Efficacy and safety during long‐term treatment f primary monosymptomatic nocturnal enuresis with desmopressin

Abstract

The Swedish Enuresis Trial (SWEET) was conducted to evaluate the long‐term safety and efficacy of intranasal desmopressin treatment in children with primary, monosymptomatic nocturnal enuresis (PMNE). The study had an open, multicentre design and comprised a 4‐wk observation period, a 6‐wk dose titration period (with 20‐40 μg desmopressin) and a 1‐y, long‐term treatment period. A treatment‐free week was introduced every 3 mo to identify dry patients. In total, 399 children aged 6‐12 y with PMNE were recruited. Of these, 245 patients (61%) experienced ≥ 50% reduction in the number of wet nights during the last 4 wk of dose titration compared with the observation period. These responders entered the long‐term phase of the trial. The mean number of wet nights per week decreased from a median of 5.3 (range 1.3‐7.0) during the observation period to a median of 0.8 (range 0.0‐5.0) during the last 3‐mo period. Seventy‐seven children became dry, 63 (83%) within 6 mo of treatment initiation. The percentage of children who became dry was similar in all age groups. Significantly fewer children in the lowest age group were defined as responders (52%; 95% CI 45, 59) among the 6‐7‐y‐olds compared to 65% (56, 74) and 81% (72, 90) in the two older age groups. Desmopressin was well tolerated. No serious drug‐related adverse events were recorded and no clinical symptoms of hyponatraemia were reported. The SWEET trial has demonstrated that desmopressin is both safe and effective for the long‐term treatment of PMNE, with a significant therapeutic effect also in children of 6–7 y of age.