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

Not Applicable

Recruiting

Conditions: Overactive Bladder (OAB)
Transcutaneous Neurostimulation
Posterior Tibial Nerve Stimulation

Brief 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.

Recruitment & Eligibility

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)

Primary Outcome Measures

Name	Time	Method
Variation of DVISS score between PTNS treatment group and oxybutynin group	at 3 months	DVISS score is : Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) Questionnaire. The DVISS is a 13-item instrument that includes 1 QOL question. The first 5 questions are scored using an ordinal scale with the remainder in binary format. The DVISS scores are based on the estimated odds ratio (OR) for each question between cases and controls. For example, a score of 1 is given if the item's OR is between 2 and 10, and a score of 5 is given if the OR is greater than 50. The total score can range from 0 to 35 with a cutoff score of 8.5 having 90% sensitivity and specificity at detecting BBD.

Secondary Outcome Measures

Name	Time	Method
variation of treatment duration between both groups	at 6 months
variation of time to treatment efficacy between both groups	at 6 months
variation of tolerance between both groups	at 6 months
variation of compliance between both groups	at 6 months	variation of compliance between both groups
variation of long-term efficacy between both groups	at 18 months
variation of long-term efficacy of AOB frequency between both groups	at 24 months	Long term efficacy of OAB frequency is measured with DVISS score. The DVISS is a 13-item instrument that includes 1 QOL question. The first 5 questions are scored using an ordinal scale with the remainder in binary format. The DVISS scores are based on the estimated odds ratio (OR) for each question between cases and controls. For example, a score of 1 is given if the item's OR is between 2 and 10, and a score of 5 is given if the OR is greater than 50. The total score can range from 0 to 35 with a cutoff score of 8.5 having 90% sensitivity and specificity at detecting BBD.