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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2029-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Overactive Bladder (OAB) Transcutaneous Neurostimulation Posterior Tibial Nerve Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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oxybutynin

Group Type ACTIVE_COMPARATOR

Oxybutynin

Intervention Type OTHER

oxybutynin

TENS

Group Type EXPERIMENTAL

medical device Urostim

Intervention Type DEVICE

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

Interventions

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Oxybutynin

oxybutynin

Intervention Type OTHER

medical device Urostim

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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No