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Efficacy and Safety of Desmopressin Add-On Therapy for Men with Persistent Nocturia on α-Blocker Monotherapy for Lower Urinary Tract Symptoms: A Randomized, Double-Blind, Placebo Controlled Study

Kim JC et al.

The Journal of Urology, Volume 197, Issue 2, February 2017, Pages 459–464

Commentary by Philip Van Kerrebroeck

The authors investigated the efficacy and safety of desmopressin as an add-on therapy in men with persistent nocturia after initial therapy with an α-blocker for lower urinary tract symptoms. It is a placebo controlled study, in which men were included (40 to 65 years old) with lower urinary tract symptoms and persistent nocturia despite at least 8 weeks of α-blocker therapy. Patients were randomized to once daily placebo or desmopressin 0.2 mg for an 8 week trial faze. The primary end point was to assess changes in the mean number of nocturia episodes from baseline to the final assessment. Other secondary end points were also studied and adverse events were evaluated and compared in both groups. In total 86 patients were included in this study. Of these 39 were randomized to placebo and 47 to desmopressin 0.2 mg. The baseline characteristics in the 2 groups were similar. As a result the authors found that the effect of desmopressin add-on was significantly superior to placebo in terms of the change from baseline in the mean number of nocturia episodes (-1.13 ± 0.92 vs -0.68 ± 0.79, p = 0.034), the changes in nocturnal urine volume (p <0.001), total I-PSS (International Prostate Symptom Score) (p = 0.041), the nocturnal polyuria index (p = 0.001) and ICIQ-N (International Consultation on Incontinence Questionnaire-Nocturia) (p = 0.001), and the willingness to continue (p = 0.025). However the incidence of adverse events in the desmopressin add-on group was similar to that in the placebo group. Furthermore if adverse events were present they were in general mild. Based on these results the investigators conclude that desmopressin add-on therapy in men 40 to 65 years old with persistent nocturia after α-blocker monotherapy for lower urinary tract symptoms, is effective and also well tolerated.

These conclusions could potentially have clinical implications of this important group of patients that frequently consult the urologist after failed first-line treatment.