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

RecruitingNAAges 6 Years - 16 YearsAllCentre Hospitalier Universitaire, Amiens
NCT07030803 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 6 to 16 years * Showing signs of OAB (pollakiuria (\> 8 micturitions/d and/or urgenturia(\>x2/week) and/or daytime urine leakage (1/d) and/or nocturia x2/night) * No treatment for more than 3 months * Urotherapy rules followed for at least 1 month * Beneficiary of a social security plan * Signature of consent by parents/legal guardian(s) and child's agreement Exclusion Criteria: * Neurological cause of bladder dysfunction, * History of pelvic surgery, * Significant post-micturition residual (\> 10% of micturition), * Recurrent urinary tract infections (\> 3) in the 6 months prior to inclusion or urinary tract infection at inclusion. * Pregnant or breast-feeding adolescents * Severe constipation resistant to treatment (Rome IV), * Contraindication to oxybutynin * Contraindication to the use of TENS (Urostim)
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What it tests

  • Oxybutynin
  • medical device Urostim
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Where

1 site
CHRU Amiens
Amiens, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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