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.
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
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.
Parallel
Oxybutynin
Other interventionoxybutynin
medical device Urostim
Devicemedical device used to deliver posterior tibial nerve stimulation (PTNS)
Variation of DVISS score between PTNS treatment group and oxybutynin group
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.
variation of treatment duration between both groups
variation of time to treatment efficacy between both groups
variation of tolerance between both groups
variation of tolerance between both groups
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Centre Hospitalier Universitaire, Amiens
Lead sponsor
University Hospital, Rouen
Collaborator
