PURPOSE: Awakening from sleep to urinate is the hallmark of nocturia, a condition that impacts several facets of health-related quality of life and where current therapy is suboptimal.
Given the paucity of prospective data on antimuscarinics for the management of nocturia, we investigated the efficacy and safety of flexible-dose fesoterodine for treatment of nocturnal urgency in subjects with nocturia and overactive bladder.
MATERIALS AND METHODS: Subjects with ≥2 but ≤ 8 nocturnal urgency episodes/24 hours began a 2-week, single-blind, placebo run-in, followed by 1:1 randomization to 12 weeks of double-blind treatment with fesoterodine (4 mg/day for 4 weeks with optional increase to 8 mg) or placebo using predefined criteria for nocturnal urgency episodes, nocturnal urine volume voided, and total 24-hour urine volume voided. Primary endpoint was change from baseline to week 12 in mean number of micturition-related nocturnal urgency episodes/24 hours.
RESULTS: 963 subjects were randomized from2990 screened; 82% of fesoterodine-treated subjects and 84% of placebo-treated subjects completed the study. Significant improvements in the primary endpoint (-1.28 vs -1.07) and in nocturnal micturitions/24 hours (-1.02 vs -0.85) and nocturnal frequency urgency sum (-4.01 vs -3.42) were observed with fesoterodine versus placebo (all p≤ 0.01). Health-related quality of life measures (Overactive Bladder-questionnaire Symptom Bother (-20.1 vs -16.5), Sleep (22.3 vs 19.9) and other domains; all p< 0.05) were improved with fesoterodine.
CONCLUSIONS: This is the first prospective study to assess antimuscarinic efficacy for reducing nocturnal urgency. Flexible-dose fesoterodine significantly reduced nocturnal urgency episodes versus placebo in subjects with overactive bladder.
Written by:
Weiss JP, Jumadilova Z, Johnson TM 2nd, Fitzgerald MP, Carlsson M, Martire DL, Malhotra A. Are you the author?
SUNY Downstate College of Medicine, Brooklyn, New York.
Reference: J Urol. 2012 Nov 14. pii: S0022-5347(12)05557-7.
doi: 10.1016/j.juro.2012.11.067
PubMed Abstract
PMID: 23159276
