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

NCT02816151 Phase 3 COMPLETED

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.

Details

Lead sponsor	CHU de Reims
Phase	Phase 3
Status	COMPLETED
Enrolment	29
Start date	2011-02
Completion	2016-05

Conditions

• Neurogenic Vesical Hyperactivity Syndrom

Interventions

• full dose at 16 UI/kg for Dysport or 6,5 UA/kg for Botox
• half dose at 8 UI/kg for Dysport or 3,25 UA/kg for Botox

Primary outcomes

• Detrusor pression decrease in neurogenic vesical hyperactivity syndrom for child — up to 6 weeks after intradetrusor injection
  maximal vesical capacity and maximal pression at the end of filling mesured during the course of cystomanometry exam. These points were mesured at leak point or bladder point or when pain appear

Countries

France