To assess side effects of MELT monotherapy and MELT in association with oxybutynin in children suffering from nocturnal enuresis (NE). We enrolled 340 enuretic children admitted to our Pediatric Service, Campus Bio-Medico University of Rome, from April 2014 to April 2018; 23 children were excluded. The research was structured in 2 steps. During step 1, a patient’s medical history was carefully collected and physical assessment was performed. During step 2, after 3-month treatment period with MELT (Minirin/dDAVP®) at the dose of 120 mcg a day or MELT plus oxybutynin (Ditropan®), voiding calendar, adherence to treatment and any side effects were examined. The study was conducted in accordance with the Helsinki Declaration. Among 317 patients enrolled in the study, 18 male and 8 female (n=26; 26/317: 8.2%) children, with a mean age 10.86 ± 2.42 years, referred side effects: 13 cases (n=13, 13/26: 50%) treated with MELT monotherapy, 11 cases (n=11, 11/26: 42.3%) treated with MELT plus oxybutynin, 2 cases (n=2, 2/26: 7.7%) who received only oxybutynin. In our research, higher bioavailability of MELT guaranteed lower frequency of adverse effects with a spontaneous and rapid resolution. Several studies demonstrate that dDAVP is an effective and safe drug for NE and MELT formulation is actually considered for first-line therapy of NE, although further research is needed to endorse the observations of the authors.
- Adverse Effects