Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- International Index of Erectile Function (IIEF) outcome increases by 5 points
研究概览
简要总结
The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is an effective treatment for erectile dysfunction.
详细描述
Erectile dysfunction has a negative impact on quality of life and relationships. Thirty to sixty- five percent of men over 40 years of age have erection disorders. Current challenges of medical treatment are met with high costs and risks of side effects. Emerging new therapy with low-energy shock waves stimulate production of endothelial growth factor and nitrogen oxide which results in angiogenesis. It is our aim to assess efficaciousness of this method on potential to improve erectile dysfunction. We propose a prospective double-blind, randomised, cross-over, sham-controlled trial, to assess how effective shock waves therapy is for erectile dysfunction. Patients will receive one treatment per week for ten weeks. Subjects will be followed for up to one year after treatment. Standardized questionnaires will assess study endpoints for erectile dysfunction. We hypothesize that shock wave therapy could represent a low cost, low risk treatment for erectile dysfunction in men.
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
- 40 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Erectile dysfunction for at least 6 months
- •In relationships
- •Patient accept not to use any other therapy against erectile dysfunction
排除标准
- •Prostatectomy
- •Radiotherapy in pelvis
- •Hormonal therapy against prostate cancer
- •Anatomical penis disorder
- •Penile prosthesis
- •Treatment with anticoagulants (except acetylsalicylic acid 75 mg)
- •Psychiatric disorder
- •Hypogonadism
- •IIEF score higher than 25
- •Pregnant partner og delivered within last 12 months
- •Critical health disease
- •Neurological disorders
结局指标
主要结局
International Index of Erectile Function (IIEF) outcome increases by 5 points
时间窗: 1 year
次要结局
- Erectile Hardness Scale (EHS) outcome is equal or higher than 3.(1 year)
研究者
Grzegorz Fojecki
MD
University of Southern Denmark
