Efficacy and Safety of Mirabegron 25 mg Versus Oral Desmopressin 120 mcg in Treatment of Primary Nocturnal Enuresis

Abstract

Objective: To evaluate the effectiveness and safety of mirabegron in the management of primary nocturnal enuresis.

Methods: This prospective, randomized controlled study included 150 patients randomized into 2 equal groups: desmopressin and mirabegron. All patients underwent evaluation over a 6-month period, with assessments conducted at the end of each month. Evaluations included the frequency of wet nights per month, clinical outcomes, the percentage reduction in wet nights during treatment, and relapse following treatment. The side effects of the drugs in the studied groups were also recorded.

Results: At 2, 3, 4, 5, and 6 months, the mirabegron group showed a significant increase in median percentage reduction in wet nights from baseline compared with the desmopressin group. Furthermore, there was a significant improvement in clinical outcomes for the mirabegron group compared to the desmopressin group (P < .01*). At the 1-month follow-up after treatment, 10.7% of patients in the mirabegron group had a relapse, whereas the relapse rate in the desmopressin group was 22.7%, indicating a statistically significant difference (P = .049*); the relative risk of relapse with mirabegron was 0.47 (95% CI: 0.22-1.02). The mirabegron group exhibited a significant increase in maximum bladder capacity (MBC) (270.8 ± 73.80) compared to the desmopressin group (230.933 ± 67.35; P < .001). Both groups exhibited a statistically significant increase in MBC posttreatment compared with pretreatment (P < .001*). No significant difference was observed between the 2 groups regarding any of the reported side effects.

Conclusion: Mirabegron is an effective treatment for nocturnal enuresis, with better outcomes, fewer relapses, and tolerable side effects.

Cite this article as: Abo-Elnasr HA, Alhefnawy MA, Farag M, El Gharably MA. Efficacy and safety of mirabegron 25 mg versus oral desmopressin 120 mcg in treatment of primary nocturnal enuresis. Urol Res Pract. 2026, 52, 0009, doi: 10.5152/ tud.2026.26009.