1963 EFFECT OF ANTIMUSCARINIC TREATMENT IN SUBJECTS WITH OVERACTIVE BLADDER, INCLUDING NOCTURNAL URINARY URGENCY

Abstract

INTRODUCTION AND OBJECTIVES: Antimuscarinic treatment has been shown to be effective in treating overactive bladder (OAB) symptoms such as urgency, frequency, and urgency urinary incontinence but has not been proven effective in decreasing nocturnal urgency episodes. This trial evaluated the efficacy of flexible-dose fesoterodine vs placebo (PBO) in reducing micturition-related nocturnal urgency episodes and nocturnal micturitions. METHODS: This was a large, prospective, randomized, double-blind, placebo-controlled trial. Subjects were aged 18 y with self-reported OAB symptoms including nocturnal urgency for 3 mo. At screening, baseline, and wks 4 and 12, subjects completed a 3-d bladder diary in which they recorded all micturitions, including nocturnal urgency episodes (ie, micturitions rated 3 on the Urinary Sensation Scale recorded in the bedtime section). In the baseline and wk 12 diaries, subjects also recorded voided volume for each micturition for 1 of the 3 diary days. Subjects were randomized to receive fesoterodine or PBO for 12 wk if they had 2-8 nocturnal urgency episodes/24 h at baseline and a 35% reduction of nocturnal urgency episodes during PBO run-in. Fesoterodine was initiated at 4 mg/d for 4 wk, after which the dose could be increased to 8 mg. The primary efficacy endpoint was change from baseline in mean number of micturition-related nocturnal urgency episodes/24 h at wk 12. RESULTS: 937 subjects were randomized and received 1 treatment. In the fesoterodine group (n 463), the mean age was 58 y, 80% were white, and 68% were women. In the PBO group (n 474), the mean age was 58 y, 79% were white, and 66% were women. By wk 12, changes from baseline in mean number of micturition-related nocturnal urgency episodes/24 h (primary endpoint) and mean number of total nocturnal micturitions/24 h were significantly greater in the fesoterodine group vs PBO (Table). 188 (40.6%) fesoterodine and 152 (32.1%) placebo subjects had 1 AE; the most common AEs were dry mouth (fesoterodine , 21.2%; PBO, 7.6%) and constipation (3.2%; 1.5%). The rate of urinary retention was 0.6% and 0.2% in the fesoterodine and PBO groups, respectively. CONCLUSIONS: Flexible-dose fesoterodine was superior to PBO in reducing nocturnal urgency episodes and nocturnal micturitions in patients with OAB. Fesoterodine was well tolerated. Table. PBO (n 445) Fesoterodine (n 421) Mean number of nocturnal urgency micturition episodes/24 h Baseline, mean (SD) 2.93 (0.98) 2.91 (0.90) Change from baseline to week 12, LS mean (SE) 1.06 (0.06) 1.29 (0.06)* Mean number of nocturnal micturitions/24 h Baseline, mean (SD) 3.19 (1.05) 3.15 (0.99) Change from baseline to week 12, LS mean (SE) 0.84 (0.05) 1.02 (0.06)* *P 0.01 vs PBO. P value based on analysis of covariance with treatment and center as factors and centered baseline value as a covariate.