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RECRUITING
NCT07030803
NA

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

Sponsor: Centre Hospitalier Universitaire, Amiens

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

6 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-11-05

Completion Date

2029-03

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

OTHER

Oxybutynin

oxybutynin

DEVICE

medical device Urostim

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

Locations (1)

CHRU Amiens

Amiens, France