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Efficacy and Tolerability of Mirabegron versus Oxybutynin in children with Posterior urethral valve after adequate fulgration: A Randomised Prospective Study
Monika Bawa, M.S (General Surgery), M.Ch (Pediatric Surgery), Prajacta Patil, M.S, M.Ch, Jai K. Mahajan, M.S, M.Ch.
Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Background:Posterior urethral valves represent the most common congenital cause of bladder outlet obstruction in male children, frequently leading to persistent bladder dysfunction and chronic kidney disease despite adequate fulguration. Optimal pharmacological management of post-fulguration bladder dysfunction remains a clinical challenge. Anticholinergics such as oxybutynin have been the mainstay, though associated with systemic side effects. Mirabegron, a selective β3-adrenoceptor agonist, offers a potential alternative with a favorable safety profile, but pediatric evidence is limited.
Objective:To evaluate and compare the efficacy and tolerability of oxybutynin versus mirabegron in children with adequately fulgurated PUV based on clinical outcomes, urodynamic parameters, and renal function.
Methods:This single-center, prospective, randomized controlled trial was conducted in the Department of Pediatric Surgery, PGIMER, Chandigarh, from August 2023 to December 2024. Forty male children (>1 year) who had undergone adequate transurethral fulguration were randomized into two groups: Group A (Oxybutynin n=20) and Group B (Mirabegron n=20). Patients were followed for one year with assessment of renal function tests, imaging (USG, DMSA, MCU), and urodynamic studies at baseline, 6 months, and 12 months. Primary outcomes included improvement in urodynamic parameters and clinical symptoms (Dysfunctional Voiding Symptom Score). Secondary outcomes included renal function (serum creatinine, GFR, CKD stage) and drug tolerability. Statistical analysis was performed using paired/unpaired t-tests and McNemar’s test with p<0.05 considered significant.
Results:Both groups demonstrated significant within-group improvement in bladder compliance, capacity, and DVSS scores. Mirabegron reduced DVSS from 16.85±4.48 to 10.15±4.12, while Oxybutynin reduced it from 17.15±5.77 to 13.20±5.87 (p=0.065 between groups). Renal function parameters (serum creatinine and GFR) remained stable in both groups, with a non-significant trend toward improved GFR in the mirabegron group. CKD staging showed no significant progression in either group. Side effects such as dry mouth and constipation were noted in Oxybutynin, while Mirabegron was well tolerated without systemic adverse effects.
Conclusion:Both Oxybutynin and Mirabegron are effective and safe for managing bladder dysfunction in children after PUV fulguration, with comparable renal outcomes. Mirabegron demonstrates superior tolerability and represents a preferable alternative, especially in patients at risk of anticholinergic side effects.
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