Effect of Botox Treatment for Neurogenic Detrusor Overactivity on the Prevention of Autonomic Dysreflexia Following Spinal Cord Injury
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Assess the efficacy of 200 U BOTOX® intradetrusor injections on amelioration of episodes of autonomic dysreflexia (AD) in individuals with chronic spinal cord injury during urodynamics (i.e. one month following treatment compared to baseline assessment)
研究概览
简要总结
The purpose of this study is to investigate the impact of 200 U intradetrusor injected OnabotulinumtoxinA (Botox®, Allergan, Inc.) (20 sites, trigone sparing) for neurogenic detrusor overactivity (NDO) and its role on reducing autonomic dysreflexia (AD) in those with chronic, traumatic spinal cord injury (SCI). In clinical practice, urinary bladder dysfunctions are commonly associated with episodes of AD. If AD is misdiagnosed or poorly managed, it may result in myocardial infarction, stroke, seizure, intracerebral hemorrhaging or even death. Reducing AD would dramatically improve the health and well-being of Canadians with SCI, and positively impact health care costs. There are an estimated 7,343 hospital re-admissions due to SCI-related conditions in Canada every year, with an estimated 5-year cost of $661 million. Reducing hospital re-admissions for secondary complications of SCI by only 10% over this time period could result in a costs savings of $66 million for Canada.
Considering these statistics, the present study could be a first attempt to evaluate the economic impact of using Botox® to manage the urinary bladder following SCI. We will be able to examine its impact on episodes of AD and consequently calculate the cost saving for the Canadian health system. A significant number of individuals with SCI will require frequent emergency room visits due to episodes of uncontrolled AD that originate predominately from the urinary bladder. There is clinical evidence demonstrating that costs of bladder management following SCI will depend on the understanding of the volumes that the urinary bladder can safely hold. This is one of the positive outcomes that have been established in previous trials of Botox® therapy for the neurogenic bladder.
Hypothesis: 200 U of intradetrusor injected Botox® (20 sites, trigone sparing) for neurogenic bladder detrusor hyperreflexia will decrease the severity of AD in individuals with SCI one month following treatment.
详细描述
Purpose: This study is a Phase IV pilot study. A phase IV study is a study of an approved drug or treatment conducted to obtain information regarding the drug's or treatment's, benefits and optimal use. The investigators will assess the efficacy of Botox® on reducing autonomic dysreflexia (AD) during regular treatment for neurogenic detrusor overactivity (NDO) in those with spinal cord injury (SCI). The aim of the study is not to prove the positive/negative effects of Botox® injections on urinary bladder function (this has been previously been established in randomized controlled clinical trials), but to gain information if this intervention could ameliorate changes in arterial blood pressure (namely to prevent AD) that commonly occurs due to NDO. This study will particularly determine whether established Botox® therapy for NDO could decrease the severity of episodes of AD by at least 50%.
Objective 1: The primary objective of this study is to assess the efficacy of intradetrusor injected Botox® on amelioration of episodes of AD in individuals with chronic SCI.
Primary outcome:
To assess the effect of Botox® on reducing AD as per the average systolic blood pressure change (maximum systolic blood pressure subtracted the average supine baseline systolic blood pressure) induced by urodynamics.
The end point of the trial will be a decrease of severity of AD in 50% of participants. By definition AD is is a constellation of signs and/or symptoms in SCI at and usually above T6 in response to noxious or non-noxious stimuli below the level of injury defined by an increase in systolic BP (>20 mmHg above baseline), including headache, flushing, piloerection, stuffy nose, sweating above the level of the lesion, vasoconstriction below the level of the lesion, and dysrhythmias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients or outpatients with SCI (AIS A-D)
- •Male and female
- •Age between 18 - 65
- •Chronic, traumatic SCI (> 1 year post injury)
- •Affected by urinary incontinence
- •We are expecting individuals with the following levels of injury:
- •individuals with spinal segment thoracic (T) 6 and above (with history of episodes of AD) Presence of AD will be determined using a validated AD questionnaire.
- •Good command and comprehension of English
- •Capable of giving informed consent
排除标准
- •Age older than 66 years
- •Documented traumatic brain injury
- •Acute co-morbidities
- •Other diseases of the neural system
- •Previous genitourinary disease or operation,
- •Current urinary tract infection
- •Multiple injury levels
- •Previous history of systemic illness, such as cardiovascular diseases (as hypertension and cardiac infarction), cerebrovascular accident, diabetes, etc
- •Poor command of English language
- •Pregnancy
研究组 & 干预措施
BOTOX
BOTOX® Total dose per patient: 200U Number of cycles:1 cycle Treatments will be conducted according to established protocol, 200 BOTOX® units with intradetrusor injections under cystoscopic guided injections into 20 sites, trigone sparing. One month later, urodynamics with continuous arterial blood pressure and electrocardiogram measurements will be repeated, as well as 24 hour ambulatory blood pressure monitoring. AD- HR QoL and I-QOL questionnaires will be administered to evaluate the effect of Botox on AD HR-QoL and bladder-related QoL.
干预措施: BOTOX (Drug)
结局指标
主要结局
Assess the efficacy of 200 U BOTOX® intradetrusor injections on amelioration of episodes of autonomic dysreflexia (AD) in individuals with chronic spinal cord injury during urodynamics (i.e. one month following treatment compared to baseline assessment)
时间窗: One month
To assess the effect of intradetrusor injected BOTOX® on reducing AD (i.e. a smaller increase in systolic blood pressure during bladder filling compared to baseline) during urodynamics posttreatment vs pre-operative.
次要结局
- Cost analysis of BOTOX® treatment on AD following six months of treatment.(One year)
- Reduction of spontaneous AD during daily living assessed with 24-hour ambulatory blood pressure monitoring (ABPM) following intradetrusor injections of BOTOX®.(One month)
- The impact of BOTOX® to ameliorate AD-related QoL compared to baseline (i.e. improved AD HR-QoL posttreatment vs pre-operative).(One month)
- The impact of BOTOX® to ameliorate incontinence-related QoL compared to baseline (i.e. better I-QOL posttreatment vs pre-operative).(One month)