Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Failure ratio
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NDO due to MS, SCI or spina-bifida.
- •follow-up ≥3 years from the first Botox® injection.
- •Performing clean intermittent catheterization
排除标准
- •bladder surgery
研究组 & 干预措施
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
干预措施: detrusor infection of Botulinum toxin (Drug)
结局指标
主要结局
Failure ratio
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Risk factors for failures based on and clinical, radiological and urodynamic parameters(7 years)