CompletedNCT01340027SymphonyUpdated Oct 31, 2024Results posted

A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder

A Phase 2 interventional study of Mirabegron and Solifenacin succinate in Urologic Diseases, Urinary Bladder Diseases and Urological Manifestations, sponsored by Astellas Pharma Europe B.V.. Completed at 133 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.

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

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 B.V. (part of Astellas Pharma Inc) · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 1,307
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.

Conditions studied

Urologic Diseases
Urinary Bladder Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder, Overactive

Browse trials for

Urologic Diseases 221Registry's first term
Urinary Bladder Diseases 62
Signs and Symptoms 221
Urinary Bladder, Overactive 858Primary · reclassified
Urinary Incontinence 983

Keywords

Urinary incontinence
Overactive bladder (OAB)
Micturition
Frequency
YM178
Urgency incontinence
Urgency

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 1,307 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 B.V. is the lead sponsor of 94 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

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 →

Who can participate

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

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria at Visit 1/Screening:
- Subject has a (BMI) of between 18 and 35 kg/m\^2 and a total body weight between 50 and 95 kg;
- Subject is willing and able to complete the micturition diary and questionnaires correctly and is willing and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
- Subject has symptoms of overactive bladder (OAB; urinary frequency, urgency and/or urgency incontinence) for at least 3 months.
Inclusion Criteria at Visit 3/Baseline:
- Subject has experienced frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period (incontinence episode should not be counted as a micturition);
- Subject must experience at least 1 episode of urgency (grade 3 or 4) per 24-hour period (with or without urgency incontinence) during the 3 day micturition diary period.

Exclusion Criteria:

Exclusion Criteria at Visit 1/Screening:
- Subject is breastfeeding, pregnant or intends to become pregnant during the study. The pregnancy test (Beta Human Chorionic Gonadotropin in serum) at Screening must be negative in women of ;
- Female subjects of childbearing potential and not using a highly effective method of during the study and for 30 days after final study drug administration.
- Male subjects (unless surgically sterile) with female spouses/partners who are of childbearing potential, and not using a barrier method of contraception during the study and for 30 days after final study drug administration. In addition, female spouses/partners of male subjects and who are of childbearing potential should also use a highly effective method of birth control during the study and for 30 days after final study drug administration. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.
- Subject has significant post-void residual (PVR) volume (> 150 mL);
- 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 the cough provocation test);
- Subject has a neurological cause for detrusor overactivity;
- Subject has an indwelling catheter or practices intermittent self-catheterization;
- Subject has diabetic neuropathy;
- Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
- Subject has had previous lower urinary tract or pelvic floor surgery (except cystoscopy);
- Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;
- Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis or Crohn's Disease, toxic megacolon, myasthenia gravis or any other condition which makes the use of anticholinergics ;
- Subject has cardiovascular or cerebrovascular diseases within 6 months prior to Screening, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, heart failure and stroke;
- Subject is receiving current 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 is using medications intended to treat OAB or prohibited medications.
- Subject has known or suspected to solifenacin succinate, mirabegron or any of their ;
- Subject has any significant neurological disease or defect affecting bladder function (e.g., neurogenic bladder, systemic or central neurological disease such as multiple sclerosis [MS] and Parkinson's disease);
- Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg;
Exclusion Criteria at Visit 2/Placebo Run-In:
- Subject has evidence of a urinary tract infection (UTI) (urine culture containing > 100,000 cfu/mL). The subject can be enrolled into the study after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture). However, the subject must be re screened if the initial screening visit was > 28 days;
- Subject has a > 450 ms or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia) or is on drug treatment known to be associated with QT prolongation;
- Subject has clinically significant abnormalities on the 12 lead (ECG);
- Subject has serum creatinine > 150 µmol/L, (AST) and/or alanine aminotransferase (ALT) > 2x (ULN), gamma-glutamyltransferase (γ-GT) > 3x ULN, or total > 2x ULN, as assessed in Screening samples;
Exclusion Criteria at Visit 3/Baseline:
- Subject had an average total daily urine volume > 3000 mL as recorded in the micturition diary period;
- Subject has severe hypertension which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or an average diastolic blood pressure ≥ 110 mmHg.

Terms in these criteria, in plain language(12)

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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.

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.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 1,307 participants (actual)

Study arms

Placebo comparator
Placebo
Participants received matching placebo tablets orally once a day for 12 weeks
Drug: Placebo
Active comparator
Mirabegron 25 mg
Participants received mirabegron 25 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
Active comparator
Mirabegron 50 mg
Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
Drug: Mirabegron
Active comparator
Solifenacin 2.5 mg
Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks
Drug: Solifenacin succinate
Active comparator
Solifenacin 5 mg
Participants received solifenacin 5 mg tablets orally once a day for 12 weeks
Drug: Solifenacin succinate
Active comparator
Solifenacin 10 mg
Participants received solifenacin 10 mg tablets orally once a day for 12 weeks
Drug: Solifenacin succinate
Experimental
Solifenacin 2.5 mg and Mirabegron 25 mg
Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Drug: Mirabegron · Drug: Solifenacin succinate
Experimental
Solifenacin 2.5 mg and Mirabegron 50 mg
Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Drug: Mirabegron · Drug: Solifenacin succinate
Experimental
Solifenacin 5 mg and Mirabegron 25 mg
Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Drug: Mirabegron · Drug: Solifenacin succinate
Experimental
Solifenacin 5 mg and Mirabegron 50 mg
Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Drug: Mirabegron · Drug: Solifenacin succinate
Experimental
Solifenacin 10 mg and Mirabegron 25 mg
Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks
Drug: Mirabegron · Drug: Solifenacin succinate
Experimental
Solifenacin 10 mg and Mirabegron 50 mg
Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks
Drug: Mirabegron · Drug: Solifenacin succinate

Interventions

DrugMirabegron
oral
Also known as: Betmiga, Myrbetric, Myrbetriq, Betanis, YM178
DrugSolifenacin succinate
oral
Also known as: Vesikur, Vesicare
DrugPlacebo
oral

What researchers measure

Primary outcomes

Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.
Time frame: Baseline and Week 12

Secondary outcomes

Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.
Time frame: Baseline and Week 12
Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Percentage of Participants With a Micturition Response
A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Percentage of Participants With Zero Incontinence Episodes Post-baseline
The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant.
Time frame: Weeks 2, 4, 8 and 12
Percentage of Participants With 50% Reduction in Incontinence Episodes
The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Level of Urgency
Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.
Time frame: Baseline and Weeks 2, 4, 8 and 12
Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.
Time frame: Baseline and Week 12
Percentage of Participants With Improvement in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score.
Time frame: Baseline and Week 12
Percentage of Participants With Major Improvement in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.
Time frame: Baseline and Week 12
Percentage of Participants With Deterioration in PPBC
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.
Time frame: Baseline and Week 12
Percentage of Participants With a Symptom Bother Response
Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.
Time frame: Baseline and Week 12
Percentage of Participants With a Health-related Quality of Life Total Score Response
Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.
Time frame: Baseline and Week 12
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Time frame: Baseline and Week 12
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Time frame: Baseline and Week 12
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Time frame: Baseline and Week 12
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category.
Time frame: Baseline and Week 12
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.
Time frame: Baseline and Week 12

Results

Posted Jul 21, 2015

Limitations and caveats

Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Participant flow

Male and female patients with symptoms of overactive bladder (OAB; urgency, urinary frequency and/or urgency incontinence) for at least 3 months. The study was conducted at 141 sites in 20 countries in Europe.

Participant flow — Overall Study
Milestone	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Started	81	78	79	79	156	78	149	149	144	152	81	81
Received treatment	81	78	78	79	156	78	149	149	144	152	81	81
Completed	76	71	75	75	146	74	142	142	136	146	79	77
Not completed	5	7	4	4	10	4	7	7	8	6	2	4
Withdrew: Randomized but never received study drug	0	0	1	0	0	0	0	0	0	0	0	0
Withdrew: Adverse event	0	1	2	0	1	2	2	1	4	1	1	3
Withdrew: Lack of efficacy	0	0	0	0	0	0	1	1	1	0	0	0
Withdrew: Lost to follow-up	0	1	0	0	0	0	1	0	0	1	0	0
Withdrew: Protocol violation	1	2	0	0	6	0	0	1	2	2	0	0
Withdrew: Withdrawal by subject	4	3	1	3	3	2	3	4	1	2	0	1
Withdrew: Miscellaneous	0	0	0	1	0	0	0	0	0	0	1	0

Outcome measures

PrimaryChange From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition

The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · mL

Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition
mL	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition	14.0 ± 5.91	24.9 ± 6.06	34.5 ± 6.02	36.4 ± 6.02	36.0 ± 4.32	36.2 ± 6.06	39.4 ± 4.37	41.9 ± 4.36	53.6 ± 4.45	54.2 ± 4.31	57.6 ± 5.99	62.3 ± 5.90

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · ANCOVA · p = 0.97 · Ls mean difference: 0.3 · 95% CI -14.3 to 14.9
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.58 · Ls mean difference: 3.4 · 95% CI -8.6 to 15.5
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.33 · Ls mean difference: 5.9 · 95% CI -6.1 to 18.0
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.005 · Ls mean difference: 17.6 · 95% CI 5.4 to 29.8
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.003 · Ls mean difference: 18.2 · 95% CI 6.2 to 30.2
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.003 · Ls mean difference: 21.7 · 95% CI 7.2 to 36.1
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = <0.001 · Ls mean difference: 26.3 · 95% CI 11.9 to 40.7
Placebo vs Mirabegron 25 mg · ANCOVA · p = 0.20 · Ls mean difference: 11.0 · 95% CI -5.6 to 27.6
Placebo vs Mirabegron 50 mg · ANCOVA · p = 0.015 · Ls mean difference: 20.5 · 95% CI 4.0 to 37.1
Placebo vs Solifenacin 2.5 mg · ANCOVA · p = 0.008 · Ls mean difference: 22.4 · 95% CI 5.9 to 39.0
Placebo vs Solifenacin 5 mg · ANCOVA · p = 0.003 · Ls mean difference: 22.0 · 95% CI 7.6 to 36.3
Placebo vs Solifenacin 10 mg · ANCOVA · p = 0.009 · Ls mean difference: 22.2 · 95% CI 5.6 to 38.8
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = <0.001 · Ls mean difference: 25.4 · 95% CI 11.0 to 39.8
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = <0.001 · Ls mean difference: 27.9 · 95% CI 13.5 to 42.3
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = <0.001 · Ls mean difference: 39.6 · 95% CI 25.1 to 54.1
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = <0.001 · Ls mean difference: 40.2 · 95% CI 25.8 to 54.5
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = <0.001 · Ls mean difference: 43.6 · 95% CI 27.1 to 60.1
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = <0.001 · Ls mean difference: 48.3 · 95% CI 31.9 to 64.7

SecondaryChange From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours

The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · micturitions

Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
micturitions	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours	-2.43 ± 0.291	-2.48 ± 0.298	-2.56 ± 0.296	-2.44 ± 0.296	-2.54 ± 0.212	-3.22 ± 0.298	-2.58 ± 0.215	-2.93 ± 0.215	-2.56 ± 0.219	-3.34 ± 0.212	-3.42 ± 0.294	-3.52 ± 0.291

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · ANCOVA · p = 0.062 · Ls mean difference: -0.68 · 95% CI -1.40 to 0.03
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.91 · Ls mean difference: -0.04 · 95% CI -0.63 to 0.56
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.20 · Ls mean difference: -0.39 · 95% CI -0.98 to 0.20
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.96 · Ls mean difference: -0.02 · 95% CI -0.62 to 0.58
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.007 · Ls mean difference: -0.80 · 95% CI -1.39 to -0.22
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.016 · Ls mean difference: -0.88 · 95% CI -1.59 to -0.16
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.007 · Ls mean difference: -0.98 · 95% CI -1.68 to -0.27
Placebo vs Mirabegron 25 mg · ANCOVA · p = 0.91 · Ls mean difference: -0.05 · 95% CI -0.87 to 0.77
Placebo vs Mirabegron 50 mg · ANCOVA · p = 0.76 · Ls mean difference: -0.13 · 95% CI -0.94 to 0.69
Placebo vs Solifenacin 2.5 mg · ANCOVA · p = 0.99 · Ls mean difference: -0.01 · 95% CI -0.82 to 0.81
Placebo vs Solifenacin 5 mg · ANCOVA · p = 0.77 · Ls mean difference: -0.11 · 95% CI -0.82 to 0.60
Placebo vs Solifenacin 10 mg · ANCOVA · p = 0.058 · Ls mean difference: -0.79 · 95% CI -1.61 to 0.03
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.69 · Ls mean difference: -0.14 · 95% CI -0.85 to 0.57
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.17 · Ls mean difference: -0.50 · 95% CI -1.21 to 0.21
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.73 · Ls mean difference: -0.12 · 95% CI -0.84 to 0.59
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.012 · Ls mean difference: -0.91 · 95% CI -1.62 to -0.20
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.018 · Ls mean difference: -0.98 · 95% CI -1.80 to -0.17
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.009 · Ls mean difference: -1.08 · 95% CI -1.89 to -0.28

SecondaryChange From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours

The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · incontinence episodes

Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
incontinence episodes	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours	-0.95 ± 0.365	-0.74 ± 0.415	-0.90 ± 0.353	-1.26 ± 0.386	-0.88 ± 0.252	-0.97 ± 0.386	-0.75 ± 0.251	-0.85 ± 0.260	-1.22 ± 0.266	-1.14 ± 0.306	-0.27 ± 0.304	-0.97 ± 0.333

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · Stratified Rank ANCOVA · p = 0.51 (Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.) · Ls mean difference: -0.09 · 95% CI -1.00 to 0.82P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.21 · Ls mean difference: 0.13 · 95% CI -0.57 to 0.83
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · Stratified Rank ANCOVA · p = 0.89 · Ls mean difference: 0.03 · 95% CI -0.68 to 0.74
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.001 (P values were calculated from a pairwise comparison of the combination treatment groups vs solifenacin succinate 5 mg or placebo within the ANCOVA model.) · Ls mean difference: -0.34 · 95% CI -1.06 to 0.38
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · Stratified Rank ANCOVA · p = 0.058 · Ls mean difference: -0.26 · 95% CI -1.04 to 0.52
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.15 · Ls mean difference: 0.60 · 95% CI -0.17 to 1.38
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · Stratified Rank ANCOVA · p = 0.41 · Ls mean difference: -0.09 · 95% CI -0.91 to 0.73
Placebo vs Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.44 · Ls mean difference: 0.21 · 95% CI -0.88 to 1.30
Placebo vs Mirabegron 50 mg · Stratified Rank ANCOVA · p = 0.85 · Ls mean difference: 0.05 · 95% CI -0.95 to 1.04
Placebo vs Solifenacin 2.5 mg · Stratified Rank ANCOVA · p = 0.83 · Ls mean difference: -0.31 · 95% CI -1.36 to 0.74
Placebo vs Solifenacin 5 mg · Stratified Rank ANCOVA · p = 0.56 · Ls mean difference: 0.07 · 95% CI -0.80 to 0.95
Placebo vs Solifenacin 10 mg · Stratified Rank ANCOVA · p = 0.48 · Ls mean difference: -0.02 · 95% CI -1.07 to 1.03
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.13 · Ls mean difference: 0.20 · 95% CI -0.67 to 1.07
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · Stratified Rank ANCOVA · p = 0.62 · Ls mean difference: 0.10 · 2% CI -0.78 to 0.99
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.34 · Ls mean difference: -0.27 · 95% CI -1.16 to 0.63
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · Stratified Rank ANCOVA · p = 0.24 · Ls mean difference: -0.19 · 95% CI -1.12 to 0.74
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.88 · Ls mean difference: 0.68 · 95% CI -0.26 to 1.61
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · Stratified Rank ANCOVA · p = 0.83 · Ls mean difference: -0.02 · 95% CI -0.99 to 0.95

SecondaryChange From Baseline to Each Visit in Mean Volume Voided Per Micturition

Time frame:: Baseline and Weeks 2, 4, 8 and 12
Reported as:: Least squares mean · mL

Change From Baseline to Each Visit in Mean Volume Voided Per Micturition
mL	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Week 2; n=80,71,76,74,148,73,145,145,136,141,76,77	8.7 ± 4.44	14.3 ± 4.71	26.0 ± 4.55	22.7 ± 4.62	23.1 ± 3.26	16.1 ± 4.64	22.5 ± 3.30	29.2 ± 3.30	29.9 ± 3.40	32.3 ± 3.34	29.5 ± 4.56	42.1 ± 4.52
Week 4; n=79,72,74,76,146,72,141,142,138,144,77,75	10.2 ± 4.93	16.8 ± 5.16	29.4 ± 5.09	24.8 ± 5.02	29.6 ± 3.63	28.3 ± 5.16	29.2 ± 3.69	36.5 ± 3.67	42.7 ± 3.73	44.5 ± 3.65	45.7 ± 5.00	54.5 ± 5.06
Week 8; n=77,70,73,75,147,73,143,142,134,143,76,74	13.5 ± 5.56	24.6 ± 5.83	35.4 ± 5.71	28.3 ± 5.63	30.1 ± 4.03	37.7 ± 5.71	35.6 ± 4.08	42.3 ± 4.09	49.7 ± 4.21	52.2 ± 4.08	55.8 ± 5.60	68.5 ± 5.67
Week 12;n=75,68,73,73,144,72,138,138,133,140,72,73	14.7 ± 6.12	23.0 ± 6.43	35.5 ± 6.20	36.9 ± 6.20	34.6 ± 4.42	35.8 ± 6.25	38.6 ± 4.52	43.7 ± 4.51	54.7 ± 4.60	56.6 ± 4.48	59.8 ± 6.26	66.2 ± 6.20

SecondaryChange From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours

Time frame:: Baseline and Weeks 2, 4, 8 and 12
Reported as:: Least squares mean · micturitions

Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours
micturitions	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77	-1.18 ± 0.240	-1.69 ± 0.255	-1.60 ± 0.246	-1.49 ± 0.249	-1.16 ± 0.176	-1.32 ± 0.251	-1.52 ± 0.178	-1.95 ± 0.178	-1.68 ± 0.184	-2.21 ± 0.181	-1.74 ± 0.244	-2.35 ± 0.244
Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75	-1.68 ± 0.261	-2.02 ± 0.273	-1.99 ± 0.269	-2.10 ± 0.266	-1.80 ± 0.191	-2.25 ± 0.271	-2.03 ± 0.195	-2.11 ± 0.194	-2.29 ± 0.197	-2.77 ± 0.193	-2.55 ± 0.264	-2.69 ± 0.267
Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74	-2.27 ± 0.270	-2.27 ± 0.283	-2.42 ± 0.277	-2.46 ± 0.273	-2.22 ± 0.196	-2.97 ± 0.275	-2.58 ± 0.198	-2.66 ± 0.199	-2.43 ± 0.205	-3.20 ± 0.197	-3.04 ± 0.270	-3.49 ± 0.275
Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73	-2.59 ± 0.302	-2.51 ± 0.314	-2.67 ± 0.306	-2.38 ± 0.306	-2.58 ± 0.218	-3.31 ± 0.306	-2.64 ± 0.222	-3.02 ± 0.222	-2.64 ± 0.227	-3.35 ± 0.218	-3.47 ± 0.302	-3.63 ± 0.306

SecondaryPercentage of Participants With a Micturition Response

A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.

Time frame:: Baseline and Weeks 2, 4, 8 and 12
Reported as:: Number · percentage of participants

Percentage of Participants With a Micturition Response
percentage of participants	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Week 2; n=79,70,75,71,144,72,143,143,135,137,77,76	27.8	25.7	37.3	29.6	26.4	34.7	36.4	38.5	34.1	36.5	36.4	46.1
Week 4; n=78,72,73,73,144,72,139,140,137,140,77,74	42.3	27.8	43.8	35.6	34.0	44.4	45.3	42.1	48.2	56.4	48.1	41.9
Week 8; n=76,70,73,72,145,73,141,140,133,142,77,73	53.9	35.7	50.7	43.1	40.0	56.2	46.8	54.3	49.6	56.3	57.1	64.4
Week 12;n=74,69,72,69,142,72,136,136,132,142,75,72	55.4	46.4	47.2	53.6	47.9	55.6	55.1	55.1	53.8	62.0	65.3	61.1
EOT; n=79,75,76,73,146,75,144,145,140,146,78,79	53.2	42.7	47.4	54.8	47.9	54.7	54.2	53.1	52.1	61.6	65.4	58.2

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · Regression, Logistic · p = 0.42 · Odds ratio (or): 1.29 · 95% CI 0.69 to 2.39
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.48 · Odds ratio (or): 1.20 · 95% CI 0.72 to 2.00
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.69 · Odds ratio (or): 1.11 · 95% CI 0.67 to 1.83
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.95 · Odds ratio (or): 1.02 · 95% CI 0.61 to 1.69
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.015 · Odds ratio (or): 1.91 · 95% CI 1.14 to 3.21
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.023 · Odds ratio (or): 2.06 · 95% CI 1.11 to 3.84
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.16 · Odds ratio (or): 1.54 · 95% CI 0.84 to 2.84
Placebo vs Mirabegron 25 mg · Regression, Logistic · p = 0.73 · Odds ratio (or): 0.89 · 95% CI 0.45 to 1.76
Placebo vs Mirabegron 50 mg · Regression, Logistic · p = 0.70 · Odds ratio (or): 0.88 · 95% CI 0.45 to 1.72
Placebo vs Solifenacin 2.5 mg · Regression, Logistic · p = 0.26 · Odds ratio (or): 1.49 · 95% CI 0.74 to 2.99
Placebo vs Solifenacin 5 mg · Regression, Logistic · p = 0.69 · Odds ratio (or): 1.13 · 95% CI 0.63 to 2.04
Placebo vs Solifenacin 10 mg · Regression, Logistic · p = 0.29 · Odds ratio (or): 1.45 · 95% CI 0.73 to 2.89
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.31 · Odds ratio (or): 1.36 · 95% CI 0.75 to 2.45
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.45 · Odds ratio (or): 1.25 · 95% CI 0.70 to 2.25
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.64 · Odds ratio (or): 1.15 · 95% CI 0.64 to 2.07
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.013 · Odds ratio (or): 2.16 · 95% CI 1.18 to 3.94
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.017 · Odds ratio (or): 2.33 · 95% CI 1.16 to 4.66
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.11 · Odds ratio (or): 1.74 · 95% CI 0.88 to 3.45

SecondaryChange From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours

Time frame:: Baseline and Weeks 2, 4, 8 and 12
Reported as:: Least squares mean · incontinence episodes

Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours
incontinence episodes	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19	-0.83 ± 0.168	-0.43 ± 0.191	-0.85 ± 0.162	-0.98 ± 0.178	-0.67 ± 0.119	-0.71 ± 0.184	-0.49 ± 0.116	-0.64 ± 0.120	-0.70 ± 0.122	-0.65 ± 0.150	-1.14 ± 0.140	-0.77 ± 0.157
Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19	-0.87 ± 0.146	-0.48 ± 0.189	-0.89 ± 0.141	-1.20 ± 0.155	-0.80 ± 0.102	-0.84 ± 0.160	-0.73 ± 0.102	-0.67 ± 0.109	-0.81 ± 0.106	-0.88 ± 0.125	-1.18 ± 0.122	-0.71 ± 0.137
Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20	-0.82 ± 0.163	-0.65 ± 0.210	-0.92 ± 0.157	-1.12 ± 0.178	-0.72 ± 0.114	-1.04 ± 0.172	-0.78 ± 0.112	-0.82 ± 0.122	-1.01 ± 0.118	-0.95 ± 0.142	-0.93 ± 0.136	-0.91 ± 0.149
Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20	-0.93 ± 0.373	-0.59 ± 0.482	-0.89 ± 0.361	-1.21 ± 0.424	-0.84 ± 0.261	-0.95 ± 0.409	-0.74 ± 0.265	-0.88 ± 0.279	-1.20 ± 0.280	-1.11 ± 0.319	-0.27 ± 0.311	-0.96 ± 0.341

SecondaryPercentage of Participants With Zero Incontinence Episodes Post-baseline

The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant.

Time frame:: Weeks 2, 4, 8 and 12
Reported as:: Number · percentage of participants

Percentage of Participants With Zero Incontinence Episodes Post-baseline
percentage of participants	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19	47.1	23.1	44.4	40.0	45.5	50.0	40.0	51.5	65.6	52.4	70.8	52.6
Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19	64.7	20.0	55.6	73.3	64.7	71.4	55.9	46.7	62.5	52.2	79.2	52.6
Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20	58.8	50.0	61.1	71.4	50.0	73.3	54.3	50.0	71.9	77.3	79.2	65.0
Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20	82.4	50.0	61.1	69.2	58.8	57.1	51.5	63.3	86.7	87.0	79.2	75.0
EOT; n=17,13,18,15,35,15,35,33,32,24,24,20	82.4	46.2	61.1	66.7	60.0	53.3	54.3	60.6	87.5	87.5	79.2	75.0

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · Regression, Logistic · p = 0.52 · Odds ratio (or): 0.64 · 95% CI 0.16 to 2.56
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.48 · Odds ratio (or): 0.67 · 95% CI 0.23 to 1.99
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.93 · Odds ratio (or): 0.95 · 95% CI 0.32 to 2.81
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.013 · Odds ratio (or): 6.12 · 95% CI 1.47 to 25.60
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.031 · Odds ratio (or): 5.49 · 95% CI 1.17 to 25.77
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.059 · Odds ratio (or): 3.84 · 95% CI 0.95 to 15.58
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.36 · Odds ratio (or): 1.91 · 95% CI 0.48 to 7.58
Placebo vs Mirabegron 25 mg · Regression, Logistic · p = 0.26 · Odds ratio (or): 0.34 · 95% CI 0.05 to 2.17
Placebo vs Mirabegron 50 mg · Regression, Logistic · p = 0.33 · Odds ratio (or): 0.43 · 95% CI 0.08 to 2.31
Placebo vs Solifenacin 2.5 mg · Regression, Logistic · p = 0.94 · Odds ratio (or): 1.07 · 95% CI 0.17 to 6.68
Placebo vs Solifenacin 5 mg · Regression, Logistic · p = 0.29 · Odds ratio (or): 0.44 · 95% CI 0.09 to 2.02
Placebo vs Solifenacin 10 mg · Regression, Logistic · p = 0.15 · Odds ratio (or): 0.28 · 95% CI 0.05 to 1.60
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.11 · Odds ratio (or): 0.29 · 95% CI 0.06 to 1.34
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.26 · Odds ratio (or): 0.41 · 95% CI 0.09 to 1.89
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.28 · Odds ratio (or): 2.67 · 95% CI 0.44 to 16.17
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.36 · Odds ratio (or): 2.39 · 95% CI 0.37 to 15.46
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.56 · Odds ratio (or): 1.68 · 95% CI 0.29 to 9.72
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.84 · Odds ratio (or): 0.83 · 95% CI 0.15 to 4.76

SecondaryPercentage of Participants With 50% Reduction in Incontinence Episodes

The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary.

Time frame:: Baseline and Weeks 2, 4, 8 and 12
Reported as:: Number · percentage of participants

Percentage of Participants With 50% Reduction in Incontinence Episodes
percentage of participants	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Week 2; n=17,13,18,15,33,14,35,33,32,21,24,19	64.7	30.8	66.7	73.3	57.6	57.1	51.4	66.7	71.9	66.7	91.7	68.4
Week 4; n=17,10,18,15,34,14,34,30,32,23,24,19	82.4	40.0	72.2	86.7	76.5	78.6	64.7	63.3	75.0	78.3	95.8	68.4
Week 8; n=17,10,18,14,34,15,35,30,32,22,24,20	76.5	60.0	77.8	85.7	58.8	86.7	82.9	73.3	90.6	81.8	91.7	75.0
Week 12; n=17,10,18,13,34,14,33,30,30,23,24,20	94.1	70.0	77.8	84.6	73.5	64.3	66.7	80.0	96.7	95.7	95.8	90.0
EOT; n=17,13,18,15,35,15,35,33,32,24,24,20	94.1	61.5	77.8	86.7	74.3	66.7	68.6	75.8	96.9	95.8	95.8	90.0

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · Regression, Logistic · p = 0.48 · Odds ratio (or): 0.61 · 95% CI 0.16 to 2.38
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.58 · Odds ratio (or): 0.74 · 95% CI 0.25 to 2.17
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.93 · Odds ratio (or): 1.05 · 95% CI 0.34 to 3.28
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.023 · Odds ratio (or): 12.16 · 95% CI 1.40 to 105.30
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.042 · Odds ratio (or): 9.48 · 95% CI 1.08 to 83.24
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.047 · Odds ratio (or): 9.03 · 95% CI 1.03 to 79.19
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.23 · Odds ratio (or): 2.79 · 95% CI 0.52 to 14.90
Placebo vs Mirabegron 25 mg · Regression, Logistic · p = 0.058 · Odds ratio (or): 0.10 · 95% CI 0.01 to 1.08
Placebo vs Mirabegron 50 mg · Regression, Logistic · p = 0.15 · Odds ratio (or): 0.18 · 95% CI 0.02 to 1.87
Placebo vs Solifenacin 2.5 mg · Regression, Logistic · p = 0.55 · Odds ratio (or): 0.46 · 95% CI 0.04 to 5.99
Placebo vs Solifenacin 5 mg · Regression, Logistic · p = 0.11 · Odds ratio (or): 0.16 · 95% CI 0.02 to 1.48
Placebo vs Solifenacin 10 mg · Regression, Logistic · p = 0.054 · Odds ratio (or): 0.10 · 95% CI 0.01 to 1.05
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.059 · Odds ratio (or): 0.12 · 95% CI 0.01 to 1.08
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.12 · Odds ratio (or): 0.17 · 95% CI 0.02 to 1.58
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.64 · Odds ratio (or): 2.00 · 95% CI 0.11 to 35.46
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.76 · Odds ratio (or): 1.56 · 95% CI 0.09 to 27.42
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.79 · Odds ratio (or): 1.49 · 95% CI 0.08 to 26.47
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.55 · Odds ratio (or): 0.46 · 95% CI 0.04 to 5.77

SecondaryChange From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours

Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.

Time frame:: Baseline and Weeks 2, 4, 8 and 12
Reported as:: Least squares mean · urgency incontinence episodes

Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours
urgency incontinence episodes	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Week 2; n=14,13,17,15,33,12,29,33,31,21,24,18	-0.80 ± 0.178	-0.59 ± 0.184	-0.83 ± 0.161	-0.96 ± 0.171	-0.66 ± 0.115	-0.77 ± 0.191	-0.52 ± 0.123	-0.68 ± 0.115	-0.68 ± 0.120	-0.64 ± 0.145	-1.12 ± 0.135	-0.76 ± 0.156
Week 4; n=14,10,17,15,34,12,28,30,31,22,24,18	-0.83 ± 0.157	-0.48 ± 0.185	-0.93 ± 0.142	-1.13 ± 0.151	-0.77 ± 0.100	-1.00 ± 0.169	-0.73 ± 0.111	-0.70 ± 0.107	-0.81 ± 0.106	-0.86 ± 0.125	-1.20 ± 0.120	-0.68 ± 0.138
Week 8; n=14,10,17,14,34,13,29,30,31,21,24,19	-0.86 ± 0.173	-0.65 ± 0.204	-1.00 ± 0.157	-1.04 ± 0.172	-0.76 ± 0.110	-1.16 ± 0.179	-0.86 ± 0.119	-0.84 ± .118	-0.99 ± 0.117	-0.89 ± 0.141	-0.91 ± 0.132	-0.88 ± 0.148
Week 12; n=14,10,17,13,34,12,28,30,29,22,24,19	-0.84 ± 0.420	-0.54 ± 0.493	-0.87 ± 0.379	-1.13 ± 0.433	-0.83 ± 0.267	-1.13 ± 0.451	-0.81 ± 0.295	-0.91 ± 0.286	-1.19 ± 0.292	-1.06 ± 0.334	-0.28 ± 0.319	-0.93 ± 0.358
EOT; n=14,13,17,15,35,13,29,33,31,23,24,19	-0.86 ± 0.411	-0.80 ± 0.424	-0.88 ± 0.372	-1.17 ± 0.394	-0.86 ± 0.258	-1.13 ± 0.424	-0.81 ± 0.283	-0.87 ± 0.266	-1.20 ± 0.277	-1.08 ± 0.321	-0.28 ± 0.312	-0.94 ± 0.351

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · Stratified Rank ANCOVA · p = 0.25 (All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.) · Ls mean difference: -0.27 · 95% CI -1.24 to 0.71P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.35 · Ls mean difference: 0.05 · 95% CI -0.70 to 0.81
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · Stratified Rank ANCOVA · p = 1.0 · Ls mean difference: -0.01 · 95% CI -0.74 to 0.72
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.003 · Ls mean difference: -0.34 · 95% CI -1.08 to 0.41
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · Stratified Rank ANCOVA · p = 0.12 · Ls mean difference: -0.22 · 95% CI -1.04 to 0.59
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.24 · Ls mean difference: 0.58 · 95% CI -0.21 to 1.38
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · Stratified Rank ANCOVA · p = 0.54 · Ls mean difference: -0.08 · 95% CI -0.94 to 0.78
Placebo vs Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.95 · Ls mean difference: 0.06 · 95% CI -1.10 to 1.22
Placebo vs Mirabegron 50 mg · Stratified Rank ANCOVA · p = 0.74 · Ls mean difference: -0.02 · 95% CI -1.11 to 1.07
Placebo vs Solifenacin 2.5 mg · Stratified Rank ANCOVA · p = 0.89 · Ls mean difference: -0.31 · 95% CI -1.43 to 0.82
Placebo vs Solifenacin 5 mg · Stratified Rank ANCOVA · p = 0.82 · Ls mean difference: -0.00 · 95% CI -0.96 to 0.96
Placebo vs Solifenacin 10 mg · Stratified Rank ANCOVA · p = 0.58 · Ls mean difference: -0.27 · 95% CI -1.44 to 0.90
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.46 · Ls mean difference: 0.05 · 95% CI -0.93 to 1.04
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · Stratified Rank ANCOVA · p = 0.95 · Ls mean difference: -0.01 · 95% CI -0.97 to 0.96
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.18 · Ls mean difference: -0.34 · 95% CI -1.32 to 0.65
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · Stratified Rank ANCOVA · p = 0.21 · Ls mean difference: -0.22 · 95% CI -1.24 to 0.80
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · Stratified Rank ANCOVA · p = 0.72 · Ls mean difference: 0.58 · 95% CI -0.43 to 1.60
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · Stratified Rank ANCOVA · p = 0.92 · Ls mean difference: -0.08 · 95% CI -1.15 to 0.98

SecondaryChange From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours

The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.

Time frame:: Baseline and Weeks 2, 4, 8 and 12
Reported as:: Least squares mean · urgency episodes

Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours
urgency episodes	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77	-2.07 ± 0.276	-2.06 ± 0.292	-1.91 ± 0.282	-2.49 ± 0.286	-1.63 ± 0.202	-1.97 ± 0.288	-1.84 ± 0.205	-2.59 ± 0.205	-2.30 ± 0.211	-2.57 ± 0.207	-2.35 ± 0.281	-2.23 ± 0.281
Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75	-2.55 ± 0.308	-2.70 ± 0.322	-2.70 ± 0.317	-3.16 ± 0.313	-2.24 ± 0.225	-3.02 ± 0.320	-2.64 ± 0.230	-3.14 ± 0.229	-3.08 ± 0.233	-3.17 ± 0.228	-3.04 ± 0.311	-2.81 ± 0.316
Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74	-3.42 ± 0.318	-2.86 ± 0.332	-3.27 ± 0.325	-3.61 ± 0.321	-2.67 ± 0.229	-3.63 ± 0.323	-3.34 ± 0.232	-3.60 ± 0.233	-3.60 ± 0.240	-3.85 ± 0.231	-3.53 ± 0.317	-3.63 ± 0.323
Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73	-3.69 ± 0.334	-3.31 ± 0.347	-3.65 ± 0.338	-3.54 ± 0.338	-2.71 ± 0.240	-4.15 ± 0.337	-3.26 ± 0.246	-4.24 ± 0.246	-3.98 ± 0.250	-4.09 ± 0.240	-3.76 ± 0.333	-3.93 ± 0.338
EOT; n=80,76,77,77,150,76,146,147,141,150,78,80	-3.53 ± 0.328	-3.23 ± 0.336	-3.44 ± 0.334	-3.62 ± 0.334	-2.73 ± 0.239	-3.98 ± 0.336	-3.21 ± 0.242	-3.97 ± 0.242	-3.86 ± 0.247	-4.10 ± 0.239	-3.71 ± 0.332	-3.91 ± 0.327

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · ANCOVA · p = 0.002 · Ls mean difference: -1.26 · 95% CI -2.06 to -0.45
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.16 · Ls mean difference: -0.48 · 95% CI -1.15 to 0.19
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = <0.001 · Ls mean difference: -1.24 · 95% CI -1.91 to -0.57
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.001 · Ls mean difference: -1.13 · 95% CI -1.80 to -0.46
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = <0.001 · Ls mean difference: -1.37 · 95% CI -2.03 to -0.70
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.017 · Ls mean difference: -0.98 · 95% CI -1.78 to -0.18
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.004 · Ls mean difference: -1.18 · 95% CI -1.98 to -0.39
Placebo vs Mirabegron 25 mg · ANCOVA · p = 0.53 · Ls mean difference: 0.29 · 95% CI -0.63 to 1.22
Placebo vs Mirabegron 50 mg · ANCOVA · p = 0.85 · Ls mean difference: 0.09 · 95% CI -0.83 to 1.01
Placebo vs Solifenacin 2.5 mg · ANCOVA · p = 0.84 · Ls mean difference: -0.09 · 95% CI -1.01 to 0.83
Placebo vs Solifenacin 5 mg · ANCOVA · p = 0.050 · Ls mean difference: 0.80 · 95% CI -0.00 to 1.59
Placebo vs Solifenacin 10 mg · ANCOVA · p = 0.33 · Ls mean difference: -0.46 · 95% CI -1.38 to 0.46
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.44 · Ls mean difference: 0.32 · 95% CI -0.48 to 1.12
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.28 · Ls mean difference: -0.44 · 95% CI -1.24 to 0.36
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.42 · Ls mean difference: -0.33 · 95% CI -1.14 to 0.47
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.16 · Ls mean difference: -0.57 · 95% CI -1.37 to 0.23
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.70 · Ls mean difference: -0.18 · 95% CI -1.10 to 0.73
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.40 · Ls mean difference: -0.39 · 95% CI -1.30 to 0.52

SecondaryChange From Baseline to Each Visit in Mean Level of Urgency

Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.

Time frame:: Baseline and Weeks 2, 4, 8 and 12
Reported as:: Least squares mean · units on a scale

Change From Baseline to Each Visit in Mean Level of Urgency
units on a scale	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Week 2; n=80,71,76,74,148,73,145,145,136,141,77,77	-0.24 ± 0.043	-0.19 ± 0.046	-0.15 ± 0.044	-0.25 ± 0.045	-0.14 ± 0.032	-0.21 ± 0.045	-0.19 ± 0.032	-0.26 ± 0.032	-0.26 ± 0.033	-0.28 ± 0.033	-0.31 ± 0.044	-0.20 ± 0.044
Week 4; n=79,72,74,76,147,73,141,142,138,144,77,75	-0.32 ± 0.052	-0.28 ± 0.054	-0.26 ± 0.053	-0.33 ± 0.053	-0.23 ± 0.038	-0.35 ± 0.054	-0.32 ± 0.039	-0.35 ± 0.039	-0.35 ± 0.039	-0.37 ± 0.038	-0.41 ± 0.052	-0.31 ± 0.053
Week 8; n=77,70,73,75,147,74,143,142,134,145,77,74	-0.42 ± 0.059	-0.30 ± 0.062	-0.36 ± 0.061	-0.45 ± 0.060	-0.30 ± 0.043	-0.44 ± 0.60	-0.39 ± 0.043	-0.41 ± 0.044	-0.45 ± 0.045	-0.46 ± 0.043	-0.53 ± 0.059	-0.43 ± 0.060
Week 12;n=75,69,73,73,144,73,138,138,133,144,75,73	-0.48 ± 0.064	-0.35 ± 0.067	-0.44 ± 0.065	-0.42 ± 0.065	-0.33 ± 0.046	-0.49 ± 0.065	-0.43 ± 0.047	-0.54 ± 0.047	-0.50 ± 0.048	-0.54 ± 0.046	-0.61 ± 0.064	-0.49 ± 0.065
EOT; n=80,76,77,77,150,76,146,147,141,150,78,80	-0.46 ± 0.063	-0.33 ± 0.064	-0.41 ± 0.064	-0.45 ± 0.064	-0.33 ± 0.064	-0.47 ± 0.064	-0.42 ± 0.046	-0.50 ± 0.046	-0.48 ± 0.047	-0.55 ± 0.046	-0.59 ± 0.063	-0.47 ± 0.063

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · ANCOVA · p = 0.062 · Ls mean difference: -0.15 · 95% CI -0.30 to 0.01
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.15 · Ls mean difference: -0.09 · 95% CI -0.22 to 0.03
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.007 · Ls mean difference: -0.18 · 95% CI -0.30 to -0.05
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.017 · Ls mean difference: -0.16 · 95% CI -0.29 to -0.03
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = <0.001 · Ls mean difference: -0.23 · 95% CI -0.35 to -0.10
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = <0.001 · Ls mean difference: -0.26 · 95% CI -0.41 to -0.11
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.070 · Ls mean difference: -0.14 · 95% CI -0.29 to 0.01
Placebo vs Mirabegron 25 mg · ANCOVA · p = 0.15 · Ls mean difference: 0.13 · 95% CI -0.05 to 0.31
Placebo vs Mirabegron 50 mg · ANCOVA · p = 0.57 · Ls mean difference: 0.05 · 95% CI -0.12 to 0.23
Placebo vs Solifenacin 2.5 mg · ANCOVA · p = 0.89 · Ls mean difference: 0.01 · 95% CI -0.16 to 0.19
Placebo vs Solifenacin 5 mg · ANCOVA · p = 0.086 · Ls mean difference: 0.13 · 95% CI -0.02 to 0.29
Placebo vs Solifenacin 10 mg · ANCOVA · p = 0.88 · Ls mean difference: -0.01 · 95% CI -0.19 to 0.16
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.61 · Ls mean difference: 0.04 · 95% CI -0.11 to 0.19
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.58 · Ls mean difference: -0.04 · 95% CI -0.20 to 0.11
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.76 · Ls mean difference: -0.02 · 95% CI -0.18 to 0.13
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.23 · Ls mean difference: -0.09 · 95% CI -0.25 to 0.06
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.15 · Ls mean difference: -0.13 · 95% CI -0.30 to 0.05
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.94 · Ls mean difference: -0.01 · 95% CI -0.18 to 0.17

SecondaryChange From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours

The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.

Time frame:: Baseline and Weeks 2, 4, 8 and 12
Reported as:: Least squares mean · pads

Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours
pads	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Week 2; n=33,33,34,31,74,23,62,55,62,62,45,30	-0.81 ± 0.212	-0.87 ± 0.212	-0.88 ± 0.209	-1.31 ± 0.219	-0.92 ± 0.142	-0.91 ± 0.255	-0.86 ± 0.155	-0.96 ± 0.164	-0.89 ± 0.155	-1.02 ± 0.155	-1.13 ± 0.182	-1.31 ± 0.223
Week 4; n=32,31,35,31,75,23,61,52,64,62,45,30	-0.76 ± 0.224	-0.93 ± 0.228	-0.70 ± 0.214	-1.62 ± 0.228	-1.26 ± 0.147	-1.23 ± 0.265	-0.94 ± 0.162	-1.09 ± 0.176	-1.24 ± 0.159	-1.30 ± 0.161	-1.35 ± 0.189	-1.36 ± 0.231
Week 8; n=30,31,34,31,74,24,63,52,64,61,45,30	-0.97 ± 0.226	-0.90 ± 0.223	-1.11 ± 0.213	-1.47 ± 0.223	-1.25 ± 0.144	-1.53 ± 0.253	-1.10 ± 0.156	-1.39 ± 0.172	-1.29 ± 0.155	-1.51 ± 0.159	-1.37 ± 0.185	-1.56 ± 0.227
Week 12; n=30,31,34,29,72,23,60,52,63,62,45,31	-0.92 ± 0.246	-0.97 ± 0.242	-0.93 ± 0.231	-1.35 ± 0.251	-1.39 ± 0.159	-1.75 ± 0.282	-1.02 ± 0.174	-1.44 ± 0.187	-1.45 ± 0.170	-1.63 ± 0.172	-1.60 ± 0.201	-1.60 ± 0.243
EOT; n=33,34,35,32,76,24,63,56,64,65,46,32	-0.63 ± 0.244	-1.04 ± 0.241	-0.95 ± 0.237	-1.44 ± 0.248	-1.38 ± 0.161	-1.73 ± 0.287	-1.04 ± 0.177	-1.38 ± 0.188	-1.46 ± 0.176	-1.63 ± 0.174	-1.59 ± 0.207	-1.63 ± 0.248

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · ANCOVA · p = 0.29 · Ls mean difference: -0.35 · 95% CI -0.99 to 0.30
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.15 · Ls mean difference: 0.35 · 95% CI -0.12 to 0.82
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.99 · Ls mean difference: 0.00 · 95% CI -0.48 to 0.49
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.76 · Ls mean difference: -0.07 · 95% CI -0.54 to 0.40
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.30 · Ls mean difference: -0.25 · 95% CI -0.71 to 0.22
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.43 · Ls mean difference: -0.21 · 95% CI -0.72 to 0.31
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.40 · Ls mean difference: -0.25 · 95% CI -0.83 to 0.33
Placebo vs Mirabegron 25 mg · ANCOVA · p = 0.24 · Ls mean difference: -0.40 · 95% CI -1.08 to 0.27
Placebo vs Mirabegron 50 mg · ANCOVA · p = 0.36 · Ls mean difference: -0.31 · 95% CI -0.98 to 0.36
Placebo vs Solifenacin 2.5 mg · ANCOVA · p = 0.020 · Ls mean difference: -0.81 · 95% CI -1.49 to -0.13
Placebo vs Solifenacin 5 mg · ANCOVA · p = 0.011 · Ls mean difference: -0.75 · 95% CI -1.33 to -0.18
Placebo vs Solifenacin 10 mg · ANCOVA · p = 0.004 · Ls mean difference: -1.10 · 95% CI -1.84 to -0.36
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.18 · Ls mean difference: -0.40 · 95% CI -1.00 to 0.19
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.015 · Ls mean difference: -0.75 · 95% CI -1.35 to -0.14
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.006 · Ls mean difference: -0.82 · 95% CI -1.41 to -0.23
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = <0.001 · Ls mean difference: -1.00 · 95% CI -1.59 to -0.41
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.003 · Ls mean difference: -0.96 · 95% CI -1.59 to -0.33
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.004 · Ls mean difference: -1.00 · 95% CI -1.68 to -0.31

SecondaryChange From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours

Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.

Time frame:: Baseline and Weeks 2, 4, 8 and 12
Reported as:: Least squares mean · nocturia episodes

Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours
nocturia episodes	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Week 2; n=78,69,75,72,144,71,142,138,133,138,74,73	-0.33 ± 0.115	-0.37 ± 0.123	-0.60 ± 0.118	-0.38 ± 0.120	-0.30 ± 0.085	-0.45 ± 0.121	-0.43 ± 0.086	-0.51 ± 0.087	-0.49 ± 0.088	-0.61 ± 0.087	-0.43 ± 0.119	-0.53 ± 0.119
Week 4; n=77,69,74,74,143,71,138,135,134,141,74,71	-0.50 ± 0.116	-0.60 ± 0.123	-0.71 ± 0.118	-0.55 ± 0.118	-0.47 ± 0.085	-0.74 ± 0.121	-0.59 ± 0.087	-0.54 ± 0.088	-0.69 ± 0.088	-0.80 ± 0.086	-0.67 ± 0.119	-0.75 ± 0.121
Week 8; n=75,67,73,73,143,72,140,135,130,142,74,70	-0.64 ± 0.126	-0.65 ± 0.133	-0.68 ± 0.127	-0.80 ± 0.127	-0.65 ± 0.091	-1.01 ± 0.128	-0.76 ± 0.092	-0.79 ± 0.094	-0.76 ± 0.095	-0.98 ± 0.091	-0.81 ± 0.127	-0.91 ± 0.130
Week 12;n=73,66,73,71,140,71,135,131,130,141,72,69	-0.79 ± 0.146	-0.69 ± 0.154	-0.84 ± 0.146	-0.59 ± 0.148	-0.70 ± 0.106	-0.99 ± 0.148	-0.75 ± 0.108	-0.81 ± 0.109	-0.80 ± 0.110	-1.05 ± 0.105	-0.98 ± 0.147	-1.03 ± 0.150
EOT; n=78,73,76,75,146,74,143,140,137,147,75,76	-0.74 ± 0.140	-0.69 ± 0.145	-0.82 ± 0.142	-0.68 ± 0.143	-0.69 ± 0.102	-0.95 ± 0.144	-0.73 ± 0.104	-0.77 ± 0.105	-0.77 ± 0.106	-1.04 ± 0.102	-0.94 ± 0.143	-0.96 ± 0.142

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · ANCOVA · p = 0.15 · Ls mean difference: -0.25 · 95% CI -0.60 to 0.09
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.78 · Ls mean difference: -0.04 · 95% CI -0.33 to 0.25
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.58 · Ls mean difference: -0.08 · 95% CI -0.37 to 0.21
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.60 · Ls mean difference: -0.08 · 95% CI -0.37 to 0.21
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.017 · Ls mean difference: -0.35 · 95% CI -0.63 to -0.06
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.16 · Ls mean difference: -0.25 · 95% CI -0.60 to 0.10
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.13 · Ls mean difference: -0.27 · 95% CI -0.61 to 0.08
Placebo vs Mirabegron 25 mg · ANCOVA · p = 0.81 · Ls mean difference: 0.05 · 95% CI -0.35 to 0.44
Placebo vs Mirabegron 50 mg · ANCOVA · p = 0.67 · Ls mean difference: -0.08 · 95% CI -0.48 to 0.31
Placebo vs Solifenacin 2.5 mg · ANCOVA · p = 0.77 · Ls mean difference: 0.06 · 95% CI -0.33 to 0.45
Placebo vs Solifenacin 5 mg · ANCOVA · p = 0.81 · Ls mean difference: 0.04 · 95% CI -0.30 to 0.38
Placebo vs Solifenacin 10 mg · ANCOVA · p = 0.30 · Ls mean difference: -0.21 · 95% CI -0.60 to 0.18
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.99 · Ls mean difference: 0.00 · 95% CI -0.34 to 0.34
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.82 · Ls mean difference: -0.04 · 95% CI -0.38 to 0.30
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.84 · Ls mean difference: -0.04 · 95% CI -0.38 to 0.31
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.080 · Ls mean difference: -0.30 · 95% CI -0.64 to 0.04
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.30 · Ls mean difference: -0.21 · 95% CI -0.60 to 0.18
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.26 · Ls mean difference: -0.22 · 95% CI -0.62 to 0.17

SecondaryChange From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · units on a scale

Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)
units on a scale	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)	-1.4 ± 0.14	-1.4 ± 0.14	-1.5 ± 0.14	-1.5 ± 0.14	-1.3 ± 0.10	-1.5 ± 0.14	-1.4 ± 0.10	-1.7 ± 0.10	-1.7 ± 0.10	-1.8 ± 0.10	-1.8 ± 0.14	-1.6 ± 0.14

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · ANCOVA · p = 0.38 · Ls mean difference: -0.1 · 95% CI -0.5 to 0.2
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.85 · Ls mean difference: -0.0 · 95% CI -0.3 to 0.3
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.024 · Ls mean difference: -0.3 · 95% CI -0.6 to -0.0
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.005 · Ls mean difference: -0.4 · 95% CI -0.7 to -0.1
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.003 · Ls mean difference: -0.4 · 95% CI -0.7 to -0.1
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.004 · Ls mean difference: -0.5 · 95% CI -0.8 to -0.2
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.15 · Ls mean difference: -0.2 · 95% CI -0.6 to 0.1
Placebo vs Mirabegron 25 mg · ANCOVA · p = 0.99 · Ls mean difference: 0.0 · 95% CI -0.4 to 0.4
Placebo vs Mirabegron 50 mg · ANCOVA · p = 0.67 · Ls mean difference: -0.1 · 95% CI -0.5 to 0.3
Placebo vs Solifenacin 2.5 mg · ANCOVA · p = 0.44 · Ls mean difference: -0.1 · 95% CI -0.5 to 0.2
Placebo vs Solifenacin 5 mg · ANCOVA · p = 0.88 · Ls mean difference: 0.0 · 95% CI -0.3 to 0.4
Placebo vs Solifenacin 10 mg · ANCOVA · p = 0.53 · Ls mean difference: -0.1 · 95% CI -0.5 to 0.3
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 1.0 · Ls mean difference: -0.0 · 95% CI -0.3 to 0.3
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.084 · Ls mean difference: -0.3 · 95% CI -0.6 to 0.0
Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.030 · Ls mean difference: -0.4 · 95% CI -0.7 to -0.0
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.020 · Ls mean difference: -0.4 · 95% CI -0.7 to -0.1
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.017 · Ls mean difference: -0.5 · 95% CI -0.8 to -0.1
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.26 · Ls mean difference: -0.2 · 95% CI -0.6 to 0.2

SecondaryPercentage of Participants With Improvement in PPBC

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score.

Time frame:: Baseline and Week 12
Reported as:: Number · percentage of participants

Percentage of Participants With Improvement in PPBC
percentage of participants	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Percentage of Participants With Improvement in PPBC	69.2	76.7	78.9	68.0	72.8	84.9	74.5	83.2	77.9	82.6	82.9	75.6

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · Regression, Logistic · p = 0.040 · Odds ratio (or): 2.26 · 95% CI 1.04 to 4.95
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.73 · Odds ratio (or): 1.10 · 95% CI 0.63 to 1.92
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.050 · Odds ratio (or): 1.82 · 95% CI 1.00 to 3.30
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.21 · Odds ratio (or): 1.45 · 95% CI 0.81 to 2.59
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.021 · Odds ratio (or): 2.02 · 95% CI 1.11 to 3.66
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.19 · Odds ratio (or): 1.64 · 95% CI 0.79 to 3.40
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.74 · Odds ratio (or): 1.12 · 95% CI 0.57 to 2.19
Placebo vs Mirabegron 25 mg · Regression, Logistic · p = 0.57 · Odds ratio (or): 1.25 · 95% CI 0.58 to 2.71
Placebo vs Mirabegron 50 mg · Regression, Logistic · p = 0.19 · Odds ratio (or): 1.67 · 95% CI 0.77 to 3.64
Placebo vs Solifenacin 2.5 mg · Regression, Logistic · p = 0.69 · Odds ratio (or): 0.86 · 95% CI 0.41 to 1.79
Placebo vs Solifenacin 5 mg · Regression, Logistic · p = 0.90 · Odds ratio (or): 1.04 · 95% CI 0.55 to 1.99
Placebo vs Solifenacin 10 mg · Regression, Logistic · p = 0.048 · Odds ratio (or): 2.36 · 95% CI 1.01 to 5.55
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.67 · Odds ratio (or): 1.15 · 95% CI 0.60 to 2.22
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.070 · Odds ratio (or): 1.90 · 95% CI 0.95 to 3.78
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.23 · Odds ratio (or): 1.51 · 95% CI 0.77 to 2.98
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.034 · Odds ratio (or): 2.11 · 95% CI 1.06 to 4.19
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.20 · Odds ratio (or): 1.71 · 95% CI 0.76 to 3.84
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.68 · Odds ratio (or): 1.17 · 95% CI 0.55 to 2.49

SecondaryPercentage of Participants With Major Improvement in PPBC

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.

Time frame:: Baseline and Week 12
Reported as:: Number · percentage of participants

Percentage of Participants With Major Improvement in PPBC
percentage of participants	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Percentage of Participants With Major Improvement in PPBC	39.7	42.5	38.2	44.0	42.2	46.6	48.2	52.4	54.4	54.9	57.9	50.0

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · Regression, Logistic · p = 0.62 · Odds ratio (or): 1.16 · 95% CI 0.64 to 2.12
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.25 · Odds ratio (or): 1.33 · 95% CI 0.82 to 2.17
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.11 · Odds ratio (or): 1.48 · 95% CI 0.91 to 2.41
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.020 · Odds ratio (or): 1.81 · 95% CI 1.10 to 2.97
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.012 · Odds ratio (or): 1.87 · 95% CI 1.15 to 3.05
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.072 · Odds ratio (or): 1.72 · 95% CI 0.95 to 3.10
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.29 · Odds ratio (or): 1.37 · 95% CI 0.77 to 2.44
Placebo vs Mirabegron 25 mg · Regression, Logistic · p = 0.94 · Odds ratio (or): 0.98 · 95% CI 0.49 to 1.93
Placebo vs Mirabegron 50 mg · Regression, Logistic · p = 0.80 · Odds ratio (or): 0.91 · 95% CI 0.46 to 1.81
Placebo vs Solifenacin 2.5 mg · Regression, Logistic · p = 0.67 · Odds ratio (or): 1.16 · 95% CI 0.59 to 2.28
Placebo vs Solifenacin 5 mg · Regression, Logistic · p = 1.0 · Odds ratio (or): 1.00 · 95% CI 0.55 to 1.80
Placebo vs Solifenacin 10 mg · Regression, Logistic · p = 0.66 · Odds ratio (or): 1.16 · 95% CI 0.59 to 2.31
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.35 · Odds ratio (or): 1.33 · 95% CI 0.73 to 2.40
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.19 · Odds ratio (or): 1.48 · 95% CI 0.82 to 2.67
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.054 · Odds ratio (or): 1.80 · 95% CI 0.99 to 3.28
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.038 · Odds ratio (or): 1.87 · 95% CI 1.04 to 3.38
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.12 · Odds ratio (or): 1.72 · 95% CI 0.87 to 3.39
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.36 · Odds ratio (or): 1.37 · 95% CI 0.70 to 2.67

SecondaryPercentage of Participants With Deterioration in PPBC

The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.

Time frame:: Baseline and Week 12
Reported as:: Number · percentage of participants

Percentage of Participants With Deterioration in PPBC
percentage of participants	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Percentage of Participants With Deterioration in PPBC	6.4	4.1	5.3	4.0	4.8	2.7	4.3	2.8	2.9	1.4	1.3	6.4

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · Regression, Logistic · p = 0.32 · Odds ratio (or): 0.40 · 95% CI 0.06 to 2.43
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.65 · Odds ratio (or): 0.75 · 95% CI 0.21 to 2.61
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.39 · Odds ratio (or): 0.54 · 95% CI 0.13 to 2.19
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.22 · Odds ratio (or): 0.41 · 95% CI 0.10 to 1.67
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.082 · Odds ratio (or): 0.22 · 95% CI 0.04 to 1.22
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.36 · Odds ratio (or): 0.36 · 95% CI 0.04 to 3.20
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.51 · Odds ratio (or): 1.55 · 95% CI 0.42 to 5.71
Placebo vs Mirabegron 25 mg · Regression, Logistic · p = 0.99 · Odds ratio (or): 1.01 · 95% CI 0.19 to 5.36
Placebo vs Mirabegron 50 mg · Regression, Logistic · p = 0.96 · Odds ratio (or): 1.04 · 95% CI 0.24 to 4.59
Placebo vs Solifenacin 2.5 mg · Regression, Logistic · p = 0.57 · Odds ratio (or): 0.62 · 95% CI 0.12 to 3.30
Placebo vs Solifenacin 5 mg · Regression, Logistic · p = 0.93 · Odds ratio (or): 1.06 · 95% CI 0.28 to 3.95
Placebo vs Solifenacin 10 mg · Regression, Logistic · p = 0.37 · Odds ratio (or): 0.42 · 95% CI 0.06 to 2.79
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.74 · Odds ratio (or): 0.79 · 95% CI 0.20 to 3.13
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.46 · Odds ratio (or): 0.57 · 95% CI 0.12 to 2.59
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.28 · Odds ratio (or): 0.44 · 95% CI 0.10 to 1.96
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.11 · Odds ratio (or): 0.23 · 95% CI 0.04 to 1.40
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.40 · Odds ratio (or): 0.38 · 95% CI 0.04 to 3.66
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.50 · Odds ratio (or): 1.64 · 95% CI 0.39 to 6.85

SecondaryChange From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)

Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · units on a scale

Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)
units on a scale	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)	-25.5 ± 1.96	-27.1 ± 2.01	-27.5 ± 2.00	-29.8 ± 1.99	-26.8 ± 1.42	-29.9 ± 2.01	-28.0 ± 1.45	-31.7 ± 1.45	-32.0 ± 1.48	-33.5 ± 1.44	-33.6 ± 1.97	-31.4 ± 1.97

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · ANCOVA · p = 0.21 · Ls mean difference: -3.1 · 95% CI -8.0 to 1.7
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.54 · Ls mean difference: -1.3 · 95% CI -5.2 to 2.7
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.016 · Ls mean difference: -4.9 · 95% CI -8.9 to -0.9
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.011 · Ls mean difference: -5.2 · 95% CI -9.3 to -1.2
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = <0.001 · Ls mean difference: -6.7 · 95% CI -10.7 to -2.8
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.005 · Ls mean difference: -6.8 · 95% CI -11.6 to -2.0
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.056 · Ls mean difference: -4.7 · 95% CI -9.4 to 0.1
Placebo vs Mirabegron 25 mg · ANCOVA · p = 0.56 · Ls mean difference: -1.6 · 95% CI -7.1 to 3.9
Placebo vs Mirabegron 50 mg · ANCOVA · p = 0.48 · Ls mean difference: -2.0 · 95% CI -7.5 to 3.5
Placebo vs Solifenacin 2.5 mg · ANCOVA · p = 0.13 · Ls mean difference: -4.3 · 95% CI -9.8 to 1.2
Placebo vs Solifenacin 5 mg · ANCOVA · p = 0.61 · Ls mean difference: -1.2 · 95% CI -6.0 to 3.5
Placebo vs Solifenacin 10 mg · ANCOVA · p = 0.12 · Ls mean difference: -4.4 · 95% CI -9.9 to 1.2
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.31 · Ls mean difference: -2.5 · 95% CI -7.3 to 2.3
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.012 · Ls mean difference: -6.1 · 95% CI -10.9 to -1.3
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.008 · Ls mean difference: -6.5 · 95% CI -11.3 to -1.7
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.001 · Ls mean difference: -8.0 · 95% CI -12.8 to -3.2
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.004 · Ls mean difference: -8.0 · 95% CI -13.5 to -2.6
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.035 · Ls mean difference: -5.9 · 95% CI -11.4 to -0.4

SecondaryPercentage of Participants With a Symptom Bother Response

Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.

Time frame:: Baseline and Week 12
Reported as:: Number · percentage of participants

Percentage of Participants With a Symptom Bother Response
percentage of participants	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Percentage of Participants With a Symptom Bother Response	73.4	84.0	78.9	85.7	81.3	85.3	82.6	85.5	85.6	88.4	88.5	83.3

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · Regression, Logistic · p = 0.40 · Odds ratio (or): 1.42 · 95% CI 0.63 to 3.20
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.89 · Odds ratio (or): 1.04 · 95% CI 0.55 to 1.97
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.57 · Odds ratio (or): 1.21 · 95% CI 0.63 to 2.33
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.36 · Odds ratio (or): 1.36 · 95% CI 0.70 to 2.66
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.15 · Odds ratio (or): 1.66 · 95% CI 0.83 to 3.32
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.31 · Odds ratio (or): 1.55 · 95% CI 0.67 to 3.59
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.81 · Odds ratio (or): 0.91 · 95% CI 0.42 to 1.95
Placebo vs Mirabegron 25 mg · Regression, Logistic · p = 0.19 · Odds ratio (or): 1.75 · 95% CI 0.75 to 4.08
Placebo vs Mirabegron 50 mg · Regression, Logistic · p = 0.59 · Odds ratio (or): 1.25 · 95% CI 0.56 to 2.77
Placebo vs Solifenacin 2.5 mg · Regression, Logistic · p = 0.13 · Odds ratio (or): 1.97 · 95% CI 0.83 to 4.71
Placebo vs Solifenacin 5 mg · Regression, Logistic · p = 0.20 · Odds ratio (or): 1.57 · 95% CI 0.78 to 3.16
Placebo vs Solifenacin 10 mg · Regression, Logistic · p = 0.070 · Odds ratio (or): 2.24 · 95% CI 0.94 to 5.34
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.17 · Odds ratio (or): 1.64 · 95% CI 0.81 to 3.33
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.084 · Odds ratio (or): 1.90 · 95% CI 0.92 to 3.92
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.043 · Odds ratio (or): 2.14 · 95% CI 1.02 to 4.48
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.013 · Odds ratio (or): 2.61 · 95% CI 1.22 to 5.58
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.053 · Odds ratio (or): 2.43 · 95% CI 0.99 to 5.97
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.39 · Odds ratio (or): 1.43 · 95% CI 0.63 to 3.26

SecondaryChange From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score

Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · units on a scale

Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score
units on a scale	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score	24.5 ± 2.03	22.5 ± 2.08	25.8 ± 2.07	27.7 ± 2.05	23.7 ± 1.47	26.6 ± 2.08	25.5 ± 1.50	28.5 ± 1.50	29.2 ± 1.53	30.1 ± 1.49	30.3 ± 2.04	28.9 ± 2.04

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · ANCOVA · p = 0.26 · Ls mean difference: 2.9 · 95% CI -2.1 to 7.9
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.38 · Ls mean difference: 1.8 · 95% CI -2.3 to 6.0
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.022 · Ls mean differrence: 4.8 · 95% CI 0.7 to 8.9
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.010 · Ls mean difference: 5.5 · 95% CI 1.3 to 9.7
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.002 · Ls mean difference: 6.4 · 95% CI 2.3 to 10.5
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.008 · Ls mean difference: 6.7 · 95% CI 1.7 to 11.6
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.037 · Ls mean difference: 5.3 · 95% CI 0.3 to 10.2
Placebo vs Mirabegron 25 mg · ANCOVA · p = 0.50 · Ls mean difference: -2.0 · 95% CI -7.7 to 3.7
Placebo vs Mirabegron 50 mg · ANCOVA · p = 0.65 · Ls mean difference: 1.3 · 95% CI -4.4 to 7.0
Placebo vs Solifenacin 2.5 mg · ANCOVA · p = 0.25 · Ls mean difference: 3.3 · 95% CI -2.4 to 8.9
Placebo vs Solifenacin 5 mg · ANCOVA · p = 0.76 · Ls mean difference: -0.8 · 95% CI -5.7 to 4.1
Placebo vs Solifenacin 10 mg · ANCOVA · p = 0.47 · Ls mean difference: 2.1 · 95% CI -3.6 to 7.8
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.67 · Ls mean difference: 1.1 · 95% CI -3.9 to 6.0
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.11 · Ls mean difference: 4.0 · 95% CI -0.9 to 9.0
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.062 · Ls mean difference: 4.7 · 95% CI -0.2 to 9.7
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.025 · Ls mean difference: 5.6 · 95% CI 0.7 to 10.6
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.041 · Ls mean difference: 5.9 · 95% CI 0.2 to 11.5
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.12 · Ls mean difference: 4.5 · 95% CI -1.2 to 10.1

SecondaryPercentage of Participants With a Health-related Quality of Life Total Score Response

Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.

Time frame:: Baseline and Week 12
Reported as:: Number · percentage of participants

Percentage of Participants With a Health-related Quality of Life Total Score Response
percentage of participants	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Percentage of Participants With a Health-related Quality of Life Total Score Response	67.1	57.3	71.1	74.0	72.7	74.7	72.9	78.6	77.0	84.2	79.5	82.1

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · Regression, Logistic · p = 0.92 · Odds ratio (or): 1.04 · 95% CI 0.52 to 2.08
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.98 · Odds ratio (or): 1.01 · 95% CI 0.58 to 1.77
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.45 · Odds ratio (or): 1.25 · 95% CI 0.70 to 2.23
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.24 · Odds ratio (or): 1.41 · 95% CI 0.79 to 2.53
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.012 · Odds ratio (or): 2.21 · 95% CI 1.19 to 4.09
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.32 · Odds ratio (or): 1.43 · 95% CI 0.70 to 2.90
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.27 · Odds ratio (or): 1.51 · 95% CI 0.72 to 3.14
Placebo vs Mirabegron 25 mg · Regression, Logistic · p = 0.064 · Odds ratio (or): 0.50 · 95% CI 0.24 to 1.04
Placebo vs Mirabegron 50 mg · Regression, Logistic · p = 0.57 · Odds ratio (or): 1.24 · 95% CI 0.59 to 2.61
Placebo vs Solifenacin 2.5 mg · Regression, Logistic · p = 0.55 · Odds ratio (or): 1.26 · 95% CI 0.59 to 2.68
Placebo vs Solifenacin 5 mg · Regression, Logistic · p = 0.75 · Odds ratio (or): 1.11 · 95% CI 0.58 to 2.13
Placebo vs Solifenacin 10 mg · Regression, Logistic · p = 0.72 · Odds ratio (or): 1.15 · 95% CI 0.53 to 2.49
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.74 · Odds ratio (or): 1.12 · 95% CI 0.58 to 2.15
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.34 · Odds ratio (or): 1.39 · 95% CI 0.71 to 2.71
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.19 · Odds ratio (or): 1.57 · 95% CI 0.80 to 3.07
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.012 · Odds ratio (or): 2.45 · 95% CI 1.22 to 4.94
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · Regression, Logistic · p = 0.25 · Odds ratio (or): 1.59 · 95% CI 0.72 to 3.47
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · Regression, Logistic · p = 0.21 · Odds ratio (or): 1.67 · 95% CI 0.74 to 3.75

SecondaryChange From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score

The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems in walking about; I have some problems in walking about; I am confined to bed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.

Time frame:: Baseline and Week 12
Reported as:: Number · participants

Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score
participants	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
No problem → No problem	60	58	63	59	118	54	94	113	102	120	59	56
No problem → Some problems	6	1	4	4	6	4	9	5	9	1	0	5
No problem → Confined to bed	0	0	0	0	0	0	0	0	0	0	0	0
No problem → Missing data	1	1	1	0	0	1	1	1	1	1	0	2
Some problems → No problems	5	6	6	4	11	8	21	15	13	14	11	8
Some problems → Some problems	8	10	3	10	15	9	20	12	15	11	8	9
Some problems → Confined to bed	0	0	0	0	0	0	0	0	0	0	0	0
Some problems → Missing data	0	0	0	0	0	0	0	0	1	1	0	0
Confined → No problems	0	0	0	0	0	0	0	0	0	0	0	0
Confined → Some problems	0	0	0	0	0	0	0	0	0	0	0	0
Confined → Confined to bed	0	0	0	0	0	0	0	0	0	0	0	0
Confined → Missing data	0	0	0	0	0	0	0	0	0	0	0	0
Missing data → No problem	0	0	0	0	0	0	1	0	0	2	0	0
Missing data → Some problems	0	0	0	0	0	0	0	1	0	0	0	0
Missing data → Confined to bed	0	0	0	0	0	0	0	0	0	0	0	0
Missing data → Missing data	0	0	0	0	0	0	0	0	0	0	0	0

SecondaryChange From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score

The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.

Time frame:: Baseline and Week 12
Reported as:: Number · participants

Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score
participants	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
No problem → No problem	76	69	73	72	138	68	128	138	130	141	74	72
No problem → Some problems	0	1	3	2	2	2	5	2	1	1	1	0
No problem → Unable	0	0	0	0	1	1	0	0	0	0	0	0
No problem → Missing data	1	0	1	0	0	1	1	1	2	2	0	2
Some problems → No problems	1	4	0	1	6	3	8	3	3	2	1	2
Some problems → Some problems	2	1	0	2	3	1	3	2	4	2	2	4
Some problems → Unable	0	0	0	0	0	0	0	0	1	0	0	0
Some problems → Missing data	0	1	0	0	0	0	0	0	0	0	0	0
Unable → No problems	0	0	0	0	0	0	0	0	0	0	0	0
Unable → Some problems	0	0	0	0	0	0	0	0	0	0	0	0
Unable → Unable	0	0	0	0	0	0	0	0	0	0	0	0
Unable → Missing data	0	0	0	0	0	0	0	0	0	0	0	0
Missing data → No problem	0	0	0	0	0	0	1	0	0	2	0	0
Missing data → Some problems	0	0	0	0	0	0	0	1	0	0	0	0
Missing data → Unable	0	0	0	0	0	0	0	0	0	0	0	0
Missing data → Missing data	0	0	0	0	0	0	0	0	0	0	0	0

SecondaryChange From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score

The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.

Time frame:: Baseline and Week 12
Reported as:: Number · participants

Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score
participants	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
No problem → No problem	62	52	58	60	115	57	89	110	106	109	57	48
No problem → Some problems	2	2	3	2	3	4	8	3	9	4	1	5
No problem → Unable	0	0	0	0	0	1	0	0	0	0	0	1
No problem → Missing data	0	0	1	0	0	1	1	1	1	2	0	2
Some problems → No problems	11	11	8	11	16	7	29	24	12	21	14	14
Some problems → Some problems	4	10	6	4	13	6	18	8	11	12	4	8
Some problems → Unable	0	0	0	0	2	0	0	0	0	0	1	0
Some problems → Missing data	1	1	0	0	0	0	0	0	1	0	0	0
Unable → No problems	0	0	0	0	1	0	0	0	1	0	0	0
Unable → Some problems	0	0	1	0	0	0	0	0	0	0	1	2
Unable → Unable	0	0	0	0	0	0	0	0	0	0	0	0
Unable → Missing data	0	0	0	0	0	0	0	0	0	0	0	0
Missing data → No problem	0	0	0	0	0	0	1	0	0	2	0	0
Missing data → Some problems	0	0	0	0	0	0	0	1	0	0	0	0
Missing data → Unable	0	0	0	0	0	0	0	0	0	0	0	0
Missing data → Missing data	0	0	0	0	0	0	0	0	0	0	0	0

SecondaryChange From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score

The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category.

Time frame:: Baseline and Week 12
Reported as:: Number · participants

Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score
participants	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
No pain → No pain	38	33	40	38	70	35	67	61	66	73	39	32
No pain → Moderate pain	9	12	6	4	15	3	6	11	14	7	8	6
No pain → Extreme pain	0	0	0	0	0	1	1	0	0	0	0	0
No pain → Missing data	0	0	0	0	0	1	1	1	0	1	0	2
Moderate pain → No pain	12	14	10	12	24	13	24	34	28	36	14	20
Moderate pain → Moderate pain	16	15	19	19	37	18	37	33	27	25	12	18
Moderate pain → Extreme pain	1	1	0	1	0	0	4	1	0	0	1	2
Moderate pain → Missing data	1	0	0	0	0	0	0	0	2	1	0	0
Extreme pain → No pain	1	0	0	1	1	2	3	1	1	1	0	0
Extreme pain → Moderate pain	2	0	0	1	1	0	2	2	2	4	3	0
Extreme pain → Extreme pain	0	0	1	1	2	3	0	2	1	0	1	0
Extreme pain → Missing data	0	1	1	0	0	0	0	0	0	0	0	0
Missing data → No pain	0	0	0	0	0	0	0	0	0	2	0	0
Missing data → Moderate pain	0	0	0	0	0	0	1	1	0	0	0	0
Missing data → Extreme pain	0	0	0	0	0	0	0	0	0	0	0	0
Missing data → Missing data	0	0	0	0	0	0	0	0	0	0	0	0

SecondaryChange From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score

The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state: I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category.

Time frame:: Baseline and Week 12
Reported as:: Number · participants

Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score
participants	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
No anxiety → No anxiety	41	38	39	42	76	36	81	78	76	80	44	36
No anxiety → Moderate anxiety	5	8	7	4	11	6	7	5	9	3	5	6
No anxiety → Extreme anxiety	1	0	0	0	1	0	0	1	0	0	0	0
No anxiety → Missing data	0	0	0	0	0	0	1	1	1	1	0	2
Moderate anxiety → No anxiety	17	9	15	21	24	19	25	35	28	33	15	14
Moderate anxiety → Moderate anxiety	13	18	14	9	33	12	21	22	19	26	8	19
Moderate anxiety → Extreme anxiety	0	0	1	0	2	1	1	0	1	1	0	1
Moderate anxiety → Missing data	0	1	1	0	0	1	0	0	1	1	0	0
Extreme anxiety → No anxiety	0	0	0	0	2	0	1	2	2	2	3	2
Extreme anxiety → Moderate anxiety	2	1	0	0	0	1	7	1	4	1	1	0
Extreme anxiety → Extreme anxiety	0	1	0	1	1	0	1	1	0	0	2	0
Extreme anxiety → Missing data	1	0	0	0	0	0	0	0	0	0	0	0
Missing data → No anxiety	0	0	0	0	0	0	1	0	0	2	0	0
Missing data → Moderate anxiety	0	0	0	0	0	0	0	0	0	0	0	0
Missing data → Extreme anxiety	0	0	0	0	0	0	0	1	0	0	0	0
Missing data → Missing data	0	0	0	0	0	0	0	0	0	0	0	0

SecondaryChange From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)

The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.

Time frame:: Baseline and Week 12
Reported as:: Mean · units on a scale

Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
units on a scale	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)	13.1 ± 21.11	5.8 ± 19.38	14.3 ± 22.38	11.1 ± 19.26	11.9 ± 21.33	13.3 ± 21.81	11.6 ± 21.94	12.5 ± 19.95	11.8 ± 18.91	15.9 ± 20.94	15.3 ± 24.17	11.1 ± 23.18

SecondaryChange From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)

This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.

Time frame:: Baseline and Week 12
Reported as:: Mean · units on a scale

Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)
units on a scale	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Percent work time missed	-2.44 ± 10.580	0.53 ± 3.031	-0.24 ± 1.988	-2.85 ± 11.205	-1.29 ± 12.606	-0.28 ± 2.737	-0.55 ± 12.816	-0.83 ± 17.199	-0.84 ± 5.330	-1.65 ± 4.654	0.79 ± 6.757	-1.12 ± 11.025
Percent impairment while working	-7.50 ± 24.539	-16.13 ± 24.314	-10.00 ± 22.220	-16.67 ± 25.207	-17.33 ± 22.689	-10.00 ± 17.728	-8.43 ± 27.523	-17.72 ± 26.187	-13.85 ± 27.664	-13.39 ± 24.515	-18.00 ± 29.642	-9.29 ± 26.377
Percent overall work impairment	-9.50 ± 24.090	-16.32 ± 24.653	-9.91 ± 21.464	-17.88 ± 28.134	-17.26 ± 25.196	-9.95 ± 17.988	-8.59 ± 29.521	-17.16 ± 27.695	-14.00 ± 27.384	-14.18 ± 25.092	-17.69 ± 29.323	-10.32 ± 27.580
Percent activity impairment	-9.62 ± 26.989	-14.52 ± 27.439	-13.95 ± 26.386	-13.73 ± 27.052	-14.38 ± 24.182	-17.12 ± 27.813	-14.11 ± 31.398	-25.31 ± 26.158	-17.43 ± 29.008	-20.42 ± 27.094	-19.34 ± 27.439	-19.74 ± 30.021

SecondaryChange From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)

The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · units on a scale

Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)
units on a scale	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg + Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg
Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)	2.44 ± 0.298	2.61 ± 0.307	3.17 ± 0.301	3.10 ± 0.303	2.78 ± 0.217	2.96 ± 0.307	2.96 ± 0.221	3.24 ± 0.220	3.47 ± 0.225	3.24 ± 0.219	3.51 ± 0.301	3.72 ± 0.297

Statistical analysis

Solifenacin 5 mg vs Solifenacin 10 mg · ANCOVA · p = 0.63 · Ls mean difference: 0.18 · 95% CI -0.56 to 0.92
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.56 · Ls mean difference: 0.18 · 95% CI -0.43 to 0.79
Solifenacin 5 mg vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.14 · Ls mean difference: 0.46 · 95% CI -0.15 to 1.06
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.027 · Ls mean difference: 0.69 · 95% CI 0.08 to 1.30
Solifenacin 5 mg vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.13 · Ls mean difference: 0.46 · 95% CI -0.14 to 1.07
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.049 · Ls mean difference: 0.73 · 95% CI 0.00 to 1.46
Solifenacin 5 mg vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.011 · Ls mean difference: 0.94 · 95% CI 0.22 to 1.66
Placebo vs Mirabegron 25 mg · ANCOVA · p = 0.70 · Ls mean difference: 0.17 · 95% CI -0.67 to 1.01
Placebo vs Mirabegron 50 mg · ANCOVA · p = 0.084 · Ls mean difference: 0.73 · 95% CI -0.10 to 1.56
Placebo vs Solifenacin 2.5 mg · ANCOVA · p = 0.12 · Ls mean difference: 0.66 · 95% CI -0.18 to 1.49
Placebo vs Solifenacin 5 mg · ANCOVA · p = 0.36 · Ls mean difference: 0.34 · 95% CI -0.39 to 1.06
Placebo vs Solifenacin 10 mg · ANCOVA · p = 0.23 · Ls mean difference: 0.52 · 95% CI -0.32 to 1.36
Placebo vs Solifenacin 2.5 mg + Mirabegron 25 mg · ANCOVA · p = 0.16 · Ls mean difference: 0.52 · 95% CI -0.21 to 1.25
Placebo vs Solifenacin 2.5 mg + Mirabegron 50 mg · ANCOVA · p = 0.032 · Ls mean difference: 0.79 · 95% CI 0.07 to 1.52
Placebo vs Solifenacin 5 mg + Mirabegron 25 mg · ANCOVA · p = 0.006 · Ls mean difference: 1.03 · 95% CI 0.30 to 1.76
Placebo vs Solifenacin 5 mg + Mirabegron 50 mg · ANCOVA · p = 0.031 · Ls mean difference: 0.80 · 95% CI 0.07 to 1.52
Placebo vs Solifenacin 10 mg + Mirabegron 25 mg · ANCOVA · p = 0.012 · Ls mean difference: 1.07 · 95% CI 0.24 to 1.90
Placebo vs Solifenacin 10 mg + Mirabegron 50 mg · ANCOVA · p = 0.002 · Ls mean difference: 1.28 · 95% CI 0.45 to 2.10

Adverse events

Collected over Adverse events summarized for the Safety Analysis Set (SAF) were reported after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	0/81 (0%)	16/81 (19.8%)
Mirabegron 25 mg	—	0/77 (0%)	16/77 (20.8%)
Mirabegron 50 mg	—	2/78 (2.6%)	21/78 (26.9%)
Solifenacin 2.5 mg	—	1/79 (1.3%)	19/79 (24.1%)
Solifenacin 5 mg	—	0/156 (0%)	48/156 (30.8%)
Solifenacin 10 mg	—	1/78 (1.3%)	33/78 (42.3%)
Solifenacin 2.5 mg and Mirabegron 25 mg	—	3/149 (2%)	36/149 (24.2%)
Solifenacin 2.5 mg and Mirabegron 50 mg	—	2/149 (1.3%)	34/149 (22.8%)
Solifenacin 5 mg and Mirabegron 25 mg	—	2/144 (1.4%)	40/144 (27.8%)
Solifenacin 5 mg and Mirabegron 50 mg	—	2/153 (1.3%)	39/153 (25.5%)
Solifenacin 10 mg and Mirabegron 25 mg	—	1/81 (1.2%)	30/81 (37%)
Solifenacin 10 mg and Mirabegron 50 mg	—	1/81 (1.2%)	35/81 (43.2%)

Most frequent serious events

Showing 10 of 18

Most frequent serious events
Event	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg and Mirabegron 25 mg	Solifenacin 2.5 mg and Mirabegron 50 mg	Solifenacin 5 mg and Mirabegron 25 mg	Solifenacin 5 mg and Mirabegron 50 mg	Solifenacin 10 mg and Mirabegron 25 mg	Solifenacin 10 mg and Mirabegron 50 mg
Abortion spontaneousPregnancy, puerperium and perinatal conditions	0/81	0/77	1/78	0/79	0/156	0/78	0/149	0/149	0/144	0/153	0/81	0/81
Confusional statePsychiatric disorders	0/81	0/77	0/78	0/79	0/156	1/78	0/149	0/149	0/144	0/153	0/81	0/81
Pelvic painReproductive system and breast disorders	0/81	0/77	1/78	0/79	0/156	0/78	0/149	0/149	0/144	0/153	0/81	0/81
Muscular weaknessMusculoskeletal and connective tissue disorders	0/81	0/77	0/78	1/79	0/156	0/78	0/149	0/149	0/144	0/153	0/81	0/81
Foreign body traumaInjury, poisoning and procedural complications	0/81	0/77	0/78	0/79	0/156	0/78	0/149	0/149	0/144	0/153	1/81	0/81
Abortion inducedSurgical and medical procedures	0/81	0/77	0/78	0/79	0/156	0/78	0/149	0/149	0/144	0/153	0/81	1/81
PyelonephritisInfections and infestations	0/81	0/77	0/78	0/79	0/156	0/78	0/149	0/149	1/144	0/153	0/81	0/81
NeuralgiaNervous system disorders	0/81	0/77	0/78	0/79	0/156	0/78	0/149	0/149	1/144	0/153	0/81	0/81
Trigeminal nerve disorderNervous system disorders	0/81	0/77	0/78	0/79	0/156	0/78	0/149	0/149	1/144	0/153	0/81	0/81
DysphagiaGastrointestinal disorders	0/81	0/77	0/78	0/79	0/156	0/78	0/149	1/149	0/144	0/153	0/81	0/81

Most frequent other events

Most frequent other events
Event	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg and Mirabegron 25 mg	Solifenacin 2.5 mg and Mirabegron 50 mg	Solifenacin 5 mg and Mirabegron 25 mg	Solifenacin 5 mg and Mirabegron 50 mg	Solifenacin 10 mg and Mirabegron 25 mg	Solifenacin 10 mg and Mirabegron 50 mg
Dry mouthGastrointestinal disorders	3/81	2/77	4/78	6/79	18/156	23/78	19/149	13/149	21/144	20/153	16/81	14/81
HypertensionVascular disorders	7/81	9/77	11/78	8/79	18/156	5/78	11/149	11/149	11/144	9/153	7/81	11/81
ConstipationGastrointestinal disorders	0/81	0/77	3/78	1/79	3/156	4/78	7/149	6/149	4/144	2/153	6/81	8/81
NasopharyngitisInfections and infestations	2/81	5/77	5/78	5/79	6/156	2/78	4/149	6/149	7/144	6/153	6/81	6/81
Escherichia urinary tract infectionInfections and infestations	2/81	1/77	2/78	1/79	6/156	5/78	3/149	2/149	3/144	4/153	3/81	1/81
Urinary tract infectionInfections and infestations	3/81	1/77	2/78	1/79	4/156	5/78	1/149	2/149	2/144	3/153	0/81	3/81

Baseline characteristics

Baseline Measure data are provided for all randomized patients who took at least 1 dose of double-blind study drug (Safety Analysis Set). One participant randomized to the Mirabegron 25 mg arm received treatment with Solifenacin 5 mg + Mirabegron 50 mg in error and is counted in that arm for safety analysis set analyses.

Age, Continuous
Age, Continuous(years)	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg +Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg	Total
Mean	54.6 ± 13.37	55.2 ± 14.45	53.4 ± 13.98	56.1 ± 11.71	54.2 ± 15.53	55.0 ± 12.82	55.8 ± 13.82	53.7 ± 14.55	55.0 ± 14.57	54.1 ± 14.09	56.5 ± 12.34	55.5 ± 13.82	54.8 ± 13.97

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg +Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg	Total
Female	54	52	52	51	103	53	100	100	95	101	52	54	867
Male	27	25	26	28	53	25	49	49	49	52	29	27	439

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg +Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg	Total
White	81	77	78	78	156	77	149	148	143	153	81	81	1302
Black or African American	0	0	0	1	0	0	0	1	0	0	0	0	2
Asian	0	0	0	0	0	1	0	0	1	0	0	0	2
Other	0	0	0	0	0	0	0	0	0	0	0	0	0

Type of Overactive Bladder (OAB)
Type of Overactive Bladder (OAB)(participants)	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg +Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg	Total
Urge Incontinence	14	27	19	18	39	19	42	33	35	35	23	20	324
Mixed	9	10	10	10	27	11	22	20	19	18	14	10	180
Frequency	56	39	48	50	89	48	84	95	90	100	44	50	793
Missing	2	1	1	1	1	0	1	1	0	0	0	1	9

Duration of OAB Symptoms
Duration of OAB Symptoms(months)	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg +Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg	Total
Mean	48.3 ± 38.37	61.2 ± 68.03	56.9 ± 66.62	60.2 ± 67.85	61.8 ± 78.21	52.4 ± 56.98	57.7 ± 68.91	57.0 ± 66.85	56.3 ± 84.78	57.4 ± 81.53	64.9 ± 100.57	57.4 ± 80.12	57.8 ± 73.82

Mean Number of Micturitions per 24 Hours
Mean Number of Micturitions per 24 Hours(micturitions)	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg +Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg	Total
Mean	10.36 ± 2.036	11.29 ± 2.581	10.78 ± 2.254	11.10 ± 3.056	11.34 ± 3.158	11.29 ± 2.896	11.25 ± 3.643	11.00 ± 2.260	10.92 ± 2.386	11.25 ± 3.171	11.14 ± 2.268	11.24 ± 2.453	11.10 ± 2.794

Mean Volume Voided per Micturition
Mean Volume Voided per Micturition(mL)	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg +Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg	Total
Mean	156.4 ± 52.80	152.7 ± 56.70	156.8 ± 52.33	162.4 ± 57.59	145.5 ± 59.34	148.0 ± 52.74	156.8 ± 61.97	149.8 ± 50.05	155.0 ± 55.55	153.1 ± 51.88	141.4 ± 51.29	155.3 ± 62.13	152.5 ± 55.65

Mean Number of Urgency Episodes per 24 Hours
Mean Number of Urgency Episodes per 24 Hours(urgency episodes)	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 2.5 mg	Solifenacin 5 mg	Solifenacin 10 mg	Solifenacin 2.5 mg +Mirabegron 25 mg	Solifenacin 2.5 mg + Mirabegron 50 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Solifenacin 10 mg + Mirabegron 25 mg	Solifenacin 10 mg + Mirabegron 50 mg	Total
Mean	5.26 ± 3.079	6.25 ± 3.332	6.58 ± 3.981	6.20 ± 3.870	6.41 ± 4.154	6.37 ± 4.530	6.05 ± 3.749	6.78 ± 3.419	6.26 ± 3.928	6.49 ± 4.238	6.91 ± 4.319	6.81 ± 4.312	6.37 ± 3.931

4 further baseline measures are reported on the registry.

Study locations

133 sites

BY37101
Minsk, 220036, Belarus
BY37102
Minsk, 220119, Belarus
BY37103
Minsk, 223010, Belarus
BY37104
Vitebsk, 210037, Belarus
BE32102
Brussels, 1090, Belgium
BE32104
Edegem, 2650, Belgium
BE32103
Gent, 9000, Belgium
BE32101
Leuven, 3000, Belgium
CZ42005
Bohumín, 73581, Czechia
CZ42003
Hradec Kralove, 500 02, Czechia
CZ42011
Ostrava, 700 30, Czechia
CZ42006
Plzen, 301 24, Czechia
CZ42007
Prague 4, 14000, Czechia
CZ42001
Prague, 128 51, Czechia
CZ42009
Prague, 15006, Czechia
CZ42010
Roudnice nad Labem, 413 01, Czechia
CZ42012
Sternberk, 78501, Czechia
CZ42002
Uherske Hradiste, 68608, Czechia
DK45101
Aarhus N, 8200, Denmark
DK45102
Herlev, 2730, Denmark
DK45104
Holstebro, 7500, Denmark
FI35803
Helsinki, 00029, Finland
FI35804
Kouvola, 45200, Finland
FI35801
Oulu, 90220, Finland
FI35802
Tampere, 33521, Finland
FR33104
Colmar Cedex, 68024, France
FR33108
Dijon, 21079, France
FR33103
Orleans, 45067, France
FR33111
Paris Cedex 13, 75651, France
FR33112
Paris cedex 20, 75970, France
FR33106
Toulouse, 31059, France
FR33110
Tours, 37044, France
DE49109
Bad Ems, 56130, Germany
DE49103
Göttingen, 37075, Germany
DE49117
Hagenow, 19230, Germany
DE49105
Hettstedt, 06333, Germany
DE49108
Leipzig, 04105, Germany
DE49110
Neustadt I. Sachsen, 01844, Germany
DE49118
Reutlingen, 72764, Germany
DE49101
Rostock, 18107, Germany
DE49111
Sangerhausen, 06526, Germany
DE49104
Wismar, 23970, Germany
HU36108
Csongrád, 6640, Hungary
HU36101
Gyor, 9024, Hungary
HU36106
Körmend, 9900, Hungary
HU36110
Miskolc, 3526, Hungary
HU36104
Sopron, 9400, Hungary
HU36103
Szekszárd, 7100, Hungary
HU36107
Tatabánya, 2800, Hungary
IT39103
Avellino, 83100, Italy
IT39101
Catanzaro, 88100, Italy
IT39105
Florence, 50139, Italy
IT39102
Treviglio (BG), 24047, Italy
NL31104
Amsterdam, 1100 AD, Netherlands
NL31106
Maastricht, Netherlands
NL31102
Sneek, 8601 ZK, Netherlands
NL31101
Winterswijk, 7101 BN, Netherlands
NO47104
Elverum, 2408, Norway
NO47102
Hamar, 2317, Norway
PL48107
Krakow, 31-530, Poland
PL48103
Lodz, 90-602, Poland
PL48108
Lublin, 20-954, Poland
PL48106
Piaseczno, 05-500, Poland
PL48104
Pulawy, 24-100, Poland
PL48101
Warsaw, 02-507, Poland
PL48105
Warsaw, 02-929, Poland
PL48112
Wiecbork, 89-410, Poland
PL48111
Wroclaw, 01-432, Poland
PT35102
Coimbra, 3000-075, Portugal
PT35105
Coimbra, 3041-801, Portugal
PT35104
Lisbon, 1050-199, Portugal
PT35107
Lisbon, 1649-035, Portugal
PT35110
Porto, 4099-001, Portugal
PT35101
Porto, 4200-319, Portugal
PT35106
Tomar, 2304-909, Portugal
RO40106
Brasov, 500152, Romania
RO40102
Bucharest, 042122, Romania
RO40104
Bucharest, 050659, Romania
RO40103
Bucharest, 200642, Romania
RO40108
Bucharest, 22328, Romania
RO40101
Craiova, 20116, Romania
RO40105
Craiova, 20116, Romania
RO40107
Sibiu, 550245, Romania
RU70112
Kazan, 420012, Russian Federation
RU70108
Moscow, 105425, Russian Federation
RU70110
Moscow, 115682, Russian Federation
RU70102
Saint Petersburg, 191015, Russian Federation
RU70103
Saint Petersburg, 194178, Russian Federation
RU70101
Saint Petersburg, 197136, Russian Federation
RU70107
Saint Petersburg, 198013, Russian Federation
RU70106
St. Petersburg, 197089, Russian Federation
RU70109
St. Petersburg, 198103, Russian Federation
RU70113
Ufa, 450096, Russian Federation
SK42109
Banska Bystrica, 975 01, Slovakia
SK42112
Bratislava, 832 63, Slovakia
SK42107
Kosice, 04011, Slovakia
SK42113
Malacky, 90101, Slovakia
SK42104
Nitra, 949 01, Slovakia
SK42106
Piestany, 921 01, Slovakia
SK42105
Pieštany, 921 01, Slovakia

Showing the first 100 of 133 sites across 20 countries. Choose a country and city above to see the rest.

References and documents

Publications

Abrams P, Kelleher C, Staskin D, Rechberger T, Kay R, Martina R, Newgreen D, Paireddy A, van Maanen R, Ridder A. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony). Eur Urol. 2015 Mar;67(3):577-88. doi: 10.1016/j.eururo.2014.02.012. Epub 2014 Feb 19. PubMed 24612659 ↗

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01340027
Lead sponsor: Astellas Pharma Europe B.V.
Responsible party: Sponsor
First posted: Apr 21, 2011
Start date: Mar 29, 2011
Primary completion: Jun 28, 2012
Completion: Jun 28, 2012
Results posted: Jul 21, 2015
Last update: Oct 31, 2024

Study contacts

Study Physician

study director · Astellas Pharma Europe B.V.

Principal Investigator

principal investigator · Bristol Urological Institute

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Mirabegron · Solifenacin

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Urinary Bladder, Overactive →

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A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder

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Urinary Bladder, Overactive Reclassified

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