Neurogenic BladderNDOTOXNCT03042052
Toxin Retrospective Study
An observational study of Neurogenic Bladder, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Aims of this study were to assess the long-term outcomes of detrusor injection of OnabotulinumtoxinA (Botox® injection) associated with clean intermittent-catheterization (CIC) for the treatment of neurogenic detrusor overactivity (NDO) and to identify risk factors for failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bladder
- What is being tested?
- detrusor infection of Botulinum toxin
- Type of treatment
- Injection or infusion
- How many people
- 292 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2014to 1 Jun 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from neurogenic detrusor overactivity managed by detrusor injections of Botulinum toxin A and performing clean intermittent catheterization
Who may be able to join
- NDO due to MS, SCI or spina-bifida.
- follow-up ≥3 years from the first Botox® injection.
- Performing clean intermittent catheterization
Who cannot join
- bladder surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity
Aims of this study were to assess the long-term outcomes of detrusor injection of OnabotulinumtoxinA (Botox® injection) associated with clean intermittent-catheterization (CIC) for the treatment of neurogenic detrusor overactivity (NDO) and to identify risk factors for failure.
Read the detailed description
Neurogenic detrusor overactivity (NDO) remains a major concern for patients with neurological diseases. Fifty to eighty percent of patients with multiple sclerosis (MS) or traumatic spinal cord injury (SCI) and more than 60% of patients with myelomeningocele suffer from urinary incontinence episodes (UI) due to NDO. NDO is characterized by involuntary detrusor contractions during the filling phase, leading to leakage and increase in bladder pressure, which can, precipitate renal failure. Detrusor injection of OnabotulinumtoxinA (Botox®), is licensed worldwide and recommended as a second line therapy for the treatment of urinary incontinence due to NDO after failure of anticholinergic drugs (Grade A).
These recommendations are based on the results of international multicentric, randomized controlled trials.
These studies established not only clinical benefits, with a significant decrease of urinary incontinence episodes, but also urodynamic benefits.
There are very few data about the real prevalence of failure of Botox® in the long term.
Thus, aims of this study were to assess the long-term outcomes of detrusor injections of Botox® associated with clean intermittent-catheterization (CIC) for the treatment of NDO and to identify risk factors for failure .
- Conditions
- Neurogenic Bladder
- Being tested
- detrusor infection of Botulinum toxin
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detrusor infection of Botulinum toxinDrug
detrusor injection
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering from NDO managed with Botox | Doses used were 300 units Botox® from January 2001 to January 2011 and 200 units after 2011
Frequency depended on patient's symptoms
Duration was an outcome of the study Receives: Drug: detrusor infection of Botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure ratio
Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
Measured: 3 years of follow up
Failure ratio
Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
Measured: 5 years of follow up
Failure ratio
Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
Measured: Seven years of follow up
withdrawal ratio
Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
Measured: 3 years of follow up
withdrawal ratio
Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
Measured: 5 years of follow up
Withdrawal ratio
Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
Measured: 7 years of follow up
Secondary outcomes (3)
Risk factors for failures based on and clinical, radiological and urodynamic parameters
univariate analysis and multivariate analysis using Cox model
Measured: 3 years
Risk factors for failures based on and clinical, radiological and urodynamic parameters
univariate analysis and multivariate analysis using Cox model
Measured: 5 years
Risk factors for failures based on and clinical, radiological and urodynamic parameters
univariate analysis and multivariate analysis using Cox model
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Jan 2014
- Primary completion1 May 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EVEN Alexia, MD, Study chair, HOPITAL RAYMOND POINCARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042052
- Sponsor's protocol ID
- 1637154
- Acronym
- NDOTOX
- Status last verified
- Feb 2017
- First submitted
- 27 Jan 2017
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity
- ClinicalTrials.gov ID
- NCT03042052
- Acronym / sponsor ID
- NDOTOX / 1637154
- Conditions
- Neurogenic Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 3 Feb 2017 (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.
Aims of this study were to assess the long-term outcomes of detrusor injection of OnabotulinumtoxinA (Botox® injection) associated with clean intermittent-catheterization (CIC) for the treatment of neurogenic detrusor overactivity (NDO) and to identify risk factors for failure.
Detailed description
Neurogenic detrusor overactivity (NDO) remains a major concern for patients with neurological diseases. Fifty to eighty percent of patients with multiple sclerosis (MS) or traumatic spinal cord injury (SCI) and more than 60% of patients with myelomeningocele suffer from urinary incontinence episodes (UI) due to NDO. NDO is characterized by involuntary detrusor contractions during the filling phase, leading to leakage and increase in bladder pressure, which can, precipitate renal failure. Detrusor injection of OnabotulinumtoxinA (Botox®), is licensed worldwide and recommended as a second line therapy for the treatment of urinary incontinence due to NDO after failure of anticholinergic drugs (Grade A).
These recommendations are based on the results of international multicentric, randomized controlled trials.
These studies established not only clinical benefits, with a significant decrease of urinary incontinence episodes, but also urodynamic benefits.
There are very few data about the real prevalence of failure of Botox® in the long term.
Thus, aims of this study were to assess the long-term outcomes of detrusor injections of Botox® associated with clean intermittent-catheterization (CIC) for the treatment of NDO and to identify risk factors for failure .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from NDO managed with Botox | – | Drug: detrusor infection of Botulinum toxinDoses used were 300 units Botox® from January 2001 to January 2011 and 200 units after 2011 Frequency depended on patient's symptoms Duration was an outcome of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from neurogenic detrusor overactivity managed by detrusor injections of Botulinum toxin A and performing clean intermittent catheterization
Key inclusion criteria (3 listed)
- NDO due to MS, SCI or spina-bifida.
- follow-up ≥3 years from the first Botox® injection.
- Performing clean intermittent catheterization
Key exclusion criteria (1 listed)
- bladder surgery
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 |
|---|---|---|
| detrusor infection of Botulinum toxindetrusor injection | Drug | Patients suffering from NDO managed with Botox |
Primary outcome
failure ratio
Time frame: 3 years of follow up
Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
Failure ratio
Time frame: 5 years of follow up
Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
Failure ratio
Time frame: Seven years of follow up
Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
withdrawal ratio
Time frame: 3 years of follow up
Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
withdrawal ratio
Time frame: 5 years of follow up
Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
Withdrawal ratio
Time frame: 7 years of follow up
Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method.
3 secondary outcomes
Risk factors for failures based on and clinical, radiological and urodynamic parameters
Time frame: 3 years
Risk factors for failures based on and clinical, radiological and urodynamic parameters
Time frame: 5 years
Risk factors for failures based on and clinical, radiological and urodynamic parameters
Time frame: 7 years
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 3 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Neurogenic Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Active, not recruitingObservational study
Pediatric Locomotor Training Bladder Study
Spinal Cord Injuries, Neurogenic Bladder
RecruitingEarly Phase 1
Concomitant Renal and Urinary Bladder Allograft Transplantation
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Active, not recruitingObservational study
Qualitative Assessment of the Impact of TTNS on QOL and Participation
Neurogenic Bladder, Urinary Retention
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.
EVEN Alexia, MD study chair
HOPITAL RAYMOND POINCARE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Bladder, run by Centre d'Investigation Clinique et Technologique 805 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 3 inclusion and 1 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 3 Feb 2017. 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.
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?
failure ratio (time frame: 3 years of follow up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2017.