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Efficacy of desmopressin in the treatment of nocturia: a double‐blind placebo‐controlled study in men
Author(s) -
Mattiasson A.,
Abrams P.,
Van Kerrebroeck P.,
Walter S.,
Weiss J.
Publication year - 2002
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1046/j.1464-410x.2002.02791.x
Subject(s) - desmopressin , nocturia , placebo , medicine , anesthesia , urology , urinary system , alternative medicine , pathology
Objective To investigate the efficacy and safety of oral desmopressin in the treatment of nocturia in men. Patients and methods Men aged 18 years with verified nocturia (two voids/night) and nocturnal urine production greater than their maximum functional bladder capacity were recruited. A 3‐week 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, 151 patients entered the double‐blind period (86 treated with desmopressin, 65 with placebo). In 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 an 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 an effective and well‐tolerated treatment for nocturia in men.