Trials / Recruiting
RecruitingNCT07030803
Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- Sponsor
- Centre Hospitalier Universitaire, Amiens · Academic / Other
- Sex
- All
- Age
- 6 Years – 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Oxybutynin | oxybutynin |
| DEVICE | medical device Urostim | medical device used to deliver posterior tibial nerve stimulation (PTNS) |
Timeline
- Start date
- 2025-11-05
- Primary completion
- 2029-03-01
- Completion
- 2029-03-01
- First posted
- 2025-06-22
- Last updated
- 2025-11-18
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT07030803. Inclusion in this directory is not an endorsement.