of Percentage of patients micturitions
per day 1 [less than or equal to]8 6.
Stimulation of the beta-3 adrenoreceptor relaxes detrusor smooth muscle, decreases afferent signaling from the bladder, improves bladder compliance upon filling, and increases bladder capacity with no change in micturition
pressure and residual volume.
Treatment with 50 mg mirabegron reduced the mean number of micturitions
Frequency was defined as at least eight micturitions
in 24 hours and urgency urinary incontinence as at least one episode in 24 hours.
8 years; 91% female) were having eight or more episodes of urge urinary incontinence per week with no more than one incontinence-free day, and an average of eight micturitions
daily based on a 7-day voiding diary.
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.
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
Data from the first study showed that SANCTURA met all key endpoints of the trial, including a reduction in micturitions
(toilet voids) and a reduction in urge urinary incontinence episodes, as well as additional secondary endpoints.
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 Company's ongoing Phase III trial with trospium will include approximately 500 patients enrolled at 50 clinical sites and will compare both the reduction in micturitions
and incontinence episodes among trospium-treated patients versus placebo patients during a 12-week double-blind period.
This trial will include over 500 patients and will compare the reduction in both micturitions
and incontinence episodes among trospium-treated patients versus placebo-treated patients during a 12-week double-blind treatment period.
To be included in the study patients had to have bladder symptoms for at least 6 months, including frequent urination (eight or more micturitions
in 24 hours) and urge incontinence (five or more episodes per week).
The Phase III trial will include approximately 500 patients enrolled at 50 clinical sites and will compare both the reduction in micturitions
and incontinence episodes among trospium-treated patients versus placebo patients during a 12-week double-blind treatment period.
Additionally, women saw mean reductions in micturition
ranging from 2.