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

Phase 3

Completed

• Conditions: Neurogenic Vesical Hyperactivity Syndrom
• Interventions: Drug: full dose at 16 UI/kg for Dysport or 6,5 UA/kg for Botox; Drug: half dose at 8 UI/kg for Dysport or 3,25 UA/kg for Botox

• Registration Number: NCT02816151
• Lead Sponsor: CHU de Reims

Brief 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.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	full dose at 16 UI/kg for Dysport or 6,5 UA/kg for Botox	-
Group 2	half dose at 8 UI/kg for Dysport or 3,25 UA/kg for Botox	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 France, Reims, France