An interventional study of Oxybutynin and medical device Urostim in Overactive Bladder (OAB), Transcutaneous Neurostimulation and Posterior Tibial Nerve Stimulation, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's planned enrollment of 124 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Oxybutynin
Device: medical device Urostim
oxybutynin
medical 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.
Time frame: at 3 months
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
variation of compliance between both groups
Time frame: at 3 months
variation of compliance between both groups
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
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.
Time frame: at 24 months
Plan to share: No
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Centre Hospitalier Universitaire, Amiens