Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain (ROBOT)
There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with scrotal pain that we found published.
We proposed a pilot study using Botox to block the nerves on a small group of men with chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using local anaesthetic drug.
The encourage results of the pilot study has given us the background information to proceed with a formal randomised control trial of Botox vs placebo.
We hypothesized that Botox injections to block the testicular nerve will be effective in providing long term pain relief for men with scrotal pain.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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-
Ontario
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Toronto、Ontario、加拿大、M5G 1X5
- Mount Sinai Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18-65
- Have nociceptive scrotal pain,
- Have no identifiable, reversible causes for the scrotal pain
- Have failed standard medical therapy
- Have responded temporarily to cord blocks
Exclusion Criteria:
- Are interested in trying to conceive with their partners in the next 6 months,
- Have any local infection near the site of the injections,
- Have had an allergic reaction to Botox in the past,
- Are unable to provide informed consent
- Have a history of motor neuron disease or neurogenic bladder
- Who have hemostatic disorder or who are taking aspirin, Coumadin (warfarin), Xarelto (rivaroxaban) or other blood thinners
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Botox
Botox 200 units reconstituted in 10ml of normal saline for a one-time injection
|
其他名称：
|
|
安慰剂比较：Saline
Saline 10ml of normal saline for a one-time injection
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reduction in the visual analog scales for pain
大体时间：6 months after entering in trial
|
A measure of the change in the visual analog scales for pain.
|
6 months after entering in trial
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reduction in scrotal pain
大体时间：6 months after entering in trial
|
It will be assessed by the Chronic Epididymitis Symptom Index score.
|
6 months after entering in trial
|
合作者和调查者
调查人员
- 首席研究员：Keith Jarvi, MD、Mount Sinai Hospital, Canada
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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