OBJECTIVE: To investigate the efficacy of fesoterodine vs placebo on nocturia, sleep disturbance, and sleep-related quality of life (QoL) in patients with overactive bladder and nocturia.
METHODS: This posthoc analysis used data from a 12-week, randomized, placebo-controlled trial of fesoterodine 4 and 8 mg per day in Asian adults reporting ≥8 micturitions and ≥1 urgency urinary incontinence episodes per 24 hours at baseline. Patients who reported ≥1 nocturnal micturition/24 h were included in this analysis. Efficacy variables included change from baseline to week 12/end of treatment in nocturnal micturitions/24 h, nocturnal voided volume/micturition, and hours of undisturbed sleep. Sleep-related QoL was assessed using King's Health Questionnaire Sleep/Energy domain. Treatment comparisons were made using analysis of covariance.
RESULTS: Among 555 patients, reductions in nocturnal micturitions with fesoterodine 4 mg (-0.63) and 8 mg (-0.77) were numerically greater vs placebo (-0.56), but differences were not significant (P >.05). When patients with a nocturnal polyuria index >33% were excluded, the decrease in nocturnal micturitions was significantly greater with fesoterodine 8 mg vs placebo (-0.24; P = .031). Increases in nocturnal voided volume/micturition were significantly greater with fesoterodine 4 (38.07 mL; P = .013) and 8 mg (42.05 mL; P < .001) vs placebo (14.89 mL). Hours of undisturbed sleep was significantly longer with fesoterodine 4 mg vs placebo (80 vs 54 minutes; P = .032); improvement in King's Health Questionnaire Sleep/Energy scores was significantly greater with fesoterodine 4 (P = .034) and 8 mg (P = .019) vs placebo.
CONCLUSION: These results suggest that fesoterodine may reduce nocturnal micturitions and improve sleep quality and QoL in overactive bladder patients with nocturia.
Written by:
Yokoyama O, Hiro S, Hotta S, Mogami S, Yamagami H. Are you the author?
Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan; Pfizer Japan Inc, Tokyo, Japan.
Reference: Urology. 2014 Feb 8. pii: S0090-4295(13)01543-4.
doi: 10.1016/j.urology.2013.12.008
PubMed Abstract
PMID: 24518285
