A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

Exclusion Criteria

• •Main Exclusion at Screening:
• •1. Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO).
• •2. Subject has significant Post-void residual (PVR) volume (PVR \> 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 an indwelling catheter or practices intermittent self catheterization.
• •5. Subject has evidence of a UTI.
• •6. Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
• •7. Subject has moderate to severe hepatic impairment
• •8. Subject has severe renal impairment or End Stage Renal disease
• •9. Subject has a clinically significant abnormal Electrocardiogram (ECG)
• •10. Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
• •11. Subject has a QTcF interval \> 450 ms for males or \> 470 ms for females or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
• •12. Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
• •13. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
• •Main Exclusion at Randomization (visit 3):
• •1. Subject has achieved 100% continence from Visit 2 to Visit 3 (no incontinence episodes are recorded in the 3 day diary administered for 3 days prior to Visit 3).
• •2. Subject does not desire an increase in study medication.
• •3. Subject has an average total daily urine volume \> 3000ml as recorded in the micturition diary.
• •4. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
• •5. Subject has a clinically significant abnormal ECG