Actively Recruiting
Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-11-18
124
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire, Amiens
Lead Sponsor
U
University Hospital, Rouen
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 6 to 16 years
- Signs of overactive bladder such as frequent urination (more than 8 times a day), urgency (more than twice a week), daytime urine leakage (once a day), or waking at night to urinate (twice a night)
- No treatment for overactive bladder in the past 3 months
- Following urotherapy behavioral rules for at least 1 month
- Covered by a social security plan
- Signed consent from parents or legal guardians and agreement from the child
You will not qualify if you...
- Neurological cause of bladder dysfunction
- History of pelvic surgery
- Significant urine left in bladder after urination (more than 10% of bladder volume)
- More than 3 urinary tract infections in the past 6 months or infection at study start
- Pregnant or breastfeeding adolescents
- Severe constipation not responding to treatment
- Contraindication to oxybutynin
- Contraindication to use of TENS device (Urostim)
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHRU Amiens
Amiens, France
Actively Recruiting
Research Team
E
Elodie Haraux, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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