This study showed that 12 weeks of once daily treatment with mirabegron 25 mg or 50 mg reduced the mean numbers of incontinence episodes per 24 h and micturitions
per 24 h in the subgroups of patients aged [beta]65 years and [beta]75 years.
The mean number of micturition
's during the day and night before the surgery was 6.30 +- 2.83 (min.
The patients were considered as having PPUR when there was no micturition
within 6 hours of delivery.
 showed that significant improvements were observed with fesoterodine compared to placebo in the number of micturition-related nocturnal urgency episodes (-1.28 versus -1.07, p = 0.003), in the number of nocturnal micturitions
per 24 hours (-1.02 versus -0.85, p = 0.011), and in the nocturnal frequency urgency sum, defined as the sum of Urinary Sensation Scale (USS) ratings recorded for all nocturnal micturitions
(-4.01 versus -3.42, p < 0.003).
The symptoms were micturition
frequency and incontinence episodes (the co-primary endpoints of the SCORPIO study), each of which had five levels of severity (Table 1).
Frequency was defined as at least eight micturitions
in 24 hours and urgency urinary incontinence as at least one episode in 24 hours.
Women randomized to either 4 mg or 8 mg of the investigational drug showed significantly greater improvement in the number of micturitions
per day, and the number of urgency urinary incontinence episodes per day, and perceived treatment response, Dr.
* Comment: Approval was based on four 12-week trials of 3,027 patients (mostly white females, mean age 58), who had OAB symptoms for at least 3 years, with 11.5-12.2 micturitions
over 24 hours at baseline.
* OUTCOMES MEASURED The primary outcomes included the number of incontinent episodes per 24-hour period, the quantity of pads used per 24 hours, the number of micturitions
per 24 hours, and the mean voided volume per micturition
The combination was also associated with significant improvements relative to placebo in urgency urinary incontinence, urgency episodes without incontinence, micturitions
per 24 hours, micturitions
per night, total International Prostate Symptom Score (IPSS) and the IPSS quality-of-life item.
Women randomized to either 4 mg or 8 mg of fesoterodine showed significantly greater improvement in the average number of micturitions
per day, the average number of urgency urinary incontinence episodes per day, and perceived treatment response, Dr.
The Phase III study in Japan met its objective by demonstrating efficacy in mirabegron treatment groups in mean change from baseline in number of micturitions
per 24-hour (primary endpoint) compared to placebo.