Completed

NCT Number: NCT02816151

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

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.

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Key information

Conditions

Neurogenic Vesical Hyperactivity Syndrom

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chu Reims

France, Reims, 51092

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

full dose at 16 UI/kg for Dysport or 6,5 UA/kg for Botox

Drug

Intradetrusor injection under general anesthesia. Injection done through 25 points of 1cc each.

half dose at 8 UI/kg for Dysport or 3,25 UA/kg for Botox

Drug

Intradetrusor injection under general anesthesia. Injection done through 25 points of 1cc each.

Primary outcomes

Detrusor pression decrease in neurogenic vesical hyperactivity syndrom for child

Time frame: 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

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: TBIDE

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Jun 28, 2016
Registry last updated: Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.