Children Toxine Botulinum Detrusor Injection in Neurogenic Vesical Hyperactivity Syndrom: Non Inferiority Multicenter Controlled Therapeutic Study Between Two Reported Weight's Doses

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Detrusor hyperactivity is an urodynamic observation defined by involuntary detrusor contractions during the vesical filling. Within neurological bladders childs, especially related to spinal dysraphisms, this hyperactivity, associated or not with vesical compliance disorders, can involve a urinary incontinence obstructing social integration and possibly vesical pressure rise in the intra- potentially generating the high urinary tract lesions. Anticholinergic drugs possibly associated with a vesical draining constitute the treatment of first intention. In approximately 15 to 20% of the cases, intradetrusor iterative injections of type A Botulinum Toxin are proposed fault of satisfactory results. Largely used according to the European consensus of 2008 without AM, actual studies remain realized on small numbers with low level of proof. Posology remains discussed between pharmaceutical laboratories (derivative of the effective maximum amount per adult kg of weight) and weaker amounts used with clinical results.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CHU de Reims
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

inclusion criteria

• Old ≥3 years and ≤15 years

• Syndrome of vesical hyperactivity associated with a manometric detrusor hyperactivity

• Neurogenic vesico-sphincter disorders

• Anticholinergic treatment total/partial Failure/ intolerance

• Native Bladder and TB virgin

• Bladder patient or ready to be it, or possibly straight bladder

• 3 months delay if TB injection in another site

• Agreement to stop anticholinergic treatment 1 month before and throughout all protocol

non- inclusion criteria

• Toxin Botulinic use counter-indication (myasthenia, infantil spinal amyotrophy)

• General anaesthesia counter-indication

• Haemostasis disorders

• Children less than 3 years and more than 16 years

• non-neurogenic vesical hyperactivity

• Good tolerance and effectiveness of the anticholinergic treatment

• Bladder increased or already treated by one or more Toxin injections

• Having toxin injection in another site since less than 3 months

• Child wouldn't sondered