A Phase 3 interventional study of Mirabegron and Tolterodine in Urinary Bladder, Overactive, sponsored by Astellas Pharma Inc. Completed at 308 sites in 30 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Astellas Pharma Inc · Phase 3, Interventional, and Treatment
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.
Patients who completed 178-CL-046 (NCT00689104) or 178-CL-047 (NCT00662909) or new patients could be enrolled in this study if eligible.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 2,792 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
Drug: Mirabegron · Drug: Placebo to Tolterodine
Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
Drug: Mirabegron · Drug: Placebo to Tolterodine
Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
Drug: Tolterodine · Drug: Placebo to Mirabegron
Tablets
Also known as: Myrbetriq, YM178
Extended release capsules
Matching mirabegron placebo tablets.
Matching tolterodine placebo capsules.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
| Milestone | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Started | 815 | 824 | 813 |
| Safety analysis set (saf) | 812 | 820 | 812 |
| Full analysis set (fas) | 789 | 802 | 791 |
| Full analysis set incontinence (fas-i) | 479 | 483 | 488 |
| Completed | 629 | 645 | 621 |
| Not completed | 186 | 179 | 192 |
| Withdrew: Eligibility criterion not met | 7 | 7 | 10 |
| Withdrew: Adverse event | 52 | 51 | 50 |
| Withdrew: Lack of efficacy | 34 | 25 | 45 |
| Withdrew: Withdrawal by subject | 66 | 75 | 65 |
| Withdrew: Lost to follow-up | 14 | 7 | 7 |
| Withdrew: Protocol violation | 6 | 9 | 11 |
| Withdrew: Randomized but never received study drug | 1 | 0 | 0 |
| Withdrew: Non-compliance with study procedures | 5 | 3 | 4 |
| Withdrew: Taking exclusionary medications | 1 | 0 | 0 |
| Withdrew: Site closure | 0 | 1 | 0 |
| Withdrew: Violation of exclusion criterion | 0 | 1 | 0 |
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.
| participants | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Mild adverse events | 222 | 240 | 251 |
| Moderate adverse events | 212 | 211 | 218 |
| Severe adverse events | 51 | 52 | 39 |
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.
| micturitions | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 1 [N=786; 797; 786] | -0.94 ± 0.069 | -1.10 ± 0.068 | -1.02 ± 0.069 |
| Month 3 [N=742; 741; 735] | -1.13 ± 0.079 | -1.46 ± 0.079 | -1.27 ± 0.080 |
| Month 6 [N=684; 705; 684] | -1.25 ± 0.083 | -1.43 ± 0.082 | -1.30 ± 0.083 |
| Month 9 [N=656; 667; 645] | -1.33 ± 0.086 | -1.37 ± 0.086 | -1.38 ± 0.087 |
| Month 12 [N=627; 642; 623] | -1.30 ± 0.089 | -1.46 ± 0.088 | -1.50 ± 0.089 |
| Final Visit (LOCF) [N=789; 802; 791] | -1.27 ± 0.083 | -1.41 ± 0.082 | -1.39 ± 0.083 |
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.
| incontinence episodes | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 1 [N=478; 479; 485] | -0.94 ± 0.079 | -1.03 ± 0.079 | -0.96 ± 0.078 |
| Month 3 [N=447; 443; 452] | -1.10 ± 0.083 | -1.28 ± 0.084 | -1.09 ± 0.083 |
| Month 6 [N=409; 428; 418] | -1.11 ± 0.088 | -1.27 ± 0.086 | -1.17 ± 0.087 |
| Month 9 [N=387; 402; 391] | -1.17 ± 0.083 | -1.32 ± 0.082 | -1.26 ± 0.083 |
| Month 12 [N=370; 387; 379] | -1.14 ± 0.094 | -1.19 ± 0.092 | -1.36 ± 0.093 |
| Final Visit (LOCF) [N=479; 483; 488] | -1.01 ± 0.087 | -1.24 ± 0.086 | -1.26 ± 0.086 |
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.
| mL | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 1 [N=785; 797; 786] | 12.1 ± 1.31 | 16.7 ± 1.30 | 16.0 ± 1.31 |
| Month 3 [N=741; 741; 735] | 14.8 ± 1.50 | 20.4 ± 1.50 | 17.4 ± 1.51 |
| Month 6 [N=684; 705; 684] | 18.6 ± 1.69 | 23.0 ± 1.66 | 18.8 ± 1.69 |
| Month 9 [N=655; 667; 645] | 20.5 ± 1.78 | 23.5 ± 1.77 | 17.9 ± 1.80 |
| Month 12 [N=626; 642; 623] | 18.5 ± 1.86 | 24.3 ± 1.83 | 18.9 ± 1.86 |
| Final Visit (LOCF) [N=789; 802; 791] | 17.5 ± 1.65 | 21.5 ± 1.63 | 18.1 ± 1.64 |
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.
| urgency incontinence episodes | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 1 [N=471; 467; 471] | -0.92 ± 0.072 | -1.04 ± 0.073 | -0.95 ± 0.072 |
| Month 3 [N=441; 432; 440] | -1.05 ± 0.077 | -1.23 ± 0.078 | -1.06 ± 0.077 |
| Month 6 [N=404; 417; 408] | -1.13 ± 0.080 | -1.32 ± 0.079 | -1.11 ± 0.080 |
| Month 9 [N=382; 392; 382] | -1.13 ± 0.077 | -1.33 ± 0.076 | -1.25 ± 0.077 |
| Month 12 [N=366; 377; 371] | -1.17 ± 0.087 | -1.20 ± 0.085 | -1.29 ± 0.086 |
| Final Visit (LOCF) [N=472; 471; 474] | -1.01 ± 0.082 | -1.23 ± 0.082 | -1.21 ± 0.081 |
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.
| urgency episodes | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 1 [N=783; 791; 780] | -1.30 ± 0.092 | -1.31 ± 0.091 | -1.11 ± 0.092 |
| Month 3 [N=738; 737; 733] | -1.37 ± 0.103 | -1.83 ± 0.103 | -1.55 ± 0.103 |
| Month 6 [N=683; 701; 680] | -1.75 ± 0.108 | -1.95 ± 0.106 | -1.63 ± 0.108 |
| Month 9 [N=653; 665; 643] | -1.77 ± 0.114 | -1.71 ± 0.113 | -1.78 ± 0.115 |
| Month 12 [N=621; 637; 621] | -1.81 ± 0.116 | -1.79 ± 0.115 | -1.89 ± 0.116 |
| Final Visit (LOCF) [N=788; 799; 788] | -1.62 ± 0.108 | -1.80 ± 0.107 | -1.63 ± 0.108 |
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.
| scores on a scale | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 1 [N=784; 793; 780] | -0.18 ± 0.016 | -0.19 ± 0.016 | -0.17 ± 0.016 |
| Month 3 [N=739; 738; 733] | -0.21 ± 0.019 | -0.28 ± 0.019 | -0.24 ± 0.019 |
| Month 6 [N=684; 702; 680] | -0.29 ± 0.021 | -0.32 ± 0.021 | -0.27 ± 0.021 |
| Month 9 [N=654; 666; 643] | -0.30 ± 0.022 | -0.30 ± 0.022 | -0.31 ± 0.022 |
| Month 12 [N=622; 638; 621] | -0.33 ± 0.023 | -0.31 ± 0.023 | -0.32 ± 0.023 |
| Final Visit (LOCF) [N=789; 801; 788] | -0.29 ± 0.020 | -0.29 ± 0.020 | -0.27 ± 0.020 |
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.
| pads | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 1 [N=324; 305; 313] | -0.75 ± 0.084 | -0.79 ± 0.086 | -0.79 ± 0.085 |
| Month 3 [N=307; 280; 286] | -0.80 ± 0.093 | -0.94 ± 0.097 | -0.95 ± 0.096 |
| Month 6 [N=277; 271; 264] | -0.88 ± 0.097 | -0.94 ± 0.098 | -0.99 ± 0.099 |
| Month 9 [N=264; 255; 250] | -0.99 ± 0.092 | -0.96 ± 0.094 | -0.99 ± 0.094 |
| Month 12 [N=254; 247; 241] | -0.87 ± 0.100 | -0.92 ± 0.101 | -1.13 ± 0.102 |
| Final Visit (LOCF) [N=325; 307; 314] | -0.81 ± 0.089 | -0.88 ± 0.092 | -1.02 ± 0.090 |
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.
| nocturia episodes | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 1 [N=690; 698; 690] | -0.26 ± 0.034 | -0.29 ± 0.033 | -0.29 ± 0.034 |
| Month 3 [N=654; 651; 643] | -0.41 ± 0.037 | -0.45 ± 0.037 | -0.37 ± 0.037 |
| Month 6 [N=604; 618; 602] | -0.42 ± 0.041 | -0.38 ± 0.040 | -0.35 ± 0.041 |
| Month 9 [N=580; 583; 567] | -0.50 ± 0.040 | -0.41 ± 0.040 | -0.39 ± 0.040 |
| Month 12 [N=554; 562; 550] | -0.48 ± 0.042 | -0.40 ± 0.041 | -0.46 ± 0.042 |
| Final Visit (LOCF) [N=693; 703; 693] | -0.46 ± 0.038 | -0.39 ± 0.038 | -0.43 ± 0.038 |
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 | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 1 [N=478; 479; 485] | 35.4 | 36.7 | 33.4 |
| Month 3 [N=447; 443; 452] | 40.9 | 45.4 | 39.2 |
| Month 6 [N=409; 428; 418] | 43.3 | 45.1 | 43.5 |
| Month 9 [N=387; 402; 391] | 47.5 | 46.8 | 44.2 |
| Month 12 [N=370; 387; 379] | 47.8 | 47.5 | 49.1 |
| Final Visit (LOCF) [N=479; 483; 488] | 43.4 | 45.8 | 45.1 |
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.
| percentage of participants | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 1 [N=478; 479; 485] | 58.2 | 57.0 | 56.3 |
| Month 3 [N=447; 443; 452] | 61.7 | 66.1 | 61.5 |
| Month 6 [N=409; 428; 418] | 65.5 | 66.8 | 63.9 |
| Month 9 [N=387; 402; 391] | 65.6 | 67.2 | 66.0 |
| Month 12 [N=370; 387; 379] | 67.6 | 68.5 | 71.2 |
| Final Visit (LOCF) [N=479; 483; 488] | 63.7 | 66.3 | 66.8 |
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.
| scores on a scale | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 1 [N=775; 784; 771] | -10.5 ± 0.55 | -12.5 ± 0.55 | -11.5 ± 0.55 |
| Month 3 [N=736; 733; 739] | -13.4 ± 0.61 | -16.1 ± 0.61 | -13.5 ± 0.60 |
| Month 6 [N=680; 699; 682] | -14.5 ± 0.65 | -16.5 ± 0.64 | -14.6 ± 0.64 |
| Month 9 [N=649; 661; 639] | -14.2 ± 0.68 | -15.6 ± 0.68 | -14.3 ± 0.69 |
| Month 12 [N=622; 636; 612] | -14.1 ± 0.70 | -15.7 ± 0.69 | -16.3 ± 0.71 |
| Final Visit (LOCF) [N=779; 795; 781] | -13.1 ± 0.65 | -14.8 ± 0.65 | -14.3 ± 0.65 |
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.
| scores on a scale | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 1 [N=774; 787; 773] | 7.7 ± 0.48 | 8.9 ± 0.48 | 8.9 ± 0.48 |
| Month 3 [N=736; 740; 739] | 9.9 ± 0.54 | 11.9 ± 0.54 | 10.6 ± 0.54 |
| Month 6 [N=681; 700; 686] | 11.7 ± 0.56 | 12.9 ± 0.56 | 11.6 ± 0.56 |
| Month 9 [N=650; 667; 644] | 11.3 ± 0.60 | 12.2 ± 0.59 | 12.4 ± 0.60 |
| Month 12 [N=619; 640; 613] | 11.7 ± 0.62 | 12.6 ± 0.61 | 13.2 ± 0.62 |
| Final Visit (LOCF) [N=779; 798; 783] | 10.7 ± 0.58 | 11.7 ± 0.57 | 11.4 ± 0.58 |
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.
| scores on a scale | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 12 [N=601; 616; 611] | -0.8 ± 0.04 | -0.9 ± 0.04 | -0.9 ± 0.04 |
| Final Visit (LOCF) [N=655; 673; 673] | -0.8 ± 0.04 | -0.9 ± 0.04 | -0.8 ± 0.04 |
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.
| scores on a scale | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 12 [N=599; 620; 613] | 2.27 ± 0.175 | 2.27 ± 0.172 | 2.52 ± 0.173 |
| Final Visit (LOCF) [N=654; 676; 676] | 2.08 ± 0.167 | 2.11 ± 0.164 | 2.27 ± 0.164 |
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.
| Percent work time missed | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 3 [N=215; 217; 211] | -0.06 ± 7.48 | -1.0 ± 9.41 | -0.6 ± 12.38 |
| Month 6 [N=183; 203; 200] | -1.3 ± 6.80 | -1.5 ± 10.62 | -0.7 ± 6.26 |
| Month 12 [N=181; 185; 188] | -0.5 ± 9.55 | -0.8 ± 12.39 | -1.2 ± 8.08 |
| Final Visit (LOCF) [N=245; 256; 249] | -0.5 ± 8.98 | -0.9 ± 10.98 | -0.8 ± 11.37 |
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.
| Percent impairment while working | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 3 [N=233; 236; 231] | -10.6 ± 23.36 | -9.9 ± 23.65 | -10.9 ± 22.56 |
| Month 6 [N=207; 216; 213] | -13.0 ± 22.44 | -11.9 ± 21.88 | -11.1 ± 22.21 |
| Month 12 [N=194; 196; 201] | -11.9 ± 24.37 | -14.4 ± 26.00 | -12.3 ± 24.60 |
| Final Visit (LOCF) [N=261; 272; 265] | -10.9 ± 24.51 | -11.8 ± 25.12 | -10.6 ± 24.34 |
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.
| Percent overall work impairment | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 3 [N=208; 208; 204] | -11.4 ± 23.92 | -10.9 ± 24.50 | -11.0 ± 23.10 |
| Month 6 [N=181; 195; 193] | -12.4 ± 22.29 | -13.0 ± 23.99 | -11.1 ± 22.48 |
| Month 12 [N=175; 177; 183] | -11.5 ± 25.36 | -14.1 ± 27.02 | -13.6 ± 25.75 |
| Final Visit (LOCF) [N=240; 250; 244] | -11.2 ± 25.21 | -12.4 ± 25.56 | -11.5 ± 24.74 |
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.
| Percent activity impairment | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 3 [N=691; 690; 692] | -12.0 ± 24.21 | -13.7 ± 25.75 | -12.3 ± 25.34 |
| Month 6 [N=640; 663; 651] | -14.0 ± 25.47 | -15.6 ± 26.38 | -13.4 ± 26.25 |
| Month 12 [N=582; 603; 598] | -13.3 ± 26.50 | -15.2 ± 28.84 | -15.0 ± 28.07 |
| Final Visit (LOCF) [N=728; 737; 733] | -12.5 ± 26.37 | -13.9 ± 28.53 | -12.8 ± 28.10 |
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.
| participants | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| No problem -> No problem | 567 | 601 | 573 |
| No problem -> Some problems | 36 | 42 | 39 |
| No problem -> Confined to bed | 1 | 1 | 0 |
| No problem -> Missing data | 4 | 3 | 2 |
| Some problems -> No problems | 64 | 55 | 62 |
| Some problems -> Some problems | 105 | 97 | 106 |
| Some problems -> Confined to bed | 1 | 0 | 0 |
| Some problems -> Missing data | 0 | 1 | 2 |
| Confined to bed -> No problems | 0 | 1 | 0 |
| Confined to bed -> Some problems | 0 | 0 | 0 |
| Confined to bed -> Confined to bed | 0 | 0 | 0 |
| Confined to bed -> Missing data | 0 | 0 | 0 |
| Missing data -> No problem | 11 | 1 | 7 |
| Missing data -> Some problems | 0 | 0 | 0 |
| Missing data -> Confined to bed | 0 | 0 | 0 |
| Missing data -> Missing data | 0 | 0 | 0 |
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.
| participants | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| No problem -> No problem | 718 | 735 | 720 |
| No problem -> Some problems | 16 | 15 | 23 |
| No problem -> Unable to wash or dress myself | 1 | 0 | 3 |
| No problem -> Missing data | 4 | 4 | 4 |
| Some problems -> No problems | 19 | 19 | 13 |
| Some problems -> Some problems | 18 | 25 | 20 |
| Some problems -> Unable to wash or dress myself | 0 | 0 | 0 |
| Some problems -> Missing data | 0 | 0 | 0 |
| Unable to wash or dress myself -> No problems | 0 | 2 | 0 |
| Unable to wash or dress myself -> Some problems | 0 | 1 | 0 |
| Unable to wash or dress -> Unable to wash or dress | 0 | 0 | 0 |
| Unable to wash or dress myself -> Missing data | 0 | 0 | 0 |
| Missing data -> No problem | 13 | 1 | 8 |
| Missing data -> Some problems | 0 | 0 | 0 |
| Missing data -> Unable to wash or dress myself | 0 | 0 | 0 |
| Missing data -> Missing data | 0 | 0 | 0 |
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.
| participants | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| No problem -> No problem | 536 | 569 | 542 |
| No problem -> Some problems | 40 | 55 | 53 |
| No problem -> Unable to perform usual activities | 2 | 1 | 2 |
| No problem -> Missing data | 3 | 1 | 1 |
| Some problems -> No problems | 97 | 88 | 96 |
| Some problems -> Some problems | 94 | 76 | 79 |
| Some problems-> Unable to perform usual activities | 1 | 2 | 1 |
| Some problems -> Missing data | 1 | 2 | 3 |
| Unable to perform usual activities -> No problems | 0 | 2 | 0 |
| Unable to perform usual activities-> Some problems | 2 | 4 | 5 |
| Unable to perform -> Unable to perform | 2 | 0 | 1 |
| Unable to perform usual activities -> Missing data | 10 | 2 | 7 |
| Missing data -> No problem | 1 | 0 | 1 |
| Missing data -> Some problems | 0 | 0 | 0 |
| Missing data -> Unable to perform usual activities | 0 | 0 | 0 |
| Missing data -> Missing data | 0 | 0 | 0 |
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.
| participants | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| No pain -> No pain | 398 | 396 | 398 |
| No pain -> Moderate pain | 54 | 69 | 63 |
| No pain -> Extreme pain | 4 | 2 | 4 |
| No pain -> Missing data | 4 | 2 | 2 |
| Moderate pain -> No pain | 104 | 107 | 105 |
| Moderate pain -> Moderate pain | 173 | 196 | 182 |
| Moderate pain -> Extreme pain | 14 | 5 | 8 |
| Moderate pain -> Missing data | 1 | 2 | 2 |
| Extreme pain -> No pain | 3 | 4 | 4 |
| Extreme pain -> Moderate pain | 13 | 6 | 9 |
| Extreme pain -> Extreme pain | 10 | 10 | 8 |
| Extreme pain -> Missing data | 0 | 0 | 0 |
| Missing data-> No pain | 8 | 3 | 6 |
| Missing data -> Moderate pain | 3 | 0 | 0 |
| Missing data -> Extreme pain | 0 | 0 | 0 |
| Missing data -> Missing data | 0 | 0 | 0 |
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.
| participants | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Not anxious -> Not anxious | 413 | 453 | 429 |
| Not anxious -> Moderately anxious | 43 | 34 | 43 |
| Not anxious -> Extremely anxious | 3 | 3 | 1 |
| Not anxious -> Missing data | 3 | 1 | 2 |
| Moderately anxious -> Not anxious | 108 | 99 | 105 |
| Moderately anxious -> Moderately anxious | 174 | 181 | 169 |
| Moderately anxious -> Extremely anxious | 7 | 9 | 11 |
| Moderately anxious -> Missing data | 1 | 2 | 2 |
| Extremely anxious -> Not anxious | 3 | 5 | 3 |
| Extremely anxious -> Moderately anxious | 8 | 9 | 14 |
| Extremely anxious -> Extremely anxious | 15 | 5 | 6 |
| Extremely anxious -> Missing data | 0 | 0 | 0 |
| Missing data -> Not anxious | 7 | 0 | 3 |
| Missing data -> Moderately anxious | 4 | 1 | 2 |
| Missing data -> Extremely anxious | 0 | 0 | 1 |
| Missing data -> Missing data | 0 | 0 | 0 |
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.
| scores on a scale | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 1 [N=767; 787; 770] | 3.8 ± 12.85 | 3.9 ± 13.64 | 3.1 ± 12.78 |
| Month 3 [N=734; 740; 731] | 5.0 ± 15.33 | 5.4 ± 15.27 | 4.3 ± 13.48 |
| Month 6 [N=676; 697; 678] | 6.5 ± 16.97 | 6.4 ± 16.54 | 5.2 ± 15.40 |
| Month 9 [N=645; 665; 637] | 6.6 ± 17.52 | 6.5 ± 16.55 | 6.3 ± 15.91 |
| Month 12 [N=615; 637; 612] | 8.2 ± 17.39 | 6.8 ± 17.56 | 7.9 ± 16.48 |
| Final Visit (LOCF) [N=776; 797; 777] | 6.8 ± 17.47 | 5.9 ± 17.35 | 6.0 ± 16.64 |
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.
| Physician visits | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Month 3 [N=748; 750; 744] | 0.0 ± 0.22 | 0.0 ± 0.15 | 0.0 ± 0.14 |
| Month 6 [N=690; 705; 687] | 0.0 ± 0.17 | 0.0 ± 0.13 | 0.0 ± 0.18 |
| Month 12 [N=628; 640; 622] | 0.0 ± 0.25 | 0.0 ± 0.13 | 0.0 ± 0.11 |
| Final Visit (LOCF) [N=773; 769; 760] | 0.0 ± 0.25 | 0.0 ± 0.15 | 0.0 ± 0.14 |
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.
| percentage of participants | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Improvement: Month12 [N=616; 630; 620] | 55.7 | 60.6 | 56.6 |
| Improvement: Final Visit [N=671; 688; 684] | 52.9 | 59.6 | 54.4 |
| Major Improvement: Month 12 [N=616; 630; 620] | 27.4 | 29.7 | 28.2 |
| Major Improvement: Final Visit [N=671; 688; 684] | 26.2 | 28.2 | 26.6 |
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.
| participants | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Adverse events | 485 | 503 | 508 |
| Treatment-related adverse events (TRAEs) | 213 | 192 | 224 |
| Deaths | 2 | 0 | 2 |
| Serious adverse events (SAEs) | 42 | 51 | 44 |
| Treatment-related serious adverse events | 10 | 4 | 5 |
| AEs leading to study drug discontinuation | 48 | 50 | 46 |
| TRAEs leading to study drug discontinuation | 35 | 29 | 31 |
Collected over Adverse events starting or worsening in the period from first double-blind study drug intake until 30 days after last double-blind study drug intake.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mirabegron 50 mg | — | 42/812 (5.2%) | 136/812 (16.7%) |
| Mirabegron 100 mg | — | 51/820 (6.2%) | 137/820 (16.7%) |
| Tolterodine ER 4 mg | — | 44/812 (5.4%) | 181/812 (22.3%) |
| Event | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| Atrial fibrillationCardiac disorders | 2/812 | 0/820 | 3/812 |
| Cerebrovascular accidentNervous system disorders | 3/812 | 0/820 | 1/812 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/812 | 2/820 | 2/812 |
| Myocardial infarctionCardiac disorders | 1/812 | 0/820 | 2/812 |
| Angina pectorisCardiac disorders | 0/812 | 0/820 | 2/812 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/812 | 1/820 | 1/812 |
| CholelithiasisHepatobiliary disorders | 0/812 | 1/820 | 2/812 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/812 | 2/820 | 0/812 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/812 | 2/820 | 0/812 |
| Uterine prolapseReproductive system and breast disorders | 0/812 | 2/820 | 0/812 |
| Event | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg |
|---|---|---|---|
| HypertensionVascular disorders | 74/812 | 80/820 | 78/812 |
| Dry mouthGastrointestinal disorders | 23/812 | 19/820 | 70/812 |
| Urinary tract infectionInfections and infestations | 48/812 | 45/820 | 52/812 |
| Age, Continuous(years) | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg | Total |
|---|---|---|---|---|
| Mean | 59.2 ± 12.56 | 60.1 ± 11.92 | 59.6 ± 12.47 | 59.6 ± 12.32 |
| Sex: Female, Male(Participants) | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg | Total |
|---|---|---|---|---|
| Female | 602 | 608 | 600 | 1810 |
| Male | 210 | 212 | 212 | 634 |
| Type of overactive bladder (OAB)(participants) | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg | Total |
|---|---|---|---|---|
| Urge incontinence | 296 | 305 | 317 | 918 |
| Mixed | 232 | 228 | 210 | 670 |
| Frequency | 284 | 287 | 285 | 856 |
| Duration of OAB symptoms(months) | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg | Total |
|---|---|---|---|---|
| Mean | 87.4 ± 96.28 | 87.9 ± 91.52 | 83.8 ± 87.34 | 86.4 ± 91.77 |
| Summary of previous treatment(participants) | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg | Total |
|---|---|---|---|---|
| Placebo | 190 | 174 | 180 | 544 |
| Mirabegron 50 mg | 170 | 180 | 171 | 521 |
| Mirabegron 100 mg | 183 | 198 | 197 | 578 |
| Tolterodine ER 4 mg | 130 | 107 | 108 | 345 |
| Naive | 139 | 161 | 156 | 456 |
| Mean number of micturitions per 24 Hours(micturitions) | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg | Total |
|---|---|---|---|---|
| Mean | 11.12 ± 2.809 | 11.16 ± 2.917 | 10.94 ± 2.668 | 11.08 ± 2.801 |
| Mean volume voided per micturition(mL) | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg | Total |
|---|---|---|---|---|
| Mean | 160.4 ± 58.80 | 164.6 ± 58.62 | 160.8 ± 56.98 | 162.0 ± 58.15 |
| Mean number of urgency episodes (grade 3 or 4) per 24 hours(urgency episodes) | Mirabegron 50 mg | Mirabegron 100 mg | Tolterodine ER 4 mg | Total |
|---|---|---|---|---|
| Mean | 5.66 ± 3.601 | 5.61 ± 3.722 | 5.44 ± 3.453 | 5.57 ± 3.594 |
3 further baseline measures are reported on the registry.
Showing the first 100 of 308 sites across 30 countries.
Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Supporting information: Study protocol, Sap, Csr
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