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Recruiting NCT07030803

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

No phase Interventional Overactive Bladder (OAB) Transcutaneous Neurostimulation Posterior Tibial Nerve Stimulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxybutynin, medical device Urostim.
Who it may be relevant to
Registry conditions: Overactive Bladder (OAB), Transcutaneous Neurostimulation, Posterior Tibial Nerve Stimulation. Basic parameters: 6 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Oxybutynin
    oxybutynin
  • Device medical device Urostim
    medical device used to deliver posterior tibial nerve stimulation (PTNS)

Primary outcome measures

  • Variation of DVISS score between PTNS treatment group and oxybutynin group [Time frame: at 3 months]
Secondary outcome measures (9)
  • variation of treatment duration between both groups [Time frame: at 6 months]
  • variation of time to treatment efficacy between both groups [Time frame: at 6 months]
  • variation of tolerance between both groups [Time frame: at 3 months]
  • variation of tolerance between both groups [Time frame: at 6 months]
  • variation of compliance between both groups [Time frame: at 3 months]
  • variation of compliance between both groups [Time frame: at 6 months]
  • variation of long-term efficacy between both groups [Time frame: at 12 months]
  • variation of long-term efficacy between both groups [Time frame: at 18 months]
  • variation of long-term efficacy of AOB frequency between both groups [Time frame: at 24 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHRU Amiens — Amiens

Identifiers

NCT: NCT07030803 · PI2023_843_0176

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗