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

Centre Hospitalier Universitaire, Amiens

Status

Enrolling

Conditions

Overactive Bladder (OAB)

Transcutaneous Neurostimulation

Posterior Tibial Nerve Stimulation

Treatments

Other: Oxybutynin

Device: medical device Urostim

Study type

Interventional

Funder types

Other

Identifiers

NCT07030803

PI2023_843_0176

Details and patient eligibility

About

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.

Enrollment

124 estimated patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

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)