Study Comparing Oxybutynin and Posterior Tibial Nerve Stimulation to Treat Overactive Bladder in Children Aged 6 to 16

What this Trial Is About

Researchers are evaluating the treatment of idiopathic overactive bladder OAB in children aged 6 to 16 years. This study compares the effectiveness and tolerance of two treatments oxybutynin, a commonly used medication, and posterior tibial nerve stimulation PTNS, a form of transcutaneous neurostimulation delivered by a medical device called Urostim. The goal is to demonstrate that PTNS is not less effective than oxybutynin after three months of treatment. Before starting treatment, all participants receive instructions on urotherapy, a behavioral therapy approach for managing OAB symptoms. After confirming the diagnosis and obtaining consent, children are randomly assigned to receive either oxybutynin or PTNS. The treatments are monitored for effectiveness, tolerance, and adherence over time, with assessments continuing up to 24 months for long-term outcomes. Participants will be involved in regular evaluations including symptom scoring using the DVISS scale to measure changes in OAB symptoms at 3 months and beyond. The study also tracks treatment duration, time to effect, tolerance, and compliance at multiple time points up to 24 months. The trial is sponsored by Centre Hospitalier Universitaire, Amiens, and aims to provide evidence on the comparative benefits and challenges of these two treatment options for children with OAB.

Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation