Sclerotherapy of hydro and spermatoceles with 2ml Aetoxysclerol 30mg/ml vs. a combination of 2ml Aetoxysclerol 30mg/ml and 25ml of ethanol 99,5% with or without local anesthesia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Symptoms from the treated side 3 months from treatment
研究概览
简要总结
To compare
2ml Aetoxysclerol 30mg/ml vs. a combination of 2ml Aetoxysclerol 30mg/ml and25ml of ethanol 99.5% regarding symptom score 3 months from treatment and re-treatment rate from hydro or spermatoceles.
and
Pain during treatment with no local anesthesia (standard of care), spermatic chord bloc or instillation anesthesia
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Hydro or spermatocele
- •Informed consent
- •Inconveniance at least corresponding to symptoms that can not be ignored but does not affect activities of daily life
- •Hydro or spermatocele at least 50ml (assesed by orchidometry)
排除标准
- •Paternity wish
- •Hydro or spermatocele deemed not drainable
结局指标
主要结局
Symptoms from the treated side 3 months from treatment
Symptoms from the treated side 3 months from treatment
Pain according to numeric rating scale (0-10) during treatement
Pain according to numeric rating scale (0-10) during treatement
Anti-coaculant therapy not suitable to suspend before treatment
Anti-coaculant therapy not suitable to suspend before treatment
Allergy to ethanol, Aethoxysclerol or ant local anaestethics used in the study
Allergy to ethanol, Aethoxysclerol or ant local anaestethics used in the study
Mental disability, reluctance of the patient or language barriers making the purpose of participating in the study difficult to grasp
Mental disability, reluctance of the patient or language barriers making the purpose of participating in the study difficult to grasp
Current or just finished participation in another clinical pharmacological study
Current or just finished participation in another clinical pharmacological study
Prior participation in the study at hand
Prior participation in the study at hand
Treatment with immuno-stimulating drugs
Treatment with immuno-stimulating drugs
Hydro or spermatocele not able to be evacuated percutaneously
Hydro or spermatocele not able to be evacuated percutaneously
次要结局
- Complications 30 days from treatement
- Retreatement on the treated side
- Symptoms from the treated side 24 months from treatment
- Pain according to numeric rating scale (0-10) 1 day after treatment
研究者
Karl-Johan Lundström
Scientific
Region Jamtland Harjedalen