Children Toxine Botulinum Detrusor Injection in Neurogenic Vesical Hyperactivity Syndrom: Non Inferiority Multicenter Controlled Therapeutic Study Between Two Reported Weight's Doses
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Detrusor pression decrease in neurogenic vesical hyperactivity syndrom for child
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Group 1
干预措施: full dose at 16 UI/kg for Dysport or 6,5 UA/kg for Botox (Drug)
Group 2
干预措施: half dose at 8 UI/kg for Dysport or 3,25 UA/kg for Botox (Drug)
结局指标
主要结局
Detrusor pression decrease in neurogenic vesical hyperactivity syndrom for child
时间窗: 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
次要结局
未报告次要终点