Efficacy of desmopressin in the treatment of nocturia: a double-blind placebo-controlled study in men

Objective To investigate the efficacy and safety of oral desmopressin in the treatment of nocturia in men. Patients and methods Men aged greater than or equal to18 years with verified nocturia (greater than or equal totwo voids/night) and nocturnal urine production greater than their maximum functional bladder capacity were recruited. A dose-titration phase established the optimum desmopressin dose (0.1. 0.2 or 0.4 mg). After a 1-week 'washout' period. patients who responded in the dose-titration period were randomized to receive the optimal dose of desmopressin or placebo in a double-blind design for 3 weeks. Results In all. 1,51 patients entered file double-blind period (86 treated with desmopressin. 65 with placebo). hi the desmopressin group 28 (34%) patients and in the placebo group two (3% ) patients (P<0.001) had Fewer than half the number of nocturnal voids relative to baseline: the mean number of nocturnal voids decreased from 3.0 to 1.7 and From 3.2 to 2.7. respectively, reflecting a mean decrease of 43% and 12%, (P<0.001). The mean duration of the first sleep period increased by 59% (from 2.7 to 4.5 h) in the desmopressin group. compared with all increase of 21% (from 2.5 to 2.9 h) in the placebo group (P<0.001). The mean nocturnal diuresis decreased by 36%, (From 1.5 to 0.9 mL/min) in the desmopressin group and by 6% from 1.7 to 1.5 mL/min) in the placebo group (p<0.001). The mean ratio of night/24-h urine volume decreased by 23%) and 1% (P<0.001), and the mean ratio of night/day urine volume decreased by 27% and increased by 3% (P<0.001) For the desmopressin and placebo groups. respectively. In the double-blind treatment period, similar numbers of patients had adverse events: 15 (17%) patients in the desmopressin and 16 (25%) patients in the placebo group. Most adverse events were mild. Serum sodium levels were < 130 mmol/l, in 10 (4%) patients, and this occurred during dose-titration. Conclusions Orally administered desmopressin is all effective and well-tolerated treatment for nocturia in men.