Neurogenic Bladder
Conditions
Brief 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.
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 .
Interventions
DRUGdetrusor infection of Botulinum toxin
detrusor injection
Sponsors
Centre d'Investigation Clinique et Technologique 805
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| withdrawal ratio | 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 | 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. |
| failure ratio | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk factors for failures based on and clinical, radiological and urodynamic parameters | 3 years | univariate analysis and multivariate analysis using Cox model |
Countries
France
Outcome results
None listed