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CompletedNCT01638000BEYONDUpdated Nov 21, 2024Results posted

A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

A Phase 3 interventional study of Mirabegron and Solifenacin succinate in Urologic Diseases, Urinary Bladder, Overactive and Urinary Bladder Diseases, sponsored by Astellas Pharma Europe Ltd.. Completed at 217 sites in 33 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-21.

Primary conditionUrinary Bladder, OveractiveRegistry: Urologic DiseasesReclassifiedWhy we changed it
Registry
Urologic Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Urinary Bladder, Overactive
Why
  1. The study's listed conditions name Urinary Bladder, Overactive, a narrower term within Urologic Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Astellas Pharma Europe Ltd. (part of Astellas Pharma Inc) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,887
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

02

Conditions studied

  • Urologic Diseases
  • Urinary Bladder, Overactive
  • Urinary Bladder Diseases

Keywords

  • Vesitrim
  • Frequency
  • Urgency
  • Urgency incontinence
  • Urinary incontinence
  • Overactive Bladder (OAB)
  • Micturition
  • Mirabegron
  • YM178
  • Vesicare
  • Solifenacin
03

In context

Urinary Bladder, Overactive Reclassified

858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.

This study's enrollment of 1,887 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Astellas Pharma Europe Ltd. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.

Browse Astellas Pharma Europe B.V. studies →All Astellas Pharma Inc studies →

Compared within Urinary Bladder, Overactive, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urologic Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject is willing and able to complete the micturition diary and questionnaires correctly
  • Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for at least 3 months
  • Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. The last antimuscarinic must have been taken for at least 4 weeks and taken within 6 months prior to the Screening Visit

Exclusion criteria

Exclusion Criteria:

  • Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of is sexually active and not practicing a highly reliable method of
  • Subject has neurogenic bladder
  • Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test)
  • Subject has an indwelling catheter or practices intermittent self-catheterization
  • Subject has diabetic neuropathy
  • Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
  • Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which makes the use of anticholinergics
  • The subject is currently receiving or has a history of treatment with intravesical botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior to screening
  • Subject receives non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to screening)
  • Subject has moderate to severe hepatic impairment
  • Subject has severe renal impairment or end stage renal disease
  • Subject has severe uncontrolled hypertension
  • Subject has a abnormal (ECG) or has a known history of or currently taking medication known to prolong the QT interval
  • Subject has a known or suspected to solifenacin, mirabegron or any of the inactive ingredients
  • Subject has a concurrent or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening
  • Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives
  • Subject is using prohibited medications which cannot be stopped safely at the Screening Visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria
  • Subject's last antimuscarinic treatment was solifenacin
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,887 participants (actual)

Study arms

  • Experimental
    Mirabegron 50 mg

    Participants who received mirabegron 50 mg once daily for 12 weeks.

    Drug: Mirabegron

  • Active comparator
    Solifenacin 5 mg

    Participants who received solifenacin 5 mg once daily for 12 weeks.

    Drug: Solifenacin succinate

Interventions

  • DrugMirabegron

    oral tablet

    Also known as: Betanis, YM178, Myrbetriq, Betmiga

  • DrugSolifenacin succinate

    oral tablet

    Also known as: Vesicare, YM905, Vesikur, Vesitrim

06

What researchers measure

Primary outcomes

  1. Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours

    A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

    Time frame: Baseline and final visit (up to Week 12)

Secondary outcomes

  1. Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period

    A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder).

    Time frame: From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)

  2. Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours

    Time frame: Baseline and Week 4, Week 8, Week 12

  3. Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

    An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

    Time frame: Week 4, Week 8, Week 12

  4. Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours

    An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

    Time frame: Baseline and Week 4, Week 8, Week 12

  5. Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

    An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

    Time frame: Week 4, Week 8, Week 12

  6. Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours

    An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

    Time frame: Baseline and Week 4, Week 8, Week 12

  7. Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours

    An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

    Time frame: Baseline and Week 4, Week 8, Week 12

  8. Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency

    Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence.

    Time frame: Baseline and Week 4, Week 8, Week 12

  9. Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit

    The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

    Time frame: Week 4, Week 8, Week 12

  10. Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment

    The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

    Time frame: Baseline and Week 4, Week 8 , Week 12

  11. Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

    A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

    Time frame: Week 4, Week 8, Week 12

  12. Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment

    A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

    Time frame: Baseline and Week 4, Week 8, Week 12

  13. Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit

    A responder is defined as a participant who has ≥8 micturitions at baseline and has \<8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is \<0.

    Time frame: Week 4, Week 8, Week 12

  14. Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit

    A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit.

    Time frame: Week 4, Week 8, Week 12

  15. Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit

    A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit.

    Time frame: Week 4, Week 8, Week 12

  16. Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire

    The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 4

  17. Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 4

  18. Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 4

  19. Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 4

  20. Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 4

  21. Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 8

  22. Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 8

  23. Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 8

  24. Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 8

  25. Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 8

  26. Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 12

  27. Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 12

  28. Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 12

  29. Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 12

  30. Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and Week 12

  31. Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and final visit (up to Week 12)

  32. Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and final visit (up to Week 12)

  33. Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and final visit (up to Week 12)

  34. Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and final visit (up to Week 12)

  35. Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

    The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

    Time frame: Baseline and final visit (up to Week 12)

  36. Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)

    The Overactive Bladder Questionnaire (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, scored from 1 to 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.

    Time frame: Baseline and Week 4, Week 8, Week 12

  37. Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q

    The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is 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 indicates an improvement.

    Time frame: Baseline and Week 4, Week 8, Week 12

  38. Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)

    The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical 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.

    Time frame: Baseline and Week 4, Week 8, Week 12

  39. Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)

    The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question "Are you satisfied with your treatment?" and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely).

    Time frame: Baseline and Week 12

  40. Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale

    The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question "How satisfied were you with your treatment?" with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied).

    Time frame: Baseline and Week 12

  41. Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit

    A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline.

    Time frame: Baseline to Week 12

  42. Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit

    A responder is defined as a participant with \>=10 points improvement in the total HRQL score from baseline.

    Time frame: Baseline to Week 12

  43. Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12

    A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale.

    Time frame: Baseline to Week 12

  44. Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit

    A responder is defined as a participant with \>=1 or \>=2 or \>=3 or \>=4 or \>=5 or 6-point improvement from baseline in TS-Likert scale.

    Time frame: Baseline to final visit (up to Week 12)

  45. Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit

    A responder is defined as a participant with ≥1 point improvement in PPBC from baseline.

    Time frame: Baseline to Week 12

  46. Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit

    A responder is defined as a participant with ≥2 point improvement in PPBC from baseline.

    Time frame: Baseline to Week 12

07

Results

Posted Aug 30, 2016

Participant flow

Participants recruited for this study were men and women with overactive bladder (OAB) who had received 1 or more antimuscarinics in the past and who were dissatisfied with their last antimuscarinic treatment due to lack of efficacy (provided that their previous antimuscarinic was not solifenacin).

Participant flow — Overall Study
MilestoneMirabegron 50 mgSolifenacin 5 mg
Started943944
Received at least 1 double-blind dose936934
Completed883873
Not completed6071
Withdrew: Randomized but never received drug710
Withdrew: Adverse event1416
Withdrew: Lack of efficacy56
Withdrew: Protocol violation1113
Withdrew: Withdrawal by subject2124
Withdrew: Miscellaneous22

Outcome measures

PrimaryChange From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours

A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time frame:
Baseline and final visit (up to Week 12)
Reported as:
Least squares mean · micturitions
Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours
micturitionsMirabegron 50 mgSolifenacin 5 mg
Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours-2.95 ± 0.087-3.13 ± 0.088
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.15 (If p\<0.05, this indicated superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.18 · 95% CI -0.42 to 0.06Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
SecondaryPercentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period

A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder).

Time frame:
From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)
Reported as:
Number · percentage of participants
Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period
percentage of participantsMirabegron 50 mgSolifenacin 5 mg
Overall57.4
Dry mouth3.15.8
Dry throat0.10.1
Blurred vision0.60.4
Constipation2.22.5
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.030 (If P \<0.05, this indicates superiority in favor of the treatment group with the smallest percentage of participants with at least 1 TEAE of dry mouth, constipation or blurred vision during the double-blind period at the final visit.) · Odds ratio (or): 1.53 · 95% CI 1.04 to 2.25Included treatment group, sex, age group (\< 65, ≥ 65), number of prior antimuscarinics (1, ≥ 2) and geographic region as factors.
SecondaryChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours
Time frame:
Baseline and Week 4, Week 8, Week 12
Reported as:
Least squares mean · micturitions
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours
micturitionsMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=916,906]-2.37 ± 0.083-2.33 ± 0.083
Week 8 [N=888,876]-2.77 ± 0.084-3.00 ± 0.085
Week 12 [N=870,856]-3.02 ± 0.088-3.21 ± 0.089
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.71 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: 0.04 · 95% CI -0.19 to 0.27Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.053 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.23 · 95% CI -0.47 to 0.00Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.12 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.20 · 95% CI -0.44 to 0.05Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
SecondaryNumber of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

Time frame:
Week 4, Week 8, Week 12
Reported as:
Mean · incontinence episodes
Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
incontinence episodesMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=404,410]2.64 ± 0.2802.25 ± 0.217
Week 8 [N=387,397]2.19 ± 0.4571.28 ± 0.135
Week 12 [N=381,387]2.07 ± 0.5621.08 ± 0.124
Final visit [N=404,413]2.13 ± 0.5331.29 ± 0.157
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.33 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 0.90 · 95% CI 0.73 to 1.11Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.21 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 0.84 · 95% CI 0.64 to 1.10Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.83 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 0.97 · 95% CI 0.71 to 1.32Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.57 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 0.92 · 95% CI 0.68 to 1.24Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
SecondaryChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time frame:
Baseline and Week 4, Week 8, Week 12
Reported as:
Least squares mean · incontinence episodes
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
incontinence episodesMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=404,410]-1.22 ± 0.063-1.30 ± 0.063
Week 8 [N=387,397]-1.37 ± 0.093-1.59 ± 0.092
Week 12 [N=381,387]-1.41 ± 0.115-1.66 ± 0.114
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.36 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.08 · 95% CI -0.25 to 0.10From stratified rank ANCOVA analysis.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.12 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.22 · 95% CI -0.48 to 0.03From the stratified rank ANCOVA analysis.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.47 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.25 · 95% CI -0.57 to 0.07From the stratified rank ANCOVA analysis.
SecondaryNumber of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

Time frame:
Week 4, Week 8, Week 12
Reported as:
Mean · urgency incontinence episodes
Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
urgency incontinence episodesMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=395,399]2.27 ± 0.2302.16 ± 0.213
Week 8 [N=379,386]1.74 ± 0.2271.13 ± 0.125
Week 12 [N=373,377]1.44 ± 0.2171.03 ± 0.120
Final visit [N=395,402]1.51 ± 0.2111.23 ± 0.150
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.44 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 0.92 · 95% CI 0.74 to 1.14Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.11 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 0.79 · 95% CI 0.60 to 1.06Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.78 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 1.05 · 95% CI 0.76 to 1.45Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.85 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 0.97 · 95% CI 0.71 to 1.33Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates
SecondaryChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours

An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time frame:
Baseline and Week 4, Week 8, Week 12
Reported as:
Least squares mean · urgency incontinence episodes
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
urgency incontinence episodesMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=395,399]-1.22 ± 0.057-1.24 ± 0.057
Week 8 [N=379,386]-1.39 ± 0.050-1.56 ± 0.050
Week 12 [N=373,377]-1.49 ± 0.047-1.59 ± 0.047
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.66 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.02 · 95% CI -0.18 to 0.14From stratified rank ANCOVA analysis.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.17 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.17 · 95% CI -0.31 to -0.03From the stratified rank ANCOVA analysis.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.66 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.11 · 95% CI -0.24 to 0.02From the stratified rank ANCOVA analysis.
SecondaryChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours

An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time frame:
Baseline and Week 4, Week 8, Week 12
Reported as:
Least squares mean · urgency episodes
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
urgency episodesMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=915,905]-3.75 ± 0.113-3.88 ± 0.114
Week 8 [N=887,875]-4.44 ± 0.111-4.79 ± 0.112
Week 12 [N=869,855]-4.67 ± 0.116-4.99 ± 0.117
Final Visit [N=919,909]-4.61 ± 0.115-4.84 ± 0.115
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.43 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.13 · 95% CI -0.44 to 0.19Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.027 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.35 · 95% CI -0.66 to -0.04Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.053 · Least squares mean difference: -0.32 · 95% CI -0.64 to 0.00Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.16 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.23 · 95% CI -0.55 to 0.09Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
SecondaryChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency

Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence.

Time frame:
Baseline and Week 4, Week 8, Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency
units on a scaleMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=916,906]-0.36 ± 0.016-0.36 ± 0.017
Week 8 [N=888,876]-0.50 ± 0.019-0.52 ± 0.019
Week 12 [N=870,856]-0.60 ± 0.023-0.60 ± 0.023
Final visit [N=920,910]-0.58 ± 0.022-0.57 ± 0.022
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.99 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.00 · 95% CI -0.05 to 0.05Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.47 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.02 · 95% CI -0.07 to 0.03Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.99 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: 0.00 · 95% CI -0.06 to 0.06Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.74 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: 0.01 · 95% CI -0.05 to 0.07Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
SecondaryNumber of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit

The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

Time frame:
Week 4, Week 8, Week 12
Reported as:
Mean · pads
Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit
padsMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=574,563]4.25 ± 0.3244.26 ± 0.297
Week 8 [N=551,543]3.33 ± 0.2843.27 ± 0.236
Week 12 [N=543,532]3.19 ± 0.3043.04 ± 0.244
Final visit [N=576,565]3.32 ± 0.3003.19 ± 0.248
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.67 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 1.03 · 95% CI 0.89 to 1.20Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.073 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 1.17 · 95% CI 0.99 to 1.39Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.25 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 1.12 · 95% CI 0.92 to 1.37Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.40 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 1.08 · 95% CI 0.90 to 1.31Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
SecondaryChange From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment

The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time frame:
Baseline and Week 4, Week 8 , Week 12
Reported as:
Least squares mean · pads
Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment
padsMirabegron 50 mgSolifenacin 5 mg
Week 4 [M=574,563]-1.80 ± 0.081-1.82 ± 0.081
Week 8 [N=551,543]-2.10 ± 0.070-2.14 ± 0.070
Week 12 [N=543,532]-2.14 ± 0.078-2.20 ± 0.079
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.84 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.02 · 95% CI -0.25 to 0.20Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.63 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.05 · 95% CI -0.24 to 0.15Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.59 (if p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.06 · 95% CI -0.28 to 0.16Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
SecondaryNumber of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

Time frame:
Week 4, Week 8, Week 12
Reported as:
Mean · nocturia episodes
Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
nocturia episodesMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=877,871]4.78 ± 0.1205.12 ± 0.139
Week 8 [N=850, 844]4.26 ± 0.1184.41 ± 0.117
Week 12 [N=831,828]3.94 ± 0.1154.06 ± 0.116
Final Visit [N=879,875]4.05 ± 0.1204.13 ± 0.114
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.068 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 1.05 · 95% CI 1.00 to 1.11Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.21 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 1.04 · 95% CI 0.98 to 1.11Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.52 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 1.02 · 95% CI 0.95 to 1.10Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Poisson regression · p = 0.44 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Rate ratio: 1.03 · 95% CI 0.96 to 1.10Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
SecondaryChange From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment

A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time frame:
Baseline and Week 4, Week 8, Week 12
Reported as:
Least squares mean · nocturia episodes
Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment
nocturia episodesMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=877,871]-0.72 ± 0.033-0.63 ± 0.034
Week 8 [N=850,844]-0.90 ± 0.031-0.87 ± 0.031
Week 12 [N=831,828]-0.98 ± 0.032-0.97 ± 0.033
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.058 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: 0.09 · 95% CI -0.00 to 0.18Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.50 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: 0.03 · 95% CI -0.06 to 0.12Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.81 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: 0.01 · 95% CI -0.08 to 0.10Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
SecondaryPercentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit

A responder is defined as a participant who has ≥8 micturitions at baseline and has \<8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is \<0.

Time frame:
Week 4, Week 8, Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit
percentage of participantsMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=916,906]32.333.9
Week 8 [N=888,876]41.246.9
Week 12 [N=870,856]44.849.3
Final visit [N=920,910]44.248.8
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.67 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.05 · 95% CI 0.85 to 1.28Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.026 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.25 · 95% CI 1.03 to 1.53Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.11 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.18 · 95% CI 0.97 to 1.44Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.093 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.18 · 95% CI 0.97 to 1.43Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
SecondaryPercentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit

A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit.

Time frame:
Week 4, Week 8, Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
percentage of participantsMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=404,410]75.577.3
Week 8 [N=387,397]85.586.9
Week 12 [N=381,387]86.189.1
Final visit [N=404,413]85.188.1
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.74 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.06 · 95% CI 0.76 to 1.48Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.74 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.07 · 95% CI 0.71 to 1.63Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.29 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.27 · 95% CI 0.81 to 2.00Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.29 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.25 · 95% CI 0.82 to 1.90Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
SecondaryPercentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit

A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit.

Time frame:
Week 4, Week 8, Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
percentage of participantsMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=404,410]47.352.0
Week 8 [N=387,397]64.363.2
Week 12 [N=381,387]69.069.5
Final visit [N=404,413]67.368.5
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.20 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.22 · 95% CI 0.90 to 1.67Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.57 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 0.91 · 95% CI 0.65 to 1.26Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.92 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 0.98 · 95% CI 0.69 to 1.39Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.90 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.02 · 95% CI 0.73 to 1.42Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
SecondaryChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire

The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 4
Reported as:
Number · participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> No problems447443
No problems -> Slight problems4543
No problems -> Moderate problems2319
No problems -> Severe problems26
No problems -> Extreme problems01
No problems -> no data43
Slight problems -> no problems6680
Slight problems -> slight problems4747
Slight problems -> moderate problems2411
Slight problems -> severe problems63
Slight problems -> extreme problems01
Slight problems -> no data11
Moderate problems -> no problems3951
Moderate problems -> slight problems3945
Moderate problems -> moderate problems5046
Moderate problems -> severe problems76
Moderate problems -> extreme problems10
Moderate problems -> no data01
Severe problems -> no problems2016
Severe problems -> slight problems2434
Severe problems -> moderate problems4529
Severe problems -> severe problems1612
Severe problems -> extreme problems10
Severe problems -> no data02
Extreme problems -> no problems21
Extreme problems -> slight problems11
Extreme problems -> moderate problems00
Extreme problems -> severe problems00
Extreme problems -> extreme problems01
Extreme problems -> no data00
No data -> no problems11
No data -> slight problems11
No data -> moderate problems10
No data -> severe problems00
No data -> extreme problems00
No data -> no data87
SecondaryChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 4
Reported as:
Number · participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> No problems693703
No problems -> slight problems2623
No problems -> moderate problems124
No problems -> severe problems00
No problems -> extreme problems01
No problems -> no data55
Slight problems -> No problems3741
Slight problems -> slight problems2816
Slight problems -> moderate problems85
Slight problems -> severe problems12
Slight problems -> extreme problems00
Slight problems -> no data00
Moderate problems -> no problems2417
Moderate problems -> slight problems1828
Moderate problems -> moderate problems1715
Moderate problems -> severe problems10
Moderate problems -> extreme problems00
Moderate problems -> no data00
Severe problems -> no problems915
Severe problems -> slight problems1315
Severe problems -> moderate problems76
Severe problems -> severe problems40
Severe problems -> extreme problems01
Severe problems -> no data01
Extreme problems -> no problems41
Extreme problems -> slight problems11
Extreme problems -> moderate problems10
Extreme problems -> severe problems02
Extreme problems -> extreme problems10
Extreme problems -> no data01
No data -> no problems12
No data -> slight problems10
No data -> moderate problems10
No data -> severe problems00
No data -> extreme problems00
No data -> no data87
SecondaryChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 4
Reported as:
Number · participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems421422
No problems -> slight problems6163
No problems -> moderate problems2010
No problems -> severe problems43
No problems -> extreme problems10
No problems -> no data44
Slight problems -> no problems102101
Slight problems -> slight problems4958
Slight problems -> moderate problems1416
Slight problems -> severe problems21
Slight problems -> extreme problems11
Slight problems -> no data10
Moderate problems -> no problems4734
Moderate problems -> slight problems5959
Moderate problems -> moderate problems4539
Moderate problems -> severe problems97
Moderate problems -> extreme problems10
Moderate problems -> no data00
Severe problems -> no problems1728
Severe problems -> slight problems2119
Severe problems -> moderate problems1113
Severe problems -> severe problems77
Severe problems -> extreme problems11
Severe problems -> no data03
Extreme problems -> no problems04
Extreme problems -> slight problems35
Extreme problems -> moderate problems53
Extreme problems -> severe problems31
Extreme problems -> extreme problems11
Extreme problems -> no data00
No data -> no problems02
No data -> slight problems20
No data -> moderate problems10
No data -> severe problems00
No data -> extreme problems00
No data -> no data87
SecondaryChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 4
Reported as:
Number · participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems299285
No problems -> slight problems5767
No problems -> moderate problems1117
No problems -> severe problems15
No problems -> extreme problems10
No problems -> no data24
Slight problems -> no problems10197
Slight problems -> slight problems116109
Slight problems -> moderate problems3225
Slight problems -> severe problems24
Slight problems -> extreme problems00
Slight problems -> no data10
Moderate problems -> no problems5144
Moderate problems -> slight problems6086
Moderate problems -> moderate problems6665
Moderate problems -> severe problems1012
Moderate problems -> extrme problems11
Moderate problems -> no data21
Severe problems -> no problems2119
Severe problems -> slight problems2225
Severe problems -> moderate problems1917
Severe problems -> severe problems206
Severe problems -> extreme problems60
Severe problems -> no data01
Extreme problems -> no problems11
Extreme problems -> slight problems26
Extreme problems -> moderate problems33
Extreme problems -> severe problems12
Extreme problems -> extreme problems20
Extreme problems -> no data01
No data -> no problems11
No data -> slight problems01
No data -> moderate problems20
No data -> severe problems00
No data -> extreme problems00
No data -> no data87
SecondaryChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 4
Reported as:
Number · participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems328339
No problems -> slight problems5965
No problems -> moderate problems1111
No problems -> severe problems22
No problems -> extreme problems02
No problems -> no data42
Slight problems -> no problems98102
Slight problems -> slight problems12294
Slight problems -> moderate problems2925
Slight problems -> severe problems53
Slight problems -> extreme problems10
Slight problems -> no data00
Moderate problems -> no problems2533
Moderate problems -> slight problems6465
Moderate problems -> moderate problems3740
Moderate problems -> severe problems1210
Moderate problems -> extreme problems31
Moderate problems -> no data02
Severe problems -> no problems1217
Severe problems -> slight problems3229
Severe problems -> moderate problems2619
Severe problems -> severe problems129
Severe problems -> extreme problems20
Severe problems -> no data13
Extreme problems -> no problems712
Extreme problems -> slight problems84
Extreme problems -> moderate problems35
Extreme problems -> severe problems44
Extreme problems -> extreme problems35
Extreme problems -> no data00
No data -> no problems11
No data -> slight problems21
No data -> moderate problems00
No data -> severe problems00
No data -> extreme problems00
No data -> no data87
SecondaryChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 8
Reported as:
Number · participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems445446
No problems -> slight problems3831
No problems -> moderate problems2023
No problems -> severe problems33
No problems -> extreme problems11
No problems -> no data1411
Slight problems -> no problems7078
Slight problems -> slight problems4644
Slight problems -> moderate problems1912
Slight problems -> severe problems33
Slight problems -> extreme problems00
Slight problems -> no data66
Moderate problems -> no problems5147
Moderate problems -> slight problems4152
Moderate problems -> modrate problems3140
Moderate problems -> severe problems86
Moderate problems -> extreme problems10
Moderate problems -> no data44
Severe problems -> no problems3022
Severe problems -> slight problems3041
Severe problems -> moderate problems2115
Severe problems -> severe problems208
Severe problems -> extreme problems10
Severe problems -> no data47
Extreme problems -> no problems10
Extreme problems -> slight problems11
Extreme problems -> moderate problems10
Extreme problems -> severe problems01
Extreme problems -> extreme problems01
Extreme problems -> no data00
No data -> no problems44
No data -> slight problems31
No data -> moderate problems10
No data -> severe problems00
No data -> extreme problems00
No data -> no data34
SecondaryChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 8
Reported as:
Number · participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems672673
No problems -> slight problems3538
No problems -> moderate problems72
No problems -> severe problems11
No problems -> extreme problems11
No problems -> no data2021
Slight problems -> no problems4233
Slight problems -> slight problems1920
Slight problems -> moderate problems99
Slight problems -> severe problems10
Slight problems -> exteme problems00
Slight problems -> no data32
Moderate problems -> no problems3434
Moderate problems -> slight problems1716
Moderate problems -> moderate problems56
Moderate problems -> severe problems22
Moderate problems -> extreme problems00
Moderate problems -> no data22
Severe problems -> no problems1713
Severe problems -> slight problems915
Severe problems -> moderate problems48
Severe problems -> severe problems20
Severe problems -> extreme problems00
Severe problems -> no data12
Extreme problems -> no problems12
Extreme problems -> slight problems42
Extreme problems -> moderate problems00
Extreme problems -> severe problems00
Extreme problems -> extreme problems00
Extreme problems -> no data21
No data -> no problems65
No data -> slight problems20
No data -> moderate problems00
No data -> severe problems00
No data -> extreme problems00
No data -> no data34
SecondaryChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 8
Reported as:
Number · participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems430426
No problems -> slight problems4849
No problems -> moderate problems1511
No problems -> severe problems23
No problems -> extreme problems00
No problems -> no data1613
Slight problems -> no problems101109
Slight problems -> slight problems4550
Slight problems -> moderate problems1612
Slight problems -> severe problems32
Slight problems -> extreme problems10
Slight problems -> no data34
Moderate problems -> no problems6153
Moderate problems -> slight problems5753
Moderate problems -> moderate problems2620
Moderate problems -> severe problems106
Moderate problems -> extreme problems11
Moderate problems -> no data66
Severe problems -> no problems1316
Severe problems -> slight problems2332
Severe problems -> moderate problems1215
Severe problems -> severe problems73
Severe problems -> extreme problems00
Severe problems -> no data25
Extreme problems -> no problems54
Extreme problems -> slight problems25
Extreme problems -> moderate problems23
Extreme problems -> severe problems20
Extreme problems -> extreme problems02
Extreme problems -> no data10
No data -> no problems34
No data -> slight problems51
No data -> moderate problems00
No data -> severe problems00
No data -> extreme problems00
No data -> no data34
SecondaryChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 8
Reported as:
Number · participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems291286
No problems -> slight problems5266
No problems -> moderate problems1316
No problems -> severe problems40
No problems -> extreme problems10
No problems -> no data1010
Slight problems -> no problems10396
Slight problems -> slight problems111103
Slight problems -> moderate problems2530
Slight problems -> severe problems61
Slight problems -> extreme problems00
Slight problems -> no data75
Moderate problems -> no problems5961
Moderate problems -> slight problems6678
Moderate problems -> moderate problems4657
Moderate problems -> severe problems104
Moderate problems -> extreme problems11
Moderate problems -> no data88
Severe problems -> no problems1716
Severe problems -> slight problems3725
Severe problems -> moderate problems1215
Severe problems -> severe problems187
Severe problems -> extreme problems21
Severe problems -> no data24
Extreme problems -> no problems13
Extreme problems -> slight problems44
Extreme problems -> moderate problems24
Extreme problems -> severe problems01
Extreme problems -> extreme problems10
Extreme problems -> no data11
No data -> no problems42
No data -> slight problems43
No data -> moderate problems00
No data -> severe problems00
No data -> extreme problems00
No data -> no data34
SecondaryChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 8
Reported as:
Number · participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems325334
No problems -> slight problems5265
No problems -> moderate problems158
No problems -> severe problems21
No problems -> extreme problems00
No problems -> no data1013
Slight problems -> no problems122116
Slight problems -> slight problems9479
Slight problems -> moderate problems2620
Slight problems -> severe problems43
Slight problems -> extreme problems32
Slight problems -> no data64
Moderate problems -> no problems4249
Moderate problems -> slight problems5059
Moderate problems -> moderate problems3134
Moderate problems -> severe problems114
Moderate problems -> extreme problems00
Moderate problems -> no data75
Severe problems -> no problems2313
Severe problems -> slight problems3937
Severe problems -> moderate problems1112
Severe problems -> severe problems76
Severe problems -> extreme problems13
Severe problems -> no data46
Extreme problems -> no problems911
Extreme problems -> slight problems710
Extreme problems -> moderate problems24
Extreme problems -> severe problems31
Extreme problems -> extreme problems34
Extreme problems -> no data10
No data -> no problems52
No data -> slight problems32
No data -> moderate problems01
No data -> severe problems00
No data -> extreme problems00
No data -> no data34
SecondaryChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 12
Reported as:
Number · participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems442459
No problems -> slight problems3625
No problems -> moderate problems1010
No problems -> severe problems65
No problems -> extreme problems10
No problems -> no data2616
Slight problems -> no problems7782
Slight problems -> slight problems4332
Slight problems -> moderate problems1516
Slight problems -> severe problems22
Slight problems -> extreme problems00
Slight problems -> no data711
Moderate problems -> no problems5763
Moderate problems -> slight problems3143
Moderate problems -> moderate problems3530
Moderate problems -> severe problems74
Moderate problems -> extreme problems00
Moderate problems -> no data69
Severe problems -> no problems5351
Severe problems -> slight problems1517
Severe problems -> moderate problems157
Severe problems -> severe problems188
Severe problems -> extreme problems00
Severe problems -> no data510
Extreme problems -> no problems21
Extreme problems -> slight problems01
Extreme problems -> moderate problems00
Extreme problems -> severe problems00
Extreme problems -> extreme problems01
Extreme problems -> no data10
No data -> no problems29
No data -> slight problems50
No data -> moderate problems30
No data -> severe problems00
No data -> extreme problems00
No data -> no data10
SecondaryChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 12
Reported as:
Number · participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems667670
No problems -> slight problems2623
No problems -> moderate problems56
No problems -> severe problems11
No problems -> extreme problems10
No problems -> no data3636
Slight problems -> no problems4342
Slight problems -> slight problems1312
Slight problems -> moderate problems145
Slight problems -> severe problems11
Slight problems -> extreme problems00
Slight problems -> no data34
Moderate problems -> no problems4446
Moderate problems -> slight problems86
Moderate problems -> moderate problems56
Moderate problems -> severe problems10
Moderate problems -> extreme problems00
Moderate problems -> no data22
Severe problems -> no problems2525
Severe problems -> slight problems47
Severe problems -> moderate problems02
Severe problems -> severe problems31
Severe problems -> extreme problems00
Severe problems -> no data13
Extreme problems -> no problems44
Extreme problems -> slight problems00
Extreme problems -> moderate problems00
Extreme problems -> severe problems00
Extreme problems -> extreme problems00
Extreme problems -> no data31
No data -> no problems89
No data -> slight problems20
No data -> moderate problems00
No data -> severe problems00
No data -> extreme problems00
No data -> no data10
SecondaryChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 12
Reported as:
Number · participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems425426
No problems -> slight problems4345
No problems -> moderate problems147
No problems -> severe problems22
No problems -> extreme problems00
No problems -> no data2722
Slight problems -> no problems103107
Slight problems -> slight problems4553
Slight problems -> moderate problems129
Slight problems -> severe problems31
Slight problems -> extreme problems00
Slight problems -> no data67
Moderate problems -> no problems8179
Moderate problems -> slight problems4131
Moderate problems -> moderate problems2515
Moderate problems -> severe problems65
Moderate problems -> extreme problems00
Moderate problems -> no data89
Severe problems -> no problems3140
Severe problems -> slight problems713
Severe problems -> moderate problems66
Severe problems -> severe problems95
Severe problems -> extreme problems10
Severe problems -> no data37
Extreme problems -> no problems77
Extreme problems -> slight problems12
Extreme problems -> moderate problems23
Extreme problems -> severe problems11
Extreme problems -> extreme problems00
Extreme problems -> no data11
No data -> no problems78
No data -> slight problems31
No data -> moderate problems00
No data -> severe problems00
No data -> extreme problems00
No data -> no data10
SecondaryChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 12
Reported as:
Number · participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems287299
No problems -> slight problems5049
No problems -> moderate problems1511
No problems -> severe problems24
No problems -> extreme problems00
No problems -> no data1715
Slight problems -> no problems112116
Slight problems -> slight problems9787
Slight problems -> moderate problems2918
Slight problems -> severe problems24
Slight problems -> extreme problems00
Slight problems -> no data1210
Moderate problems -> no problems7980
Moderate problems -> slight problems4971
Moderate problems -> moderate problems4238
Moderate problems -> severe problems106
Moderate problems -> extreme problems01
Moderate problems -> no data1013
Severe problems -> no problems3934
Severe problems -> slight problems1413
Severe problems -> moderate problems1612
Severe problems -> severe problems121
Severe problems -> extreme problems21
Severe problems -> no data57
Extreme problems -> no problems45
Extreme problems -> slight problems22
Extreme problems -> moderate problems13
Extreme problems -> severe problems11
Extreme problems -> extreme problems01
Extreme problems -> no data11
No data -> no problems75
No data -> slight problems24
No data -> moderate problems10
No data -> severe problems00
No data -> extreme problems00
No data -> no data10
SecondaryChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and Week 12
Reported as:
Number · participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems323341
No problems -> slight problems5348
No problems -> moderate problems1010
No problems -> severe problems12
No problems -> extreme problems10
No problems -> no data1620
Slight problems -> no problems132118
Slight problems -> slight problems8480
Slight problems -> moderate problems2615
Slight problems -> severe problems32
Slight problems -> extreme problems00
Slight problems -> no data109
Moderate problems -> no problems5267
Moderate problems -> slight problems5144
Moderate problems -> moderate problems1828
Moderate problems -> severe problems85
Moderate problems -> extreme problems21
Moderate problems -> no data106
Severe problems -> no problems3835
Severe problems -> slight problems2517
Severe problems -> moderate problems714
Severe problems -> severe problems92
Severe problems -> extreme problems10
Severe problems -> no data59
Extreme problems -> no problems1015
Extreme problems -> slight problems52
Extreme problems -> moderate problems37
Extreme problems -> severe problems22
Extreme problems -> extreme problems12
Extreme problems -> no data42
No data -> no problems97
No data -> slight problems12
No data -> moderate problems00
No data -> severe problems00
No data -> extreme problems00
No data -> no data10
SecondaryChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and final visit (up to Week 12)
Reported as:
Number · participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems460471
No problems -> slight problems3725
No problems -> moderate problems1412
No problems -> severe problems65
No problems -> extreme problems10
No problems -> no data32
Slight problems -> no problems8088
Slight problems -> slight problems4534
Slight problems -> moderate problems1618
Slight problems -> severe problems22
Slight problems -> extreme problems00
Slight problems -> no data11
Moderate problems -> no problems6067
Moderate problems -> slight problems3346
Moderate problems -> moderate problems3631
Moderate problems -> severe problems74
Moderate problems -> extreme problems00
Moderate problems -> no data01
Severe problems -> no problems5352
Severe problems -> slight problems1517
Severe problems -> moderate problems1711
Severe problems -> severe problems2011
Severe problems -> extreme problems10
Severe problems -> no data02
Extreme problems -> no problems21
Extreme problems -> slight problems11
Extreme problems -> moderate problems00
Extreme problems -> severe problems00
Extreme problems -> extreme problems01
Extreme problems -> no data00
No data -> no problems29
No data -> slight problems50
No data -> moderate problems30
No data -> severe problems00
No data -> extreme problems00
No data -> no data10
SecondaryChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and final visit (up to Week 12)
Reported as:
Number · participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems697699
No problems -> slight problems2726
No problems -> moderate problems56
No problems -> severe problems11
No problems -> extreme problems20
No problems -> no data44
Slight problems -> no problems4343
Slight problems -> slight problems1514
Slight problems -> moderate problems156
Slight problems -> severe problems11
Slight problems -> extreme problems00
Slight problems -> no data00
Moderate problems -> no problems4546
Moderate problems -> slight problems86
Moderate problems -> moderate problems68
Moderate problems -> severe problems10
Moderate problems -> extreme problems00
Moderate problems -> no data00
Severe problems -> no problems2525
Severe problems -> slight problems47
Severe problems -> moderate problems04
Severe problems -> severe problems41
Severe problems -> extreme problems00
Severe problems -> no data01
Extreme problems -> no problems54
Extreme problems -> slight problems10
Extreme problems -> moderate problems00
Extreme problems -> severe problems00
Extreme problems -> extreme problems10
Extreme problems -> no data01
No data -> no problems89
No data -> slight problems20
No data -> moderate problems00
No data -> severe problems00
No data -> extreme data00
No data -> no data10
SecondaryChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and final visit (up to Week 12)
Reported as:
Number · participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems444440
No problems -> slight problems4649
No problems -> moderate problems158
No problems -> severe problems22
No problems -> extreme problems00
No problems -> no data43
Slight problems -> no problems106113
Slight problems -> slight problems4554
Slight problems -> moderate problems159
Slight problems -> severe problems31
Slight problems -> extreme problems00
Slight problems -> no data00
Moderate problems -> no problems8379
Moderate problems -> slight problems4234
Moderate problems -> moderate problems2920
Moderate problems -> severe problems76
Moderate problems -> extreme problems00
Moderate problems -> no data00
Severe problems -> no problems3141
Severe problems -> slight problems914
Severe problems -> moderate problems68
Severe problems -> severe problems105
Severe problems -> extreme problems10
Severe problems -> no data03
Extreme problems -> no problems77
Extreme problems -> slight problem12
Extreme problems -> moderate problem23
Extreme problems -> severe problem11
Extreme problems -> extreme problem11
Extreme problems -> no data00
No data -> no problems78
No data -> slight problems31
No data -> moderate problems00
No data -> severe problems00
No data -> extreme problems00
No data -> no data10
SecondaryChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and final visit (up to Week 12)
Reported as:
Number · participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems297306
No problems -> slight problems5552
No problems -> moderate problems1513
No problems -> severe problems24
No problems -> extreme problems00
No problems -> no data23
Slight problems -> no problems116118
Slight problems -> slight problems10393
Slight problems -> moderate problems3020
Slight problems -> severe problems24
Slight problems -> extreme problems00
Slight problems -> no data10
Moderate problems -> no problems8083
Moderate problems -> slight problems5172
Moderate problems -> moderate problems4844
Moderate problems -> severe problems107
Moderate problems -> extreme problems02
Moderate problems -> no data11
Severe problems -> no problems3934
Severe problems -> slight problems1614
Severe problems -> moderate problems1615
Severe problems -> severe problems153
Severe problems -> extreme problems21
Severe problems -> no data01
Extreme problems -> no problems45
Extreme problems -> slight problems22
Extreme problems -> moderate problems13
Extreme problems -> severe problems11
Extreme problems -> extreme problems11
Extreme problems -> no data01
No data -> no problems75
No data -> slight problems24
No data -> moderate problems10
No data -> severe problems00
No data -> extreme problems00
No data -> no data10
SecondaryChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame:
Baseline and final visit (up to Week 12)
Reported as:
Number · participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
participantsMirabegron 50 mgSolifenacin 5 mg
No problems -> no problems332356
No problems -> slight problems5552
No problems -> moderate problems1110
No problems -> severe problems22
No problems -> extreme problems10
No problems -> no data31
Slight problems -> no problems133121
Slight problems -> slight problems9283
Slight problems -> moderate problems2617
Slight problems -> severe problems42
Slight problems -> extreme problems01
Slight problems -> no data00
Moderate problems -> no problems5568
Moderate problems -> slight problems5245
Moderate problems -> moderate problems2229
Moderate problems -> severe problems106
Moderate problems -> extreme problems21
Moderate problems -> no data02
Severe problems -> no problems3835
Severe problems -> slight problems2518
Severe problems -> moderate problems815
Severe problems -> severe problems126
Severe problems -> extreme problems10
Severe problems -> no data13
Extreme problems -> no problems1015
Extreme problems -> slight problems62
Extreme problems -> moderate problems37
Extreme problems -> severe problems33
Extreme problems -> extreme problems33
Extreme problems -> no data00
No data -> no problems97
No data -> slight problems12
No data -> moderate problems00
No data -> severe problems00
No data -> extreme problems00
No data -> no data10
SecondaryChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)

The Overactive Bladder Questionnaire (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, scored from 1 to 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.

Time frame:
Baseline and Week 4, Week 8, Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
units on a scaleMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=905,896]-20.51 ± 0.576-22.20 ± 0.579
Week 8 [N=882,875]-25.96 ± 0.599-27.76 ± 0.601
Week 12 [N=865,859]-29.74 ± 0.647-31.84 ± 0.649
Final visit [N=906,897]-28.89 ± 0.652-30.76 ± 0.655
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.039 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -1.69 · 95% CI -3.29 to -0.08Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.034 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -1.80 · 95% CI -3.46 to -0.13Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.022 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -2.10 · 95% CI -3.90 to -0.30Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.043 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -1.87 · 95% CI -3.68 to -0.06Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.
SecondaryChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q

The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is 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 indicates an improvement.

Time frame:
Baseline and Week 4, Week 8, Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q
units on a scaleMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=905,896]17.09 ± 0.54318.23 ± 0.546
Week 8 [N=882,875]21.66 ± 0.56823.20 ± 0.570
Week 12 [N=865,859]25.31 ± 0.61126.85 ± 0.613
Final visit [N=906,897]24.53 ± 0.61625.94 ± 0.619
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.14 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: 1.14 · 95% CI -0.37 to 2.65Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.055 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: 1.55 · 95% CI -0.03 to 3.13Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.074 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: 1.55 · 95% CI -0.15 to 3.25Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.11 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: 1.41 · 95% CI -0.30 to 3.12Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.
SecondaryChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)

The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical 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.

Time frame:
Baseline and Week 4, Week 8, Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)
units on a scaleMirabegron 50 mgSolifenacin 5 mg
Week 4 [N=905,896]-0.91 ± 0.035-1.00 ± 0.035
Week 8 [N=882,875]-1.30 ± 0.038-1.46 ± 0.038
Week 12 [N=865,858]-1.58 ± 0.042-1.73 ± 0.042
Final visit [N=906,897]-1.53 ± 0.042-1.67 ± 0.042
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.070 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.09 · 95% CI -0.19 to 0.01Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.003 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.16 · 95% CI -0.27 to -0.06Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.015 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.15 · 95% CI -0.26 to -0.03Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.021 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: -0.14 · 95% CI -0.25 to -0.02Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.
SecondaryChange From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)

The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question "Are you satisfied with your treatment?" and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely).

Time frame:
Baseline and Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)
units on a scaleMirabegron 50 mgSolifenacin 5 mg
Week 12 [N=865,857]3.51 ± 0.0993.93 ± 0.100
Final visit [N=891,876]3.44 ± 0.0993.86 ± 0.100
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.002 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: 0.43 · 95% CI 0.15 to 0.70Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.003 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: 0.42 · 95% CI 0.14 to 0.70Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.
SecondaryChange From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale

The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question "How satisfied were you with your treatment?" with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied).

Time frame:
Baseline and Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale
units on a scaleMirabegron 50 mgSolifenacin 5 mg
Week 12 [N=876,871]2.92 ± 0.0503.07 ± 0.050
Final visit [N=897,889]2.88 ± 0.0503.03 ± 0.050
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.027 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean diffrence: 0.16 · 95% CI 0.02 to 0.29Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.
  • Mirabegron 50 mg vs Solifenacin 5 mg · ANCOVA · p = 0.034 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.) · Least squares mean difference: 0.15 · 95% CI 0.01 to 0.29Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.
SecondaryPercentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit

A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline.

Time frame:
Baseline to Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit
percentage of participantsMirabegron 50 mgSolifenacin 5 mg
Week 12 [N=865,859]77.582.4
Final visit [N=906,897]76.281.2
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.010 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.40 · 95% CI 1.08 to 1.81Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.011 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.37 · 95% CI 1.07 to 1.75Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
SecondaryPercentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit

A responder is defined as a participant with \>=10 points improvement in the total HRQL score from baseline.

Time frame:
Baseline to Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit
percentage of participantsMirabegron 50 mgSolifenacin 5 mg
Week 12 [N=865,859]69.272.6
Final visit [N=906,897]67.571.0
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.037 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.28 · 95% CI 1.02 to 1.62Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.045 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.26 · 95% CI 1.01 to 1.57Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
SecondaryPercentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12

A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale.

Time frame:
Baseline to Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12
percentage of participantsMirabegron 50 mgSolifenacin 5 mg
≥1 point improvement86.490.4
≥2 point improvement80.383.6
≥3 point improvement67.771.9
≥4 point improvement44.447.5
≥5 point improvement15.615.4
6 point improvement2.52.9
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.009 (Iif p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.51 · 95% CI 1.11 to 2.06Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.065 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.27 · 95% CI 0.99 to 1.65Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.051 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.25 · 95% CI 1.00 to 1.55treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.14 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.18 · 95% CI 0.95 to 1.47treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.89 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.02 · 95% CI 0.75 to 1.40Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.66 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.14 · 95% CI 0.64 to 2.04Participants from Canada were therefore excluded from this analysis due to low participant numbers.
SecondaryPercentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit

A responder is defined as a participant with \>=1 or \>=2 or \>=3 or \>=4 or \>=5 or 6-point improvement from baseline in TS-Likert scale.

Time frame:
Baseline to final visit (up to Week 12)
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit
percentage of participantsMirabegron 50 mgSolifenacin 5 mg
≥1 point improvement85.689.4
≥2 point improvement79.082.6
≥3 point improvement66.770.8
≥4 point improvement43.846.6
≥5 point improvement15.415.1
6 point improvement2.52.8
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.016 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.44 · 95% CI 1.07 to 1.93Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.063 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.27 · 95% CI 0.99 to 1.62Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.054 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.24 · 95% CI 1.00 to 1.53Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.15 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.17 · 95% CI 0.95 to 1.46Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.75 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.05 · 95% CI 0.77 to 1.44Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.66 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.14 · 95% CI 0.64 to 2.04Participants from Canada were therefore excluded from this analysis due to low participant numbers.
SecondaryPercentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit

A responder is defined as a participant with ≥1 point improvement in PPBC from baseline.

Time frame:
Baseline to Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit
percentage of participantsMirabegron 50 mgSolifenacin 5 mg
Week 12 [N=865,858]73.176.7
Final visit [N=906,897]71.974.9
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.082 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.24 · 95% CI 0.97 to 1.57Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.15 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.18 · 95% CI 0.94 to 1.49Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
SecondaryPercentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit

A responder is defined as a participant with ≥2 point improvement in PPBC from baseline.

Time frame:
Baseline to Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit
percentage of participantsMirabegron 50 mgSolifenacin 5 mg
Week 12 [N=865,858]47.652.6
Final visit [N=906,897]46.251.1
Statistical analysis
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.058 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.) · Odds ratio (or): 1.23 · 95% CI 0.99 to 1.53Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
  • Mirabegron 50 mg vs Solifenacin 5 mg · Regression, Logistic · p = 0.069 (If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visitI) · Odds ratio (or): 1.21 · 95% CI 0.99 to 1.50Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.

Adverse events

Collected over From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mirabegron 50 mg—14/936 (1.5%)29/936 (3.1%)
Solifenacin 5 mg—13/934 (1.4%)54/934 (5.8%)
Most frequent serious events
Showing 10 of 32
Most frequent serious events
EventMirabegron 50 mgSolifenacin 5 mg
PneumoniaInfections and infestations1/9362/934
AppendicitisInfections and infestations0/9361/934
UrosepsisInfections and infestations0/9361/934
Abdominal pain upperGastrointestinal disorders1/9361/934
Inguinal herniaGastrointestinal disorders0/9361/934
Subarachnoid haemorrhageNervous system disorders0/9361/934
VertigoEar and labyrinth disorders1/9361/934
Open angle glaucomaEye disorders0/9361/934
DysplasiaGeneral disorders0/9361/934
Cholecystitis acuteHepatobiliary disorders0/9361/934
Most frequent other events
Most frequent other events
EventMirabegron 50 mgSolifenacin 5 mg
Dry mouthGastrointestinal disorders29/93654/934

Baseline characteristics

Safety Analysis Set (SAF) - consisted of all randomized patients who received ≥ 1 dose of double-blind study drug.

Age, Continuous
Age, Continuous(years)Mirabegron 50 mgSolifenacin 5 mgTotal
Mean56.7 ± 14.2557.4 ± 13.6057.0 ± 13.93
Sex: Female, Male
Sex: Female, Male(Participants)Mirabegron 50 mgSolifenacin 5 mgTotal
Female7127091421
Male224225449
Mean Micturitions / 24 hours
Mean Micturitions / 24 hours(micturitions)Mirabegron 50 mgSolifenacin 5 mgTotal
Mean11.6 ± 3.2511.4 ± 2.8911.5 ± 3.08
Mean Incontinence Episodes / 24 hours
Mean Incontinence Episodes / 24 hours(incontinence episodes)Mirabegron 50 mgSolifenacin 5 mgTotal
Mean2.1 ± 2.302.1 ± 2.052.1 ± 2.17
Mean Urgency Incontinence Episodes / 24 hours
Mean Urgency Incontinence Episodes / 24 hours(urgency incontinence episodes)Mirabegron 50 mgSolifenacin 5 mgTotal
Mean1.9 ± 1.992.0 ± 1.942.0 ± 1.96
Mean Urgency Episodes (grade 3 or 4) / 24 hours
Mean Urgency Episodes (grade 3 or 4) / 24 hours(urgency episodes)Mirabegron 50 mgSolifenacin 5 mgTotal
Mean7.7 ± 4.757.8 ± 4.467.8 ± 4.61
Mean Level of Urgency
Mean Level of Urgency(units on a scale)Mirabegron 50 mgSolifenacin 5 mgTotal
Mean2.6 ± 0.492.6 ± 0.492.6 ± 0.49
Mean Nocturia Episodes / 24 hours
Mean Nocturia Episodes / 24 hours(nocturia episodes)Mirabegron 50 mgSolifenacin 5 mgTotal
Mean2.3 ± 1.412.3 ± 1.422.3 ± 1.41

1 further baseline measures are reported on the registry.

08

Study locations

217 sites
  • Site: 37406
    Yerevan, 0001, Armenia
  • Site: 37404
    Yerevan, 0014, Armenia
  • Site: 37403
    Yerevan, 0052, Armenia
  • Site: 37401
    Yerevan, 0078, Armenia
  • Site: 37402
    Yerevan, 0078, Armenia
  • Site: 43006
    Baden, 2500, Austria
  • Site: 43014
    Graz, 9036, Austria
  • Site: 43015
    Innsbruck, 6020, Austria
  • Site: 43013
    Linz, 4020, Austria
  • Site: 43005
    Oberwart, 7400, Austria
  • Site: 43011
    Vienna, 1020, Austria
  • Site: 43002
    Vienna, 1220, Austria
  • Site: 43003
    Wels, 4600, Austria
  • Site: 37502
    Minsk, 220119, Belarus
  • Site: 37501
    Minsk, 223041, Belarus
  • Site: 37504
    Vitebsk, 210037, Belarus
  • Site: 32006
    Brussels, 1070, Belgium
  • Site: 32008
    Deurne, 2100, Belgium
  • Site: 32001
    Edegem, 2650, Belgium
  • Site: 32004
    Gent, 9000, Belgium
  • Site: 32007
    Leuven, 3000, Belgium
  • Site: 32005
    Liege, Belgium
  • Site: 35902
    Burgas, 8000, Bulgaria
  • Site: 35909
    Haskovo, 6300, Bulgaria
  • Site: 35901
    Lovech, 5500, Bulgaria
  • Site: 35905
    Plovdiv, 4003, Bulgaria
  • Site: 35906
    Sofia, 1431, Bulgaria
  • Site: 35908
    Sofia, 1504, Bulgaria
  • Site: 35903
    Sofia, 1606, Bulgaria
  • Site: 10010
    Abbotsford, V2S 3N5, Canada
  • Site: 10011
    Barrie, L4M 7G1, Canada
  • Site: 10001
    Bathurst, E2A 4Z2, Canada
  • Site: 10003
    Brampton, L6T 4S5, Canada
  • Site: 10005
    Brantford, N3R 4N3, Canada
  • Site: 10007
    Kingston, K7L 3J7, Canada
  • Site: 10002
    Montreal, H4N 3C5, Canada
  • Site: 10009
    Sherbrooke, J1H 5N4, Canada
  • Site: 10004
    Toronto, M4N 3M5, Canada
  • Site: 10008
    Victoria, V8V 3N1, Canada
  • Site: 42004
    Bohumin, 73581, Czechia
  • Site: 42003
    Brno, 602 00, Czechia
  • Site: 42001
    Hradec Kralove, 500 05, Czechia
  • Site: 42002
    Jihlava, 586 33, Czechia
  • Site: 42006
    Plzen-Lochotin, 30460, Czechia
  • Site: 42005
    Prague 1, 110 00, Czechia
  • Site: 42007
    Prague 4, 14000, Czechia
  • Site: 42008
    Prague, 128 51, Czechia
  • Site: 45002
    Aalborg, 9000, Denmark
  • Site: 45001
    Aarhus N, 8200, Denmark
  • Site: 45005
    Frederiksbjerg, 2000, Denmark
  • Site: 45004
    Hvidovre, 2650, Denmark
  • Site: 45003
    Odense C, 9000, Denmark
  • Site: 35802
    Jyvaskyla, 40620, Finland
  • Site: 35801
    Oulu, 90029, Finland
  • Site: 35804
    Tampere, 33521, Finland
  • Site: 33010
    Angers, 49033, France
  • Site: 33007
    Colmar Cedex, 68024, France
  • Site: 33011
    Dijon, 21000, France
  • Site: 33002
    Marseille, 13285, France
  • Site: 33006
    Marseille, 13385, France
  • Site: 33013
    Nimes, 30029, France
  • Site: 33004
    Orleans Cedex 2, 45067, France
  • Site: 33001
    Paris Cedex 20, 75970, France
  • Site: 33005
    Paris Cedex 20, 75970, France
  • Site: 33003
    Rouen, 76031, France
  • Site: 33014
    Suresnes Cedex, 92151, France
  • Site: 33017
    Tours, 37044, France
  • Site: 33015
    Valence, 26953, France
  • Site: 99501
    Tbilisi, 144, Georgia
  • Site: 99502
    Tbilisi, 159, Georgia
  • Site: 99503
    Tbilisi, 159, Georgia
  • Site: 49006
    Bad Ems, 56130, Germany
  • Site: 49009
    Halle Saale, 06132, Germany
  • Site: 30005
    Alexandroupoli, 68100, Greece
  • Site: 30009
    Athens, 115 28, Greece
  • Site: 30007
    Athens, 166 73, Greece
  • Site: 30001
    Athens, Greece
  • Site: 30006
    Herakleion, 711 10, Greece
  • Site: 30008
    Larisa, 41334, Greece
  • Site: 30004
    Patras, 26500, Greece
  • Site: 30010
    Thessaloniki, 546 42, Greece
  • Site: 30002
    Thessaloniki, 56429, Greece
  • Site: 36003
    Budapest, 1082, Hungary
  • Site: 36004
    Budapest, 1237, Hungary
  • Site: 36005
    Csongrad, H-6640, Hungary
  • Site: 36006
    Nyiregyhaza, H-4400, Hungary
  • Site: 36001
    Salgotarjan, 3100, Hungary
  • Site: 36002
    Szekszard, 7100, Hungary
  • Site: 35304
    Cork, Ireland
  • Site: 35302
    Dublin, 8, Ireland
  • Site: 35306
    Dublin, 8, Ireland
  • Site: 35301
    Dublin, 9, Ireland
  • Site: 35303
    Tralee, Ireland
  • Site: 35305
    Waterford, Ireland
  • Site: 39001
    Avellino, 83100, Italy
  • Site: 39005
    Catanzaro, 88100, Italy
  • Site: 39003
    Cinisello Balsamo, 20092, Italy
  • Site: 39002
    Florence, 50139, Italy
  • Site: 39008
    Milan, 20153, Italy
  • Site: 39010
    Pavia, 27100, Italy

Showing the first 100 of 217 sites across 33 countries. Choose a country and city above to see the rest.

09

References and documents

Individual participant data

Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

Access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Data sharing details ↗ · www.clinicaltrials.astellas.com

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2012 to primary completion in Apr 2013, 10 months.

Results were first posted in Aug 2016, 3 years 4 months after primary completion.

Of 26 industry-sponsored phase 3 interventional studies under Urinary Bladder, Overactive, half reached primary completion within 16 months of starting (the median); a quarter within 11 and three quarters within 24. This study's 10 months is below that.

Counting every sponsor, half of 33 studies reached it within 18 months; a quarter within 11 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2012
First posted
Jul 11, 2012
StartActual
Jun 12, 2012
Primary completionActual
Apr 24, 2013
CompletionActual
Apr 24, 2013
Results first posted
Aug 30, 2016
Last update
Nov 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01638000
Lead sponsor
Astellas Pharma Europe Ltd.
Responsible party
Sponsor
First posted
Jul 11, 2012
Start date
Jun 12, 2012
Primary completion
Apr 24, 2013
Completion
Apr 24, 2013
Results posted
Aug 30, 2016
Last update
Nov 21, 2024

Study contacts

Clinical Study Manager
study director · Astellas Pharma Europe Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Mirabegron

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