Clinical trial NCT02045862 (phase 3, status: completed)
Conditions: urinary bladder overactive, overactive bladder, urgency incontinence, urinary bladder diseases\urologic diseases
ICD codes: N32.81, N32.81, N39.41, N39.46, N39.490, N39.491, N39.492, R32, R39.81
Drugs: solifenacin succinate, mirabegron, placebo to match solifenacin, placebo to match mirabegron
SMILES: O=C(O[C@H]1CN2CCC1CC2)N1CCC2=CC=CC=C2[C@@H]1C1=CC=CC=C1, NC1=NC(CC(=O)NC2=CC=C(CCNC[C@H](O)C3=CC=CC=C3)C=C2)=CS1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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.