5 to 15 mg daily was more effective than placebo in reducing the number of urge incontinence episodes per week, reducing the number of micturitions
per 24 hours, and increasing the volume of urine voided per micturition
Frequency was defined as at least eight micturitions
in 24 hours; urgency urinary incontinence was defined as at least one episode in 24 hours.
However, at week 12, subjects receiving the combination therapy had significantly greater improvements versus placebo plus alpha-blocker in 24-hour micturitions
, daytime micturitions
, 24-hour urgency episodes, daytime urgency episodes, nocturnal urgency episodes, frequency-urgency sum, IPSS storage subscale, OAB-q symptom bother scale and OAB-q coping domain.
Tokyo: TSE: 4503, "the Company"), today announced the results of a pivotal phase III clinical trial for mirabegron, the first of a new class of compounds under development for the treatment of overactive bladder (OAB), which show mirabegron significantly improves key OAB symptoms - urinary incontinence (leakage of urine) and frequency of micturition
(urination) compared with placebo.
It may also be that our population, with a baseline of eight micturitions
a day and five incontinence episodes a week, was not severe [enough] to have major social limitations and therefore would not have major improvements," Dr.
In addition to overall safety, efficacy will be assessed through a change from baseline in mean number of micturitions
, or urinations, per day as assessed by a patient diary at 12 months, plus a 48-month long-term evaluation phase.
The Phase III trial with trospium, initiated in September 2001, will include approximately 500 patients at 50 clinical sites and will compare both the reduction in micturitions
and incontinence episodes among trospium-treated patients versus placebo-treated patients during a 12-week treatment period," said Dr.
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.
comparing the reduction in micturitions
and incontinence episodes among trospium-treated patients versus placebo patients during a 12-week period.
The primary endpoint of the study, the change in the number of micturitions
(urinations) in a twenty-four hour period, showed a significant decrease of 2.
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.
The results from the study conducted in Europe, presented by Linda Cardozo, MD, FRCOG, professor of urogynecology, King's College Hospital, London, UK, showed that the number of micturitions
(urinations) over a 24-hour period with solifenacin succinate decreased as much as 2.