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

The absence of infectious, urological and neurological causes defines the idiopathic character of overactive bladder (OAB). Although a progressive approach starting with behavioural therapy (urotherapy) is recommended, anticholinergic agents remain the mainstay of medical treatment of overactive bladder (OAB) in children. Bladder neuromodulation is also used but no study with sufficient evidence has assessed its effectiveness and tolerance compared to the reference treatment. The purpose of HAV-O-TENS is to demonstrate the non-inferiority of treating idiopathic overactive bladder (OAB) in children using posterior tibial nerve stimulation (PTNS) compared to the reference treatment with oxybutynin after three months of treatment. Before inclusion, patients will receive instructions for urotherapy and a treatment plan. After confirming the diagnosis and obtaining informed consent, patients will be randomly assigned to either oxybutynin or PTNS (posterior tibial nerve stimulation) treatment, and their effectiveness, tolerance, and adherence will be monitored.

NCT Number	NCT07030803
Lead Sponsor	Centre Hospitalier Universitaire, Amiens Collaborators: University Hospital, Rouen
Conditions	Overactive Bladder (OAB), Transcutaneous Neurostimulation, Posterior Tibial Nerve Stimulation
Enrollment	124 participants
Start Date	2025-11-05
Primary Completion	2029-03 (estimated)
Study Completion	2029-03 (estimated)
Updated on ClinicalTrials.gov	2025-11-18