Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36091   clinical trials with a EudraCT protocol, of which   5934   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Randomized, Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate the Long-term Safety and Efficacy of Combination of Solifenacin Succinate with Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Patients with Overactive Bladder

    Summary
    EudraCT number
    2012-005736-29
    Trial protocol
    NL   BE   HU   IT   FI   GB   EE   SE   SK   CZ   LV   DK   SI   PL   ES   LT   BG   GR  
    Global end of trial date
    08 Sep 2016

    Results information
    Results version number
    v2(current)
    This version publication date
    19 Jul 2018
    First version publication date
    17 Aug 2017
    Other versions
    v1
    Version creation reason

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    178-CL-102
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02045862
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe B.V.
    Sponsor organisation address
    Sylviusweg 62, Leiden, Netherlands, 2333 BE
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Europe B.V., astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Europe B.V., astellas.resultsdisclosure@astellas.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Sep 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the safety and tolerability of long-term combination treatment with solifenacin (5 mg) and mirabegron (50 mg) compared to solifenacin and mirabegron monotherapy. The study comprised a single-blind, 2-week placebo run-in period followed by a randomized, double-blind, active-controlled, 12-month treatment period and then by a 2-week follow-up period.
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Mar 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 71
    Country: Number of subjects enrolled
    United States: 311
    Country: Number of subjects enrolled
    Mexico: 8
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Denmark: 4
    Country: Number of subjects enrolled
    Finland: 1
    Country: Number of subjects enrolled
    Germany: 94
    Country: Number of subjects enrolled
    Italy: 29
    Country: Number of subjects enrolled
    Norway: 32
    Country: Number of subjects enrolled
    Spain: 27
    Country: Number of subjects enrolled
    Sweden: 13
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Netherlands: 14
    Country: Number of subjects enrolled
    Bulgaria: 61
    Country: Number of subjects enrolled
    Czech Republic: 142
    Country: Number of subjects enrolled
    Estonia: 6
    Country: Number of subjects enrolled
    Hungary: 75
    Country: Number of subjects enrolled
    Latvia: 24
    Country: Number of subjects enrolled
    Lithuania: 39
    Country: Number of subjects enrolled
    Poland: 278
    Country: Number of subjects enrolled
    Romania: 32
    Country: Number of subjects enrolled
    Russian Federation: 86
    Country: Number of subjects enrolled
    Slovakia: 108
    Country: Number of subjects enrolled
    Slovenia: 2
    Country: Number of subjects enrolled
    Ukraine: 154
    Country: Number of subjects enrolled
    Malaysia: 3
    Country: Number of subjects enrolled
    Singapore: 8
    Country: Number of subjects enrolled
    Korea, Republic of: 122
    Country: Number of subjects enrolled
    Thailand: 4
    Country: Number of subjects enrolled
    Australia: 30
    Country: Number of subjects enrolled
    New Zealand: 12
    Country: Number of subjects enrolled
    South Africa: 26
    Worldwide total number of subjects
    1829
    EEA total number of subjects
    994
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1201
    From 65 to 84 years
    622
    85 years and over
    6

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Participants who had symptoms of “wet” overactive bladder (OAB) (urgency, urinary frequency and urgency incontinence) for ≥ 3 months were enrolled in 251 centers globally. A majority of the participants were recruited from participants who enrolled and completed studies 178-CL-101 or 905-EC-012.

    Pre-assignment
    Screening details
    A total of 2084 participants were screened, 2063 participants received placebo run-in treatment and 1829 participants were randomized into 1 of 3 treatment arms in a 1:1:4 ratio in the 52-week double-blind treatment period. Randomization was stratified by sex, age group (< 65 years, ≥ 65 years) and geographic region.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Mirabegron 50 mg
    Arm description
    Participants received mirabegron 50 mg once a day for 52 weeks.
    Arm type
    Active comparator

    Investigational medicinal product name
    Mirabegron
    Investigational medicinal product code
    YM178
    Other name
    Myrbetriq, Myrbetric, Betanis, Betmiga
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received mirabegron 50 mg orally once a day at the same time each day.

    Investigational medicinal product name
    Placebo to solifenacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

    Arm title
    Solifenacin 5 mg
    Arm description
    Participants received solifenacin 5 mg once a day for 52 weeks.
    Arm type
    Active comparator

    Investigational medicinal product name
    Solifenacin succinate
    Investigational medicinal product code
    YM905
    Other name
    Solifenacin, Vesicare, Vesikur, Vesitrim
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received solifenacin 5 mg orally once a day at the same time each day.

    Investigational medicinal product name
    Placebo to mirabegron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

    Arm title
    Solifenacin 5 mg + mirabegron 50 mg
    Arm description
    Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Mirabegron
    Investigational medicinal product code
    YM178
    Other name
    Myrbetriq, Myrbetric, Betanis, Betmiga
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received mirabegron 50 mg orally once a day at the same time each day.

    Investigational medicinal product name
    Solifenacin succinate
    Investigational medicinal product code
    YM905
    Other name
    Solifenacin, Vesicare, Vesikur, Vesitrim
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received solifenacin 5 mg orally once a day at the same time each day.

    Number of subjects in period 1
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Started
    306
    305
    1218
    Treated
    306
    303
    1210
    Safety Analysis Set (SAF)
    305
    303
    1206
    Full Analysis Set (FAS)
    302
    299
    1193
    Completed
    267
    265
    1092
    Not completed
    39
    40
    126
         Death
    -
    -
    1
         Miscellaneous
    5
    -
    8
         Withdrawal by patient
    18
    27
    57
         Protocol Violation
    -
    -
    6
         Lack of Efficacy
    8
    4
    13
         Randomized but not received study drug
    -
    2
    8
         Adverse Event
    7
    5
    27
         Lost to Follow-up
    1
    2
    6

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Mirabegron 50 mg
    Reporting group description
    Participants received mirabegron 50 mg once a day for 52 weeks.

    Reporting group title
    Solifenacin 5 mg
    Reporting group description
    Participants received solifenacin 5 mg once a day for 52 weeks.

    Reporting group title
    Solifenacin 5 mg + mirabegron 50 mg
    Reporting group description
    Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.

    Reporting group values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg Total
    Number of subjects
    306 305 1218
    Age categorical
    Units: Subjects
    Age continuous
    Randomized analysis set (RAS), comprised of all randomized participants.
    Units: years
        arithmetic mean (standard deviation)
    58.8 ± 12.7 59.0 ± 13.3 58.3 ± 13.0 -
    Gender categorical
    RAS
    Units:
        Male
    63 60 245 368
        Female
    243 245 973 1461
    Mean Number of Incontinence Episodes per 24 Hours
    RAS; data only available for 1818 participants [306, 303, 1209].
    Units: incontinence episodes
        arithmetic mean (standard deviation)
    3.17 ± 3.58 3.08 ± 3.56 3.03 ± 3.16 -
    Mean Number of Micturitions per 24 Hours
    RAS; data only available for 1818 participants [306, 303, 1209].
    Units: micturitions
        arithmetic mean (standard deviation)
    10.51 ± 2.4 10.74 ± 2.82 10.56 ± 2.73 -
    Mean Volume Voided per Micturition
    RAS; data only available for 1815 participants [306, 303, 1206].
    Units: mL
        arithmetic mean (standard deviation)
    161.37 ± 59.92 159.98 ± 58.58 158.74 ± 58.41 -
    Number of Incontinence Episodes per Week
    RAS; data only available for 1818 participants [306, 303, 1209].
    Units: incontinence episodes/week
        arithmetic mean (standard deviation)
    21.96 ± 24.91 21.45 ± 24.91 20.88 ± 21.82 -
    Mean Number of Urgency Incontinence Episodes per 24 Hours
    RAS; data only available for 1809 participants [306, 301, 1202]. Only participants with ≥ 1 urgency incontinence episode at baseline were included. An urgency incontinence episode is defined as the involuntary leakage of urine accompanied by or immediately proceeded by urgency.
    Units: urgency incontinence episodes
        arithmetic mean (standard deviation)
    2.88 ± 3.32 2.89 ± 3.47 2.74 ± 2.78 -
    Number of Urgency Incontinence Episodes per Week
    RAS; data only available for 1809 participants [306, 301, 1202]. Only participants with ≥ 1 urgency incontinence episode at baseline were included.
    Units: urgency incontinence episodes/week
        arithmetic mean (standard deviation)
    19.92 ± 23.04 20.13 ± 24.33 18.87 ± 19.07 -
    Mean Number of Urgency Episodes (Grade 3 or 4) per 24 Hours
    RAS; data only available for 1818 participants [306, 303, 1209]. Only participants with ≥ 1 urgency episode at baseline were included. An urgency episode is a complaint of a sudden, compelling desire to pass urine, which is difficult to defer; it is recorded when a micturition or incontinence episode is recorded and the severity of urinary urgency recorded is 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS).
    Units: urgency episodes
        arithmetic mean (standard deviation)
    6.38 ± 4.15 6.62 ± 4.07 6.55 ± 3.69 -
    Mean Number of Nocturia Episodes per 24 Hours
    RAS; data only available for 1563 participants [265, 256, 1042]. Only participants with ≥ 1 nocturia episode at baseline were included. A nocturia episode is defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake).
    Units: nocturia episodes
        arithmetic mean (standard deviation)
    1.49 ± 0.95 1.57 ± 0.94 1.5 ± 0.94 -
    Number of Nocturia Episodes per Week
    RAS; data only available for 1563 participants [265, 256, 1042]. Only participants with ≥ 1 nocturia episode at baseline were included.
    Units: nocturia episodes/week
        arithmetic mean (standard deviation)
    10.38 ± 6.68 10.93 ± 6.58 10.36 ± 6.48 -
    Mean Number of Pads Used per 24 Hours
    RAS; data only available for 1187 participants [204, 197, 786]. Only participants with ≥ 1 pad used at baseline were included.
    Units: pads
        arithmetic mean (standard deviation)
    2.49 ± 3.74 2.75 ± 3.12 2.57 ± 2.58 -
    Number of Pads Used per Week
    RAS; data only available for 1187 participants [204, 197, 786]. Only participants with ≥ 1 pad used at baseline were included.
    Units: pads/week
        arithmetic mean (standard deviation)
    17.13 ± 25.93 19.06 ± 21.84 17.66 ± 17.53 -

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Mirabegron 50 mg
    Reporting group description
    Participants received mirabegron 50 mg once a day for 52 weeks.

    Reporting group title
    Solifenacin 5 mg
    Reporting group description
    Participants received solifenacin 5 mg once a day for 52 weeks.

    Reporting group title
    Solifenacin 5 mg + mirabegron 50 mg
    Reporting group description
    Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.

    Primary: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Close Top of page
    End point title
    Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [1]
    End point description
    A TEAE is defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This includes abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of an AE was measured by: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities). The analysis population was the Safety Analysis Set (SAF), which consisted of all participants who received ≥ 1 dose of double-blind study drug and excluded participants from one site due to protocol noncompliance.
    End point type
    Primary
    End point timeframe
    From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no pre-determined hypothesis or comparative statistical analyses performed on the primary safety endpoint. However, hypothesis testing was performed for the primary and secondary efficacy endpoints.
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    305
    303
    1206
    Units: participants
        Any TEAEs
    126
    134
    596
        Mild TEAEs
    61
    69
    306
        Moderate TEAEs
    52
    58
    238
        Severe TEAEs
    13
    7
    52
        Drug-related TEAEs
    35
    42
    200
        Serious TEAEs
    8
    8
    51
        Drug-related serious TEAEs
    1
    0
    0
        TEAEs leading to discontiuation of study drug
    7
    5
    25
        Drug-related TEAEs leading to discont. of drug
    4
    4
    17
        TEAEs leading to death
    0
    0
    1
    No statistical analyses for this end point

    Primary: Change from Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes per 24 Hours

    Close Top of page
    End point title
    Change from Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes per 24 Hours
    End point description
    An incontinence episode is defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and week 52 clinic visits. The analysis population was the Full Analysis Set (FAS), which was comprised of all randomized participants who took ≥ 1 dose of double-blind treatment, reported ≥ 1 micturition in the baseline diary and ≥ 1 micturition postbaseline, reported ≥ 1 incontinence episode in the baseline diary and excluded participants from 2 sites due to protocol noncompliance and data integrity issues. Last observation carried forward (LOCF) was used for EoT.
    End point type
    Primary
    End point timeframe
    Baseline and Week 52
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    301
    297
    1184
    Units: incontinence episodes
        least squares mean (standard error)
    -1.58 ± 0.11
    -1.90 ± 0.11
    -2.03 ± 0.05
    Statistical analysis title
    Difference vs. Mirabegron 50 mg
    Statistical analysis description
    Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg + mirabegron 50 mg v Mirabegron 50 mg
    Number of subjects included in analysis
    1485
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [2]
    Method
    Stratified rank ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.45
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.69
         upper limit
    -0.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [2] - The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.
    Statistical analysis title
    Difference vs. Solifenacin 5 mg
    Statistical analysis description
    Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1481
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002 [3]
    Method
    Stratified rank ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.37
         upper limit
    0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [3] - The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.

    Primary: Change from Baseline to EoT in Mean Number of Micturitions per 24 Hours

    Close Top of page
    End point title
    Change from Baseline to EoT in Mean Number of Micturitions per 24 Hours
    End point description
    A micturition is defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits. The analysis population was the FAS. LOCF was used for EoT.
    End point type
    Primary
    End point timeframe
    Baseline and Week 52
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    301
    297
    1184
    Units: micturitions
        least squares mean (standard error)
    -2.10 ± 0.13
    -2.16 ± 0.13
    -2.58 ± 0.07
    Statistical analysis title
    Difference vs. Mirabegron 50 mg
    Statistical analysis description
    Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1485
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [4]
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.77
         upper limit
    -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Notes
    [4] - The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.
    Statistical analysis title
    Difference vs. Solifenacin 5 mg
    Statistical analysis description
    Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1481
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.004 [5]
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.71
         upper limit
    -0.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Notes
    [5] - The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.

    Secondary: Change from Baseline to EoT in Mean Volume Voided per Micturition

    Close Top of page
    End point title
    Change from Baseline to EoT in Mean Volume Voided per Micturition
    End point description
    The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period. The analysis population was the FAS, with baseline and at least one post-baseline measurement. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    289
    293
    1162
    Units: mL
        least squares mean (standard error)
    21.83 ± 3.12
    24.90 ± 3.10
    37.67 ± 1.55
    Statistical analysis title
    Difference vs. Solifenacin 5 mg
    Statistical analysis description
    Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1455
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    12.77
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.98
         upper limit
    19.57
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.47
    Statistical analysis title
    Difference vs. Mirabegron 50 mg
    Statistical analysis description
    Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1451
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    15.84
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    8.99
         upper limit
    22.69
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.49

    Secondary: Change from Baseline to EoT in OAB Questionnaire (OAB-q) Symptom Bother Score

    Close Top of page
    End point title
    Change from Baseline to EoT in OAB Questionnaire (OAB-q) Symptom Bother Score
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement. The analysis population was the FAS, with baseline and at least one post-baseline measurement. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    290
    294
    1163
    Units: units on a scale
        least squares mean (standard error)
    -21.96 ± 1.14
    -24.91 ± 1.13
    -29.51 ± 0.57
    Statistical analysis title
    Difference vs. Mirabegron 50 mg
    Statistical analysis description
    Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1453
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -7.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.05
         upper limit
    -5.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.27
    Statistical analysis title
    Difference vs. Solifenacin 5 mg
    Statistical analysis description
    Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1457
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -4.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.09
         upper limit
    -2.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.27

    Secondary: Change from Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)

    Close Top of page
    End point title
    Change from Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
    End point description
    The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. The analysis population was the FAS, with baseline and at least one post-baseline measurement. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    289
    294
    1163
    Units: units on a scale
        least squares mean (standard error)
    2.19 ± 0.12
    2.15 ± 0.12
    2.73 ± 0.06
    Statistical analysis title
    Difference vs. Mirabegron 50 mg
    Statistical analysis description
    Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1452
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.28
         upper limit
    0.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    Difference vs. Solifenacin 5 mg
    Statistical analysis description
    Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1457
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.32
         upper limit
    0.86
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14

    Secondary: Change from Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes per 24 Hours

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes per 24 Hours
    End point description
    An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: incontinence episodes
    least squares mean (standard error)
        Month 1 [N=291, 288, 1158]
    -0.97 ± 0.10
    -1.29 ± 0.11
    -1.45 ± 0.05
        Month 3 [N=282, 288, 1137]
    -1.31 ± 0.11
    -1.71 ± 0.11
    -1.78 ± 0.05
        Month 6 [N=266, 273, 1107]
    -1.42 ± 0.11
    -1.78 ± 0.11
    -1.93 ± 0.05
        Month 9 [N=264, 261, 1070]
    -1.53 ± 0.11
    -1.90 ± 0.11
    -2.00 ± 0.06
        Month 12 [N=258, 256, 1048]
    -1.67 ± 0.11
    -1.92 ± 0.11
    -2.06 ± 0.06
    No statistical analyses for this end point

    Secondary: Number of Incontinence Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)

    Close Top of page
    End point title
    Number of Incontinence Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)
    End point description
    An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant recorded an incontinence episode during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: incontinence episodes
    arithmetic mean (standard error)
        Month 1 [N=291, 288, 1158]
    14.88 ± 1.52
    12.41 ± 1.22
    10.80 ± 0.58
        Month 3 [N=282, 288, 1137]
    12.23 ± 1.12
    9.23 ± 1.02
    8.33 ± 0.52
        Month 6 [N=266, 273, 1107]
    10.62 ± 1.08
    8.18 ± 1.01
    7.28 ± 0.48
        Month 9 [N=264, 261, 1070]
    10.53 ± 1.19
    7.28 ± 0.91
    6.74 ± 0.45
        Month 12 [N=258, 266, 1048]
    9.09 ± 1.10
    7.06 ± 0.94
    6.10 ± 0.46
        EoT [N=301, 297, 1184]
    10.32 ± 1.08
    8.09 ± 0.94
    6.85 ± 0.47
    Statistical analysis title
    Rate ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed Effects Poisson-negative binomial
    Parameter type
    Rate ratio
    Point estimate
    0.67
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.54
         upper limit
    0.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Statistical analysis title
    Rate ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.029
    Method
    Mixed Effects Poisson-negative binomial
    Parameter type
    Rate ratio
    Point estimate
    0.77
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.61
         upper limit
    0.97
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
    End point description
    An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant recorded an incontinence episode during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: incontinence episodes
    least squares mean (standard error)
        Month 1 [N=291, 288, 1158]
    -6.77 ± 0.73
    -9.17 ± 0.73
    -10.31 ± 0.36
        Month 3 [N=282, 288, 1137]
    -9.21 ± 0.76
    -12.05 ± 0.75
    -12.55 ± 0.38
        Month 6 [N=266, 273, 1107]
    -10.36 ± 0.76
    -12.50 ± 0.75
    -13.49 ± 0.37
        Month 9 [N=264, 261, 1070]
    -10.62 ± 0.76
    -13.51 ± 0.77
    -14.06 ± 0.38
        Month 12 [N=258, 256, 1048]
    -11.84 ± 0.77
    -13.47 ± 0.77
    -14.43 ± 0.38
        EoT [N=301, 297, 1184]
    -11.17 ± 0.75
    -13.37 ± 0.75
    -14.29 ± 0.37
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Stratified rank ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -3.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.76
         upper limit
    -1.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.83
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Stratified rank ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.57
         upper limit
    0.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.84

    Secondary: Number of Incontinence-Free Days Reported During the 7-Day Micturition Diary Period Prior to Each Visit

    Close Top of page
    End point title
    Number of Incontinence-Free Days Reported During the 7-Day Micturition Diary Period Prior to Each Visit
    End point description
    The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: incontinence-free days
    arithmetic mean (standard error)
        Month 1 [N=291, 288, 1158]
    2.73 ± 0.15
    3.35 ± 0.17
    3.46 ± 0.08
        Month 3 [N=282, 288, 1137]
    3.30 ± 0.17
    3.98 ± 0.17
    4.17 ± 0.08
        Month 6 [N=266, 273, 1107]
    3.64 ± 0.17
    4.08 ± 0.17
    4.44 ± 0.08
        Month 9 [N=264, 261, 1070]
    3.97 ± 0.18
    4.33 ± 0.17
    4.56 ± 0.08
        Month 12 [N=258, 256, 1048]
    4.23 ± 0.18
    4.50 ± 0.18
    4.81 ± 0.08
        EoT [N=301, 297, 1184]
    3.98 ± 0.17
    4.29 ± 0.16
    4.64 ± 0.08
    Statistical analysis title
    Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio is from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Overdispersed binomial regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.26
         upper limit
    2.01
    Statistical analysis title
    Odds ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Odds ratio is from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.009
    Method
    Overdispersed binomial regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.08
         upper limit
    1.75

    Secondary: Number of Incontinence-Free Days with < 8 Micturitions per Day Reported During the 7-Day Micturition Diary Period Prior to Each Visit

    Close Top of page
    End point title
    Number of Incontinence-Free Days with < 8 Micturitions per Day Reported During the 7-Day Micturition Diary Period Prior to Each Visit
    End point description
    The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: days
    arithmetic mean (standard error)
        Month 1 [N=291, 288, 1158]
    1.03 ± 0.11
    1.01 ± 0.10
    1.33 ± 0.06
        Month 3 [N=282, 288, 1137]
    1.24 ± 0.12
    1.48 ± 0.13
    1.91 ± 0.07
        Month 6 [N=266, 273, 1107]
    1.56 ± 0.14
    1.66 ± 0.14
    2.13 ± 0.08
        Month 9 [N=264, 261, 1070]
    1.56 ± 0.14
    1.64 ± 0.14
    2.20 ± 0.08
        Month 12 [N=258, 256, 1048]
    1.87 ± 0.15
    1.92 ± 0.15
    2.54 ± 0.08
        EoT [N=301, 297, 1184]
    1.75 ± 0.14
    1.90 ± 0.14
    2.43 ± 0.07
    Statistical analysis title
    Odds ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Odds ratio is from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    Overdispersed binomial regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.45
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.14
         upper limit
    1.85
    Statistical analysis title
    Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio is from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Overdispersed binomial regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.61
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.26
         upper limit
    2.05

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes per 24 Hours

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes per 24 Hours
    End point description
    An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    297
    1187
    Units: urgency incontinence episodes
    least squares mean (standard error)
        Month 1 [N=291, 286, 1152]
    -0.93 ± 0.10
    -1.25 ± 0.10
    -1.43 ± 0.05
        Month 3 [N=282, 286, 1132]
    -1.30 ± 0.10
    -1.64 ± 0.10
    -1.71 ± 0.05
        Month 6 [N=266, 271, 1101]
    -1.40 ± 0.10
    -1.67 ± 0.10
    -1.86 ± 0.05
        Month 9 [N=264, 259, 1066]
    -1.60 ± 0.11
    -1.78 ± 0.11
    -1.92 ± 0.05
        Month 12 [N=258, 254, 1043]
    -1.60 ± 0.10
    -1.82 ± 0.10
    -1.98 ± 0.05
        EoT [N=301, 295, 1178]
    -1.51 ± 0.10
    -1.81 ± 0.10
    -1.94 ± 0.05
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1489
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [6]
    Method
    Stratified rank ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.43
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.65
         upper limit
    -0.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Notes
    [6] - The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1484
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.009 [7]
    Method
    Stratified rank ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.36
         upper limit
    0.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Notes
    [7] - The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.

    Secondary: Number of Urgency Incontinence Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit

    Close Top of page
    End point title
    Number of Urgency Incontinence Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
    End point description
    An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    297
    1187
    Units: urgency incontinence episodes
    arithmetic mean (standard error)
        Month 1 [N=291, 286, 1152]
    13.14 ± 1.42
    11.21 ± 1.19
    8.99 ± 0.47
        Month 3 [N=282, 286, 1132]
    10.37 ± 1.00
    8.12 ± 0.98
    6.95 ± 0.44
        Month 6 [N=266, 271, 1101]
    8.97 ± 0.95
    7.31 ± 0.96
    5.88 ± 0.41
        Month 9 [N=264, 259, 1066]
    8.08 ± 1.01
    6.51 ± 0.89
    5.47 ± 0.40
        Month 12 [N=258, 254, 1043]
    7.73 ± 1.00
    6.06 ± 0.85
    4.88 ± 0.38
        EoT [N=301, 295, 1178]
    8.86 ± 0.98
    7.04 ± 0.86
    5.57 ± 0.40
    Statistical analysis title
    Rate ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days at EoT as the offset variable.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1489
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Negative binomial regression
    Parameter type
    Rate ratio
    Point estimate
    0.62
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.48
         upper limit
    0.79
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13
    Statistical analysis title
    Rate ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day at EoT as the offset variable
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1484
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.023
    Method
    Negative binomial regression
    Parameter type
    Rate ratio
    Point estimate
    0.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.58
         upper limit
    0.96
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
    End point description
    An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: urgency incontinence episodes
    least squares mean (standard error)
        Month 1 [N=291, 286, 1152]
    -6.45 ± 0.69
    -8.77 ± 0.69
    -10.10 ± 0.34
        Month 3 [N=282, 286, 1132]
    -9.06 ± 0.72
    -11.48 ± 0.71
    -11.99 ± 0.36
        Month 6 [N=266, 271, 1101]
    -10.09 ± 0.72
    -11.71 ± 0.71
    -13.00 ± 0.35
        Month 9 [N=264, 259, 1066]
    -11.10 ± 0.72
    -12.60 ± 0.73
    -13.44 ± 0.36
        Month 12 [N=258, 254, 1043]
    -11.27 ± 0.71
    -12.80 ± 0.71
    -13.80 ± 0.35
        EoT [N=301, 295, 1178]
    -10.61 ± 0.70
    -12.66 ± 0.70
    -13.59 ± 0.35
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [8]
    Method
    Stratified rank ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -2.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.51
         upper limit
    -1.46
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.78
    Notes
    [8] - The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.006 [9]
    Method
    Stratified rank ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.47
         upper limit
    0.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.78
    Notes
    [9] - The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.

    Secondary: Change from Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions per 24 Hours

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions per 24 Hours
    End point description
    A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: micturitions
    least squares mean (standard error)
        Month 1 [N=291, 288, 1158]
    -1.09 ± 0.12
    -1.36 ± 0.12
    -1.64 ± 0.06
        Month 3 [N=282, 288, 1137]
    -1.63 ± 0.13
    -1.87 ± 0.12
    -2.16 ± 0.06
        Month 6 [N=266, 273, 1107]
    -1.85 ± 0.13
    -2.04 ± 0.13
    -2.39 ± 0.06
        Month 9 [N=264, 261, 1070]
    -2.03 ± 0.13
    -2.03 ± 0.13
    -2.42 ± 0.06
        Month 12 [N=258, 256, 1048]
    -2.20 ± 0.13
    -2.13 ± 0.14
    -2.64 ± 0.07
    No statistical analyses for this end point

    Secondary: Number of Days with < 8 Micturitions per Day Reported During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)

    Close Top of page
    End point title
    Number of Days with < 8 Micturitions per Day Reported During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)
    End point description
    The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: days
    arithmetic mean (standard error)
        Month 1 [N=291, 288, 1158]
    1.90 ± 0.13
    1.60 ± 0.12
    2.08 ± 0.07
        Month 3 [N=282, 288, 1137]
    2.07 ± 0.14
    2.14 ± 0.14
    2.66 ± 0.08
        Month 6 [N=266, 273, 1107]
    2.35 ± 0.15
    2.34 ± 0.15
    2.87 ± 0.08
        Month 9 [N=264, 261, 1070]
    2.38 ± 0.16
    2.33 ± 0.15
    2.93 ± 0.08
        Month 12 [N=258, 256, 1048]
    2.61 ± 0.16
    2.58 ± 0.16
    3.17 ± 0.08
        EoT [N=301, 297, 1184]
    2.52 ± 0.15
    2.58 ± 0.15
    3.10 ± 0.08
    Statistical analysis title
    Odds ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Odds ratio is from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.007
    Method
    Overdispersed binomial regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.37
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.09
         upper limit
    1.73
    Statistical analysis title
    Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio is from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    Overdispersed binomial regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.14
         upper limit
    1.8

    Secondary: Change from Baseline to EoT in Corrected Micturition Frequency

    Close Top of page
    End point title
    Change from Baseline to EoT in Corrected Micturition Frequency
    End point description
    Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT. The analysis population was the FAS. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    301
    297
    1184
    Units: micturitions
        least squares mean (standard error)
    -0.72 ± 0.17
    -1.11 ± 0.17
    -1.51 ± 0.08
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1485
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.16
         upper limit
    -0.41
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.19
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1481
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.037
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.77
         upper limit
    -0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.19

    Secondary: Change from Baseline to Months 3, 6 and 12 in Mean Volume Voided per Micturition

    Close Top of page
    End point title
    Change from Baseline to Months 3, 6 and 12 in Mean Volume Voided per Micturition
    End point description
    The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: mL
    least squares mean (standard error)
        Month 3 [N=274, 280, 1125]
    15.34 ± 2.96
    23.71 ± 2.92
    34.89 ± 1.45
        Month 6 [N=265, 268, 1102]
    20.87 ± 3.21
    27.08 ± 3.19
    38.56 ± 1.57
        Month 12 [N=248, 254, 1028]
    21.85 ± 3.42
    24.05 ± 3.37
    38.72 ± 1.67
    No statistical analyses for this end point

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) per 24 Hours

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) per 24 Hours
    End point description
    Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 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. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 urgency episode at baseline were included in the analysis. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: urgency episodes
    least squares mean (standard error)
        Month 1 [N=291, 288, 1158]
    -1.93 ± 0.17
    -2.31 ± 0.17
    -2.68 ± 0.09
        Month 3 [N=282, 288, 1137]
    -2.68 ± 0.17
    -3.02 ± 0.17
    -3.36 ± 0.08
        Month 6 [N=266, 273, 1107]
    -2.93 ± 0.17
    -3.17 ± 0.17
    -3.72 ± 0.08
        Month 9 [N=264, 261, 1070]
    -3.40 ± 0.18
    -3.55 ± 0.18
    -3.87 ± 0.09
        Month 12 [N=258, 256, 1048]
    -3.40 ± 0.17
    -3.56 ± 0.17
    -3.95 ± 0.09
        EoT [N=301, 297, 1184]
    -3.11 ± 0.17
    -3.45 ± 0.17
    -3.84 ± 0.08
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.73
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    -0.37
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.19
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.036
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.76
         upper limit
    -0.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.19

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes per 24 Hours

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes per 24 Hours
    End point description
    A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    262
    252
    1027
    Units: nocturia episodes
    least squares mean (standard error)
        Month 1 [N=253, 244, 1000]
    -0.20 ± 0.04
    -0.22 ± 0.04
    -0.34 ± 0.02
        Month 3 [N=247, 244, 985]
    -0.34 ± 0.04
    -0.38 ± 0.04
    -0.46 ± 0.02
        Month 6 [N=231, 231, 958]
    -0.41 ± 0.05
    -0.39 ± 0.05
    -0.49 ± 0.02
        Month 9 [N=229, 221, 927]
    -0.42 ± 0.05
    -0.44 ± 0.05
    -0.50 ± 0.02
        Month 12 [N=225, 217, 906]
    -0.46 ± 0.05
    -0.44 ± 0.05
    -0.56 ± 0.02
        EoT [N=262, 251, 1023]
    -0.45 ± 0.04
    -0.45 ± 0.04
    -0.55 ± 0.02
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1279
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.068
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.19
         upper limit
    0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1289
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.059
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.19
         upper limit
    0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05

    Secondary: Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit

    Close Top of page
    End point title
    Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
    End point description
    A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    262
    252
    1027
    Units: nocturia episodes
    arithmetic mean (standard error)
        Month 1 [N=253, 244, 1000]
    8.76 ± 0.41
    9.23 ± 0.44
    8.00 ± 0.20
        Month 3 [N=247, 244, 985]
    7.93 ± 0.39
    7.92 ± 0.40
    7.17 ± 0.19
        Month 6 [N=231, 231, 958]
    7.12 ± 0.35
    7.86 ± 0.43
    6.96 ± 0.20
        Month 9 [N=229, 221, 927]
    7.40 ± 0.38
    7.48 ± 0.41
    6.84 ± 0.20
        Month 12 [N=225, 217, 906]
    6.88 ± 0.38
    7.39 ± 0.44
    6.33 ± 0.19
        EoT [N=262, 251, 1023]
    7.13 ± 0.37
    7.47 ± 0.42
    6.51 ± 0.19
    Statistical analysis title
    Rate ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1289
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.067
    Method
    Negative binomial regression
    Parameter type
    Rate ratio
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.81
         upper limit
    1.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.06
    Statistical analysis title
    Rate ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day as the offset variable.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1279
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.131
    Method
    Negative binomial regression
    Parameter type
    Rate ratio
    Point estimate
    0.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.82
         upper limit
    1.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.06

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
    End point description
    A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    262
    252
    1027
    Units: nocturia episodes
    least squares mean (standard error)
        Month 1 [N=253, 244, 1000]
    -1.56 ± 0.29
    -1.58 ± 0.29
    -2.39 ± 0.15
        Month 3 [N=247, 244, 985]
    -2.45 ± 0.29
    -2.78 ± 0.30
    -3.26 ± 0.15
        Month 6 [N=231, 231, 958]
    -3.08 ± 0.33
    -2.81 ± 0.33
    -3.44 ± 0.16
        Month 9 [N=229, 221, 927]
    -2.91 ± 0.32
    -3.13 ± 0.32
    -3.55 ± 0.16
        Month 12 [N=225, 217, 906]
    -3.29 ± 0.32
    -3.08 ± 0.33
    -3.97 ± 0.16
        EoT [N=262, 251, 1023]
    -3.24 ± 0.31
    -3.20 ± 0.32
    -3.90 ± 0.16
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1289
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.055
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.67
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.34
         upper limit
    0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.35
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1279
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.048
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.39
         upper limit
    -0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.35

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used per 24 Hours

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used per 24 Hours
    End point description
    The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 pads used at baseline were included in the analysis. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    201
    193
    771
    Units: pads
    least squares mean (standard error)
        Month 1 [N=193, 185, 741]
    -0.67 ± 0.10
    -0.96 ± 0.11
    -1.25 ± 0.05
        Month 3 [N=188, 184, 734]
    -1.12 ± 0.11
    -1.30 ± 0.11
    -1.49 ± 0.06
        Month 6 [N=174, 173, 712]
    -1.30 ± 0.12
    -1.24 ± 0.12
    -1.59 ± 0.06
        Month 9 [N=173, 166, 689]
    -1.38 ± 0.12
    -1.31 ± 0.13
    -1.65 ± 0.06
        Month 12 [N=170, 162, 678]
    -1.35 ± 0.12
    -1.37 ± 0.13
    -1.67 ± 0.06
        EoT [N=200, 191, 762]
    -1.23 ± 0.12
    -1.38 ± 0.12
    -1.66 ± 0.06
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    972
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.69
         upper limit
    -0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    964
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.039
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.55
         upper limit
    -0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14

    Secondary: Number of Pads Used Reported During the 7-Day Micturition Diary Period Prior to Each Visit

    Close Top of page
    End point title
    Number of Pads Used Reported During the 7-Day Micturition Diary Period Prior to Each Visit
    End point description
    The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. Only participants with ≥ 1 pad used at baseline were included in the analysis. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    201
    193
    771
    Units: pads
    arithmetic mean (standard error)
        Month 1 [N=193, 185, 741]
    12.67 ± 1.98
    12.55 ± 1.59
    8.75 ± 0.50
        Month 3 [N=188, 184, 734]
    9.61 ± 1.12
    9.47 ± 1.28
    7.23 ± 0.50
        Month 6 [N=174, 173, 712]
    7.99 ± 1.03
    9.16 ± 1.28
    6.51 ± 0.47
        Month 9 [N=173, 166, 689]
    7.65 ± 1.08
    8.91 ± 1.28
    6.18 ± 0.46
        Month 12 [N=170, 162, 678]
    7.60 ± 1.05
    8.09 ± 1.23
    5.70 ± 0.44
        EoT [N=200, 191, 762]
    9.09 ± 1.07
    8.54 ± 1.10
    6.33 ± 0.45
    Statistical analysis title
    Rate ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    972
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Negative binomial regression
    Parameter type
    Rate ratio
    Point estimate
    0.58
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.45
         upper limit
    0.76
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    Rate ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    964
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.044
    Method
    Negative binomial regression
    Parameter type
    Rate ratio
    Point estimate
    0.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.58
         upper limit
    0.99
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used Reported During the 7-Day Micturition Diary Period Prior to Each Visit

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used Reported During the 7-Day Micturition Diary Period Prior to Each Visit
    End point description
    The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with ≥ 1 pad used at baseline were included in the analysis. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    201
    193
    771
    Units: pads
    least squares mean (standard error)
        Month 1 [N=193, 185, 741]
    -4.74 ± 0.71
    -6.72 ± 0.72
    -8.89 ± 0.36
        Month 3 [N=188, 184, 734]
    -7.83 ± 0.77
    -9.21 ± 0.78
    -10.47 ± 0.39
        Month 6 [N=174, 173, 712]
    -9.09 ± 0.85
    -8.86 ± 0.85
    -11.12 ± 0.42
        Month 9 [N=173, 166, 689]
    -9.59 ± 0.87
    -9.33 ± 0.89
    -11.44 ± 0.43
        Month 12 [N=170, 162, 678]
    -9.39 ± 0.85
    -9.92 ± 0.87
    -11.66 ± 0.42
        EoT [N=200, 191, 762]
    -8.59 ± 0.82
    -9.89 ± 0.84
    -11.58 ± 0.42
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    972
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -2.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.78
         upper limit
    -1.18
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.92
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    964
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.072
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -1.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.52
         upper limit
    0.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.93

    Secondary: Change from Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: units on a scale
    least squares mean (standard error)
        Month 1 [N=281, 286, 1132]
    -16.37 ± 1.08
    -20.82 ± 1.07
    -22.86 ± 0.54
        Month 3 [N=278, 286, 1137]
    -19.69 ± 1.08
    -23.13 ± 1.07
    -26.88 ± 0.53
        Month 6 [N=260, 272, 1108]
    -20.97 ± 1.14
    -24.27 ± 1.12
    -27.73 ± 0.55
        Month 9 [N=261, 264, 1077]
    -21.41 ± 1.15
    -25.82 ± 1.14
    -28.45 ± 0.56
        Month 12 [N=250, 255, 1049]
    -23.41 ± 1.19
    -25.38 ± 1.18
    -30.18 ± 0.58
    No statistical analyses for this end point

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQL): Total score

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQL): Total score
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: units on a scale
    least squares mean (standard error)
        Month 1 [N=281, 286, 1132]
    11.67 ± 0.92
    14.01 ± 0.91
    15.69 ± 0.45
        Month 3 [N=278, 286, 1137]
    15.25 ± 0.95
    16.41 ± 0.94
    19.26 ± 0.47
        Month 6 [N=260, 272, 1108]
    16.63 ± 1.02
    17.96 ± 1.00
    20.03 ± 0.49
        Month 9 [N=261, 264, 1077]
    16.69 ± 1.02
    18.53 ± 1.01
    20.75 ± 0.50
        Month 12 [N=250, 255, 1049]
    17.33 ± 1.04
    18.80 ± 1.03
    21.82 ± 0.51
        EoT [N=290, 294, 1163]
    16.57 ± 1.00
    18.47 ± 0.99
    21.33 ± 0.50
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    4.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.56
         upper limit
    6.96
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.12
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.01
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    2.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.68
         upper limit
    5.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.11

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life (HRQL) Subscale Score: Coping

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life (HRQL) Subscale Score: Coping
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: units on a scale
    least squares mean (standard error)
        Month 1 [N=281, 286, 1132]
    13.05 ± 1.09
    15.40 ± 1.08
    17.58 ± 0.54
        Month 3 [N=278, 286, 1137]
    17.57 ± 1.14
    18.38 ± 1.13
    21.64 ± 0.56
        Month 6 [N=260, 272, 1108]
    19.68 ± 1.22
    20.53 ± 1.19
    22.73 ± 0.59
        Month 9 [N=261, 264, 1077]
    19.54 ± 1.21
    21.21 ± 1.20
    23.58 ± 0.59
        Month 12 [N=250, 255, 1049]
    19.47 ± 1.25
    21.90 ± 1.23
    24.86 ± 0.61
        EoT [N=290, 294, 1163]
    18.54 ± 1.19
    21.13 ± 1.18
    24.14 ± 0.59
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    5.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.99
         upper limit
    8.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.33
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.022
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    3.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.43
         upper limit
    5.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.32

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life (HRQL) Subscale Score: Concern

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life (HRQL) Subscale Score: Concern
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: units on a scale
    least squares mean (standard error)
        Month 1 [N=281, 286, 1132]
    13.24 ± 1.03
    15.49 ± 1.02
    17.60 ± 0.51
        Month 3 [N=278, 286, 1137]
    16.37 ± 1.05
    17.64 ± 1.04
    21.23 ± 0.52
        Month 6 [N=260, 272, 1108]
    17.77 ± 1.10
    19.05 ± 1.07
    21.73 ± 0.53
        Month 9 [N=261, 264, 1077]
    18.15 ± 1.11
    19.74 ± 1.10
    22.30 ± 0.54
        Month 12 [N=250, 255, 1049]
    19.10 ± 1.12
    19.40 ± 1.10
    23.30 ± 0.54
        EoT [N=290, 294, 1163]
    17.98 ± 1.08
    19.22 ± 1.07
    23.00 ± 0.54
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    5.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.65
         upper limit
    7.38
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.21
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    3.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.43
         upper limit
    6.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life (HRQL) Subscale Score: Sleep

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life (HRQL) Subscale Score: Sleep
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: units on a scale
    least squares mean (standard error)
        Month 1 [N=281, 286, 1132]
    10.96 ± 1.08
    14.24 ± 1.07
    15.82 ± 0.54
        Month 3 [N=278, 286, 1137]
    14.09 ± 1.12
    16.71 ± 1.10
    19.75 ± 0.55
        Month 6 [N=260, 272, 1108]
    14.84 ± 1.22
    17.70 ± 1.19
    20.09 ± 0.59
        Month 9 [N=261, 264, 1077]
    14.86 ± 1.22
    17.73 ± 1.21
    21.15 ± 0.60
        Month 12 [N=250, 255, 1049]
    16.53 ± 1.29
    18.28 ± 1.27
    22.17 ± 0.63
        EoT [N=290, 294, 1163]
    16.44 ± 1.22
    18.32 ± 1.21
    21.59 ± 0.61
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    5.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.47
         upper limit
    7.83
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.36
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.016
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    3.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.62
         upper limit
    5.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.35

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life (HRQL) Subscale Score: Social

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life (HRQL) Subscale Score: Social
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: units on a scale
    least squares mean (standard error)
        Month 1 [N=281, 286, 1132]
    7.99 ± 0.84
    9.41 ± 0.83
    9.89 ± 0.42
        Month 3 [N=278, 286, 1137]
    11.14 ± 0.85
    11.19 ± 0.84
    12.22 ± 0.42
        Month 6 [N=260, 272, 1108]
    11.89 ± 0.89
    12.54 ± 0.87
    13.30 ± 0.43
        Month 9 [N=261, 264, 1077]
    11.92 ± 0.90
    13.33 ± 0.89
    13.64 ± 0.44
        Month 12 [N=250, 255, 1049]
    12.25 ± 0.90
    13.47 ± 0.89
    14.52 ± 0.44
        EoT [N=290, 294, 1163]
    11.57 ± 0.87
    13.22 ± 0.87
    14.25 ± 0.43
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.006
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    2.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.77
         upper limit
    4.59
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.98
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.287
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    1.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.87
         upper limit
    2.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.97

    Secondary: Change from Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
    End point description
    The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: units on a scale
    least squares mean (standard error)
        Month 1 [N=280, 286, 1131]
    1.88 ± 0.12
    1.95 ± 0.12
    2.27 ± 0.06
        Month 3 [N=277, 286, 1136]
    2.10 ± 0.11
    2.06 ± 0.11
    2.57 ± 0.06
        Month 6 [N=260, 272, 1108]
    2.22 ± 0.12
    2.25 ± 0.12
    2.72 ± 0.06
        Month 9 [N=261, 263, 1076]
    2.24 ± 0.12
    2.28 ± 0.12
    2.74 ± 0.06
        Month 12 [N=250, 255, 1049]
    2.33 ± 0.12
    2.34 ± 0.12
    2.89 ± 0.06
    No statistical analyses for this end point

    Secondary: Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)

    Close Top of page
    End point title
    Change from Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)
    End point description
    The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 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; 6. Causes me many severe problems. The analysis population is FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: units on a scale
    least squares mean (standard error)
        Month 1 [N=281, 287, 1133]
    -0.84 ± 0.07
    -0.89 ± 0.07
    -1.05 ± 0.03
        Month 3 [N=278, 286, 1137]
    -1.09 ± 0.07
    -1.08 ± 0.07
    -1.33 ± 0.03
        Month 6 [N=260, 272, 1108]
    -1.11 ± 0.07
    -1.18 ± 0.07
    -1.42 ± 0.04
        Month 9 [N=261, 264, 1077]
    -1.25 ± 0.07
    -1.31 ± 0.07
    -1.48 ± 0.04
        Month 12 [N=251, 255, 1049]
    -1.29 ± 0.08
    -1.36 ± 0.07
    -1.59 ± 0.04
        EoT [N=290, 294, 1163]
    -1.22 ± 0.07
    -1.34 ± 0.07
    -1.54 ± 0.04
    Statistical analysis title
    Difference vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.47
         upper limit
    -0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08
    Statistical analysis title
    Difference vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.011
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.36
         upper limit
    -0.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08

    Secondary: Percentage of Participants in Each Category of Patient’s Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT

    Close Top of page
    End point title
    Percentage of Participants in Each Category of Patient’s Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT
    End point description
    The PGIC is a 2-part questionnaire, assessing both the change in the participant’s overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). The analysis population was the FAS. The number of participants analyzed includes participants with data available. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: percentage of participants
    number (not applicable)
        Month 12: Very much improved
    25.5
    23.4
    33.8
        Month 12: Much improved
    30.5
    35.8
    34.0
        Month 12: Minimally improved
    21.9
    19.7
    16.1
        Month 12: No change
    5.0
    6.4
    4.5
        Month 12: Minimally worse
    0.7
    0.7
    0.4
        Month 12: Much worse
    1.0
    0.3
    0.1
        Month 12: Very much worse
    0.3
    0.3
    0.5
        EoT: Very much improved
    25.8
    24.4
    34.1
        EoT: Much improved
    31.5
    37.1
    34.7
        EoT: Minimally improved
    22.2
    20.4
    16.6
        EoT: No change
    6.3
    7.0
    5.1
        EoT: Minimally worse
    0.7
    0.7
    0.4
        EoT: Much worse
    1.3
    0.7
    0.1
        EoT: Very much worse
    0.3
    0.3
    0.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT

    Close Top of page
    End point title
    Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT
    End point description
    The PGIC is a 2-part questionnaire, assessing both the change in the participant’s overall condition and change in bladder condition since the start of the study (from very much worse to very much improved). The analysis population was the FAS. The number of participants analyzed includes participants with data available. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: percentage of participants
    number (not applicable)
        Month 12: Very much improved
    12.9
    14.7
    18.0
        Month 12: Much improved
    23.8
    26.8
    28.7
        Month 12: Minimally improved
    18.9
    17.1
    18.7
        Month 12: No change
    24.2
    24.7
    20.7
        Month 12: Minimally worse
    3.6
    2.7
    2.7
        Month 12: Much worse
    0.7
    0
    0.4
        Month 12: Very much worse
    0.7
    0.7
    0.3
        EoT: Very much improved
    13.2
    15.1
    18.3
        EoT: Much improved
    24.5
    27.8
    28.9
        EoT: Minimally improved
    19.2
    18.1
    19.1
        EoT: No change
    25.8
    25.8
    21.6
        EoT: Minimally worse
    3.6
    3.0
    2.8
        EoT: Much worse
    1.0
    0.3
    0.5
        EoT: Very much worse
    0.7
    0.7
    0.3
    No statistical analyses for this end point

    Secondary: Number of Participants With Change from Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility

    Close Top of page
    End point title
    Number of Participants With Change from Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility
    End point description
    The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The analysis population was the FAS. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: participants
    number (not applicable)
        No problems -> no problems
    164
    164
    675
        No problems -> slight problems
    15
    15
    56
        No problems -> moderate problems
    10
    4
    26
        No problems -> severe problems
    1
    1
    2
        No problems -> unable to walk about
    1
    0
    0
        No problems -> no data
    3
    0
    7
        Slight problems -> no problems
    19
    24
    83
        Slight problems -> slight problems
    18
    29
    87
        Slight problems -> moderate problems
    4
    6
    26
        Slight problems -> severe problems
    3
    1
    2
        Slight problems -> unable to walk about
    0
    0
    0
        Slight problems -> no data
    2
    1
    0
        Moderate problems -> no problems
    14
    11
    38
        Moderate problems -> slight problems
    13
    17
    47
        Moderate problems -> moderate problems
    9
    5
    50
        Moderate problems -> severe problems
    2
    4
    8
        Moderate problems -> unable to walk about
    0
    0
    0
        Moderate problems -> no data
    0
    0
    1
        Severe problems -> no problems
    2
    4
    15
        Severe problems -> slight problems
    2
    2
    13
        Severe problems -> moderate problems
    6
    4
    16
        Severe problems -> severe problems
    5
    3
    15
        Severe problems -> unable to walk about
    1
    0
    2
        Severe problems -> no data
    0
    0
    0
        Unable to walk about -> no problems
    0
    0
    1
        Unable to walk about -> slight problems
    0
    0
    1
        Unable to walk about -> moderate problems
    0
    0
    0
        Unable to walk about -> severe problems
    0
    0
    0
        Unable to walk about -> unable to walk about
    0
    0
    0
        Unable to walk about -> no data
    0
    0
    0
        No data -> no problems
    4
    3
    19
        No data -> slight problems
    4
    1
    3
        No data -> moderate problems
    0
    0
    0
        No data -> severe problems
    0
    0
    0
        No data -> unable to walk about
    0
    0
    0
        No data -> no data
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care

    Close Top of page
    End point title
    Number of Participants With Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care
    End point description
    The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The analysis population was the FAS. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: participants
    number (not applicable)
        No problems -> no problems
    223
    232
    906
        No problems -> slight problems
    12
    9
    40
        No problems -> moderate problems
    8
    0
    12
        No problems -> severe problems
    0
    1
    2
        No problems -> unable to wash/dress myself
    0
    0
    0
        No problems -> no data
    5
    1
    7
        Slight problems -> no problems
    16
    18
    64
        Slight problems -> slight problems
    9
    14
    44
        Slight problems -> moderate problems
    0
    4
    12
        Slight problems -> severe problems
    0
    1
    1
        Slight problems -> unable to wash/dress myself
    0
    0
    0
        Slight problems -> no data
    0
    0
    1
        Moderate problems -> no problems
    5
    4
    18
        Moderate problems -> slight problems
    5
    6
    20
        Moderate problems -> moderate problems
    5
    3
    21
        Moderate problems -> severe problems
    0
    0
    2
        Moderate problems -> unable to wash/dress myself
    0
    0
    0
        Moderate problems -> no data
    0
    0
    0
        Severe problems -> no problems
    0
    1
    8
        Severe problems -> slight problems
    1
    0
    3
        Severe problems -> moderate problems
    3
    1
    4
        Severe problems -> severe problems
    1
    0
    5
        Severe problems -> unable to wash/dress myself
    0
    0
    0
        Severe problems -> no data
    0
    0
    0
        Unable to wash/dress myself -> no problems
    0
    0
    0
        Unable to wash/dress myself -> slight problems
    0
    0
    1
        Unable to wash/dress myself -> moderate problems
    0
    0
    0
        Unable to wash/dress myself -> severe problems
    0
    0
    0
        Unable to wash/dress myself ->unable to wash/dress
    1
    0
    0
        Unable to wash/dress myself -> no data
    0
    0
    0
        No data -> no problems
    6
    3
    22
        No data -> slight problems
    2
    1
    0
        No data -> moderate problems
    0
    0
    0
        No data -> severe problems
    0
    0
    0
        No data -> unable to wash/dress myself
    0
    0
    0
        No data -> no data
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities

    Close Top of page
    End point title
    Number of Participants With Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities
    End point description
    The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The analysis population was the FAS. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: participants
        No problems -> No problems
    165
    160
    672
        No problems -> Slight problems
    13
    16
    65
        No problems -> Moderate problems
    8
    4
    15
        No problems -> Severe problems
    1
    0
    1
        No problems -> unable to do usual activities
    0
    0
    0
        No problems -> no data
    4
    0
    7
        Slight problems -> no problems
    27
    39
    131
        Slight problems -> slight problems
    28
    33
    85
        Slight problems -> moderate problems
    5
    6
    26
        Slight problems -> severe problems
    2
    1
    1
        Slight problems ->unable to do usual activities
    0
    0
    0
        Slight problems -> no data
    1
    0
    0
        Moderate problems -> no problems
    12
    12
    40
        Moderate problems -> slight problems
    11
    9
    44
        Moderate problems -> moderate problems
    7
    4
    43
        Moderate problems -> severe problems
    2
    0
    2
        Moderate problems ->unable to do usual activities
    0
    0
    0
        Moderate problems -> no data
    0
    1
    1
        Severe problems -> no problems
    2
    1
    10
        Severe problems -> slight problems
    0
    2
    9
        Severe problems -> moderate problems
    0
    6
    7
        Severe problems -> severe problems
    4
    1
    6
        Severe problems -> unable to do usual activities
    0
    0
    1
        Severe problems -> no data
    0
    0
    0
        Unable to do usual activities -> no problems
    0
    0
    0
        Unable to do usual activities -> slight problems
    0
    0
    1
        Unable to do usual activities -> moderate problems
    1
    0
    4
        Unable to do usual activities -> severe problems
    0
    0
    0
        Unable to do usual activities -> unable to do
    1
    0
    0
        Unable to do usual activities -> no data
    0
    0
    0
        No data -> no problems
    6
    2
    20
        No data -> slight problems
    1
    2
    2
        No data -> moderate problems
    1
    0
    0
        No data -> severe problems
    0
    0
    0
        No data -> unable to do usual activities
    0
    0
    0
        No data -> no data
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort

    Close Top of page
    End point title
    Number of Participants With Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort
    End point description
    The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The analysis population was the FAS. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: participants
        No pain/discomfort -> no pain/discomfort
    120
    119
    495
        No pain/discomfort -> slight pain/discomfort
    21
    19
    70
        No pain/discomfort -> moderate pain/discomfort
    7
    1
    20
        No pain/discomfort -> severe pain/discomfort
    1
    0
    3
        No pain/discomfort -> extreme pain/discomfort
    0
    0
    0
        No pain/discomfort -> no data
    2
    1
    6
        Slight pain/discomfort -> no pain/discomfort
    44
    37
    132
        Slight pain/discomfort -> slight pain/discomfort
    24
    48
    152
        Slight pain/discomfort -> moderate pain/discomfort
    11
    9
    26
        Slight pain/discomfort -> severe pain/discomfort
    2
    1
    5
        Slight pain/discomfort -> extreme pain/discomfort
    0
    0
    1
        Slight pain/discomfort -> no data
    0
    0
    1
        Moderate pain/discomfort -> no pain/discomfort
    9
    11
    49
        Moderate pain/discomfort -> slight pain/discomfort
    19
    17
    78
        Moderate pain/discomfort -> moderate pain/discomf
    16
    10
    65
        Moderate pain/discomfort -> severe pain/discomfort
    2
    3
    8
        Moderate pain/discomfort -> extreme pain/discomf
    0
    0
    1
        Moderate pain/discomfort -> no data
    1
    0
    1
        Severe pain/discomfort -> no pain/discomfort
    3
    6
    15
        Severe pain/discomfort -> slight pain/discomfort
    2
    3
    9
        Severe pain/discomfort -> moderate pain/discomfort
    5
    5
    13
        Severe pain/discomfort -> severe pain/discomfort
    2
    3
    11
        Severe pain/discomfort -> extreme pain/discomfort
    0
    0
    1
        Severe pain/discomfort -> no data
    1
    0
    0
        Extreme pain/discomfort -> no pain/discomfort
    0
    0
    0
        Extreme pain/discomfort -> slight pain/discomfort
    0
    0
    3
        Extreme pain/discomfort -> moderate pain/discomf
    1
    0
    2
        Extreme pain/discomfort -> severe pain/discomfort
    0
    2
    2
        Extreme pain/discomfort -> extreme pain/discomfort
    0
    0
    2
        Extreme pain/discomfort -> no data
    1
    0
    0
        No data -> no pain/discomfort
    5
    1
    11
        No data -> slight pain/discomfort
    3
    3
    11
        No data -> moderate pain/discomfort
    0
    0
    0
        No data -> severe pain/discomfort
    0
    0
    0
        No data -> extreme pain/discomfort
    0
    0
    0
        No data -> no data
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression

    Close Top of page
    End point title
    Number of Participants With Change from Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression
    End point description
    The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The analysis population was the FAS. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: participants
        Not anxious -> not anxious
    137
    142
    588
        Not anxious -> slightly anxious
    22
    18
    68
        Not anxious -> moderately anxious
    4
    1
    7
        Not anxious -> severely anxious
    1
    0
    1
        Not anxious -> extremely anxious
    0
    0
    0
        Not anxious -> no data
    3
    1
    5
        Slightly anxious -> not anxious
    35
    43
    177
        Slightly anxious -> slightly anxious
    30
    33
    106
        Slightly anxious -> moderately anxious
    4
    8
    21
        Slightly anxious -> severely anxious
    3
    1
    0
        Slightly anxious -> extremely anxious
    0
    1
    1
        Slightly anxious -> no data
    1
    0
    1
        Moderately anxious -> not anxious
    15
    11
    37
        Moderately anxious -> slightly anxious
    11
    14
    55
        Moderately anxious -> moderately anxious
    12
    8
    35
        Moderately anxious -> severely anxious
    1
    1
    5
        Moderately anxious -> extremely anxious
    0
    0
    0
        Moderately anxious -> no data
    0
    0
    1
        Severely anxious -> not anxious
    2
    2
    10
        Severely anxious -> slightly anxious
    3
    2
    14
        Severely anxious -> moderately anxious
    5
    3
    13
        Severely anxious -> severely anxious
    2
    1
    7
        Severely anxious -> extremely anxious
    1
    0
    1
        Severely anxious -> no data
    1
    0
    1
        Extremely anxious -> not anxious
    0
    1
    4
        Extremely anxious -> slightly anxious
    0
    2
    2
        Extremely anxious -> moderately anxious
    1
    0
    8
        Extremely anxious -> severely anxious
    0
    2
    2
        Extremely anxious -> extremely anxious
    0
    0
    1
        Extremely anxious -> no data
    0
    0
    0
        No data -> not anxious
    6
    3
    14
        No data -> slightly anxious
    1
    1
    7
        No data -> moderately anxious
    1
    0
    0
        No data -> severely anxious
    0
    0
    0
        No data -> extremely anxious
    0
    0
    1
        No data -> no data
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed

    Close Top of page
    End point title
    Change from Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed
    End point description
    The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with both baseline and post-baseline values are included in the analysis. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 6,12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    114
    136
    468
    Units: percentage of work time missed
    arithmetic mean (standard deviation)
        Month 6 [N=86, 112, 379]
    -0.49 ± 17.12
    -0.59 ± 15.67
    -3.11 ± 20.68
        Month 12 [N=83, 110, 359]
    0.39 ± 15.55
    -1.95 ± 18.51
    -3.74 ± 23.83
        EoT [N=96, 124, 421]
    -0.45 ± 18.51
    -1.30 ± 18.04
    -3.26 ± 22.88
    No statistical analyses for this end point

    Secondary: Change from Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working

    Close Top of page
    End point title
    Change from Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working
    End point description
    The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Only participants with both baseline and post-baseline values and who were employed during the study are included in the analysis. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 6,12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    114
    135
    461
    Units: percentage of impairment while working
    arithmetic mean (standard deviation)
        Month 6 [N=85, 111, 372]
    -16.94 ± 24.10
    -12.97 ± 21.05
    -13.41 ± 24.37
        Month 12 [N=83, 108, 349]
    -19.16 ± 23.38
    -14.72 ± 27.32
    -16.68 ± 24.16
        EoT [N=96, 123, 414]
    -17.81 ± 23.45
    -13.90 ± 27.18
    -15.63 ± 25.61
    No statistical analyses for this end point

    Secondary: Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment

    Close Top of page
    End point title
    Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment
    End point description
    The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. N is the number of participants analyzed with data available at each time point. Only participants with both baseline and post-baseline values and who were employed during the study are included in the analysis. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 6, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    114
    135
    461
    Units: percentage of overall work impairment
    arithmetic mean (standard deviation)
        Month 6 [N= 85, 111, 372]
    -16.33 ± 27.58
    -12.09 ± 22.26
    -13.99 ± 26.04
        Month 12 [N= 83, 108, 349]
    -17.83 ± 26.90
    -15.38 ± 27.97
    -17.27 ± 27.25
        EoT [N= 96, 123, 414]
    -16.83 ± 27.63
    -14.16 ± 27.51
    -16.15 ± 28.51
    No statistical analyses for this end point

    Secondary: Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment

    Close Top of page
    End point title
    Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment
    End point description
    The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement. N is the number of participants analyzed with data available at each time point. Only participants with both baseline and post-baseline values during the study are included in the analysis. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 6, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    292
    285
    1167
    Units: percentage of activity impairment
    arithmetic mean (standard deviation)
        Month 6 [N= 258, 272, 1105]
    -15.04 ± 27.08
    -16.25 ± 24.78
    -16.94 ± 28.49
        Month 12 [N= 248, 255, 1045]
    -16.85 ± 27.57
    -14.12 ± 29.87
    -18.91 ± 29.26
        EoT [N= 274, 281, 1124]
    -16.02 ± 27.63
    -14.02 ± 30.29
    -18.75 ± 29.14
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Zero Incontinence Episodes per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT

    Close Top of page
    End point title
    Percentage of Participants with Zero Incontinence Episodes per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT
    End point description
    An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: percentage of participants
    number (not applicable)
        Month 1 [N=291, 288, 1158]
    24.4
    39.9
    38.3
        Month 3 [N=282, 288, 1137]
    40.1
    44.8
    49.6
        Month 6 [N=266, 273, 1107]
    40.6
    50.5
    54.7
        Month 9 [N=264, 261, 1070]
    47.0
    54.4
    55.8
        Month 12 [N=258, 256, 1048]
    51.6
    55.5
    61.2
        EoT [N=301, 297, 1184]
    47.8
    53.2
    58.8
    Statistical analysis title
    Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.26
         upper limit
    2.15
    Statistical analysis title
    Odds ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.08
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.97
         upper limit
    1.67

    Secondary: Percentage of Participants with ≥ 10 Points Improvement from Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT

    Close Top of page
    End point title
    Percentage of Participants with ≥ 10 Points Improvement from Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: percentage of participants
    number (not applicable)
        Month 1 [N=281, 286, 1132]
    63.7
    67.5
    72.8
        Month 3 [N=278, 286, 1137]
    69.1
    71.3
    81.8
        Month 6 [N=260, 272, 1108]
    70.4
    74.6
    80.5
        Month 9 [N=261, 264, 1077]
    70.1
    76.1
    82.9
        Month 12 [N=250, 255, 1049]
    72.8
    74.1
    84.4
        EoT [N=290, 294, 1163]
    70.7
    72.4
    82.9
    Statistical analysis title
    Odds ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.87
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.37
         upper limit
    2.57
    Statistical analysis title
    Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.49
         upper limit
    2.78

    Secondary: Percentage of Participants with ≥ 10 Points Improvement from Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT

    Close Top of page
    End point title
    Percentage of Participants with ≥ 10 Points Improvement from Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT
    End point description
    The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: percentage of participants
    number (not applicable)
        Month 1 [N=281, 286, 1132]
    46.6
    53.8
    57.0
        Month 3 [N=278, 286, 1137]
    53.6
    59.4
    64.6
        Month 6 [N=260, 272, 1108]
    56.9
    62.9
    66.1
        Month 9 [N=261, 264, 1077]
    57.1
    62.9
    67.7
        Month 12 [N=250, 255, 1049]
    58.4
    62.4
    69.0
        EoT [N=290, 294, 1163]
    56.2
    61.6
    68.4
    Statistical analysis title
    Odds ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.014
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.08
         upper limit
    1.92
    Statistical analysis title
    Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.36
         upper limit
    2.43

    Secondary: Percentage of Participants with 50% Reduction in Mean Number of Incontinence Episodes per 24 Hours at Months 1, 3, 6, 9, 12 and EoT

    Close Top of page
    End point title
    Percentage of Participants with 50% Reduction in Mean Number of Incontinence Episodes per 24 Hours at Months 1, 3, 6, 9, 12 and EoT
    End point description
    An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: percentage of participants
    number (not applicable)
        Month 1 [N=291, 288, 1158]
    46.7
    55.2
    62.0
        Month 3 [N=282, 288, 1137]
    58.2
    67.0
    73.3
        Month 6 [N=266, 273, 1107]
    63.2
    71.8
    76.6
        Month 9 [N=264, 261, 1070]
    67.0
    73.6
    77.8
        Month 12 [N=258, 256, 1048]
    72.9
    75.4
    81.3
        EoT [N=301, 297, 1184]
    69.1
    73.1
    79.5
    Statistical analysis title
    Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.34
         upper limit
    2.41
    Statistical analysis title
    Odds ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.019
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.06
         upper limit
    1.95

    Secondary: Percentage of Participants with Zero Incontinence Episodes per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT

    Close Top of page
    End point title
    Percentage of Participants with Zero Incontinence Episodes per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT
    End point description
    An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: percentage of participants
    number (not applicable)
        Month 1 [N=291, 288, 1158]
    17.2
    26.4
    27.9
        Month 3 [N=282, 288, 1137]
    27.0
    35.1
    40.0
        Month 6 [N=266, 273, 1107]
    32.3
    39.9
    44.7
        Month 9 [N=264, 261, 1070]
    37.1
    43.7
    46.9
        Month 12 [N=258, 256, 1048]
    41.9
    47.3
    52.5
        EoT [N=301, 297, 1184]
    38.9
    45.1
    49.7
    Statistical analysis title
    Odds ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.133
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.94
         upper limit
    1.62
    Statistical analysis title
    Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.67
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.26
         upper limit
    2.19

    Secondary: Percentage of Participants with Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT

    Close Top of page
    End point title
    Percentage of Participants with Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT
    End point description
    The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at months 1, 3, 6, 9, 12 and EoT. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. Participants with less < 8 micturitions per 24 hours at baseline were not included in the analysis. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: percentage of participants
    number (not applicable)
        Month 1 [N=290, 287, 1155]
    34.5
    29.3
    36.8
        Month 3 [N=281, 287, 1135]
    36.7
    36.6
    46.6
        Month 6 [N=265, 272, 1105]
    42.3
    43.4
    51.4
        Month 9 [N=263, 260, 1069]
    44.5
    41.9
    52.5
        Month 12 [N=257, 255, 1047]
    46.3
    44.7
    56.4
        EoT [N=300, 296, 1181]
    46.0
    46.3
    55.9
    Statistical analysis title
    Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.18
         upper limit
    2.03
    Statistical analysis title
    Odds ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.006
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.12
         upper limit
    1.95

    Secondary: Percentage of Participants with ≥ 1 Point Improvement from Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT

    Close Top of page
    End point title
    Percentage of Participants with ≥ 1 Point Improvement from Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
    End point description
    The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 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; 6. Causes me many severe problems. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: percentage of participants
    number (not applicable)
        Month 1 [N=281, 287, 1133]
    53.0
    59.2
    64.1
        Month 3 [N=278, 286, 1137]
    61.9
    65.7
    72.5
        Month 6 [N=260, 272, 1108]
    64.6
    68.8
    73.8
        Month 9 [N=261, 264, 1077]
    65.5
    68.9
    75.1
        Month 12 [N=251, 255, 1049]
    69.7
    73.7
    76.9
        EoT [N=290, 294, 1163]
    66.2
    71.4
    76.0
    Statistical analysis title
    Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.24
         upper limit
    2.29
    Statistical analysis title
    Odds ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.109
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.94
         upper limit
    1.77

    Secondary: Percentage of Participants with Major (≥ 2 points) Improvement from Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT

    Close Top of page
    End point title
    Percentage of Participants with Major (≥ 2 points) Improvement from Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT
    End point description
    The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 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; 6. Causes me many severe problems. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: percentage of participants
    number (not applicable)
        Month 1 [N=281, 287, 1133]
    24.9
    28.2
    30.7
        Month 3 [N=278, 286, 1137]
    31.3
    33.9
    42.8
        Month 6 [N=260, 272, 1108]
    35.0
    38.2
    45.4
        Month 9 [N=261, 264, 1077]
    37.5
    40.9
    47.0
        Month 12 [N=251, 255, 1049]
    40.6
    40.4
    51.9
        EoT [N=290, 294, 1163]
    38.3
    39.8
    50.3
    Statistical analysis title
    Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.26
         upper limit
    2.25
    Statistical analysis title
    Odds ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.62
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.22
         upper limit
    2.16

    Secondary: Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT

    Close Top of page
    End point title
    Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT
    End point description
    An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: percentage of participants
    number (not applicable)
        Month 1 [N=274, 279, 1115]
    36.1
    46.6
    52.6
        Month 3 [N=270, 281, 1109]
    47.8
    55.5
    65.1
        Month 6 [N=250, 267, 1080]
    50.4
    56.9
    65.8
        Month 9 [N=254, 252, 1048]
    53.1
    61.9
    69.2
        Month 12 [N=245, 248, 1018]
    59.2
    60.9
    73.2
        EoT [N=289, 292, 1156]
    55.7
    58.2
    70.8
    Statistical analysis title
    Odds ratio vs. Mirabegron 50 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.
    Comparison groups
    Mirabegron 50 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1495
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.5
         upper limit
    2.62
    Statistical analysis title
    Odds ratio vs. Solifenacin 5 mg (EoT)
    Statistical analysis description
    Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.
    Comparison groups
    Solifenacin 5 mg v Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects included in analysis
    1492
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Logistic regression
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.35
         upper limit
    2.36

    Secondary: Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT

    Close Top of page
    End point title
    Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT
    End point description
    An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. The analysis population was the FAS. N is the number of participants analyzed with data available at each time point. LOCF was used for EoT.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 3, 6, 9, 12
    End point values
    Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + mirabegron 50 mg
    Number of subjects analysed
    302
    299
    1193
    Units: percentage of participants