Evaluation of Botox Treatment in Patients With Chronic Scrotal Pain: a Randomized Double Blinded Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Effect on pain 3 months after treatment
研究概览
简要总结
The aim of the study is to evaluate the effect of botox injections at the spermatic cord in patients with chronical scrotal pain.
A lot of patients experiences depressive symptoms and a lot feel isolated. The etiology if not fully understood and the condition poses a challenge for physicians.
The is no efficient minimal invasive treatment for these patients, and in severe cases patients are having there testicle removed.
By inject botox around the spermatic cord the investigators hope to relieve some of the pain in these patients and offer patients a new minimal invasive treatment.
The investigators aim to include 50 patients in this study, There will be randomised 1:1 to either the intervention arm (Botox) or control arm (sterile saline). Both patients and physicians will be blinded to the treatment.
Patients will undergo a thorough physical examination and will be asked to fill out questionaries to asses their quality of life.
After inclusion, patients will be followed closely for three months with physical examination and questionnaires.
After three months, patients in the control arm will have the opportunity to cross over to the intervention arm.
Data will be reported continuously.
详细描述
Background:
Chronic scrotal pain (CSP) is a common condition with a prevalence of 2.5-4.8% in male outpatients. Up to 40% of these patients report depressive symptoms and many feel isolated.
CSP is defined as intermittent or constant unilateral or bilateral scrotal pain with a significant impact on the patients daily life. The etiology of CSP is not fully understood but can be related to surgical procedures such as vasectomy, inguinal hernia repair, scrotal surgery and abdominal and groin surgery, even though no apparent cause can be identified in 25-50% of the cases.
When no obvious source of pain is found the most common approach usually begins with conservative treatment including analgesia, antibiotics and in some cases anticonvulsants and antidepressants. When conservative treatment fails, a minimal invasive procedure with local anesthesia cord block is often used before more invasive treatments such as denervation, vasovasostomy, orchiectomy or epididymectomy.
Of the minimally invasive procedures, spermatic cord block has proven to significantly reduce pain briefly in patients with CSP. Because of these findings, it has been proposed that a longer-lasting effect could be obtained with the use of OnabotulinumtoxinA (BTX). BTX is widely used in pain management in many painful diseases such as chronic pain syndrome, myofascial syndrome, headaches, arthritis, and neuropathic 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
- Double (Participant, Investigator)
盲法说明
For randomization the research coordinator will place an information sheet containing the randomization in sealed envelopes (1:1 block randomization). At first treatment the research coordinator will open a sealed envelope revealing the randomization and prepare the solution needed. The patient and physician will be blinded for the treatment.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age of 18 - 70 years
- •Unilateral or bilateral scrotal pain > 3 months
- •No other identifiable cause of pain
- •Insufficient effect of conservative treatment
- •A positive effect of local anesthesia spermatic cord block
排除标准
- •Inability to provide informed consent
- •Interest in trying to conceive with partner in the following 6 months
- •Local infection near the proposed injection site
- •History with an allergic reaction to BTX and / or human serum albumin
- •History of motor neuron disease or hemostatic disorder
- •Active urogenital cancer
- •Current use of botox injections which would result in a total dose of botox higher than 300 IE in the span of 3 months
研究组 & 干预措施
Botox injections
Patients randomised to the intervention arm will be treated with injection of 100 units of botox in 10 ml sterile saline close to superficial inguinal ring.
干预措施: Botulinum toxin type A (Drug)
Sterile saline injections
Patients randomised to the control arm will be treated with injection of 10 ml sterile saline close to superficial inguinal ring.
干预措施: Sterile saline (Other)
结局指标
主要结局
Effect on pain 3 months after treatment
时间窗: 3 months
Pain is evaluated on a Visual Analog Scale (VAS) from 0-10, where 0 is no pain and 10 is the maximal pain a patient can report. VAS prior to the treatment is compared to VAS 3 months after treatment.
次要结局
- Duration of effect(3 months)
- Changes in patient reported Quality of Life(3 months)
研究者
Nicolai Skov Schiellerup
Principal investigator
Odense University Hospital