Neurogenic Vesical Hyperactivity SyndromPhase 3TBIDENCT02816151
Children Toxine Botulinum Detrusor Injection in Neurogenic Vesical Hyperactivity Syndrom: Non Inferiority Multicenter Controlled Therapeutic Study Between Two Reported Weight's Doses
A Phase 3 study testing full dose at 16 UI/kg for Dysport or 6,5 UA/kg for Botox and half dose at 8 UI/kg for Dysport or 3,25 UA/kg for Botox in people with Neurogenic Vesical Hyperactivity Syndrom, run by CHU de Reims at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Neurogenic Vesical Hyperactivity Syndrom
- What is being tested?
- full dose at 16 UI/kg for Dysport or 6,5 UA/kg for Botox and half dose at 8 UI/kg for Dysport or 3,25 UA/kg for Botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to May 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Neurogenic Vesical Hyperactivity Syndrom
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full dose at 16 UI/kg for Dysport or 6,5 UA/kg for BotoxDrug
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 BotoxDrug
Intradetrusor injection under general anesthesia. Injection done through 25 points of 1cc each.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Drug: full dose at 16 UI/kg for Dysport or 6,5 UA/kg for Botox |
| Group 2 | Experimental | Not described Receives: Drug: half dose at 8 UI/kg for Dysport or 3,25 UA/kg for Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detrusor pression decrease in neurogenic vesical hyperactivity syndrom for child
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
Measured: up to 6 weeks after intradetrusor injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startFeb 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurogenic Vesical Hyperactivity SyndromStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816151
- Sponsor's protocol ID
- PN10002
- Acronym
- TBIDE
- Status last verified
- Jun 2016
- First submitted
- 24 Jun 2016
- Last updated
- 21 Jan 2026
- Results posted
- No
Publications
Leon P, Jolly C, Binet A, Fiquet C, Vilette C, Lefebvre F, Bouche-Pillon-Persyn MA, Poli-Merol ML. Botulinum toxin injections in the management of non-neurogenic overactive bladders in children. J Pediatr Surg. 2014 Sep;49(9):1424-8. doi: 10.1016/j.jpedsurg.2014.04.004. Epub 2014 May 14.
PubMed 25148752
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children Toxine Botulinum Detrusor Injection in Neurogenic Vesical Hyperactivity Syndrom: Non Inferiority Multicenter Controlled Therapeutic Study Between Two Reported Weight's Doses
- ClinicalTrials.gov ID
- NCT02816151
- Acronym / sponsor ID
- TBIDE / PN10002
- Conditions
- Neurogenic Vesical Hyperactivity Syndrom
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: full dose at 16 UI/kg for Dysport or 6,5 UA/kg for Botox |
| Group 2 | Experimental | Drug: half dose at 8 UI/kg for Dysport or 3,25 UA/kg for Botox |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| full dose at 16 UI/kg for Dysport or 6,5 UA/kg for BotoxIntradetrusor injection under general anesthesia. Injection done through 25 points of 1cc each. | Drug | Group 1 |
| half dose at 8 UI/kg for Dysport or 3,25 UA/kg for BotoxIntradetrusor injection under general anesthesia. Injection done through 25 points of 1cc each. | Drug | Group 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 25148752Leon P, Jolly C, Binet A, Fiquet C, Vilette C, Lefebvre F, Bouche-Pillon-Persyn MA, Poli-Merol ML. Botulinum toxin injections in the management of non-neurogenic overactive bladders in children. J Pediatr Surg. 2014 Sep;49(9):1424-8. doi: 10.1016/j.jpedsurg.2014.04.004. Epub 2014 May 14.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing full dose at 16 UI/kg for Dysport or 6,5 UA/kg for Botox and half dose at 8 UI/kg for Dysport or 3,25 UA/kg for Botox in people with Neurogenic Vesical Hyperactivity Syndrom, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detrusor pression decrease in neurogenic vesical hyperactivity syndrom for child (time frame: up to 6 weeks after intradetrusor injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.