Actively Recruiting
Comparative Study of Treatment for Idiopathic Overactive Bladder (OAB) in Children Using Oxybutynin or Transcutaneous Neurostimulation
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-11-18
124
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the treatment of idiopathic overactive bladder (OAB) in children aged 6 to 16 years. This study compares the effectiveness and tolerance of two treatments: oxybutynin, a commonly used medication, and posterior tibial nerve stimulation (PTNS), a form of transcutaneous neurostimulation delivered by a medical device called Urostim. The goal is to demonstrate that PTNS is not less effective than oxybutynin after three months of treatment. Before starting treatment, all participants receive instructions on urotherapy, a behavioral therapy approach for managing OAB symptoms. After confirming the diagnosis and obtaining consent, children are randomly assigned to receive either oxybutynin or PTNS. The treatments are monitored for effectiveness, tolerance, and adherence over time, with assessments continuing up to 24 months for long-term outcomes. Participants will be involved in regular evaluations including symptom scoring using the DVISS scale to measure changes in OAB symptoms at 3 months and beyond. The study also tracks treatment duration, time to effect, tolerance, and compliance at multiple time points up to 24 months. The trial is sponsored by Centre Hospitalier Universitaire, Amiens, and aims to provide evidence on the comparative benefits and challenges of these two treatment options for children with OAB.
CONDITIONS
Brief 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
- Showing signs of overactive bladder such as frequent urination, urgency, daytime leakage, or nighttime urination
- No treatment for overactive bladder for more than 3 months
- Following urotherapy rules for at least 1 month
- Beneficiary of 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 post-micturition residual volume over 10% of urination
- Recurrent urinary tract infections (more than 3 in the past 6 months) or infection at inclusion
- Pregnant or breastfeeding adolescents
- Severe constipation resistant to treatment
- Contraindication to oxybutynin
- Contraindication to use of TENS (Urostim device)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive either oxybutynin medication or transcutaneous neurostimulation using a medical device to treat overactive bladder.
Regular visits during treatment period as per protocol
Duration - Up to 24 months
Participants are monitored for long-term treatment effects and efficacy up to 24 months.
Periodic visits for assessments up to 24 months
Trial Site Locations
Total: 1 location
1
CHRU Amiens
Amiens, France
Actively Recruiting
Research Team
E
Elodie Haraux, Pr
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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