NCT01317693Unknown3 期
Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success
研究概览
简要总结
Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered through the applicator covering the corpora cavernosa of the penis. In previous studies the investigators used a medium focused probe and in this study the investigators are evaluating results of this therapy using a wider focus probe in the aim of improving results of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •ED of more than 6 months
- •At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
- •Positive response to PDE-5 inhibitors
- •IIEF-5 domain score of 12-20 denoting mild to severe ED
- •Non-Neurological pathology
- •Stable heterosexual relationship for more than 3 months
排除标准
- •NPT - normal/flat
- •Prior prostatectomy surgery
- •Any cause of ED other than vascular related
- •Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
- •Clinically significant chronic hematological disease
- •Cardiovascular conditions that prevent sexual activity
- •History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
- •Cancer within the past 5 years.
- •Anti-androgens, oral or injectable androgens
- •Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories
结局指标
主要结局
Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success
时间窗: 13 weeks
次要结局
- Rigidity Score Questionaire- an increase by at least 1 point is considered success(13 weeks)
研究者
i_gruenwald
MD
Rambam Health Care Campus
研究点 (1)
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