In addition, ADD-ON treatment was both non-inferior and superior to SOLI 10 mg for daily reduction in micturitions
Treatment with 50 mg mirabegron reduced the mean number of micturitions
Tolterodine and oxybutynin were equivalent in decreasing urinary frequency: the number of micturitions
per 24 hours decreased by 19.
TM)] in reducing the frequency of micturition
(urination) and incontinence episodes per day, as compared to both placebo control and active control Detrol[sup.
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.
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.
Furthermore, as patient-reported outcomes become increasingly important in the assessment of treatments for OAB, this study suggests that reductions in incontinence episodes and micturitions
are associated with improved quality of life," said Dr.
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.
Preliminary results show that the trial met all of its primary and secondary endpoints with a high degree of statistical significance, including a reduction in both micturitions
(urinations) and urinary incontinence episodes among patients treated with trospium versus placebo.
The clinical trial showed a statistically significant 25 percent reduction of micturitions
and a 75 percent reduction of incontinence episodes.
This trial will include approximately 500 patients at more than 50 clinical sites and will compare the reduction in micturitions
and incontinence episodes among trospium-treated patients versus placebo-treated patients during a 12-week 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 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.