1 Assistant Professor of Pediatrics, Department of Pediatrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

2 Kidney Transplantation Complication Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

3 Department of Pediatrics, Mashhad University of Medical Sciences, Mashhad, Iran.

4 Department of Community Medicine, Mashhad Branch, Islamic Azad University, Mashhad, Iran.


Background: Primary nocturnal enuresis (PNE), with a prevalence of 5-30%, is a common and important disease in children. We aimed to investigate the efficacy of fluvoxamine in the treatment of refractory PNE and to compare it with standard desmopressin-oxybutynin treatment.
Materials and Methods: In this pilot clinical trial study,children with PNE referred to the Dr. Sheikh Hospital (Mashhad, Iran, 2019) who were resistant to the first line of behavioral and drug treatment and did not have any other psychological disorders were enrolled in the present pilot clinical trial. Patients were randomly divided into fluvoxamine (25 mg at bedtime for one month), combination therapy (desmopressin, 10μg intranasal), and oxybutynin (0.1 mg/kg for one month). The recovery status of patients in the two groups was investigated and compared based on the number of wet nights during one month.
Results: 30 patients with PNE were included in this study. Three patients of the treatment group were excluded from the study due to lack of referral and follow-up. At the end of follow-up in the fluvoxamine treatment group, full recovery was observed in 8 patients (66.7%), partial recovery in 2 patients (16.7%), and no recovery in 2 patients (16.7%). Also, the desmopressin-oxybutynin treatment resulted in full recovery in 7 patients (46.7%), partial recovery in 4 patients (26.7%), and no recovery in 4 patients (26.7%), but there was no significant difference between the two groups in terms of therapeutic results (P> 0.05).
Conclusion: Based on the results, there was no difference between the two groups of fluvoxamine and desmopressin-oxybutynin combination in the treatment of nocturnal enuresis.