Toxin Retrospective Study

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity

Conditions
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Neurogenic Bladder

Intervention / Treatment
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* Drug: detrusor infection of Botulinum toxin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients suffering from NDO managed with Botox<br>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<br>* detrusor injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure ratio | Survival curves of withdrawals and failures of treatment were calculated with a 95-confidence interval using the Kaplan-Meier method. | 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. | 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. | 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. | 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. | 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. | 7 years of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for failures based on and clinical, radiological and urodynamic parameters | univariate analysis and multivariate analysis using Cox model | 3 years | 
| Risk factors for failures based on and clinical, radiological and urodynamic parameters | univariate analysis and multivariate analysis using Cox model | 5 years | 
| Risk factors for failures based on and clinical, radiological and urodynamic parameters | univariate analysis and multivariate analysis using Cox model | 7 years |