A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

Inclusion Criteria:

Main Inclusion at Screening (Visit 1):

- Subject had completed study 178-CL-101 or study 905-EC-012 (This inclusion criterion
would no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012
had been completed. In that case the subject had to have symptoms of "wet" OAB
(urinary frequency and urgency with incontinence) for at least 3 months);

- Subject was 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;

Main Inclusion at Randomization (Visit 2):

- Subject had a micturition frequency of on average ≥ 8 times per 24-hour period during
the last 7 days of the micturition diary period (incontinence episode should not be
counted as a micturition).

- Subject had experienced at least 3 incontinence episodes during the last 7 days of the
micturition diary period.

- Subject had experienced on average 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.

Exclusion Criteria:

Main Exclusion at Screening (Visit 1):

- Subject had clinically significant bladder outflow obstruction at risk of urinary
retention;

- Subject had significant PVR volume (> 150 mL);

- Subject had significant stress incontinence or mixed stress/urgency incontinence where
stress is the predominant factor;

- Subject has an indwelling catheter or practices intermittent self-catheterization;

- Subject had evidence of a UTI (urine culture containing > 100,000 cfu/mL), chronic
inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation
therapy or previous or current malignant disease of the pelvic organs;

- Subject had intravesical treatment in the past 12 months with e.g., botulinum toxin,
resiniferatoxin, capsaicin;

Main Exclusion at Randomization (Visit 2):

- Subject had evidence of a urinary tract infection (UTI) (urine culture containing >
100,000 cfu/mL) as assessed in the Screening visit (V1) samples. The subject could be
rescreened after successful treatment of the UTI (confirmed by a dipstick negative for
nitrite).

- Subject had an average total daily urine volume > 3000 mL as recorded in the
micturition diary period.