Desmopressin in the treatment of nocturia:: A double-blind, placebo-controlled study

Objectives: To investigate efficacy, safety, and impact on quality of sleep of desmopressin in the treatment of nocturia. Methods: Adults aged >= 18 yr with nocturia (>= 2 voids/night) received desmopressin tablets (0.1, 0.2, or 0.4 mg) during a 3-wk dose-titration period. Patients should show sufficient response during the dose-titration period (>= 20% reduction in nocturnal diuresis) and a return of nocturnal diuresis to >= 80% of baseline levels during washout. Eligible patients then entered a 3-wk double-blind treatment period and received either desmopressin or placebo. Results: 127 patients were randomised to either desmopressin (n = 61) or placebo (n = 66). Twenty (33%) desmopressin-treated patients compared with seven (11%) placebo-treated patients showed a clinical response, defined as a >= 50% reduction in the number of nocturnal voids compared with baseline (p = 0.0014). Compared with placebo, desmopressin resulted in a significant reduction in the mean number of nocturnal voids (39% reduction with desmopressin vs. 15% with placebo; absolute difference -0.84, p < 0.0001) and duration of the first sleep period (prolonged by 108 min with desmopressin vs. 41 min with placebo; p < 0.0001). Quality of sleep was also improved with clesmopressin versus placebo (statistically significant for one of the two parameters evaluated). Adverse events were mainly mild. Conclusions: Oral clesmopressin tablets provide an effective and well-tolerated treatment for nocturia. Compared with placebo, nocturnal voiding frequency is reduced, duration of the first sleep period is increased, and sleep quality may be improved. (c) 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved.