NCT01811797终止不适用
A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy Associated With Treating Patients Suffering From Erectile Dysfunction With Low Intensity Shockwaves by Renova
Initia1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 3 and 6 months post treatment
研究概览
简要总结
This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Good general health
- •Vascular ED for at least 6 months
- •International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
- •Positive response to PDE5-I (able to penetrate on demand=Responders)
- •Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage = Non-responders)
- •Stable heterosexual relationship for more than 3 months
排除标准
- •Hormonal, neurological or psychological pathology
- •Past radical prostatectomy or extensive pelvic surgery
- •Recovering from cancer during last 5 years
- •Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
- •Clinically significant chronic hematological disease
- •Anti-androgens, oral or injectable androgens
- •Past radiotherapy treatment of the pelvic region
- •International normalized ratio (INR) > 3 for patients using blood thinners (such as Coumadin)
结局指标
主要结局
Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 3 and 6 months post treatment
时间窗: 1, 3 and 6 months post treatment
次要结局
- Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 3 and 6 months post treatment(1, 3 and 6 months post treatment)
- Change from baseline in the GAQ (Global Assessment Questions) at 3 and 6 months post treatment(1, 3 and 6 months post treatment)
- Change from baseline in the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment(1, 3 and 6 months post treatment)
- Change from baseline in the Partner EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment(1, 3 and 6 months post treatment)
- Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment(0 and 6 months post treatment)
研究者
研究点 (1)
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