ATLANTA—Flexible-dose fesoterodine is superior to placebo in decreasing the number of nocturnal urgency episodes and nocturnal micturitions in patients with overactive bladder (OAB), researchers reported at the American Urological Association 2012 annual meeting.

In a prospective, double-blind study of 937 patients with self-reported OAB symptoms, including nocturnal urgency for three or more months, Jeffrey Weiss, MD, of the State University of New York Downstate College of Medicine in Brooklyn, and collaborators randomly assigned 463 patients to receive fesoterodine and 474 to receive placebo.

The mean number of nocturnal urgency micturition episodes per 24 hours declined from baseline by 1.29 in the fesoterodine group and by 1.06 from baseline in the placebo arm. The mean number of nocturnal micturitions per 24 hours declined from baseline by 1.02 among the fesoterodine recipients and 0.84 in the placebo group. The mean number of urgency episodes per 24 hours declined by 3.50 and 2.72, respectively. All the differences between the two groups were statistically significant.

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The most common adverse event was dry mouth, which occurred more frequently in the fesoterodine than the placebo group (21.2% vs. 7.6%).