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This entry refers to a clinical trial intervention protocol (NCT01432366) sponsored by the CHU de Reims (Centre Hospitalier Universitaire de Reims) that evaluates the efficacy and safety of botulinum toxin type A in pediatric patients. The study is a phase 3, randomized, multicenter, non-inferiority trial comparing two distinct commercial formulations of botulinum toxin type A: Dysport (abobotulinumtoxinA) and Botox (onabotulinumtoxinA). The trial focuses on children aged 3 to 15 years suffering from neurogenic vesical hyperactivity syndrome (neurogenic detrusor overactivity) that has proven resistant to standard anticholinergic treatments. Botulinum toxin type A functions as a neurotoxin that inhibits the release of acetylcholine at the neuromuscular junction by cleaving the SNAP-25 protein. When injected into the detrusor muscle of the bladder, it reduces involuntary contractions, thereby increasing bladder capacity and improving urinary continence.
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