Signs and Symptoms, Urinary Bladder Diseases, Urinary Bladder, Overactive, Urological Manifestations, Urologic Diseases
Conditions
Keywords
Urinary incontinence, Overactive bladder (OAB), Micturition, Frequency, YM178, Urgency incontinence, Urgency
Brief summary
The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.
Interventions
DRUGMirabegron
oral
DRUGSolifenacin succinate
oral
DRUGPlacebo
oral
Sponsors
Astellas Pharma Europe B.V.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria at Visit 1/Screening: * Subject has a Body Mass Index (BMI) of between 18 and 35 kg/m\^2 and a total body weight between 50 and 95 kg; * Subject is willing and able to complete the micturition diary and questionnaires correctly and is willing and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings; * Subject has symptoms of overactive bladder (OAB; urinary frequency, urgency and/or urgency incontinence) for at least 3 months. * Inclusion Criteria at Visit 3/Baseline: * Subject has experienced frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period (incontinence episode should not be counted as a micturition); * Subject must experience at least 1 episode of urgency (grade 3 or 4) per 24-hour period (with or without urgency incontinence) during the 3 day micturition diary period.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition | Baseline and Week 12 | The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Week 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 participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits. |
| Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Baseline and Weeks 2, 4, 8 and 12 | The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit. |
| Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Baseline and Weeks 2, 4, 8 and 12 | The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit. |
| Percentage of Participants With a Micturition Response | Baseline and Weeks 2, 4, 8 and 12 | A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline. |
| Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and Weeks 2, 4, 8 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 participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit. |
| Percentage of Participants With Zero Incontinence Episodes Post-baseline | Weeks 2, 4, 8 and 12 | The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant. |
| Percentage of Participants With 50% Reduction in Incontinence Episodes | Baseline and Weeks 2, 4, 8 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 participant's micturition diary. |
| Percentage of Participants With Major Improvement in PPBC | Baseline and Week 12 | The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score. |
| Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and Weeks 2, 4, 8 and 12 | Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. |
| Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Baseline and Weeks 2, 4, 8 and 12 | The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. |
| Change From Baseline to Each Visit in Mean Level of Urgency | Baseline and Weeks 2, 4, 8 and 12 | Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 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. |
| Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Baseline and Weeks 2, 4, 8 and 12 | The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. |
| Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Baseline and Weeks 2, 4, 8 and 12 | Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary. |
| Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) | Baseline and Week 12 | The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement. |
| Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | Baseline and Week 12 | The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits. |
| Percentage of Participants With Deterioration in PPBC | Baseline and Week 12 | The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score. |
| Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | Baseline and Week 12 | Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements. |
| Percentage of Participants With a Symptom Bother Response | Baseline and Week 12 | Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline. |
| Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score | Baseline and Week 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. |
| Percentage of Participants With a Health-related Quality of Life Total Score Response | Baseline and Week 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. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline. |
| Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Baseline and Week 12 | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category. |
| Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Baseline and Week 12 | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category. |
| Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Baseline and Week 12 | The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category. |
| Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Baseline and Week 12 | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category. |
| Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Baseline and Week 12 | The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category. |
| Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline and Week 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 End of Treatment in Work Productivity and Activity Impairment (WPAI) | Baseline and Week 12 | This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement. |
| Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | Baseline and Week 12 | The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement. |
| Percentage of Participants With Improvement in PPBC | Baseline and Week 12 | The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score. |
Countries
Belarus, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, Spain, Sweden, Ukraine, United Kingdom
Participant flow
Recruitment details
Male and female patients with symptoms of overactive bladder (OAB; urgency, urinary frequency and/or urgency incontinence) for at least 3 months. The study was conducted at 141 sites in 20 countries in Europe.
Pre-assignment details
After screening, 1658 participants entered a 2-week, single-blind, placebo run-in period. After completion of the run-in period, 1307 participants were randomly assigned to 1 of the 12 treatment arms in a 1:1:1:1:2:1:2:2:2:2:1:1 ratio.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received matching placebo tablets orally once a day for 12 weeks. | 81 |
| Mirabegron 25 mg Participants received mirabegron 25 mg tablets orally once a day for 12 weeks. | 77 |
| Mirabegron 50 mg Participants received mirabegron 50 mg tablets orally once a day for 12 weeks. | 78 |
| Solifenacin 2.5 mg Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks. | 79 |
| Solifenacin 5 mg Participants received solifenacin 5 mg tablets orally once a day for 12 weeks. | 156 |
| Solifenacin 10 mg Participants received solifenacin 10 mg tablets orally once a day for 12 weeks. | 78 |
| Solifenacin 2.5 mg +Mirabegron 25 mg Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks. | 149 |
| Solifenacin 2.5 mg + Mirabegron 50 mg Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks. | 149 |
| Solifenacin 5 mg + Mirabegron 25 mg Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks. | 144 |
| Solifenacin 5 mg + Mirabegron 50 mg Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks. | 153 |
| Solifenacin 10 mg + Mirabegron 25 mg Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks. | 81 |
| Solifenacin 10 mg + Mirabegron 50 mg Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks. | 81 |
| Total | 1,306 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 2 | 0 | 1 | 2 | 2 | 1 | 4 | 1 | 1 | 3 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Miscellaneous | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 2 | 0 | 0 | 6 | 0 | 0 | 1 | 2 | 2 | 0 | 0 |
| Overall Study | Randomized but Never Received Study Drug | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 3 | 1 | 3 | 3 | 2 | 3 | 4 | 1 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Mirabegron 25 mg | Total | Solifenacin 10 mg + Mirabegron 50 mg | Solifenacin 10 mg + Mirabegron 25 mg | Solifenacin 5 mg + Mirabegron 50 mg | Placebo | Solifenacin 5 mg + Mirabegron 25 mg | Solifenacin 2.5 mg + Mirabegron 50 mg | Solifenacin 2.5 mg +Mirabegron 25 mg | Solifenacin 10 mg | Solifenacin 5 mg | Solifenacin 2.5 mg | Mirabegron 50 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 14.45 | 54.8 years STANDARD_DEVIATION 13.97 | 55.5 years STANDARD_DEVIATION 13.82 | 56.5 years STANDARD_DEVIATION 12.34 | 54.1 years STANDARD_DEVIATION 14.09 | 54.6 years STANDARD_DEVIATION 13.37 | 55.0 years STANDARD_DEVIATION 14.57 | 53.7 years STANDARD_DEVIATION 14.55 | 55.8 years STANDARD_DEVIATION 13.82 | 55.0 years STANDARD_DEVIATION 12.82 | 54.2 years STANDARD_DEVIATION 15.53 | 56.1 years STANDARD_DEVIATION 11.71 | 53.4 years STANDARD_DEVIATION 13.98 |
| Duration of OAB Symptoms | 61.2 months STANDARD_DEVIATION 68.03 | 57.8 months STANDARD_DEVIATION 73.82 | 57.4 months STANDARD_DEVIATION 80.12 | 64.9 months STANDARD_DEVIATION 100.57 | 57.4 months STANDARD_DEVIATION 81.53 | 48.3 months STANDARD_DEVIATION 38.37 | 56.3 months STANDARD_DEVIATION 84.78 | 57.0 months STANDARD_DEVIATION 66.85 | 57.7 months STANDARD_DEVIATION 68.91 | 52.4 months STANDARD_DEVIATION 56.98 | 61.8 months STANDARD_DEVIATION 78.21 | 60.2 months STANDARD_DEVIATION 67.85 | 56.9 months STANDARD_DEVIATION 66.62 |
| Mean Level of Urgency | 2.53 units on a scale STANDARD_DEVIATION 0.439 | 2.52 units on a scale STANDARD_DEVIATION 0.479 | 2.53 units on a scale STANDARD_DEVIATION 0.473 | 2.57 units on a scale STANDARD_DEVIATION 0.493 | 2.51 units on a scale STANDARD_DEVIATION 0.441 | 2.45 units on a scale STANDARD_DEVIATION 0.503 | 2.50 units on a scale STANDARD_DEVIATION 0.491 | 2.59 units on a scale STANDARD_DEVIATION 0.446 | 2.49 units on a scale STANDARD_DEVIATION 0.445 | 2.48 units on a scale STANDARD_DEVIATION 0.503 | 2.49 units on a scale STANDARD_DEVIATION 0.508 | 2.53 units on a scale STANDARD_DEVIATION 0.539 | 2.55 units on a scale STANDARD_DEVIATION 0.508 |
| Mean Number of Incontinence Episodes per 24 Hours | 1.87 incontinence episodes STANDARD_DEVIATION 1.578 | 1.31 incontinence episodes STANDARD_DEVIATION 1.109 | 1.25 incontinence episodes STANDARD_DEVIATION 0.858 | 1.53 incontinence episodes STANDARD_DEVIATION 1.235 | 1.17 incontinence episodes STANDARD_DEVIATION 1.196 | 0.95 incontinence episodes STANDARD_DEVIATION 0.765 | 1.24 incontinence episodes STANDARD_DEVIATION 1.108 | 1.14 incontinence episodes STANDARD_DEVIATION 0.791 | 1.27 incontinence episodes STANDARD_DEVIATION 1.096 | 1.40 incontinence episodes STANDARD_DEVIATION 1.28 | 1.33 incontinence episodes STANDARD_DEVIATION 1.242 | 1.80 incontinence episodes STANDARD_DEVIATION 1.167 | 1.26 incontinence episodes STANDARD_DEVIATION 1 |
| Mean Number of Micturitions per 24 Hours | 11.29 micturitions STANDARD_DEVIATION 2.581 | 11.10 micturitions STANDARD_DEVIATION 2.794 | 11.24 micturitions STANDARD_DEVIATION 2.453 | 11.14 micturitions STANDARD_DEVIATION 2.268 | 11.25 micturitions STANDARD_DEVIATION 3.171 | 10.36 micturitions STANDARD_DEVIATION 2.036 | 10.92 micturitions STANDARD_DEVIATION 2.386 | 11.00 micturitions STANDARD_DEVIATION 2.26 | 11.25 micturitions STANDARD_DEVIATION 3.643 | 11.29 micturitions STANDARD_DEVIATION 2.896 | 11.34 micturitions STANDARD_DEVIATION 3.158 | 11.10 micturitions STANDARD_DEVIATION 3.056 | 10.78 micturitions STANDARD_DEVIATION 2.254 |
| Mean Number of Nocturia Episodes per 24 Hours | 2.18 nocturia episodes STANDARD_DEVIATION 1.392 | 2.33 nocturia episodes STANDARD_DEVIATION 1.701 | 2.41 nocturia episodes STANDARD_DEVIATION 2.001 | 2.65 nocturia episodes STANDARD_DEVIATION 2.525 | 2.27 nocturia episodes STANDARD_DEVIATION 1.305 | 2.19 nocturia episodes STANDARD_DEVIATION 1.584 | 2.28 nocturia episodes STANDARD_DEVIATION 1.449 | 2.05 nocturia episodes STANDARD_DEVIATION 1.219 | 2.64 nocturia episodes STANDARD_DEVIATION 2.259 | 2.50 nocturia episodes STANDARD_DEVIATION 1.859 | 2.19 nocturia episodes STANDARD_DEVIATION 1.399 | 2.46 nocturia episodes STANDARD_DEVIATION 1.852 | 2.31 nocturia episodes STANDARD_DEVIATION 1.517 |
| Mean Number of Urgency Episodes per 24 Hours | 6.25 urgency episodes STANDARD_DEVIATION 3.332 | 6.37 urgency episodes STANDARD_DEVIATION 3.931 | 6.81 urgency episodes STANDARD_DEVIATION 4.312 | 6.91 urgency episodes STANDARD_DEVIATION 4.319 | 6.49 urgency episodes STANDARD_DEVIATION 4.238 | 5.26 urgency episodes STANDARD_DEVIATION 3.079 | 6.26 urgency episodes STANDARD_DEVIATION 3.928 | 6.78 urgency episodes STANDARD_DEVIATION 3.419 | 6.05 urgency episodes STANDARD_DEVIATION 3.749 | 6.37 urgency episodes STANDARD_DEVIATION 4.53 | 6.41 urgency episodes STANDARD_DEVIATION 4.154 | 6.20 urgency episodes STANDARD_DEVIATION 3.87 | 6.58 urgency episodes STANDARD_DEVIATION 3.981 |
| Mean Number of Urgency Incontinence Episodes per 24 Hours | 1.54 urgency incontinence episodes STANDARD_DEVIATION 1.337 | 1.20 urgency incontinence episodes STANDARD_DEVIATION 1.072 | 1.20 urgency incontinence episodes STANDARD_DEVIATION 0.901 | 1.51 urgency incontinence episodes STANDARD_DEVIATION 1.247 | 1.08 urgency incontinence episodes STANDARD_DEVIATION 1.193 | 0.78 urgency incontinence episodes STANDARD_DEVIATION 0.807 | 1.23 urgency incontinence episodes STANDARD_DEVIATION 1.118 | 1.06 urgency incontinence episodes STANDARD_DEVIATION 0.757 | 0.96 urgency incontinence episodes STANDARD_DEVIATION 0.903 | 1.18 urgency incontinence episodes STANDARD_DEVIATION 1.308 | 1.32 urgency incontinence episodes STANDARD_DEVIATION 1.227 | 1.56 urgency incontinence episodes STANDARD_DEVIATION 1.052 | 1.19 urgency incontinence episodes STANDARD_DEVIATION 1.043 |
| Mean Volume Voided per Micturition | 152.7 mL STANDARD_DEVIATION 56.7 | 152.5 mL STANDARD_DEVIATION 55.65 | 155.3 mL STANDARD_DEVIATION 62.13 | 141.4 mL STANDARD_DEVIATION 51.29 | 153.1 mL STANDARD_DEVIATION 51.88 | 156.4 mL STANDARD_DEVIATION 52.8 | 155.0 mL STANDARD_DEVIATION 55.55 | 149.8 mL STANDARD_DEVIATION 50.05 | 156.8 mL STANDARD_DEVIATION 61.97 | 148.0 mL STANDARD_DEVIATION 52.74 | 145.5 mL STANDARD_DEVIATION 59.34 | 162.4 mL STANDARD_DEVIATION 57.59 | 156.8 mL STANDARD_DEVIATION 52.33 |
| Race/Ethnicity, Customized Asian | 0 participants | 2 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants | 2 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Other | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 77 participants | 1302 participants | 81 participants | 81 participants | 153 participants | 81 participants | 143 participants | 148 participants | 149 participants | 77 participants | 156 participants | 78 participants | 78 participants |
| Sex: Female, Male Female | 52 Participants | 867 Participants | 54 Participants | 52 Participants | 101 Participants | 54 Participants | 95 Participants | 100 Participants | 100 Participants | 53 Participants | 103 Participants | 51 Participants | 52 Participants |
| Sex: Female, Male Male | 25 Participants | 439 Participants | 27 Participants | 29 Participants | 52 Participants | 27 Participants | 49 Participants | 49 Participants | 49 Participants | 25 Participants | 53 Participants | 28 Participants | 26 Participants |
| Type of Overactive Bladder (OAB) Frequency | 39 participants | 793 participants | 50 participants | 44 participants | 100 participants | 56 participants | 90 participants | 95 participants | 84 participants | 48 participants | 89 participants | 50 participants | 48 participants |
| Type of Overactive Bladder (OAB) Missing | 1 participants | 9 participants | 1 participants | 0 participants | 0 participants | 2 participants | 0 participants | 1 participants | 1 participants | 0 participants | 1 participants | 1 participants | 1 participants |
| Type of Overactive Bladder (OAB) Mixed | 10 participants | 180 participants | 10 participants | 14 participants | 18 participants | 9 participants | 19 participants | 20 participants | 22 participants | 11 participants | 27 participants | 10 participants | 10 participants |
| Type of Overactive Bladder (OAB) Urge Incontinence | 27 participants | 324 participants | 20 participants | 23 participants | 35 participants | 14 participants | 35 participants | 33 participants | 42 participants | 19 participants | 39 participants | 18 participants | 19 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 81 | 16 / 77 | 21 / 78 | 19 / 79 | 48 / 156 | 33 / 78 | 36 / 149 | 34 / 149 | 40 / 144 | 39 / 153 | 30 / 81 | 35 / 81 |
| serious Total, serious adverse events | 0 / 81 | 0 / 77 | 2 / 78 | 1 / 79 | 0 / 156 | 1 / 78 | 3 / 149 | 2 / 149 | 2 / 144 | 2 / 153 | 1 / 81 | 1 / 81 |
Outcome results
Primary
Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.
Time frame: Baseline and Week 12
Population: The Full Analysis Set (FAS) comprised all participants took at least 1 dose of double-blind study medication after randomization and had primary efficacy data (mean volume voided) derived from the diary at Baseline and at least 1 post-baseline visit. Last observation carried forward imputation (LOCF) was utilized.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition | 14.0 mL | Standard Error 5.91 |
| Mirabegron 25 mg | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition | 24.9 mL | Standard Error 6.06 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition | 34.5 mL | Standard Error 6.02 |
| Solifenacin 2.5 mg | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition | 36.4 mL | Standard Error 6.02 |
| Solifenacin 5 mg | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition | 36.0 mL | Standard Error 4.32 |
| Solifenacin 10 mg | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition | 36.2 mL | Standard Error 6.06 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition | 39.4 mL | Standard Error 4.37 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition | 41.9 mL | Standard Error 4.36 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition | 53.6 mL | Standard Error 4.45 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition | 54.2 mL | Standard Error 4.31 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition | 57.6 mL | Standard Error 5.99 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition | 62.3 mL | Standard Error 5.9 |
Comparison: Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and Baseline value as a covariate.~Least squares (LS) mean differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.p-value: 0.9795% CI: [-14.3, 14.9]ANCOVA
p-value: 0.5895% CI: [-8.6, 15.5]ANCOVA
p-value: 0.3395% CI: [-6.1, 18]ANCOVA
p-value: 0.00595% CI: [5.4, 29.8]ANCOVA
p-value: 0.00395% CI: [6.2, 30.2]ANCOVA
p-value: 0.00395% CI: [7.2, 36.1]ANCOVA
p-value: <0.00195% CI: [11.9, 40.7]ANCOVA
p-value: 0.295% CI: [-5.6, 27.6]ANCOVA
p-value: 0.01595% CI: [4, 37.1]ANCOVA
p-value: 0.00895% CI: [5.9, 39]ANCOVA
p-value: 0.00395% CI: [7.6, 36.3]ANCOVA
p-value: 0.00995% CI: [5.6, 38.8]ANCOVA
p-value: <0.00195% CI: [11, 39.8]ANCOVA
p-value: <0.00195% CI: [13.5, 42.3]ANCOVA
p-value: <0.00195% CI: [25.1, 54.1]ANCOVA
p-value: <0.00195% CI: [25.8, 54.5]ANCOVA
p-value: <0.00195% CI: [27.1, 60.1]ANCOVA
p-value: <0.00195% CI: [31.9, 64.7]ANCOVA
Secondary
Change From Baseline 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 End of Treatment health status and reports the number of patients in that category.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → No anxiety | 17 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Moderate anxiety | 5 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Extreme anxiety | 1 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Missing data | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → No anxiety | 41 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Moderate anxiety | 13 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Extreme anxiety | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Missing data | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → No anxiety | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Moderate anxiety | 2 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Extreme anxiety | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Missing data | 1 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → No anxiety | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Moderate anxiety | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Extreme anxiety | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → No anxiety | 9 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → No anxiety | 38 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Extreme anxiety | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Moderate anxiety | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Extreme anxiety | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → No anxiety | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Extreme anxiety | 1 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Moderate anxiety | 1 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Moderate anxiety | 8 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → No anxiety | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Missing data | 1 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Extreme anxiety | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Moderate anxiety | 18 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Extreme anxiety | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Moderate anxiety | 14 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → No anxiety | 15 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → No anxiety | 39 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Moderate anxiety | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Extreme anxiety | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Missing data | 1 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Moderate anxiety | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → No anxiety | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Extreme anxiety | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Moderate anxiety | 7 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → No anxiety | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Extreme anxiety | 1 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Moderate anxiety | 4 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Extreme anxiety | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → No anxiety | 21 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Moderate anxiety | 9 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Extreme anxiety | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → No anxiety | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Moderate anxiety | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Extreme anxiety | 1 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → No anxiety | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Moderate anxiety | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Extreme anxiety | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → No anxiety | 42 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Moderate anxiety | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → No anxiety | 2 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Moderate anxiety | 11 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Extreme anxiety | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Extreme anxiety | 2 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Moderate anxiety | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Moderate anxiety | 33 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → No anxiety | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Extreme anxiety | 1 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → No anxiety | 76 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → No anxiety | 24 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Extreme anxiety | 1 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Moderate anxiety | 1 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → No anxiety | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Missing data | 1 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Extreme anxiety | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → No anxiety | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Extreme anxiety | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → No anxiety | 19 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Moderate anxiety | 6 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Moderate anxiety | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → No anxiety | 36 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Extreme anxiety | 1 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Moderate anxiety | 12 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Extreme anxiety | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Moderate anxiety | 7 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Moderate anxiety | 21 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Extreme anxiety | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → No anxiety | 81 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Missing data | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → No anxiety | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Moderate anxiety | 7 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Extreme anxiety | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Extreme anxiety | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → No anxiety | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Moderate anxiety | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Extreme anxiety | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → No anxiety | 25 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Moderate anxiety | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Extreme anxiety | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → No anxiety | 2 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Moderate anxiety | 22 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Moderate anxiety | 5 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Extreme anxiety | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → No anxiety | 35 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Moderate anxiety | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Missing data | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Extreme anxiety | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → No anxiety | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → No anxiety | 78 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Extreme anxiety | 1 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Extreme anxiety | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Moderate anxiety | 4 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → No anxiety | 28 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Extreme anxiety | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Missing data | 1 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → No anxiety | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Extreme anxiety | 1 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Moderate anxiety | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Missing data | 1 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Extreme anxiety | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Moderate anxiety | 9 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Moderate anxiety | 19 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → No anxiety | 2 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → No anxiety | 76 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → No anxiety | 33 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → No anxiety | 80 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Missing data | 1 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Extreme anxiety | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → No anxiety | 2 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Moderate anxiety | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Moderate anxiety | 3 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Extreme anxiety | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → No anxiety | 2 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Extreme anxiety | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Moderate anxiety | 26 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Missing data | 1 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Moderate anxiety | 1 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Extreme anxiety | 1 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Moderate anxiety | 8 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Extreme anxiety | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → No anxiety | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Extreme anxiety | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Extreme anxiety | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → No anxiety | 44 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Moderate anxiety | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Moderate anxiety | 5 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → No anxiety | 3 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Moderate anxiety | 1 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Extreme anxiety | 2 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → No anxiety | 15 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → No anxiety | 2 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Extreme anxiety | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Extreme anxiety | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Moderate anxiety | 6 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Extreme anxiety | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Extreme anxiety | 1 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → No anxiety | 36 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → No anxiety | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Moderate anxiety | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → No anxiety | 14 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | No anxiety → Missing data | 2 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Moderate anxiety → Moderate anxiety | 19 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score | Extreme anxiety → Moderate anxiety | 0 participants |
Secondary
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → No problems | 5 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Some problems | 6 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Confined to bed | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Missing data | 1 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → No problem | 60 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Some problems | 8 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Confined to bed | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Missing data | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → No problems | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Some problems | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Confined to bed | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Missing data | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → No problem | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Some problems | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Confined to bed | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → No problems | 6 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → No problem | 58 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Confined to bed | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Some problems | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Confined to bed | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → No problem | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Confined to bed | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Some problems | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Missing data | 1 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Some problems | 1 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → No problems | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Confined to bed | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Some problems | 10 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Confined to bed | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Some problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → No problems | 6 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → No problem | 63 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Some problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Confined to bed | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Some problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → No problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Confined to bed | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Some problems | 4 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → No problem | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Missing data | 1 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Confined to bed | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Some problems | 4 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Confined to bed | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → No problems | 4 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Some problems | 10 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Confined to bed | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → No problems | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Some problems | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Confined to bed | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → No problem | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Some problems | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Confined to bed | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → No problem | 59 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Some problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → No problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Some problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Confined to bed | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Confined to bed | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Some problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Some problems | 15 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → No problem | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Confined to bed | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → No problem | 118 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → No problems | 11 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Confined to bed | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Some problems | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → No problem | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Confined to bed | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → No problems | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Confined to bed | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → No problems | 8 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Some problems | 4 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Some problems | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → No problem | 54 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Missing data | 1 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Confined to bed | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Some problems | 9 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Confined to bed | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Some problems | 9 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Some problems | 20 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Confined to bed | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → No problem | 94 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Missing data | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → No problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Some problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Confined to bed | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Confined to bed | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → No problem | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Some problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Confined to bed | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → No problems | 21 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Some problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Confined to bed | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → No problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Some problems | 12 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Some problems | 5 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Confined to bed | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → No problems | 15 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Some problems | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Missing data | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Confined to bed | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → No problem | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → No problem | 113 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Confined to bed | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Confined to bed | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Some problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → No problems | 13 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Confined to bed | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Missing data | 1 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → No problem | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Confined to bed | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Some problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Missing data | 1 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Confined to bed | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Some problems | 9 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Some problems | 15 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → No problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → No problem | 102 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → No problems | 14 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → No problem | 120 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Missing data | 1 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Confined to bed | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → No problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Some problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Some problems | 1 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Confined to bed | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → No problem | 2 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Confined to bed | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Some problems | 11 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Missing data | 1 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Some problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Confined to bed | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Some problems | 8 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Confined to bed | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → No problem | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Confined to bed | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Confined to bed | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → No problem | 59 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Some problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Some problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → No problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Some problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Confined to bed | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → No problems | 11 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → No problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Confined to bed | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Confined to bed | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Some problems | 5 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Confined to bed | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Confined to bed | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → No problem | 56 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → No problem | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Some problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → No problems | 8 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | No problem → Missing data | 2 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Some problems → Some problems | 9 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score | Confined → Some problems | 0 participants |
Secondary
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Moderate pain | 16 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Moderate pain | 2 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Moderate pain | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Extreme pain | 1 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Extreme pain | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → No pain | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Moderate pain | 9 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Missing data | 1 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → No pain | 1 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → No pain | 38 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → No pain | 12 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Missing data | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Missing data | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Missing data | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Extreme pain | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Extreme pain | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → No pain | 33 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Moderate pain | 15 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Extreme pain | 1 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Extreme pain | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Moderate pain | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Extreme pain | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → No pain | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Extreme pain | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → No pain | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → No pain | 14 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Moderate pain | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Missing data | 1 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Moderate pain | 12 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Moderate pain | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → No pain | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Moderate pain | 6 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → No pain | 40 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → No pain | 10 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Extreme pain | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Extreme pain | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Moderate pain | 19 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Moderate pain | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → No pain | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Extreme pain | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Missing data | 1 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Extreme pain | 1 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Moderate pain | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Extreme pain | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → No pain | 12 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Extreme pain | 1 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Moderate pain | 1 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → No pain | 38 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Extreme pain | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → No pain | 1 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → No pain | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Moderate pain | 19 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Moderate pain | 4 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Extreme pain | 1 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → No pain | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → No pain | 24 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Moderate pain | 37 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Extreme pain | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → No pain | 1 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Moderate pain | 1 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Extreme pain | 2 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Extreme pain | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Moderate pain | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Extreme pain | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → No pain | 70 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Moderate pain | 15 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Extreme pain | 3 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Moderate pain | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Extreme pain | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Extreme pain | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Moderate pain | 18 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → No pain | 13 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Moderate pain | 3 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → No pain | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → No pain | 35 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Missing data | 1 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → No pain | 2 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Extreme pain | 1 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Moderate pain | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Moderate pain | 37 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Missing data | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Moderate pain | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → No pain | 3 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Extreme pain | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Moderate pain | 6 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Extreme pain | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Extreme pain | 4 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Moderate pain | 2 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → No pain | 24 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → No pain | 67 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → No pain | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Extreme pain | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Missing data | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → No pain | 34 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → No pain | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → No pain | 61 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → No pain | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Moderate pain | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Moderate pain | 2 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Extreme pain | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Extreme pain | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Extreme pain | 2 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Moderate pain | 11 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Extreme pain | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Moderate pain | 33 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Extreme pain | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → No pain | 1 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Moderate pain | 14 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Extreme pain | 1 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Extreme pain | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Extreme pain | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → No pain | 66 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Moderate pain | 27 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → No pain | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Moderate pain | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Moderate pain | 2 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Missing data | 2 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → No pain | 28 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Missing data | 1 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Moderate pain | 4 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Extreme pain | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Extreme pain | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Moderate pain | 7 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Moderate pain | 25 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → No pain | 2 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Moderate pain | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → No pain | 36 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Extreme pain | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Missing data | 1 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → No pain | 73 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Extreme pain | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → No pain | 1 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → No pain | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Moderate pain | 8 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Extreme pain | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → No pain | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Moderate pain | 12 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Extreme pain | 1 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Extreme pain | 1 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Moderate pain | 3 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → No pain | 39 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Moderate pain | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Extreme pain | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → No pain | 14 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Moderate pain | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Moderate pain | 6 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → No pain | 20 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → No pain | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Moderate pain | 18 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → No pain | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → No pain | 32 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Moderate pain | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Extreme pain | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Extreme pain → Extreme pain | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Moderate pain → Extreme pain | 2 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | No pain → Missing data | 2 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score | Missing data → Extreme pain | 0 participants |
Secondary
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → No problems | 1 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Some problems | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Unable | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Missing data | 1 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → No problem | 76 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Some problems | 2 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Unable | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Missing data | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → No problems | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Some problems | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Unable | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Missing data | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → No problem | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Some problems | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Unable | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → No problems | 4 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → No problem | 69 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Unable | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Some problems | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Unable | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → No problem | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Unable | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Some problems | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Some problems | 1 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → No problems | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Missing data | 1 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Unable | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Some problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Unable | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Some problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → No problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → No problem | 73 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Some problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Unable | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Some problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → No problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Unable | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Some problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → No problem | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Missing data | 1 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Unable | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Some problems | 2 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Unable | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → No problems | 1 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Some problems | 2 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Unable | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → No problems | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Some problems | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Unable | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → No problem | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Some problems | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Unable | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → No problem | 72 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Some problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → No problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Some problems | 2 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Unable | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Unable | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Some problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Some problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → No problem | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Unable | 1 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → No problem | 138 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → No problems | 6 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Unable | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Some problems | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → No problem | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Unable | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → No problems | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Unable | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → No problems | 3 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Some problems | 2 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Some problems | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → No problem | 68 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Missing data | 1 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Unable | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Some problems | 1 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Unable | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Some problems | 5 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Some problems | 3 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → No problem | 128 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Missing data | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → No problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Some problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → No problem | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Some problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → No problems | 8 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Some problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → No problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Some problems | 2 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Some problems | 2 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → No problems | 3 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Some problems | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Missing data | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → No problem | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → No problem | 138 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Some problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → No problems | 3 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → No problem | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Unable | 1 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Some problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Missing data | 2 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Some problems | 1 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Some problems | 4 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → No problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → No problem | 130 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → No problems | 2 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → No problem | 141 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Missing data | 2 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → No problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Some problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Some problems | 1 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → No problem | 2 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Some problems | 2 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Some problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Some problems | 2 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → No problem | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → No problem | 74 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Some problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Some problems | 1 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → No problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Some problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → No problems | 1 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → No problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Some problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → No problem | 72 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → No problem | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Some problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | No problem → Missing data | 2 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → Some problems | 4 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Some problems → No problems | 2 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score | Unable → Some problems | 0 participants |
Secondary
Change From Baseline 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 End of Treatment health status and reports the number of patients in that category.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → No problems | 11 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Some problems | 2 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Unable | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Missing data | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → No problem | 62 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Some problems | 4 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Unable | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Missing data | 1 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → No problems | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Some problems | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Unable | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Missing data | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → No problem | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Some problems | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Unable | 0 participants |
| Placebo | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → No problems | 11 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → No problem | 52 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Unable | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Some problems | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Unable | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → No problem | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Unable | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Some problems | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Missing data | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Some problems | 2 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → No problems | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Missing data | 1 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Unable | 0 participants |
| Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Some problems | 10 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Unable | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Some problems | 6 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → No problems | 8 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → No problem | 58 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Some problems | 1 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Unable | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Some problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → No problems | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Unable | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Some problems | 3 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → No problem | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Missing data | 1 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Missing data | 0 participants |
| Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Unable | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Some problems | 2 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Unable | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → No problems | 11 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Some problems | 4 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Unable | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → No problems | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Some problems | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Unable | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Missing data | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → No problem | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Some problems | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Unable | 0 participants |
| Solifenacin 2.5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → No problem | 60 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Some problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → No problems | 1 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Some problems | 3 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Unable | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Unable | 2 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Some problems | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Some problems | 13 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → No problem | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Unable | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → No problem | 115 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → No problems | 16 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Missing data | 0 participants |
| Solifenacin 5 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Unable | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Some problems | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → No problem | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Unable | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → No problems | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Missing data | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Unable | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → No problems | 7 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Some problems | 4 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Some problems | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → No problem | 57 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Missing data | 1 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Unable | 0 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Some problems | 6 participants |
| Solifenacin 10 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Unable | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Some problems | 8 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Some problems | 18 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → No problem | 89 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Missing data | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → No problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Some problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → No problem | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Some problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → No problems | 29 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Some problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → No problems | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Some problems | 8 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Some problems | 3 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → No problems | 24 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Some problems | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Missing data | 1 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Unable | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → No problem | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → No problem | 110 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Missing data | 0 participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Some problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → No problems | 12 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Missing data | 1 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → No problem | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Some problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Missing data | 1 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Some problems | 9 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Some problems | 11 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → No problems | 1 participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → No problem | 106 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → No problems | 21 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → No problem | 109 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Missing data | 2 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → No problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Some problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Some problems | 4 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → No problem | 2 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Unable | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Some problems | 12 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Missing data | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Some problems | 0 participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Some problems | 4 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Unable | 1 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → No problem | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → No problem | 57 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Some problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Some problems | 1 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → No problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Some problems | 1 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → No problems | 14 participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → No problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Unable | 1 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Some problems | 5 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Unable | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → No problem | 48 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → No problem | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Some problems | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → No problems | 14 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | No problem → Missing data | 2 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Some problems → Some problems | 8 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Missing data → Missing data | 0 participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score | Unable → Some problems | 2 participants |
Secondary
Change From Baseline to Each Visit in Mean Level of Urgency
Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 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.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Visit in Mean Level of Urgency | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -0.24 units on a scale | Standard Error 0.043 |
| Placebo | Change From Baseline to Each Visit in Mean Level of Urgency | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -0.46 units on a scale | Standard Error 0.063 |
| Placebo | Change From Baseline to Each Visit in Mean Level of Urgency | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -0.42 units on a scale | Standard Error 0.059 |
| Placebo | Change From Baseline to Each Visit in Mean Level of Urgency | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -0.48 units on a scale | Standard Error 0.064 |
| Placebo | Change From Baseline to Each Visit in Mean Level of Urgency | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -0.32 units on a scale | Standard Error 0.052 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -0.19 units on a scale | Standard Error 0.046 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -0.33 units on a scale | Standard Error 0.064 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -0.28 units on a scale | Standard Error 0.054 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -0.35 units on a scale | Standard Error 0.067 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -0.30 units on a scale | Standard Error 0.062 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -0.36 units on a scale | Standard Error 0.061 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -0.26 units on a scale | Standard Error 0.053 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -0.44 units on a scale | Standard Error 0.065 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -0.41 units on a scale | Standard Error 0.064 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -0.15 units on a scale | Standard Error 0.044 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -0.33 units on a scale | Standard Error 0.053 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -0.25 units on a scale | Standard Error 0.045 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Level of Urgency | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -0.45 units on a scale | Standard Error 0.064 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -0.42 units on a scale | Standard Error 0.065 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -0.45 units on a scale | Standard Error 0.06 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -0.30 units on a scale | Standard Error 0.043 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -0.14 units on a scale | Standard Error 0.032 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Level of Urgency | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -0.33 units on a scale | Standard Error 0.064 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -0.33 units on a scale | Standard Error 0.046 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -0.23 units on a scale | Standard Error 0.038 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -0.21 units on a scale | Standard Error 0.045 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Level of Urgency | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -0.47 units on a scale | Standard Error 0.064 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -0.49 units on a scale | Standard Error 0.065 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -0.44 units on a scale | Standard Error 0.6 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -0.35 units on a scale | Standard Error 0.054 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -0.39 units on a scale | Standard Error 0.043 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -0.19 units on a scale | Standard Error 0.032 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -0.32 units on a scale | Standard Error 0.039 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -0.43 units on a scale | Standard Error 0.047 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -0.42 units on a scale | Standard Error 0.046 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -0.41 units on a scale | Standard Error 0.044 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -0.35 units on a scale | Standard Error 0.039 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -0.26 units on a scale | Standard Error 0.032 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -0.54 units on a scale | Standard Error 0.047 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -0.50 units on a scale | Standard Error 0.046 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -0.50 units on a scale | Standard Error 0.048 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -0.45 units on a scale | Standard Error 0.045 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -0.48 units on a scale | Standard Error 0.047 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -0.35 units on a scale | Standard Error 0.039 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -0.26 units on a scale | Standard Error 0.033 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -0.54 units on a scale | Standard Error 0.046 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -0.55 units on a scale | Standard Error 0.046 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -0.46 units on a scale | Standard Error 0.043 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -0.37 units on a scale | Standard Error 0.038 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -0.28 units on a scale | Standard Error 0.033 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -0.31 units on a scale | Standard Error 0.044 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -0.41 units on a scale | Standard Error 0.052 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -0.59 units on a scale | Standard Error 0.063 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -0.53 units on a scale | Standard Error 0.059 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -0.61 units on a scale | Standard Error 0.064 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -0.49 units on a scale | Standard Error 0.065 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -0.31 units on a scale | Standard Error 0.053 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -0.43 units on a scale | Standard Error 0.06 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -0.20 units on a scale | Standard Error 0.044 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Level of Urgency | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -0.47 units on a scale | Standard Error 0.063 |
Comparison: All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.p-value: 0.06295% CI: [-0.3, 0.01]ANCOVA
p-value: 0.1595% CI: [-0.22, 0.03]ANCOVA
p-value: 0.00795% CI: [-0.3, -0.05]ANCOVA
p-value: 0.01795% CI: [-0.29, -0.03]ANCOVA
p-value: <0.00195% CI: [-0.35, -0.1]ANCOVA
p-value: <0.00195% CI: [-0.41, -0.11]ANCOVA
p-value: 0.0795% CI: [-0.29, 0.01]ANCOVA
p-value: 0.1595% CI: [-0.05, 0.31]ANCOVA
p-value: 0.5795% CI: [-0.12, 0.23]ANCOVA
p-value: 0.8995% CI: [-0.16, 0.19]ANCOVA
p-value: 0.08695% CI: [-0.02, 0.29]ANCOVA
p-value: 0.8895% CI: [-0.19, 0.16]ANCOVA
p-value: 0.6195% CI: [-0.11, 0.19]ANCOVA
p-value: 0.5895% CI: [-0.2, 0.11]ANCOVA
p-value: 0.7695% CI: [-0.18, 0.13]ANCOVA
p-value: 0.2395% CI: [-0.25, 0.06]ANCOVA
p-value: 0.1595% CI: [-0.3, 0.05]ANCOVA
p-value: 0.9495% CI: [-0.18, 0.17]ANCOVA
Secondary
Change From Baseline to Each 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 participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | -0.82 incontinence episodes | Standard Error 0.163 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | -0.87 incontinence episodes | Standard Error 0.146 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | -0.93 incontinence episodes | Standard Error 0.373 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | -0.83 incontinence episodes | Standard Error 0.168 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | -0.48 incontinence episodes | Standard Error 0.189 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | -0.43 incontinence episodes | Standard Error 0.191 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | -0.65 incontinence episodes | Standard Error 0.21 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | -0.59 incontinence episodes | Standard Error 0.482 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | -0.85 incontinence episodes | Standard Error 0.162 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | -0.89 incontinence episodes | Standard Error 0.141 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | -0.92 incontinence episodes | Standard Error 0.157 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | -0.89 incontinence episodes | Standard Error 0.361 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | -0.98 incontinence episodes | Standard Error 0.178 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | -1.21 incontinence episodes | Standard Error 0.424 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | -1.20 incontinence episodes | Standard Error 0.155 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | -1.12 incontinence episodes | Standard Error 0.178 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | -0.80 incontinence episodes | Standard Error 0.102 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | -0.84 incontinence episodes | Standard Error 0.261 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | -0.72 incontinence episodes | Standard Error 0.114 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | -0.67 incontinence episodes | Standard Error 0.119 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | -0.71 incontinence episodes | Standard Error 0.184 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | -0.84 incontinence episodes | Standard Error 0.16 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | -0.95 incontinence episodes | Standard Error 0.409 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | -1.04 incontinence episodes | Standard Error 0.172 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | -0.78 incontinence episodes | Standard Error 0.112 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | -0.49 incontinence episodes | Standard Error 0.116 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | -0.73 incontinence episodes | Standard Error 0.102 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | -0.74 incontinence episodes | Standard Error 0.265 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | -0.67 incontinence episodes | Standard Error 0.109 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | -0.64 incontinence episodes | Standard Error 0.12 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | -0.88 incontinence episodes | Standard Error 0.279 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | -0.82 incontinence episodes | Standard Error 0.122 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | -1.01 incontinence episodes | Standard Error 0.118 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | -1.20 incontinence episodes | Standard Error 0.28 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | -0.81 incontinence episodes | Standard Error 0.106 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | -0.70 incontinence episodes | Standard Error 0.122 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | -0.65 incontinence episodes | Standard Error 0.15 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | -0.95 incontinence episodes | Standard Error 0.142 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | -0.88 incontinence episodes | Standard Error 0.125 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | -1.11 incontinence episodes | Standard Error 0.319 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | -1.18 incontinence episodes | Standard Error 0.122 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | -0.93 incontinence episodes | Standard Error 0.136 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | -1.14 incontinence episodes | Standard Error 0.14 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | -0.27 incontinence episodes | Standard Error 0.311 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | -0.77 incontinence episodes | Standard Error 0.157 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | -0.91 incontinence episodes | Standard Error 0.149 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | -0.71 incontinence episodes | Standard Error 0.137 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | -0.96 incontinence episodes | Standard Error 0.341 |
Secondary
Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -2.27 micturitions | Standard Error 0.27 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -1.68 micturitions | Standard Error 0.261 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -2.59 micturitions | Standard Error 0.302 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.18 micturitions | Standard Error 0.24 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.02 micturitions | Standard Error 0.273 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.69 micturitions | Standard Error 0.255 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -2.27 micturitions | Standard Error 0.283 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -2.51 micturitions | Standard Error 0.314 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.60 micturitions | Standard Error 0.246 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -1.99 micturitions | Standard Error 0.269 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -2.42 micturitions | Standard Error 0.277 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -2.67 micturitions | Standard Error 0.306 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.49 micturitions | Standard Error 0.249 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -2.38 micturitions | Standard Error 0.306 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.10 micturitions | Standard Error 0.266 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -2.46 micturitions | Standard Error 0.273 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -1.80 micturitions | Standard Error 0.191 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -2.58 micturitions | Standard Error 0.218 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -2.22 micturitions | Standard Error 0.196 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.16 micturitions | Standard Error 0.176 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.32 micturitions | Standard Error 0.251 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.25 micturitions | Standard Error 0.271 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -3.31 micturitions | Standard Error 0.306 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -2.97 micturitions | Standard Error 0.275 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -2.58 micturitions | Standard Error 0.198 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.52 micturitions | Standard Error 0.178 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.03 micturitions | Standard Error 0.195 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -2.64 micturitions | Standard Error 0.222 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.11 micturitions | Standard Error 0.194 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.95 micturitions | Standard Error 0.178 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -3.02 micturitions | Standard Error 0.222 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -2.66 micturitions | Standard Error 0.199 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -2.43 micturitions | Standard Error 0.205 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -2.64 micturitions | Standard Error 0.227 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.29 micturitions | Standard Error 0.197 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.68 micturitions | Standard Error 0.184 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -2.21 micturitions | Standard Error 0.181 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -3.20 micturitions | Standard Error 0.197 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.77 micturitions | Standard Error 0.193 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -3.35 micturitions | Standard Error 0.218 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.55 micturitions | Standard Error 0.264 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -3.04 micturitions | Standard Error 0.27 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.74 micturitions | Standard Error 0.244 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -3.47 micturitions | Standard Error 0.302 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -2.35 micturitions | Standard Error 0.244 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -3.49 micturitions | Standard Error 0.275 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.69 micturitions | Standard Error 0.267 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -3.63 micturitions | Standard Error 0.306 |
Secondary
Change From Baseline to Each 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 participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: Full analysis set participants who had at least one nocturia episode at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | -0.33 nocturia episodes | Standard Error 0.115 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 | -0.74 nocturia episodes | Standard Error 0.14 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | -0.64 nocturia episodes | Standard Error 0.126 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | -0.79 nocturia episodes | Standard Error 0.146 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | -0.50 nocturia episodes | Standard Error 0.116 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | -0.37 nocturia episodes | Standard Error 0.123 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 | -0.69 nocturia episodes | Standard Error 0.145 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | -0.60 nocturia episodes | Standard Error 0.123 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | -0.69 nocturia episodes | Standard Error 0.154 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | -0.65 nocturia episodes | Standard Error 0.133 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | -0.68 nocturia episodes | Standard Error 0.127 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | -0.71 nocturia episodes | Standard Error 0.118 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | -0.84 nocturia episodes | Standard Error 0.146 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 | -0.82 nocturia episodes | Standard Error 0.142 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | -0.60 nocturia episodes | Standard Error 0.118 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | -0.55 nocturia episodes | Standard Error 0.118 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | -0.38 nocturia episodes | Standard Error 0.12 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 | -0.68 nocturia episodes | Standard Error 0.143 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | -0.59 nocturia episodes | Standard Error 0.148 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | -0.80 nocturia episodes | Standard Error 0.127 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | -0.65 nocturia episodes | Standard Error 0.091 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | -0.30 nocturia episodes | Standard Error 0.085 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 | -0.69 nocturia episodes | Standard Error 0.102 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | -0.70 nocturia episodes | Standard Error 0.106 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | -0.47 nocturia episodes | Standard Error 0.085 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | -0.45 nocturia episodes | Standard Error 0.121 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 | -0.95 nocturia episodes | Standard Error 0.144 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | -0.99 nocturia episodes | Standard Error 0.148 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | -1.01 nocturia episodes | Standard Error 0.128 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | -0.74 nocturia episodes | Standard Error 0.121 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | -0.76 nocturia episodes | Standard Error 0.092 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | -0.43 nocturia episodes | Standard Error 0.086 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | -0.59 nocturia episodes | Standard Error 0.087 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | -0.75 nocturia episodes | Standard Error 0.108 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 | -0.73 nocturia episodes | Standard Error 0.104 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | -0.79 nocturia episodes | Standard Error 0.094 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | -0.54 nocturia episodes | Standard Error 0.088 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | -0.51 nocturia episodes | Standard Error 0.087 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | -0.81 nocturia episodes | Standard Error 0.109 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 | -0.77 nocturia episodes | Standard Error 0.105 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | -0.80 nocturia episodes | Standard Error 0.11 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | -0.76 nocturia episodes | Standard Error 0.095 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 | -0.77 nocturia episodes | Standard Error 0.106 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | -0.69 nocturia episodes | Standard Error 0.088 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | -0.49 nocturia episodes | Standard Error 0.088 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | -1.05 nocturia episodes | Standard Error 0.105 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 | -1.04 nocturia episodes | Standard Error 0.102 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | -0.98 nocturia episodes | Standard Error 0.091 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | -0.80 nocturia episodes | Standard Error 0.086 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | -0.61 nocturia episodes | Standard Error 0.087 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | -0.43 nocturia episodes | Standard Error 0.119 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | -0.67 nocturia episodes | Standard Error 0.119 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 | -0.94 nocturia episodes | Standard Error 0.143 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | -0.81 nocturia episodes | Standard Error 0.127 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | -0.98 nocturia episodes | Standard Error 0.147 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69 | -1.03 nocturia episodes | Standard Error 0.15 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71 | -0.75 nocturia episodes | Standard Error 0.121 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70 | -0.91 nocturia episodes | Standard Error 0.13 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73 | -0.53 nocturia episodes | Standard Error 0.119 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours | EOT; n=78,73,76,75,146,74,143,140,137,147,75,76 | -0.96 nocturia episodes | Standard Error 0.142 |
Comparison: All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.p-value: 0.1595% CI: [-0.6, 0.09]ANCOVA
p-value: 0.7895% CI: [-0.33, 0.25]ANCOVA
p-value: 0.5895% CI: [-0.37, 0.21]ANCOVA
p-value: 0.695% CI: [-0.37, 0.21]ANCOVA
p-value: 0.01795% CI: [-0.63, -0.06]ANCOVA
p-value: 0.1695% CI: [-0.6, 0.1]ANCOVA
p-value: 0.1395% CI: [-0.61, 0.08]ANCOVA
p-value: 0.8195% CI: [-0.35, 0.44]ANCOVA
p-value: 0.6795% CI: [-0.48, 0.31]ANCOVA
p-value: 0.7795% CI: [-0.33, 0.45]ANCOVA
p-value: 0.8195% CI: [-0.3, 0.38]ANCOVA
p-value: 0.395% CI: [-0.6, 0.18]ANCOVA
p-value: 0.9995% CI: [-0.34, 0.34]ANCOVA
p-value: 0.8295% CI: [-0.38, 0.3]ANCOVA
p-value: 0.8495% CI: [-0.38, 0.31]ANCOVA
p-value: 0.0895% CI: [-0.64, 0.04]ANCOVA
p-value: 0.395% CI: [-0.6, 0.18]ANCOVA
p-value: 0.2695% CI: [-0.62, 0.17]ANCOVA
Secondary
Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: Full analysis set participants who had at least one use of pad at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | -0.81 pads | Standard Error 0.212 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 | -0.63 pads | Standard Error 0.244 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | -0.97 pads | Standard Error 0.226 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | -0.92 pads | Standard Error 0.246 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | -0.76 pads | Standard Error 0.224 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | -0.87 pads | Standard Error 0.212 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 | -1.04 pads | Standard Error 0.241 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | -0.93 pads | Standard Error 0.228 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | -0.97 pads | Standard Error 0.242 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | -0.90 pads | Standard Error 0.223 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | -1.11 pads | Standard Error 0.213 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | -0.70 pads | Standard Error 0.214 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | -0.93 pads | Standard Error 0.231 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 | -0.95 pads | Standard Error 0.237 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | -0.88 pads | Standard Error 0.209 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | -1.62 pads | Standard Error 0.228 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | -1.31 pads | Standard Error 0.219 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 | -1.44 pads | Standard Error 0.248 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | -1.35 pads | Standard Error 0.251 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | -1.47 pads | Standard Error 0.223 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | -1.25 pads | Standard Error 0.144 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | -0.92 pads | Standard Error 0.142 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 | -1.38 pads | Standard Error 0.161 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | -1.39 pads | Standard Error 0.159 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | -1.26 pads | Standard Error 0.147 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | -0.91 pads | Standard Error 0.255 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 | -1.73 pads | Standard Error 0.287 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | -1.75 pads | Standard Error 0.282 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | -1.53 pads | Standard Error 0.253 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | -1.23 pads | Standard Error 0.265 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | -1.10 pads | Standard Error 0.156 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | -0.86 pads | Standard Error 0.155 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | -0.94 pads | Standard Error 0.162 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | -1.02 pads | Standard Error 0.174 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 | -1.04 pads | Standard Error 0.177 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | -1.39 pads | Standard Error 0.172 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | -1.09 pads | Standard Error 0.176 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | -0.96 pads | Standard Error 0.164 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | -1.44 pads | Standard Error 0.187 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 | -1.38 pads | Standard Error 0.188 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | -1.45 pads | Standard Error 0.17 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | -1.29 pads | Standard Error 0.155 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 | -1.46 pads | Standard Error 0.176 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | -1.24 pads | Standard Error 0.159 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | -0.89 pads | Standard Error 0.155 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | -1.63 pads | Standard Error 0.172 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 | -1.63 pads | Standard Error 0.174 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | -1.51 pads | Standard Error 0.159 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | -1.30 pads | Standard Error 0.161 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | -1.02 pads | Standard Error 0.155 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | -1.13 pads | Standard Error 0.182 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | -1.35 pads | Standard Error 0.189 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 | -1.59 pads | Standard Error 0.207 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | -1.37 pads | Standard Error 0.185 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | -1.60 pads | Standard Error 0.201 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31 | -1.60 pads | Standard Error 0.243 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30 | -1.36 pads | Standard Error 0.231 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30 | -1.56 pads | Standard Error 0.227 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30 | -1.31 pads | Standard Error 0.223 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours | EOT; n=33,34,35,32,76,24,63,56,64,65,46,32 | -1.63 pads | Standard Error 0.248 |
Comparison: All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.p-value: 0.2995% CI: [-0.99, 0.3]ANCOVA
p-value: 0.1595% CI: [-0.12, 0.82]ANCOVA
p-value: 0.9995% CI: [-0.48, 0.49]ANCOVA
p-value: 0.7695% CI: [-0.54, 0.4]ANCOVA
p-value: 0.395% CI: [-0.71, 0.22]ANCOVA
p-value: 0.4395% CI: [-0.72, 0.31]ANCOVA
p-value: 0.495% CI: [-0.83, 0.33]ANCOVA
p-value: 0.2495% CI: [-1.08, 0.27]ANCOVA
p-value: 0.3695% CI: [-0.98, 0.36]ANCOVA
p-value: 0.0295% CI: [-1.49, -0.13]ANCOVA
p-value: 0.01195% CI: [-1.33, -0.18]ANCOVA
p-value: 0.00495% CI: [-1.84, -0.36]ANCOVA
p-value: 0.1895% CI: [-1, 0.19]ANCOVA
p-value: 0.01595% CI: [-1.35, -0.14]ANCOVA
p-value: 0.00695% CI: [-1.41, -0.23]ANCOVA
p-value: <0.00195% CI: [-1.59, -0.41]ANCOVA
p-value: 0.00395% CI: [-1.59, -0.33]ANCOVA
p-value: 0.00495% CI: [-1.68, -0.31]ANCOVA
Secondary
Change From Baseline to Each 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, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -2.07 urgency episodes | Standard Error 0.276 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -3.53 urgency episodes | Standard Error 0.328 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -3.42 urgency episodes | Standard Error 0.318 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -3.69 urgency episodes | Standard Error 0.334 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.55 urgency episodes | Standard Error 0.308 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -2.06 urgency episodes | Standard Error 0.292 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -3.23 urgency episodes | Standard Error 0.336 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.70 urgency episodes | Standard Error 0.322 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -3.31 urgency episodes | Standard Error 0.347 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -2.86 urgency episodes | Standard Error 0.332 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -3.27 urgency episodes | Standard Error 0.325 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.70 urgency episodes | Standard Error 0.317 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -3.65 urgency episodes | Standard Error 0.338 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -3.44 urgency episodes | Standard Error 0.334 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.91 urgency episodes | Standard Error 0.282 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -3.16 urgency episodes | Standard Error 0.313 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -2.49 urgency episodes | Standard Error 0.286 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -3.62 urgency episodes | Standard Error 0.334 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -3.54 urgency episodes | Standard Error 0.338 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -3.61 urgency episodes | Standard Error 0.321 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -2.67 urgency episodes | Standard Error 0.229 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.63 urgency episodes | Standard Error 0.202 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -2.73 urgency episodes | Standard Error 0.239 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -2.71 urgency episodes | Standard Error 0.24 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.24 urgency episodes | Standard Error 0.225 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.97 urgency episodes | Standard Error 0.288 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -3.98 urgency episodes | Standard Error 0.336 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -4.15 urgency episodes | Standard Error 0.337 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -3.63 urgency episodes | Standard Error 0.323 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -3.02 urgency episodes | Standard Error 0.32 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -3.34 urgency episodes | Standard Error 0.232 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -1.84 urgency episodes | Standard Error 0.205 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.64 urgency episodes | Standard Error 0.23 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -3.26 urgency episodes | Standard Error 0.246 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -3.21 urgency episodes | Standard Error 0.242 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -3.60 urgency episodes | Standard Error 0.233 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -3.14 urgency episodes | Standard Error 0.229 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -2.59 urgency episodes | Standard Error 0.205 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -4.24 urgency episodes | Standard Error 0.246 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -3.97 urgency episodes | Standard Error 0.242 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -3.98 urgency episodes | Standard Error 0.25 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -3.60 urgency episodes | Standard Error 0.24 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -3.86 urgency episodes | Standard Error 0.247 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -3.08 urgency episodes | Standard Error 0.233 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -2.30 urgency episodes | Standard Error 0.211 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -4.09 urgency episodes | Standard Error 0.24 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -4.10 urgency episodes | Standard Error 0.239 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -3.85 urgency episodes | Standard Error 0.231 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -3.17 urgency episodes | Standard Error 0.228 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -2.57 urgency episodes | Standard Error 0.207 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -2.35 urgency episodes | Standard Error 0.281 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -3.04 urgency episodes | Standard Error 0.311 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -3.71 urgency episodes | Standard Error 0.332 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -3.53 urgency episodes | Standard Error 0.317 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -3.76 urgency episodes | Standard Error 0.333 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73 | -3.93 urgency episodes | Standard Error 0.338 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75 | -2.81 urgency episodes | Standard Error 0.316 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74 | -3.63 urgency episodes | Standard Error 0.323 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77 | -2.23 urgency episodes | Standard Error 0.281 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | EOT; n=80,76,77,77,150,76,146,147,141,150,78,80 | -3.91 urgency episodes | Standard Error 0.327 |
Comparison: All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.p-value: 0.00295% CI: [-2.06, -0.45]ANCOVA
p-value: 0.1695% CI: [-1.15, 0.19]ANCOVA
p-value: <0.00195% CI: [-1.91, -0.57]ANCOVA
p-value: 0.00195% CI: [-1.8, -0.46]ANCOVA
p-value: <0.00195% CI: [-2.03, -0.7]ANCOVA
p-value: 0.01795% CI: [-1.78, -0.18]ANCOVA
p-value: 0.00495% CI: [-1.98, -0.39]ANCOVA
p-value: 0.5395% CI: [-0.63, 1.22]ANCOVA
p-value: 0.8595% CI: [-0.83, 1.01]ANCOVA
p-value: 0.8495% CI: [-1.01, 0.83]ANCOVA
p-value: 0.0595% CI: [0, 1.59]ANCOVA
p-value: 0.3395% CI: [-1.38, 0.46]ANCOVA
p-value: 0.4495% CI: [-0.48, 1.12]ANCOVA
p-value: 0.2895% CI: [-1.24, 0.36]ANCOVA
p-value: 0.4295% CI: [-1.14, 0.47]ANCOVA
p-value: 0.1695% CI: [-1.37, 0.23]ANCOVA
p-value: 0.795% CI: [-1.1, 0.73]ANCOVA
p-value: 0.495% CI: [-1.3, 0.52]ANCOVA
Secondary
Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: Full Analysis Set-Incontinence participants who had at least 1 urgency (grade 3 or 4) incontinence episode at Baseline, including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | -0.80 urgency incontinence episodes | Standard Error 0.178 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 | -0.86 urgency incontinence episodes | Standard Error 0.411 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | -0.86 urgency incontinence episodes | Standard Error 0.173 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | -0.84 urgency incontinence episodes | Standard Error 0.42 |
| Placebo | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | -0.83 urgency incontinence episodes | Standard Error 0.157 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | -0.59 urgency incontinence episodes | Standard Error 0.184 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 | -0.80 urgency incontinence episodes | Standard Error 0.424 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | -0.48 urgency incontinence episodes | Standard Error 0.185 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | -0.54 urgency incontinence episodes | Standard Error 0.493 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | -0.65 urgency incontinence episodes | Standard Error 0.204 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | -1.00 urgency incontinence episodes | Standard Error 0.157 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | -0.93 urgency incontinence episodes | Standard Error 0.142 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | -0.87 urgency incontinence episodes | Standard Error 0.379 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 | -0.88 urgency incontinence episodes | Standard Error 0.372 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | -0.83 urgency incontinence episodes | Standard Error 0.161 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | -1.13 urgency incontinence episodes | Standard Error 0.151 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | -0.96 urgency incontinence episodes | Standard Error 0.171 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 | -1.17 urgency incontinence episodes | Standard Error 0.394 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | -1.13 urgency incontinence episodes | Standard Error 0.433 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | -1.04 urgency incontinence episodes | Standard Error 0.172 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | -0.76 urgency incontinence episodes | Standard Error 0.11 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | -0.66 urgency incontinence episodes | Standard Error 0.115 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 | -0.86 urgency incontinence episodes | Standard Error 0.258 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | -0.83 urgency incontinence episodes | Standard Error 0.267 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | -0.77 urgency incontinence episodes | Standard Error 0.1 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | -0.77 urgency incontinence episodes | Standard Error 0.191 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 | -1.13 urgency incontinence episodes | Standard Error 0.424 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | -1.13 urgency incontinence episodes | Standard Error 0.451 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | -1.16 urgency incontinence episodes | Standard Error 0.179 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | -1.00 urgency incontinence episodes | Standard Error 0.169 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | -0.86 urgency incontinence episodes | Standard Error 0.119 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | -0.52 urgency incontinence episodes | Standard Error 0.123 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | -0.73 urgency incontinence episodes | Standard Error 0.111 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | -0.81 urgency incontinence episodes | Standard Error 0.295 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 | -0.81 urgency incontinence episodes | Standard Error 0.283 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | -0.84 urgency incontinence episodes | Standard Error 0.118 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | -0.70 urgency incontinence episodes | Standard Error 0.107 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | -0.68 urgency incontinence episodes | Standard Error 0.115 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | -0.91 urgency incontinence episodes | Standard Error 0.286 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 | -0.87 urgency incontinence episodes | Standard Error 0.266 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | -1.19 urgency incontinence episodes | Standard Error 0.292 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | -0.99 urgency incontinence episodes | Standard Error 0.117 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 | -1.20 urgency incontinence episodes | Standard Error 0.277 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | -0.81 urgency incontinence episodes | Standard Error 0.106 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | -0.68 urgency incontinence episodes | Standard Error 0.12 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | -1.06 urgency incontinence episodes | Standard Error 0.334 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 | -1.08 urgency incontinence episodes | Standard Error 0.321 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | -0.89 urgency incontinence episodes | Standard Error 0.141 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | -0.86 urgency incontinence episodes | Standard Error 0.125 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | -0.64 urgency incontinence episodes | Standard Error 0.145 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | -1.12 urgency incontinence episodes | Standard Error 0.135 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | -1.20 urgency incontinence episodes | Standard Error 0.12 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 | -0.28 urgency incontinence episodes | Standard Error 0.312 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | -0.91 urgency incontinence episodes | Standard Error 0.132 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | -0.28 urgency incontinence episodes | Standard Error 0.319 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19 | -0.93 urgency incontinence episodes | Standard Error 0.358 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18 | -0.68 urgency incontinence episodes | Standard Error 0.138 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19 | -0.88 urgency incontinence episodes | Standard Error 0.148 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18 | -0.76 urgency incontinence episodes | Standard Error 0.156 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours | EOT; n=14,13,17,15,35,13,29,33,31,23,24,19 | -0.94 urgency incontinence episodes | Standard Error 0.351 |
Comparison: The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.p-value: 0.2595% CI: [-1.24, 0.71]Stratified Rank ANCOVA
p-value: 0.3595% CI: [-0.7, 0.81]Stratified Rank ANCOVA
p-value: 195% CI: [-0.74, 0.72]Stratified Rank ANCOVA
p-value: 0.00395% CI: [-1.08, 0.41]Stratified Rank ANCOVA
p-value: 0.1295% CI: [-1.04, 0.59]Stratified Rank ANCOVA
p-value: 0.2495% CI: [-0.21, 1.38]Stratified Rank ANCOVA
p-value: 0.5495% CI: [-0.94, 0.78]Stratified Rank ANCOVA
p-value: 0.9595% CI: [-1.1, 1.22]Stratified Rank ANCOVA
p-value: 0.7495% CI: [-1.11, 1.07]Stratified Rank ANCOVA
p-value: 0.8995% CI: [-1.43, 0.82]Stratified Rank ANCOVA
p-value: 0.8295% CI: [-0.96, 0.96]Stratified Rank ANCOVA
p-value: 0.5895% CI: [-1.44, 0.9]Stratified Rank ANCOVA
p-value: 0.4695% CI: [-0.93, 1.04]Stratified Rank ANCOVA
p-value: 0.9595% CI: [-0.97, 0.96]Stratified Rank ANCOVA
p-value: 0.1895% CI: [-1.32, 0.65]Stratified Rank ANCOVA
p-value: 0.2195% CI: [-1.24, 0.8]Stratified Rank ANCOVA
p-value: 0.7295% CI: [-0.43, 1.6]Stratified Rank ANCOVA
p-value: 0.9295% CI: [-1.15, 0.98]Stratified Rank ANCOVA
Secondary
Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n)..
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | 13.5 mL | Standard Error 5.56 |
| Placebo | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | 10.2 mL | Standard Error 4.93 |
| Placebo | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 | 14.7 mL | Standard Error 6.12 |
| Placebo | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | 8.7 mL | Standard Error 4.44 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | 16.8 mL | Standard Error 5.16 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | 14.3 mL | Standard Error 4.71 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | 24.6 mL | Standard Error 5.83 |
| Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 | 23.0 mL | Standard Error 6.43 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | 26.0 mL | Standard Error 4.55 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | 29.4 mL | Standard Error 5.09 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | 35.4 mL | Standard Error 5.71 |
| Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 | 35.5 mL | Standard Error 6.2 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | 22.7 mL | Standard Error 4.62 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 | 36.9 mL | Standard Error 6.2 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | 24.8 mL | Standard Error 5.02 |
| Solifenacin 2.5 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | 28.3 mL | Standard Error 5.63 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | 29.6 mL | Standard Error 3.63 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 | 34.6 mL | Standard Error 4.42 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | 30.1 mL | Standard Error 4.03 |
| Solifenacin 5 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | 23.1 mL | Standard Error 3.26 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | 16.1 mL | Standard Error 4.64 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | 28.3 mL | Standard Error 5.16 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 | 35.8 mL | Standard Error 6.25 |
| Solifenacin 10 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | 37.7 mL | Standard Error 5.71 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | 35.6 mL | Standard Error 4.08 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | 22.5 mL | Standard Error 3.3 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | 29.2 mL | Standard Error 3.69 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 | 38.6 mL | Standard Error 4.52 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | 36.5 mL | Standard Error 3.67 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | 29.2 mL | Standard Error 3.3 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 | 43.7 mL | Standard Error 4.51 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | 42.3 mL | Standard Error 4.09 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | 49.7 mL | Standard Error 4.21 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 | 54.7 mL | Standard Error 4.6 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | 42.7 mL | Standard Error 3.73 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | 29.9 mL | Standard Error 3.4 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | 32.3 mL | Standard Error 3.34 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | 52.2 mL | Standard Error 4.08 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | 44.5 mL | Standard Error 3.65 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 | 56.6 mL | Standard Error 4.48 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | 45.7 mL | Standard Error 5 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | 55.8 mL | Standard Error 5.6 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | 29.5 mL | Standard Error 4.56 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 | 59.8 mL | Standard Error 6.26 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77 | 42.1 mL | Standard Error 4.52 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74 | 68.5 mL | Standard Error 5.67 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75 | 54.5 mL | Standard Error 5.06 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to Each Visit in Mean Volume Voided Per Micturition | Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73 | 66.2 mL | Standard Error 6.2 |
Secondary
Change From Baseline to End of Treatment in 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 Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | 13.1 units on a scale | Standard Deviation 21.11 |
| Mirabegron 25 mg | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | 5.8 units on a scale | Standard Deviation 19.38 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | 14.3 units on a scale | Standard Deviation 22.38 |
| Solifenacin 2.5 mg | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | 11.1 units on a scale | Standard Deviation 19.26 |
| Solifenacin 5 mg | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | 11.9 units on a scale | Standard Deviation 21.33 |
| Solifenacin 10 mg | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | 13.3 units on a scale | Standard Deviation 21.81 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | 11.6 units on a scale | Standard Deviation 21.94 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | 12.5 units on a scale | Standard Deviation 19.95 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | 11.8 units on a scale | Standard Deviation 18.91 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | 15.9 units on a scale | Standard Deviation 20.94 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | 15.3 units on a scale | Standard Deviation 24.17 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | 11.1 units on a scale | Standard Deviation 23.18 |
Secondary
Change From Baseline to End of Treatment 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.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score | 24.5 units on a scale | Standard Error 2.03 |
| Mirabegron 25 mg | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score | 22.5 units on a scale | Standard Error 2.08 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score | 25.8 units on a scale | Standard Error 2.07 |
| Solifenacin 2.5 mg | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score | 27.7 units on a scale | Standard Error 2.05 |
| Solifenacin 5 mg | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score | 23.7 units on a scale | Standard Error 1.47 |
| Solifenacin 10 mg | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score | 26.6 units on a scale | Standard Error 2.08 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score | 25.5 units on a scale | Standard Error 1.5 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score | 28.5 units on a scale | Standard Error 1.5 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score | 29.2 units on a scale | Standard Error 1.53 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score | 30.1 units on a scale | Standard Error 1.49 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score | 30.3 units on a scale | Standard Error 2.04 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score | 28.9 units on a scale | Standard Error 2.04 |
Comparison: Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.p-value: 0.2695% CI: [-2.1, 7.9]ANCOVA
p-value: 0.3895% CI: [-2.3, 6]ANCOVA
p-value: 0.02295% CI: [0.7, 8.9]ANCOVA
p-value: 0.0195% CI: [1.3, 9.7]ANCOVA
p-value: 0.00295% CI: [2.3, 10.5]ANCOVA
p-value: 0.00895% CI: [1.7, 11.6]ANCOVA
p-value: 0.03795% CI: [0.3, 10.2]ANCOVA
p-value: 0.595% CI: [-7.7, 3.7]ANCOVA
p-value: 0.6595% CI: [-4.4, 7]ANCOVA
p-value: 0.2595% CI: [-2.4, 8.9]ANCOVA
p-value: 0.7695% CI: [-5.7, 4.1]ANCOVA
p-value: 0.4795% CI: [-3.6, 7.8]ANCOVA
p-value: 0.6795% CI: [-3.9, 6]ANCOVA
p-value: 0.1195% CI: [-0.9, 9]ANCOVA
p-value: 0.06295% CI: [-0.2, 9.7]ANCOVA
p-value: 0.02595% CI: [0.7, 10.6]ANCOVA
p-value: 0.04195% CI: [0.2, 11.5]ANCOVA
p-value: 0.1295% CI: [-1.2, 10.1]ANCOVA
Secondary
Change From Baseline to End of Treatment 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 participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
Time frame: Baseline and Week 12
Population: The Full Analysis Set-Incontinence comprised participants in the FAS who reported at least 1 incontinence episode in the baseline diary. LOCF was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -0.95 incontinence episodes | Standard Error 0.365 |
| Mirabegron 25 mg | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -0.74 incontinence episodes | Standard Error 0.415 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -0.90 incontinence episodes | Standard Error 0.353 |
| Solifenacin 2.5 mg | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -1.26 incontinence episodes | Standard Error 0.386 |
| Solifenacin 5 mg | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -0.88 incontinence episodes | Standard Error 0.252 |
| Solifenacin 10 mg | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -0.97 incontinence episodes | Standard Error 0.386 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -0.75 incontinence episodes | Standard Error 0.251 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -0.85 incontinence episodes | Standard Error 0.26 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -1.22 incontinence episodes | Standard Error 0.266 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -1.14 incontinence episodes | Standard Error 0.306 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -0.27 incontinence episodes | Standard Error 0.304 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours | -0.97 incontinence episodes | Standard Error 0.333 |
Comparison: The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals (CI) for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.p-value: 0.5195% CI: [-1, 0.82]Stratified Rank ANCOVA
p-value: 0.2195% CI: [-0.57, 0.83]Stratified Rank ANCOVA
p-value: 0.8995% CI: [-0.68, 0.74]Stratified Rank ANCOVA
p-value: 0.00195% CI: [-1.06, 0.38]Stratified Rank ANCOVA
p-value: 0.05895% CI: [-1.04, 0.52]Stratified Rank ANCOVA
p-value: 0.1595% CI: [-0.17, 1.38]Stratified Rank ANCOVA
p-value: 0.4195% CI: [-0.91, 0.73]Stratified Rank ANCOVA
p-value: 0.4495% CI: [-0.88, 1.3]Stratified Rank ANCOVA
p-value: 0.8595% CI: [-0.95, 1.04]Stratified Rank ANCOVA
p-value: 0.8395% CI: [-1.36, 0.74]Stratified Rank ANCOVA
p-value: 0.5695% CI: [-0.8, 0.95]Stratified Rank ANCOVA
p-value: 0.4895% CI: [-1.07, 1.03]Stratified Rank ANCOVA
p-value: 0.1395% CI: [-0.67, 1.07]Stratified Rank ANCOVA
p-value: 0.622% CI: [-0.78, 0.99]Stratified Rank ANCOVA
p-value: 0.3495% CI: [-1.16, 0.63]Stratified Rank ANCOVA
p-value: 0.2495% CI: [-1.12, 0.74]Stratified Rank ANCOVA
p-value: 0.8895% CI: [-0.26, 1.61]Stratified Rank ANCOVA
p-value: 0.8395% CI: [-0.99, 0.95]Stratified Rank ANCOVA
Secondary
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
Time frame: Baseline and Week 12
Population: Full analysis set; LOCF was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -2.43 micturitions | Standard Error 0.291 |
| Mirabegron 25 mg | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -2.48 micturitions | Standard Error 0.298 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -2.56 micturitions | Standard Error 0.296 |
| Solifenacin 2.5 mg | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -2.44 micturitions | Standard Error 0.296 |
| Solifenacin 5 mg | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -2.54 micturitions | Standard Error 0.212 |
| Solifenacin 10 mg | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -3.22 micturitions | Standard Error 0.298 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -2.58 micturitions | Standard Error 0.215 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -2.93 micturitions | Standard Error 0.215 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -2.56 micturitions | Standard Error 0.219 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -3.34 micturitions | Standard Error 0.212 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -3.42 micturitions | Standard Error 0.294 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | -3.52 micturitions | Standard Error 0.291 |
Comparison: Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.p-value: 0.06295% CI: [-1.4, 0.03]ANCOVA
p-value: 0.9195% CI: [-0.63, 0.56]ANCOVA
p-value: 0.295% CI: [-0.98, 0.2]ANCOVA
p-value: 0.9695% CI: [-0.62, 0.58]ANCOVA
p-value: 0.00795% CI: [-1.39, -0.22]ANCOVA
p-value: 0.01695% CI: [-1.59, -0.16]ANCOVA
p-value: 0.00795% CI: [-1.68, -0.27]ANCOVA
p-value: 0.9195% CI: [-0.87, 0.77]ANCOVA
p-value: 0.7695% CI: [-0.94, 0.69]ANCOVA
p-value: 0.9995% CI: [-0.82, 0.81]ANCOVA
p-value: 0.7795% CI: [-0.82, 0.6]ANCOVA
p-value: 0.05895% CI: [-1.61, 0.03]ANCOVA
p-value: 0.6995% CI: [-0.85, 0.57]ANCOVA
p-value: 0.1795% CI: [-1.21, 0.21]ANCOVA
p-value: 0.7395% CI: [-0.84, 0.59]ANCOVA
p-value: 0.01295% CI: [-1.62, -0.2]ANCOVA
p-value: 0.01895% CI: [-1.8, -0.17]ANCOVA
p-value: 0.00995% CI: [-1.89, -0.28]ANCOVA
Secondary
Change From Baseline to End of Treatment 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.
Time frame: Baseline and Week 12
Population: Full Analysis Set participants with available Baseline and post-baseline data; LOCF imputation was used
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) | -1.4 units on a scale | Standard Error 0.14 |
| Mirabegron 25 mg | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) | -1.4 units on a scale | Standard Error 0.14 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) | -1.5 units on a scale | Standard Error 0.14 |
| Solifenacin 2.5 mg | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) | -1.5 units on a scale | Standard Error 0.14 |
| Solifenacin 5 mg | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) | -1.3 units on a scale | Standard Error 0.1 |
| Solifenacin 10 mg | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) | -1.5 units on a scale | Standard Error 0.14 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) | -1.4 units on a scale | Standard Error 0.1 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) | -1.7 units on a scale | Standard Error 0.1 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) | -1.7 units on a scale | Standard Error 0.1 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) | -1.8 units on a scale | Standard Error 0.1 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) | -1.8 units on a scale | Standard Error 0.14 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC) | -1.6 units on a scale | Standard Error 0.14 |
Comparison: Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.p-value: 0.3895% CI: [-0.5, 0.2]ANCOVA
p-value: 0.8595% CI: [-0.3, 0.3]ANCOVA
p-value: 0.02495% CI: [-0.6, 0]ANCOVA
p-value: 0.00595% CI: [-0.7, -0.1]ANCOVA
p-value: 0.00395% CI: [-0.7, -0.1]ANCOVA
p-value: 0.00495% CI: [-0.8, -0.2]ANCOVA
p-value: 0.1595% CI: [-0.6, 0.1]ANCOVA
p-value: 0.9995% CI: [-0.4, 0.4]ANCOVA
p-value: 0.6795% CI: [-0.5, 0.3]ANCOVA
p-value: 0.4495% CI: [-0.5, 0.2]ANCOVA
p-value: 0.8895% CI: [-0.3, 0.4]ANCOVA
p-value: 0.5395% CI: [-0.5, 0.3]ANCOVA
p-value: 195% CI: [-0.3, 0.3]ANCOVA
p-value: 0.08495% CI: [-0.6, 0]ANCOVA
p-value: 0.0395% CI: [-0.7, 0]ANCOVA
p-value: 0.0295% CI: [-0.7, -0.1]ANCOVA
p-value: 0.01795% CI: [-0.8, -0.1]ANCOVA
p-value: 0.2695% CI: [-0.6, 0.2]ANCOVA
Secondary
Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | -25.5 units on a scale | Standard Error 1.96 |
| Mirabegron 25 mg | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | -27.1 units on a scale | Standard Error 2.01 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | -27.5 units on a scale | Standard Error 2 |
| Solifenacin 2.5 mg | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | -29.8 units on a scale | Standard Error 1.99 |
| Solifenacin 5 mg | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | -26.8 units on a scale | Standard Error 1.42 |
| Solifenacin 10 mg | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | -29.9 units on a scale | Standard Error 2.01 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | -28.0 units on a scale | Standard Error 1.45 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | -31.7 units on a scale | Standard Error 1.45 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | -32.0 units on a scale | Standard Error 1.48 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | -33.5 units on a scale | Standard Error 1.44 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | -33.6 units on a scale | Standard Error 1.97 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) | -31.4 units on a scale | Standard Error 1.97 |
p-value: 0.05695% CI: [-9.4, 0.1]ANCOVA
p-value: 0.5695% CI: [-7.1, 3.9]ANCOVA
p-value: 0.4895% CI: [-7.5, 3.5]ANCOVA
Comparison: Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.p-value: 0.2195% CI: [-8, 1.7]ANCOVA
p-value: 0.5495% CI: [-5.2, 2.7]ANCOVA
p-value: 0.01695% CI: [-8.9, -0.9]ANCOVA
p-value: 0.01195% CI: [-9.3, -1.2]ANCOVA
p-value: <0.00195% CI: [-10.7, -2.8]ANCOVA
p-value: 0.00595% CI: [-11.6, -2]ANCOVA
p-value: 0.1395% CI: [-9.8, 1.2]ANCOVA
p-value: 0.6195% CI: [-6, 3.5]ANCOVA
p-value: 0.1295% CI: [-9.9, 1.2]ANCOVA
p-value: 0.3195% CI: [-7.3, 2.3]ANCOVA
p-value: 0.01295% CI: [-10.9, -1.3]ANCOVA
p-value: 0.00895% CI: [-11.3, -1.7]ANCOVA
p-value: 0.00195% CI: [-12.8, -3.2]ANCOVA
p-value: 0.00495% CI: [-13.5, -2.6]ANCOVA
p-value: 0.03595% CI: [-11.4, -0.4]ANCOVA
Secondary
Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | 2.44 units on a scale | Standard Error 0.298 |
| Mirabegron 25 mg | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | 2.61 units on a scale | Standard Error 0.307 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | 3.17 units on a scale | Standard Error 0.301 |
| Solifenacin 2.5 mg | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | 3.10 units on a scale | Standard Error 0.303 |
| Solifenacin 5 mg | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | 2.78 units on a scale | Standard Error 0.217 |
| Solifenacin 10 mg | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | 2.96 units on a scale | Standard Error 0.307 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | 2.96 units on a scale | Standard Error 0.221 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | 3.24 units on a scale | Standard Error 0.22 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | 3.47 units on a scale | Standard Error 0.225 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | 3.24 units on a scale | Standard Error 0.219 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | 3.51 units on a scale | Standard Error 0.301 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS) | 3.72 units on a scale | Standard Error 0.297 |
Comparison: Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group.p-value: 0.6395% CI: [-0.56, 0.92]ANCOVA
p-value: 0.5695% CI: [-0.43, 0.79]ANCOVA
p-value: 0.1495% CI: [-0.15, 1.06]ANCOVA
p-value: 0.02795% CI: [0.08, 1.3]ANCOVA
p-value: 0.1395% CI: [-0.14, 1.07]ANCOVA
p-value: 0.04995% CI: [0, 1.46]ANCOVA
p-value: 0.01195% CI: [0.22, 1.66]ANCOVA
p-value: 0.795% CI: [-0.67, 1.01]ANCOVA
p-value: 0.08495% CI: [-0.1, 1.56]ANCOVA
p-value: 0.1295% CI: [-0.18, 1.49]ANCOVA
p-value: 0.3695% CI: [-0.39, 1.06]ANCOVA
p-value: 0.2395% CI: [-0.32, 1.36]ANCOVA
p-value: 0.1695% CI: [-0.21, 1.25]ANCOVA
p-value: 0.03295% CI: [0.07, 1.52]ANCOVA
p-value: 0.00695% CI: [0.3, 1.76]ANCOVA
p-value: 0.03195% CI: [0.07, 1.52]ANCOVA
p-value: 0.01295% CI: [0.24, 1.9]ANCOVA
p-value: 0.00295% CI: [0.45, 2.1]ANCOVA
Secondary
Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent overall work impairment | -9.50 units on a scale | Standard Deviation 24.09 |
| Placebo | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent impairment while working | -7.50 units on a scale | Standard Deviation 24.539 |
| Placebo | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent activity impairment | -9.62 units on a scale | Standard Deviation 26.989 |
| Placebo | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent work time missed | -2.44 units on a scale | Standard Deviation 10.58 |
| Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent impairment while working | -16.13 units on a scale | Standard Deviation 24.314 |
| Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent work time missed | 0.53 units on a scale | Standard Deviation 3.031 |
| Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent overall work impairment | -16.32 units on a scale | Standard Deviation 24.653 |
| Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent activity impairment | -14.52 units on a scale | Standard Deviation 27.439 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent work time missed | -0.24 units on a scale | Standard Deviation 1.988 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent impairment while working | -10.00 units on a scale | Standard Deviation 22.22 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent overall work impairment | -9.91 units on a scale | Standard Deviation 21.464 |
| Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent activity impairment | -13.95 units on a scale | Standard Deviation 26.386 |
| Solifenacin 2.5 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent work time missed | -2.85 units on a scale | Standard Deviation 11.205 |
| Solifenacin 2.5 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent activity impairment | -13.73 units on a scale | Standard Deviation 27.052 |
| Solifenacin 2.5 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent impairment while working | -16.67 units on a scale | Standard Deviation 25.207 |
| Solifenacin 2.5 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent overall work impairment | -17.88 units on a scale | Standard Deviation 28.134 |
| Solifenacin 5 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent impairment while working | -17.33 units on a scale | Standard Deviation 22.689 |
| Solifenacin 5 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent activity impairment | -14.38 units on a scale | Standard Deviation 24.182 |
| Solifenacin 5 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent overall work impairment | -17.26 units on a scale | Standard Deviation 25.196 |
| Solifenacin 5 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent work time missed | -1.29 units on a scale | Standard Deviation 12.606 |
| Solifenacin 10 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent work time missed | -0.28 units on a scale | Standard Deviation 2.737 |
| Solifenacin 10 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent impairment while working | -10.00 units on a scale | Standard Deviation 17.728 |
| Solifenacin 10 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent activity impairment | -17.12 units on a scale | Standard Deviation 27.813 |
| Solifenacin 10 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent overall work impairment | -9.95 units on a scale | Standard Deviation 17.988 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent overall work impairment | -8.59 units on a scale | Standard Deviation 29.521 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent work time missed | -0.55 units on a scale | Standard Deviation 12.816 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent impairment while working | -8.43 units on a scale | Standard Deviation 27.523 |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent activity impairment | -14.11 units on a scale | Standard Deviation 31.398 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent impairment while working | -17.72 units on a scale | Standard Deviation 26.187 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent work time missed | -0.83 units on a scale | Standard Deviation 17.199 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent activity impairment | -25.31 units on a scale | Standard Deviation 26.158 |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent overall work impairment | -17.16 units on a scale | Standard Deviation 27.695 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent overall work impairment | -14.00 units on a scale | Standard Deviation 27.384 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent activity impairment | -17.43 units on a scale | Standard Deviation 29.008 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent impairment while working | -13.85 units on a scale | Standard Deviation 27.664 |
| Solifenacin 5 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent work time missed | -0.84 units on a scale | Standard Deviation 5.33 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent work time missed | -1.65 units on a scale | Standard Deviation 4.654 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent overall work impairment | -14.18 units on a scale | Standard Deviation 25.092 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent impairment while working | -13.39 units on a scale | Standard Deviation 24.515 |
| Solifenacin 5 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent activity impairment | -20.42 units on a scale | Standard Deviation 27.094 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent impairment while working | -18.00 units on a scale | Standard Deviation 29.642 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent overall work impairment | -17.69 units on a scale | Standard Deviation 29.323 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent work time missed | 0.79 units on a scale | Standard Deviation 6.757 |
| Solifenacin 10 mg + Mirabegron 25 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent activity impairment | -19.34 units on a scale | Standard Deviation 27.439 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent work time missed | -1.12 units on a scale | Standard Deviation 11.025 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent overall work impairment | -10.32 units on a scale | Standard Deviation 27.58 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent impairment while working | -9.29 units on a scale | Standard Deviation 26.377 |
| Solifenacin 10 mg + Mirabegron 50 mg | Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI) | Percent activity impairment | -19.74 units on a scale | Standard Deviation 30.021 |
Secondary
Percentage of Participants With 50% Reduction in Incontinence Episodes
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 participant's micturition diary.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 64.7 percentage of participants |
| Placebo | Percentage of Participants With 50% Reduction in Incontinence Episodes | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 94.1 percentage of participants |
| Placebo | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 76.5 percentage of participants |
| Placebo | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 94.1 percentage of participants |
| Placebo | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 82.4 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 30.8 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 61.5 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 40.0 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 70.0 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 60.0 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 77.8 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 72.2 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 77.8 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 77.8 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 66.7 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 86.7 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 73.3 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 86.7 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 84.6 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 85.7 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 58.8 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 57.6 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 74.3 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 73.5 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 76.5 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 57.1 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 66.7 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 64.3 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 86.7 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 78.6 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 82.9 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 51.4 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 64.7 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 66.7 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 68.6 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 73.3 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 63.3 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 66.7 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 80.0 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 75.8 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 96.7 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 90.6 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 96.9 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 75.0 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 71.9 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 95.7 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 95.8 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 81.8 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 78.3 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 66.7 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 91.7 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 95.8 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 95.8 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 91.7 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 95.8 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 90.0 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 68.4 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 75.0 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 68.4 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With 50% Reduction in Incontinence Episodes | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 90.0 percentage of participants |
Comparison: All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.p-value: 0.4895% CI: [0.16, 2.38]Regression, Logistic
p-value: 0.5895% CI: [0.25, 2.17]Regression, Logistic
p-value: 0.9395% CI: [0.34, 3.28]Regression, Logistic
p-value: 0.02395% CI: [1.4, 105.3]Regression, Logistic
p-value: 0.04295% CI: [1.08, 83.24]Regression, Logistic
p-value: 0.04795% CI: [1.03, 79.19]Regression, Logistic
p-value: 0.2395% CI: [0.52, 14.9]Regression, Logistic
p-value: 0.05895% CI: [0.01, 1.08]Regression, Logistic
p-value: 0.1595% CI: [0.02, 1.87]Regression, Logistic
p-value: 0.5595% CI: [0.04, 5.99]Regression, Logistic
p-value: 0.1195% CI: [0.02, 1.48]Regression, Logistic
p-value: 0.05495% CI: [0.01, 1.05]Regression, Logistic
p-value: 0.05995% CI: [0.01, 1.08]Regression, Logistic
p-value: 0.1295% CI: [0.02, 1.58]Regression, Logistic
p-value: 0.6495% CI: [0.11, 35.46]Regression, Logistic
p-value: 0.7695% CI: [0.09, 27.42]Regression, Logistic
p-value: 0.7995% CI: [0.08, 26.47]Regression, Logistic
p-value: 0.5595% CI: [0.04, 5.77]Regression, Logistic
Secondary
Percentage of Participants With a Health-related Quality of Life Total Score Response
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. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Health-related Quality of Life Total Score Response | 67.1 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With a Health-related Quality of Life Total Score Response | 57.3 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With a Health-related Quality of Life Total Score Response | 71.1 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With a Health-related Quality of Life Total Score Response | 74.0 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With a Health-related Quality of Life Total Score Response | 72.7 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With a Health-related Quality of Life Total Score Response | 74.7 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With a Health-related Quality of Life Total Score Response | 72.9 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With a Health-related Quality of Life Total Score Response | 78.6 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With a Health-related Quality of Life Total Score Response | 77.0 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With a Health-related Quality of Life Total Score Response | 84.2 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With a Health-related Quality of Life Total Score Response | 79.5 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With a Health-related Quality of Life Total Score Response | 82.1 percentage of participants |
Comparison: All statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.p-value: 0.9295% CI: [0.52, 2.08]Regression, Logistic
p-value: 0.9895% CI: [0.58, 1.77]Regression, Logistic
p-value: 0.4595% CI: [0.7, 2.23]Regression, Logistic
p-value: 0.2495% CI: [0.79, 2.53]Regression, Logistic
p-value: 0.01295% CI: [1.19, 4.09]Regression, Logistic
p-value: 0.3295% CI: [0.7, 2.9]Regression, Logistic
p-value: 0.2795% CI: [0.72, 3.14]Regression, Logistic
p-value: 0.06495% CI: [0.24, 1.04]Regression, Logistic
p-value: 0.5795% CI: [0.59, 2.61]Regression, Logistic
p-value: 0.5595% CI: [0.59, 2.68]Regression, Logistic
p-value: 0.7595% CI: [0.58, 2.13]Regression, Logistic
p-value: 0.7295% CI: [0.53, 2.49]Regression, Logistic
p-value: 0.7495% CI: [0.58, 2.15]Regression, Logistic
p-value: 0.3495% CI: [0.71, 2.71]Regression, Logistic
p-value: 0.1995% CI: [0.8, 3.07]Regression, Logistic
p-value: 0.01295% CI: [1.22, 4.94]Regression, Logistic
p-value: 0.2595% CI: [0.72, 3.47]Regression, Logistic
p-value: 0.2195% CI: [0.74, 3.75]Regression, Logistic
Secondary
Percentage of Participants With a Micturition Response
A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Population: Full analysis set participants with at least 8 micturitions per 24 hours at Baseline and including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Micturition Response | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | 53.9 percentage of participants |
| Placebo | Percentage of Participants With a Micturition Response | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | 55.4 percentage of participants |
| Placebo | Percentage of Participants With a Micturition Response | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 | 53.2 percentage of participants |
| Placebo | Percentage of Participants With a Micturition Response | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | 42.3 percentage of participants |
| Placebo | Percentage of Participants With a Micturition Response | Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | 27.8 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | 25.7 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With a Micturition Response | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 | 42.7 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | 35.7 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | 27.8 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | 46.4 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With a Micturition Response | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 | 47.4 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | 37.3 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | 47.2 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | 43.8 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | 50.7 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With a Micturition Response | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | 35.6 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With a Micturition Response | Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | 29.6 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With a Micturition Response | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | 43.1 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With a Micturition Response | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | 53.6 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With a Micturition Response | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 | 54.8 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With a Micturition Response | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | 40.0 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With a Micturition Response | Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | 26.4 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With a Micturition Response | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 | 47.9 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With a Micturition Response | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | 34.0 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With a Micturition Response | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | 47.9 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With a Micturition Response | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | 55.6 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With a Micturition Response | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | 44.4 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With a Micturition Response | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 | 54.7 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With a Micturition Response | Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | 34.7 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With a Micturition Response | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | 56.2 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | 36.4 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | 45.3 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | 46.8 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | 55.1 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 | 54.2 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 | 53.1 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | 38.5 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | 42.1 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | 54.3 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | 55.1 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | 53.8 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | 49.6 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | 34.1 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 | 52.1 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | 48.2 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 | 61.6 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | 56.3 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | 36.5 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | 62.0 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | 56.4 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | 65.3 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | 48.1 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 | 65.4 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | 57.1 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With a Micturition Response | Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | 36.4 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | EOT; n=79,75,76,73,146,75,144,145,140,146,78,79 | 58.2 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76 | 46.1 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72 | 61.1 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74 | 41.9 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With a Micturition Response | Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73 | 64.4 percentage of participants |
Comparison: All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.p-value: 0.4295% CI: [0.69, 2.39]Regression, Logistic
p-value: 0.4895% CI: [0.72, 2]Regression, Logistic
p-value: 0.6995% CI: [0.67, 1.83]Regression, Logistic
p-value: 0.9595% CI: [0.61, 1.69]Regression, Logistic
p-value: 0.01595% CI: [1.14, 3.21]Regression, Logistic
p-value: 0.02395% CI: [1.11, 3.84]Regression, Logistic
p-value: 0.1695% CI: [0.84, 2.84]Regression, Logistic
p-value: 0.7395% CI: [0.45, 1.76]Regression, Logistic
p-value: 0.795% CI: [0.45, 1.72]Regression, Logistic
p-value: 0.2695% CI: [0.74, 2.99]Regression, Logistic
p-value: 0.6995% CI: [0.63, 2.04]Regression, Logistic
p-value: 0.2995% CI: [0.73, 2.89]Regression, Logistic
p-value: 0.3195% CI: [0.75, 2.45]Regression, Logistic
p-value: 0.4595% CI: [0.7, 2.25]Regression, Logistic
p-value: 0.6495% CI: [0.64, 2.07]Regression, Logistic
p-value: 0.01395% CI: [1.18, 3.94]Regression, Logistic
p-value: 0.01795% CI: [1.16, 4.66]Regression, Logistic
p-value: 0.1195% CI: [0.88, 3.45]Regression, Logistic
Secondary
Percentage of Participants With a Symptom Bother Response
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Symptom Bother Response | 73.4 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With a Symptom Bother Response | 84.0 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With a Symptom Bother Response | 78.9 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With a Symptom Bother Response | 85.7 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With a Symptom Bother Response | 81.3 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With a Symptom Bother Response | 85.3 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With a Symptom Bother Response | 82.6 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With a Symptom Bother Response | 85.5 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With a Symptom Bother Response | 85.6 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With a Symptom Bother Response | 88.4 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With a Symptom Bother Response | 88.5 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With a Symptom Bother Response | 83.3 percentage of participants |
Comparison: All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.p-value: 0.495% CI: [0.63, 3.2]Regression, Logistic
p-value: 0.8995% CI: [0.55, 1.97]Regression, Logistic
p-value: 0.5795% CI: [0.63, 2.33]Regression, Logistic
p-value: 0.3695% CI: [0.7, 2.66]Regression, Logistic
p-value: 0.1595% CI: [0.83, 3.32]Regression, Logistic
p-value: 0.3195% CI: [0.67, 3.59]Regression, Logistic
p-value: 0.8195% CI: [0.42, 1.95]Regression, Logistic
p-value: 0.1995% CI: [0.75, 4.08]Regression, Logistic
p-value: 0.5995% CI: [0.56, 2.77]Regression, Logistic
p-value: 0.1395% CI: [0.83, 4.71]Regression, Logistic
p-value: 0.295% CI: [0.78, 3.16]Regression, Logistic
p-value: 0.0795% CI: [0.94, 5.34]Regression, Logistic
p-value: 0.1795% CI: [0.81, 3.33]Regression, Logistic
p-value: 0.08495% CI: [0.92, 3.92]Regression, Logistic
p-value: 0.04395% CI: [1.02, 4.48]Regression, Logistic
p-value: 0.01395% CI: [1.22, 5.58]Regression, Logistic
p-value: 0.05395% CI: [0.99, 5.97]Regression, Logistic
p-value: 0.3995% CI: [0.63, 3.26]Regression, Logistic
Secondary
Percentage of Participants With Deterioration in 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'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Deterioration in PPBC | 6.4 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With Deterioration in PPBC | 4.1 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Deterioration in PPBC | 5.3 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With Deterioration in PPBC | 4.0 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Deterioration in PPBC | 4.8 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Deterioration in PPBC | 2.7 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With Deterioration in PPBC | 4.3 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With Deterioration in PPBC | 2.8 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With Deterioration in PPBC | 2.9 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With Deterioration in PPBC | 1.4 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With Deterioration in PPBC | 1.3 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With Deterioration in PPBC | 6.4 percentage of participants |
Comparison: All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.p-value: 0.3295% CI: [0.06, 2.43]Regression, Logistic
p-value: 0.6595% CI: [0.21, 2.61]Regression, Logistic
p-value: 0.3995% CI: [0.13, 2.19]Regression, Logistic
p-value: 0.2295% CI: [0.1, 1.67]Regression, Logistic
p-value: 0.08295% CI: [0.04, 1.22]Regression, Logistic
p-value: 0.3695% CI: [0.04, 3.2]Regression, Logistic
p-value: 0.5195% CI: [0.42, 5.71]Regression, Logistic
p-value: 0.9995% CI: [0.19, 5.36]Regression, Logistic
p-value: 0.9695% CI: [0.24, 4.59]Regression, Logistic
p-value: 0.5795% CI: [0.12, 3.3]Regression, Logistic
p-value: 0.9395% CI: [0.28, 3.95]Regression, Logistic
p-value: 0.3795% CI: [0.06, 2.79]Regression, Logistic
p-value: 0.7495% CI: [0.2, 3.13]Regression, Logistic
p-value: 0.4695% CI: [0.12, 2.59]Regression, Logistic
p-value: 0.2895% CI: [0.1, 1.96]Regression, Logistic
p-value: 0.1195% CI: [0.04, 1.4]Regression, Logistic
p-value: 0.495% CI: [0.04, 3.66]Regression, Logistic
p-value: 0.595% CI: [0.39, 6.85]Regression, Logistic
Secondary
Percentage of Participants With Improvement in 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 1-point improvement (decrease) from Baseline in PPBC score.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Improvement in PPBC | 69.2 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With Improvement in PPBC | 76.7 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Improvement in PPBC | 78.9 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With Improvement in PPBC | 68.0 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Improvement in PPBC | 72.8 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Improvement in PPBC | 84.9 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With Improvement in PPBC | 74.5 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With Improvement in PPBC | 83.2 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With Improvement in PPBC | 77.9 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With Improvement in PPBC | 82.6 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With Improvement in PPBC | 82.9 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With Improvement in PPBC | 75.6 percentage of participants |
Comparison: All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.p-value: 0.0495% CI: [1.04, 4.95]Regression, Logistic
p-value: 0.7395% CI: [0.63, 1.92]Regression, Logistic
p-value: 0.0595% CI: [1, 3.3]Regression, Logistic
p-value: 0.2195% CI: [0.81, 2.59]Regression, Logistic
p-value: 0.02195% CI: [1.11, 3.66]Regression, Logistic
p-value: 0.1995% CI: [0.79, 3.4]Regression, Logistic
p-value: 0.7495% CI: [0.57, 2.19]Regression, Logistic
p-value: 0.5795% CI: [0.58, 2.71]Regression, Logistic
p-value: 0.1995% CI: [0.77, 3.64]Regression, Logistic
p-value: 0.6995% CI: [0.41, 1.79]Regression, Logistic
p-value: 0.995% CI: [0.55, 1.99]Regression, Logistic
p-value: 0.04895% CI: [1.01, 5.55]Regression, Logistic
p-value: 0.6795% CI: [0.6, 2.22]Regression, Logistic
p-value: 0.0795% CI: [0.95, 3.78]Regression, Logistic
p-value: 0.2395% CI: [0.77, 2.98]Regression, Logistic
p-value: 0.03495% CI: [1.06, 4.19]Regression, Logistic
p-value: 0.295% CI: [0.76, 3.84]Regression, Logistic
p-value: 0.6895% CI: [0.55, 2.49]Regression, Logistic
Secondary
Percentage of Participants With Major Improvement in 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'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.
Time frame: Baseline and Week 12
Population: Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Major Improvement in PPBC | 39.7 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With Major Improvement in PPBC | 42.5 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Major Improvement in PPBC | 38.2 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With Major Improvement in PPBC | 44.0 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Major Improvement in PPBC | 42.2 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Major Improvement in PPBC | 46.6 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With Major Improvement in PPBC | 48.2 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With Major Improvement in PPBC | 52.4 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With Major Improvement in PPBC | 54.4 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With Major Improvement in PPBC | 54.9 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With Major Improvement in PPBC | 57.9 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With Major Improvement in PPBC | 50.0 percentage of participants |
p-value: 0.6295% CI: [0.64, 2.12]Regression, Logistic
p-value: 0.2595% CI: [0.82, 2.17]Regression, Logistic
p-value: 0.1195% CI: [0.91, 2.41]Regression, Logistic
p-value: 0.0295% CI: [1.1, 2.97]Regression, Logistic
p-value: 0.01295% CI: [1.15, 3.05]Regression, Logistic
p-value: 0.07295% CI: [0.95, 3.1]Regression, Logistic
p-value: 0.2995% CI: [0.77, 2.44]Regression, Logistic
p-value: 0.9495% CI: [0.49, 1.93]Regression, Logistic
p-value: 0.895% CI: [0.46, 1.81]Regression, Logistic
p-value: 0.6795% CI: [0.59, 2.28]Regression, Logistic
p-value: 195% CI: [0.55, 1.8]Regression, Logistic
p-value: 0.6695% CI: [0.59, 2.31]Regression, Logistic
p-value: 0.3595% CI: [0.73, 2.4]Regression, Logistic
p-value: 0.1995% CI: [0.82, 2.67]Regression, Logistic
p-value: 0.05495% CI: [0.99, 3.28]Regression, Logistic
p-value: 0.03895% CI: [1.04, 3.38]Regression, Logistic
p-value: 0.1295% CI: [0.87, 3.39]Regression, Logistic
p-value: 0.3695% CI: [0.7, 2.67]Regression, Logistic
Secondary
Percentage of Participants With Zero Incontinence Episodes Post-baseline
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 participant.
Time frame: Weeks 2, 4, 8 and 12
Population: Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 47.1 percentage of participants |
| Placebo | Percentage of Participants With Zero Incontinence Episodes Post-baseline | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 82.4 percentage of participants |
| Placebo | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 58.8 percentage of participants |
| Placebo | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 82.4 percentage of participants |
| Placebo | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 64.7 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 23.1 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 46.2 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 20.0 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 50.0 percentage of participants |
| Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 50.0 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 61.1 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 55.6 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 61.1 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 61.1 percentage of participants |
| Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 44.4 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 73.3 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 40.0 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 66.7 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 69.2 percentage of participants |
| Solifenacin 2.5 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 71.4 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 50.0 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 45.5 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 60.0 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 58.8 percentage of participants |
| Solifenacin 5 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 64.7 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 50.0 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 53.3 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 57.1 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 73.3 percentage of participants |
| Solifenacin 10 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 71.4 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 54.3 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 40.0 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 55.9 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 51.5 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 54.3 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 50.0 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 46.7 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 51.5 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 63.3 percentage of participants |
| Solifenacin 2.5 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 60.6 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 86.7 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 71.9 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 87.5 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 62.5 percentage of participants |
| Solifenacin 5 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 65.6 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 87.0 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 87.5 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 77.3 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 52.2 percentage of participants |
| Solifenacin 5 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 52.4 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 70.8 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 79.2 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 79.2 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 79.2 percentage of participants |
| Solifenacin 10 mg + Mirabegron 25 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 79.2 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20 | 75.0 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19 | 52.6 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20 | 65.0 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19 | 52.6 percentage of participants |
| Solifenacin 10 mg + Mirabegron 50 mg | Percentage of Participants With Zero Incontinence Episodes Post-baseline | EOT; n=17,13,18,15,35,15,35,33,32,24,24,20 | 75.0 percentage of participants |
Comparison: All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.p-value: 0.5295% CI: [0.16, 2.56]Regression, Logistic
p-value: 0.4895% CI: [0.23, 1.99]Regression, Logistic
p-value: 0.9395% CI: [0.32, 2.81]Regression, Logistic
p-value: 0.01395% CI: [1.47, 25.6]Regression, Logistic
p-value: 0.03195% CI: [1.17, 25.77]Regression, Logistic
p-value: 0.05995% CI: [0.95, 15.58]Regression, Logistic
p-value: 0.3695% CI: [0.48, 7.58]Regression, Logistic
p-value: 0.2695% CI: [0.05, 2.17]Regression, Logistic
p-value: 0.3395% CI: [0.08, 2.31]Regression, Logistic
p-value: 0.9495% CI: [0.17, 6.68]Regression, Logistic
p-value: 0.2995% CI: [0.09, 2.02]Regression, Logistic
p-value: 0.1595% CI: [0.05, 1.6]Regression, Logistic
p-value: 0.1195% CI: [0.06, 1.34]Regression, Logistic
p-value: 0.2695% CI: [0.09, 1.89]Regression, Logistic
p-value: 0.2895% CI: [0.44, 16.17]Regression, Logistic
p-value: 0.3695% CI: [0.37, 15.46]Regression, Logistic
p-value: 0.5695% CI: [0.29, 9.72]Regression, Logistic
p-value: 0.8495% CI: [0.15, 4.76]Regression, Logistic