RecruitingNot ApplicableNCT07030803

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


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

124 participants

Start Date

Nov 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Oxybutynin and medical device Urostim for people with overactive bladder (oab), posterior tibial nerve stimulation, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROxybutynin

oxybutynin

DEVICEmedical device Urostim

medical device used to deliver posterior tibial nerve stimulation (PTNS)


Locations(1)

CHRU Amiens

Amiens, France

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NCT07030803


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