Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- International Index of Erectile Function (IIEF)
研究概览
简要总结
The proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function and triggers angiogenesis through induction of local growth factors and endothelial nitric oxide synthase. The literature generally confirms that LI-ESWT is safe and cohort studies investigating the clinical effects have been encouraging. Meanwhile, randomized trials have shown contradictory results. Thus, a randomized trial in 67 PDE5-I responders showed statistically greater improvements in the Erectile Function Domain of the International Index of Erectile Function (IIEF) with active LI-ESWT treatment compared to a sham treatment (p=0.032).
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)
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
- 是
入选标准
- •Age 18-70 years
- •A history of erectile dysfunction for >6 months
- •IIEF-ED score < 25
- •In a stable heterosexual relationship for at least 6 months
- •Willingness to attempt sexual intercourse at least twice per week during the study and follow-up
排除标准
- •Psychogenic ED as assessed by a standardized interview (attachment 2)
- •Known psychiatric illness
- •Neurological disease (including Parkinson's disease, Multiple sclerosis, spinal cord injury, and a history of stroke)
- •Traumatic nerve injury
- •Previous pelvic surgery or radiation
- •Heart disease in the form of unstable angina, NYHA class >II heart failure, uncontrolled arrhythmia, or significantly symptomatic and/or severe valvular disease
- •Endocrine disease including hypogonadism (total testosterone <12 nmol/l)
- •Insulin dependent or uncontrolled diabetes mellitus
- •Dependence on erectogenic aids other than PDE5-Inhibitors
- •Use of medications which have been shown to interfere with erections
- •Use of anticoagulant medications other than low dose aspirin
- •Active cancer
- •A diagnoses of Peyronie's disease and/or prior occurrence of priapism
- •Alcohol abuse (more than 21 containers of alcohol per week)
结局指标
主要结局
International Index of Erectile Function (IIEF)
时间窗: 1 months
次要结局
未报告次要终点
研究者
Nessn Azawi
Chief Urologist
Zealand University Hospital