N=582; 603; 598] | -15.2 Percent activity impairment | Standard Deviation 28.84 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Month 3 [N=691; 690; 692] | -13.7 Percent activity impairment | Standard Deviation 25.75 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Month 12 [N=582; 603; 598] | -15.0 Percent activity impairment | Standard Deviation 28.07 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Month 3 [N=691; 690; 692] | -12.3 Percent activity impairment | Standard Deviation 25.34 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Month 6 [N=640; 663; 651] | -13.4 Percent activity impairment | Standard Deviation 26.25 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Final Visit (LOCF) [N=728; 737; 733] | -12.8 Percent activity impairment | Standard Deviation 28.1 |
Secondary
Change From Baseline to Months 3, 6, 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 Months 3, 6 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 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 |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Month 12 [N=194; 196; 201] | -11.9 Percent impairment while working | Standard Deviation 24.37 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Final Visit (LOCF) [N=261; 272; 265] | -10.9 Percent impairment while working | Standard Deviation 24.51 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Month 3 [N=233; 236; 231] | -10.6 Percent impairment while working | Standard Deviation 23.36 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Month 6 [N=207; 216; 213] | -13.0 Percent impairment while working | Standard Deviation 22.44 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Month 12 [N=194; 196; 201] | -14.4 Percent impairment while working | Standard Deviation 26 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Month 6 [N=207; 216; 213] | -11.9 Percent impairment while working | Standard Deviation 21.88 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Final Visit (LOCF) [N=261; 272; 265] | -11.8 Percent impairment while working | Standard Deviation 25.12 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Month 3 [N=233; 236; 231] | -9.9 Percent impairment while working | Standard Deviation 23.65 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Final Visit (LOCF) [N=261; 272; 265] | -10.6 Percent impairment while working | Standard Deviation 24.34 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Month 12 [N=194; 196; 201] | -12.3 Percent impairment while working | Standard Deviation 24.6 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Month 3 [N=233; 236; 231] | -10.9 Percent impairment while working | Standard Deviation 22.56 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Month 6 [N=207; 216; 213] | -11.1 Percent impairment while working | Standard Deviation 22.21 |
Secondary
Change From Baseline to Months 3, 6, 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 Months 3, 6 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 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 |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Month 3 [N=208; 208; 204] | -11.4 Percent overall work impairment | Standard Deviation 23.92 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Month 12 [N=175; 177; 183] | -11.5 Percent overall work impairment | Standard Deviation 25.36 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Final Visit (LOCF) [N=240; 250; 244] | -11.2 Percent overall work impairment | Standard Deviation 25.21 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Month 6 [N=181; 195; 193] | -12.4 Percent overall work impairment | Standard Deviation 22.29 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Month 3 [N=208; 208; 204] | -10.9 Percent overall work impairment | Standard Deviation 24.5 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Month 6 [N=181; 195; 193] | -13.0 Percent overall work impairment | Standard Deviation 23.99 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Month 12 [N=175; 177; 183] | -14.1 Percent overall work impairment | Standard Deviation 27.02 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Final Visit (LOCF) [N=240; 250; 244] | -12.4 Percent overall work impairment | Standard Deviation 25.56 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Month 12 [N=175; 177; 183] | -13.6 Percent overall work impairment | Standard Deviation 25.75 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Month 3 [N=208; 208; 204] | -11.0 Percent overall work impairment | Standard Deviation 23.1 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Month 6 [N=181; 195; 193] | -11.1 Percent overall work impairment | Standard Deviation 22.48 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Final Visit (LOCF) [N=240; 250; 244] | -11.5 Percent overall work impairment | Standard Deviation 24.74 |
Secondary
Change From Baseline to Months 3, 6, 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 Months 3, 6 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 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 |
|---|---|---|---|---|
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Month 12 [N=181; 185; 188] | -0.5 Percent work time missed | Standard Deviation 9.55 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Final Visit (LOCF) [N=245; 256; 249] | -0.5 Percent work time missed | Standard Deviation 8.98 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Month 6 [N=183; 203; 200] | -1.3 Percent work time missed | Standard Deviation 6.8 |
| Mirabegron 50 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Month 3 [N=215; 217; 211] | -0.06 Percent work time missed | Standard Deviation 7.48 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Month 3 [N=215; 217; 211] | -1.0 Percent work time missed | Standard Deviation 9.41 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Month 6 [N=183; 203; 200] | -1.5 Percent work time missed | Standard Deviation 10.62 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Final Visit (LOCF) [N=245; 256; 249] | -0.9 Percent work time missed | Standard Deviation 10.98 |
| Mirabegron 100 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Month 12 [N=181; 185; 188] | -0.8 Percent work time missed | Standard Deviation 12.39 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Final Visit (LOCF) [N=245; 256; 249] | -0.8 Percent work time missed | Standard Deviation 11.37 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Month 3 [N=215; 217; 211] | -0.6 Percent work time missed | Standard Deviation 12.38 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Month 6 [N=183; 203; 200] | -0.7 Percent work time missed | Standard Deviation 6.26 |
| Tolterodine ER 4 mg | Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Month 12 [N=181; 185; 188] | -1.2 Percent work time missed | Standard Deviation 8.08 |
Secondary
Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit
The percentage of participants with at least a 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 Months 1, 3, 6, 9 and 12
Population: The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary \& who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Final Visit (LOCF) [N=479; 483; 488] | 63.7 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 9 [N=387; 402; 391] | 65.6 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 6 [N=409; 428; 418] | 65.5 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 1 [N=478; 479; 485] | 58.2 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 12 [N=370; 387; 379] | 67.6 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 3 [N=447; 443; 452] | 61.7 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Final Visit (LOCF) [N=479; 483; 488] | 66.3 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 1 [N=478; 479; 485] | 57.0 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 3 [N=447; 443; 452] | 66.1 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 6 [N=409; 428; 418] | 66.8 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 9 [N=387; 402; 391] | 67.2 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 12 [N=370; 387; 379] | 68.5 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Final Visit (LOCF) [N=479; 483; 488] | 66.8 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 1 [N=478; 479; 485] | 56.3 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 9 [N=387; 402; 391] | 66.0 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 12 [N=370; 387; 379] | 71.2 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 6 [N=409; 428; 418] | 63.9 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 3 [N=447; 443; 452] | 61.5 percentage of participants |
Secondary
Percentage of Participants With Improvement 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'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score.
Time frame: Baseline and Month 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. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | Improvement: Month12 [N=616; 630; 620] | 55.7 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | Improvement: Final Visit [N=671; 688; 684] | 52.9 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | Major Improvement: Month 12 [N=616; 630; 620] | 27.4 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | Major Improvement: Final Visit [N=671; 688; 684] | 26.2 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | Major Improvement: Final Visit [N=671; 688; 684] | 28.2 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | Improvement: Month12 [N=616; 630; 620] | 60.6 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | Major Improvement: Month 12 [N=616; 630; 620] | 29.7 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | Improvement: Final Visit [N=671; 688; 684] | 59.6 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | Major Improvement: Final Visit [N=671; 688; 684] | 26.6 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | Improvement: Final Visit [N=671; 688; 684] | 54.4 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | Major Improvement: Month 12 [N=616; 630; 620] | 28.2 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) | Improvement: Month12 [N=616; 630; 620] | 56.6 percentage of participants |
Secondary
Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 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: Months 1, 3, 6, 9 and 12
Population: The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline \& at least 1 postbaseline micturition measurement in the visit diary \& who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 12 [N=370; 387; 379] | 47.8 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Final Visit (LOCF) [N=479; 483; 488] | 43.4 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 6 [N=409; 428; 418] | 43.3 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 1 [N=478; 479; 485] | 35.4 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 9 [N=387; 402; 391] | 47.5 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 3 [N=447; 443; 452] | 40.9 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 1 [N=478; 479; 485] | 36.7 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 12 [N=370; 387; 379] | 47.5 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 3 [N=447; 443; 452] | 45.4 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 6 [N=409; 428; 418] | 45.1 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Final Visit (LOCF) [N=479; 483; 488] | 45.8 percentage of participants |
| Mirabegron 100 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 9 [N=387; 402; 391] | 46.8 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Final Visit (LOCF) [N=479; 483; 488] | 45.1 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 1 [N=478; 479; 485] | 33.4 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 3 [N=447; 443; 452] | 39.2 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 6 [N=409; 428; 418] | 43.5 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 9 [N=387; 402; 391] | 44.2 percentage of participants |
| Tolterodine ER 4 mg | Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit | Month 12 [N=370; 387; 379] | 49.1 percentage of participants |
Secondary
Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram
An abnormality identified during a medical test was defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant. The Investigator assessed each AE for causal relationship (not related, possible or probable) to study drug. A serious AE (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, resulted in significant disability/incapacity or congenital anomaly/birth defect, required or prolonged hospitalization or was a medically important event. The data reported represent the number of participants with adverse events in each category.
Time frame: From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.
Population: The number of participants analyzed represents the Safety Analysis Set (SAF), including all randomized patients who took at least one dose of double-blind study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mirabegron 50 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Deaths | 2 participants |
| Mirabegron 50 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | TRAEs leading to study drug discontinuation | 35 participants |
| Mirabegron 50 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Treatment-related serious adverse events | 10 participants |
| Mirabegron 50 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Serious adverse events (SAEs) | 42 participants |
| Mirabegron 50 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Treatment-related adverse events (TRAEs) | 213 participants |
| Mirabegron 50 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Adverse events | 485 participants |
| Mirabegron 50 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | AEs leading to study drug discontinuation | 48 participants |
| Mirabegron 100 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Treatment-related serious adverse events | 4 participants |
| Mirabegron 100 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Adverse events | 503 participants |
| Mirabegron 100 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Treatment-related adverse events (TRAEs) | 192 participants |
| Mirabegron 100 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Deaths | 0 participants |
| Mirabegron 100 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Serious adverse events (SAEs) | 51 participants |
| Mirabegron 100 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | AEs leading to study drug discontinuation | 50 participants |
| Mirabegron 100 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | TRAEs leading to study drug discontinuation | 29 participants |
| Tolterodine ER 4 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Treatment-related serious adverse events | 5 participants |
| Tolterodine ER 4 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Treatment-related adverse events (TRAEs) | 224 participants |
| Tolterodine ER 4 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | TRAEs leading to study drug discontinuation | 31 participants |
| Tolterodine ER 4 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | AEs leading to study drug discontinuation | 46 participants |
| Tolterodine ER 4 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Adverse events | 508 participants |
| Tolterodine ER 4 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Serious adverse events (SAEs) | 44 participants |
| Tolterodine ER 4 mg | Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram | Deaths | 2 participants |