Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity
Overview
- Phase
- Not Applicable
- Intervention
- detrusor infection of Botulinum toxin
- Conditions
- Neurogenic Bladder
- Sponsor
- Centre d'Investigation Clinique et Technologique 805
- Enrollment
- 292
- Locations
- 1
- Primary Endpoint
- Failure ratio
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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 .
Investigators
Eligibility Criteria
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
Arms & Interventions
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
Intervention: detrusor infection of Botulinum toxin
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Risk factors for failures based on and clinical, radiological and urodynamic parameters(7 years)