A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-
Controlled, Multi-center Study to Evaluate the Efficacy, Safety and
Tolerability of Combinations of Solifenacin Succinate and Mirabegron
Compared to Solifenacin Succinate and Mirabegron Monotherapy in the
Treatment of Overactive Bladder

1. Subject is male or female and at least 18 years of age.
2. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written
Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization
for U.S. sites) must be obtained from the subject or legally authorized representative prior to any
study-related procedures (including withdrawal of prohibited medication, if applicable).
3. Female subject must be either:
* Of non childbearing potential:
* post-menopausal (defined as at least 1 year without menses in the absence of other
plausible etiology) prior to Screening, or
* documented surgically sterile (at least 1 month prior to Screening) or status post
hysterectomy
* Or, if of childbearing potential:
* must have a negative urine pregnancy test at Screening, and
* must use a highly effective method of birth control, which includes established use of
oral, injected or implanted hormonal methods of contraception, placement of an
intrauterine device (IUD) or intrauterine system (IUS. Birth control must be practiced
from Screening and throughout the study period and for 28 days after the final study
drug administration.
4. Female subject must not be breastfeeding at Screening or during the study period, and for 28 days
after the final study drug administration.
5. Female subject must not donate ova starting at Screening and throughout the study period, and for
28 days after the final study drug administration.
6. Male subject and their female spouse/partners who are of childbearing potential must be using a
highly effective method of birth control, which includes established use of oral, injected or
implanted hormonal methods of contraception, placement of an IUD or IUS. Birth control must
be practiced from Screening and continue throughout the study period and for 90 days after the
final study drug administration.
7. Male subject must not donate sperm starting at Screening and throughout the study period and for
90 days after the final study drug administration.
8. Subject is willing and able to complete the micturition diary and questionnaires correctly 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.
9. Subject has symptoms of *wet* OAB (urinary frequency and urgency with incontinence) for at
least 3 months.
10. Subject agrees not to participate in another interventional study while on treatment.
At Randomization (Visit 2):
11. Subject continues to meet all inclusion criteria of Visit 1.
12. Subject has a micturition frequency of on average at least 8 times per 24-hour period during the
7-day micturition diary period (excluding incontinence episodes).
13. Subject has experienced at least 3 incontinence episodes during the 7-day micturition diary
period.
14. Subject has experienced at least 1 urgency episode (grade 3 or 4 on Patient Perception of Intensity
of Urgency Scale [PPIUS]) per 24-hour period during the 7-day micturition diary period.
Additional Inclusion Criteria ABPM sub-study
15. Subject is willing and able to undergo the ABPM assessment for 24 hours and to attend the 3
additional visits to the clinic.
Waivers to the inclusion criteria will NOT be allowed.

Subject will be excluded from participation if any of the following apply:
At Screening (Visit 1):
1. In the opinion of the investigator the subject has clinically significant bladder outflow obstruction
at risk of urinary retention.
2. Subject has significant PVR volume (> 150 mL).
3. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is
the predominant factor as determined by the investigator.
4. Subject has a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic
neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson*s
disease with autonomic component or bladder involvement). An autonomic component can be inferred when autonomic functions are affected, including heart rate, blood pressure, perspiration and digestion.
5. Subject has an indwelling catheter or practices intermittent self-catheterization.
6. Subject has chronic inflammation such as bladder pain syndrome / interstitial cystitis,
symptomatic bladder stones or any previous or current radiation cystitis.
7. Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin,
resiniferatoxin, capsaicin.
8. Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative
colitis or Crohn*s Disease, toxic megacolon, myasthenia gravis or any contraindications against
the use of anticholinergics.
9. Subject has clinically significant cardiovascular or cerebrovascular diseases within 6 months prior
to Screening, such as myocardial infarction, uncontrolled angina, significant ventricular
arrhythmias, stroke and severe cardiac failure (NYHA class * III) (Appendix 4).
10. Subject has an average QTcF interval > 450 ms for males or > 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT
prolongation (e.g., family history of long QT syndrome, hypokalaemia).
11. Subject has clinically significant abnormal 12-lead ECG.
12. 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.
13. Subject has moderate to severe hepatic impairment (Child-Pugh class B or C) (Appendix 5).
14. Subject has severe renal impairment defined as eGFR<30 mL/min/1.73 m2.
15. Subject has a current or previous malignant disease of the pelvis. Subjects with a history of (nonpelvic)
cancer are considered eligible if the subject has undergone therapy and the subject has
been considered disease free for at least 5 years. Subjects with completely excised basal cell or
squamous cell carcinoma of the skin and completely excised cervical cancer in situ are also
considered eligible.
16. Subject is receiving current non-drug treatment for OAB including electrostimulation therapy
(with the exception of a bladder training program or pelvic floor exercises which started more
than 30 days prior to Screening).
17. Subject is using medications intended to treat OAB or other prohibited medications. Subject is
excluded if using restricted medications under conditions different to those specified in section
Concomitant Medication (Section 5.1.3.2).
18. Subject has known or suspected hypersensitivity to solifenacin succinate, mirabegron or any of
their excipients.
19. Subjects with current or history of alcohol and/or drug abuse.
20. Subject has any condition which, in the investigator*s opinion, makes the subject unsuitable for
study participation.
21. Subject has received investigational therapy within 28 days or 5 half lives, whichever is longer,
prior to Screening. If local regulations stipulate a longer period, such local regulations should take
precedence.
22. Subject is an employee of the Astellas Group, third parties associated with the study or the
clinical study site team.
At Randomization (Visit 2):
23. Subject fulfills any exclusion criteria of Visit 1.
24. Subject has evidence of a UTI (urine culture containing > 100,000 cfu/mL) as assessed in the
Screening visit (V1) samples. The subject can be rescreened after successful treatment of the
UTI (confirmed by a laboratory result of negative urine culture).
25. Subject had an average total daily urine volume > 3000 mL as recorded in the micturition diary
period.
26. Subject has serum creatinine > 150 umol/L, AST and/or ALT > 2x upper limit of normal range
(ULN), or *-GT > 3x ULN, or total bilirubin > 2 ULN as assessed in Screening visit (V1)
samples.
Waivers to the exclusion criteria will NOT be allowed.
Additional Exclusion Criteria ABPM sub-study
27. Subject is a nightshift worker
28. Subject*s arm size does not fit available cuff sizes for ABPM devices
29. Subject is treated for hypertension and has a sitting average systolic blood pressure * 160 mmHg
and/or an average diastolic blood pressure * 95 mmHg.
30. Subject has a resting heart rate of < 45bpm or >90 bpm or atrial fibrillation.
31. Subject has documented venous thrombosis of the upper extremities or status post-mastectomy
with edema in the non-dominant arm.
32. Subject has a pacemaker.