A Clinical Randomized Double Blind Placebo Controlled Study on the Effect of Low Intensity Shock Wave Therapy for Erectile Dysfunction in a Group of Patients Not Responding to Oral Therapy
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- IIEF-ED Domain
研究概览
简要总结
Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply that do not respond to oral therapy (PDE-5 inhibitors).
详细描述
In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ED of more than 6 months
- •Rigidity score < 3 during PDE5i therapy
- •SHIM <21 during PDE5i therapy
- •Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months
排除标准
- •Prior prostatectomy surgery
- •Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
- •Clinically significant chronic hematological disease
- •Anti-androgens, oral or injectable androgens
- •Radiotherapy in pelvic region
研究组 & 干预措施
placebo
We use the same probe that induces the same sensation on the penis and the same noise yet no energy
干预措施: Extracorporeal Shockwave Therapy Generator (Vascuspec) (Device)
Shock wave therapy
12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment
干预措施: Low intensity shock wave therapy (Device)
结局指标
主要结局
IIEF-ED Domain
时间窗: 17 weeks
A change of 5 points or more will indicate success
次要结局
- rigidity score(17 weeks)