Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Reduction in the visual analog scales for pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Botox
Botox 200 units reconstituted in 10ml of normal saline for a one-time injection
干预措施: Botox (Drug)
Saline
Saline 10ml of normal saline for a one-time injection
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in the visual analog scales for pain
时间窗: 6 months after entering in trial
A measure of the change in the visual analog scales for pain.
次要结局
- Reduction in scrotal pain(6 months after entering in trial)