Clinical efficacy and safety of XXXX compared to placebo in detrusor overactivity.

@entity1 @entity2181 @entity322 @entity2133 @entity2182 @entity1344 @entity427
PURPOSE: We evaluated the efficacy, @entity1 acceptability and side effect profile of @entity2181 , a new antimuscarinic agent for treating @entity2182 . MATERIALS AND METHODS: In our randomized, placebo controlled, parallel group study 123, 129 and 64 @entity1 18 years old or older with proved detrusor overactivity ( @entity1344 or @entity427 ) were randomized to receive 1 or 2 mg. @entity2181 , or placebo, respectively, twice daily for 12 weeks. Main outcome measures were number of voids per 24 hours, urine volume per void and episodes of urge @entity322 per 24 hours on a frequency-volume chart with detailed recording of side effects. RESULTS: After 12 weeks of treatment mean number of voids per 24 hours plus or minus standard deviation decreased from 11.2 +/- 3.1 to 9.0 +/- 2.6 with the 2 mg. dosage (p = 0.0045 versus placebo). At this dose mean urine volume per void increased from 155 +/- 52 to 190 +/- 70 ml. (p <0.0001 versus placebo), while mean number of @entity322 episodes per 24 hours decreased from 3.6 +/- 4.0 to 1.8 +/- 3.1 (p = 0.19 versus placebo). Similar efficacy was observed in @entity1 receiving the 1 mg. dose. Severe @entity2133 was reported by only 2, 1 and 2% of @entity1 given the 1 and 2 mg. dose, and placebo, respectively. There was no clinical or electrocardiographic evidence of significant cardiac adverse events. CONCLUSIONS: @entity2181 administration resulted in a significant decrease in the frequency of voiding and improved voided volume but it was seldom associated with troublesome or severe side effects.
