Safety and efficacy of vibegron in pediatric patients with treatment-resistant nocturnal enuresis: a multicenter retrospective study
Abstract
Background Nocturnal enuresis (NE) is a common chronic condition in children. Although enuresis alarms and desmopressin are the first-line treatments recommended by clinical guidelines, 20–40% of affected children demonstrate inadequate response and require additional therapeutic interventions. β3-adrenoceptor agonists are emerging as promising alternatives to anticholinergics, offering a more favorable safety profile with a lower incidence of common side effects. This multicenter retrospective study aimed to evaluate the safety and effectiveness of vibegron in children with treatment-resistant NE (TR-NE) and compare different treatment strategies. Methods This retrospective observational study was conducted at 12 hospitals affiliated with the Japanese Society on Enuresis and Incontinence. It enrolled children aged 5–18 years who received vibegron (50 mg once daily) for refractory NE between November 2018 and December 2021. The median treatment duration was 245 (interquartile range, 126–484) days. The primary outcome was treatment efficacy, assessed by the change in the number of wet nights over 30 days from baseline to 1 month. Safety was evaluated by monitoring adverse events. Treatment response was defined using the International Children’s Continence Society criteria. Patients were classified into an “add-on” group (vibegron combined with existing therapy) or a “switch” group (transitioned from prior anticholinergics to vibegron). Results Of the 387 children enrolled,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 387 participants or records.
Read the paper
Related studies
- Sarcopenia, sarcopenic overweight/obesity and risk of cardiovascular disease and cardiac arrhythmia: A cross-sectional study
- Workplace Violence Is Associated With Impaired Work Functioning in Nurses: An Italian Cross-Sectional Study
- Vagus Nerve Dysfunction in the Post-COVID-19 Condition: a pilot cross sectional study
- Association Between Metabolic Associated Fatty Liver Disease and Chronic Kidney Disease: A Cross-Sectional Study from NHANES 2017–2018
- Efficacy and safety of solifenacin succinate 10 mg once Daily: A multicenter, phase III, randomized, double-blind, placebo-controlled, parallel-group trial in patients with overactive bladder
- Association between triglyceride glucose‐body mass index and hypertension in Chinese adults: A cross‐sectional study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.