Children Toxine Botulinum Detrusor Injection in Neurogenic Vesical Hyperactivity Syndrom: Non Inferiority Multicenter Controlled Therapeutic Study Between Two Reported Weight's Doses
Condition: Neurogenic Vesical Hyperactivity Syndrom
MeSH terms: Hyperkinesis
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      The main aim of the study is to so determine dosages with mid--amount of TBA would make it
      possible to anticipate not-inferiors results with full posology and to determine the benefit
      ratio/risk improvement. This could lead to an important reduction of the treatment costs.
      This study also aims to better identy the "non responders" patients in order to refine the
      indications. Thanks to the participation of a French urologic paediatric surgery centers, the
      study hope to homogenize practices and to use standardized common criteria of judgement.

      Lastly, this study should appreciate if it is possible not to more bring back posology to the
      weight of the child, but on detrusor surface allowing a more precise estimation of the
      amounts to be managed.

      A complementary study on the quality of life of these children before and after treatment
      will be carried out thanks to Child Health Questionnaire (CHQ 50). The diagram of the study
      is a randomized therapeutic test controlled not-inferiority aiming at comparing an amount
      full versus an half-amount with TBA.

      The population of the study will be made up children from 3 to 15 years treated for detrusor
      hyperactivity, confirmed by an aurodynamic assessment according to the criteria of
      International the Society Continence, origin neurological, and resistant to the medical care
      associated with the usual accompanying measures.
    

Intervention name(s): 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
Intervention type(s): Drug; Drug
Intervention description(s): Intradetrusor injection under general anesthesia. Injection done through 25 points of 1cc each.; Intradetrusor injection under general anesthesia. Injection done through 25 points of 1cc each.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment