Toxin Retrospective Study (NDOTOX)
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ClinicalTrials.gov Identifier: NCT03042052 |
Recruitment Status :
Completed
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
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Condition or disease | Intervention/treatment |
---|---|
Neurogenic Bladder | Drug: detrusor infection of Botulinum toxin |
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 Type : | Observational |
Actual Enrollment : | 292 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity |
Actual Study Start Date : | January 1, 2014 |
Actual Primary Completion Date : | May 1, 2016 |
Actual Study Completion Date : | June 1, 2016 |
Group/Cohort | Intervention/treatment |
---|---|
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 |
Drug: detrusor infection of Botulinum toxin
detrusor injection |
- 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.
- Risk factors for failures based on and clinical, radiological and urodynamic parameters [ Time Frame: 3 years ]univariate analysis and multivariate analysis using Cox model
- Risk factors for failures based on and clinical, radiological and urodynamic parameters [ Time Frame: 5 years ]univariate analysis and multivariate analysis using Cox model
- Risk factors for failures based on and clinical, radiological and urodynamic parameters [ Time Frame: 7 years ]univariate analysis and multivariate analysis using Cox model

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- NDO due to MS, SCI or spina-bifida.
- follow-up ≥3 years from the first Botox® injection.
- Performing clean intermittent catheterization
Exclusion Criteria:
- bladder surgery

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042052
France | |
Hopital Raymond Poincare | |
Garches, France, 92380 |
Study Chair: | EVEN Alexia, MD | HOPITAL RAYMOND POINCARE |
Responsible Party: | Centre d'Investigation Clinique et Technologique 805 |
ClinicalTrials.gov Identifier: | NCT03042052 History of Changes |
Other Study ID Numbers: |
1637154 |
First Posted: | February 3, 2017 Key Record Dates |
Last Update Posted: | February 3, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Urinary Bladder, Neurogenic Neurologic Manifestations Nervous System Diseases Urinary Bladder Diseases Urologic Diseases Signs and Symptoms Botulinum Toxins |
Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs |