Randomized Study of Early Oxybutynin Treatment in Boys Aged 3 to 6 Months With Posterior Urethral Valves After Valve Surgery

What this Trial Is About

This trial focuses on boys aged 3 to 6 months who have been diagnosed with posterior urethral valves VUP, a condition that causes bladder obstruction and can lead to chronic kidney problems or the need for transplantation. Researchers are evaluating the early use of the drug oxybutynin to treat bladder dysfunction in these patients, comparing outcomes with boys who do not receive this treatment. The study aims to provide clear evidence on whether early anticholinergic treatment benefits boys with VUP, as previous studies have been limited or lacked control groups. Participants are randomly assigned to one of two groups one receiving oxybutynin syrup at a dose of 0.1 mg per kg twice daily for 9 months, and a control group receiving no treatment affecting bladder function. The study includes detailed monitoring of bladder function through standardized urodynamic tests performed 3 months after valve resection and again after the 9-month treatment period. Pharmacokinetic analysis of oxybutynin and its metabolite will also be performed to better understand the drugs behavior in this population. Throughout the study, participants will undergo regular assessments including urodynamic studies to measure bladder capacity, voiding pressure, and compliance. Researchers will also monitor adverse events, urinary tract infections, treatment compliance, and kidney function. The main outcome is a composite measure of treatment success evaluated 9 months after inclusion. Safety and treatment effects will be closely followed to understand the impact of early oxybutynin use in boys with posterior urethral valves.

Early Oxybutinin Treatment for Boys With Posterior Urethral Valves