Conditions: Urologic Diseases Urinary Bladder Diseases Urological Manifestations Signs and Symptoms Urinary Bladder, Overactive
Keywords: Urinary incontinence Overactive bladder (OAB) Micturition Frequency YM178 Urgency incontinence Urgency
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 1307
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received matching placebo tablets orally once a day for 12 weeks arm 2: Participants received mirabegron 25 mg tablets orally once a day for 12 weeks arm 3: Participants received mirabegron 50 mg tablets orally once a day for 12 weeks arm 4: Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks arm 5: Participants received solifenacin 5 mg tablets orally once a day for 12 weeks arm 6: Participants received solifenacin 10 mg tablets orally once a day for 12 weeks arm 7: Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks arm 8: Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks arm 9: Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks arm 10: Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks arm 11: Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks arm 12: Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks

Interventions: intervention 1: Mirabegron intervention 2: Solifenacin succinate intervention 3: Placebo
Intervention descriptions: intervention 1: oral intervention 2: oral intervention 3: oral

Protocol document: