Conditions: Urinary Bladder Overactive Overactive Bladder Urgency Incontinence Urinary Bladder Diseases\Urologic Diseases
Keywords: Solifenacin Succinate Mirabegron Urinary Incontinence Combination Therapy Urgency Nocturia Overactive Bladder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1829
Healthy volunteers: no

Brief summary:
The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.

Detailed description:

Arms:
arm 1: Participants received mirabegron 50 mg once a day for 52 weeks. arm 2: Participants received solifenacin 5 mg once a day for 52 weeks. arm 3: Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.

Interventions: intervention 1: Solifenacin succinate intervention 2: Mirabegron intervention 3: Placebo to match solifenacin intervention 4: Placebo to match mirabegron
Intervention descriptions: intervention 1: Participants received solifenacin 5 mg orally once a day at the same time each day. intervention 2: Participants received mirabegron 50 mg orally once a day at the same time each day. intervention 3: Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study. intervention 4: Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

Protocol document: