Efficacy of oral extended-release @entity11440 in cognitively impaired older nursing home residents with urge XXXX : a randomized placebo-controlled trial.

@entity1 @entity73 @entity322 @entity11440
OBJECTIVES: To determine the efficacy of oral extended-release @entity11440 for urge @entity322 in older female nursing home residents with mild to severe @entity73 . DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Twelve skilled nursing homes. @entity1 : Fifty @entity1 aged 65 and older with urge @entity322 and @entity73 . INTERVENTION: Four-week treatment with daily oral extended-release @entity11440 5 mg or placebo. MEASUREMENTS: @entity322 , urinary frequency, and total dryness assessed hourly over two 8-hour days (8 AM TO 4 PM), and evening and night nursing staff ratings of urinary symptoms. RESULTS: Of the @entity1 , 96% (n = 25) on @entity11440 and 92% (n = 22) on placebo completed the trial. Compared with baseline, both groups achieved a  significant median decrease in mean @entity322 and urinary frequency at 4 weeks (P  = .01-.05). There were no significant between-group differences in any urological outcome. In the exploratory analysis, there were no significant differences from baseline or placebo in any urological outcome with @entity11440 in @entity1 with mild to moderate @entity73 and/or adequate mobility compared with @entity1 with more severe @entity73 . Staff ratings found that more @entity1 had improvement in urinary symptoms from baseline with @entity11440 than placebo but significant only for delaying evening voiding (P = .02). CONCLUSION: Extended-release @entity11440 5 mg per day for 4 weeks in older cognitively impaired female nursing home residents did not significantly reduce @entity322 and urinary frequency or achieve dryness. @entity1 with mild to moderate @entity73 were no more likely to benefit from @entity11440 than more severely impaired individuals in an exploratory analysis but further research in a larger population and perhaps using a larger dose is needed.
