Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-01 @ 5:01 PM
Study NCT ID:
NCT07030803
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation
Sponsor:
Centre Hospitalier Universitaire, Amiens
Organization:
Study Overview
Official Title:
Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HAV-O-TENS
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: