Low Intensity Shock Wave Therapy for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors- a Double Blind Placebo Controlled Study (LI-ESWT)
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success
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 (damage that can occur after radical prostatectomy in addition to neural damage or solely) that do not respond to oral therapy (PDE-5 inhibitors).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prior prostatectomy surgery
- •ED of more than 6 months
- •Rigidity score < 3 during PDE5i therapy
- •Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months
排除标准
- •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
Treatment LI-ESWT
Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
干预措施: Omnispec model ED1000 (Device)
Sham control
We use the same probe that induces the same sensation on the penis and the same noise yet no energy.
干预措施: Sham control (Device)
结局指标
主要结局
Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success
时间窗: 3 months
次要结局
- Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success(3 months)
研究者
i_gruenwald
MD
Rambam Health Care Campus