NCT02152683终止不适用
Linear Focused Shockwave Treatment for Erectile Dysfunction
Initia1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2014年3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
- 84
- 试验地点
- 1
- 主要终点
- IIEF-EF- International Index of Erectile Function questionnaire score
研究概览
简要总结
The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols.
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
- None
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
- •Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years.
- •International Index of Erectile Function 6 (IIEF-EF) between 17 and 25
- •Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors
- •Stable sexual relationship for at least 3 months prior to treatment
- •Minimum of two sexual attempts per month
排除标准
- •Hormonal, neurological or psychological pathology
- •Past radical prostatectomy or extensive pelvic surgery
- •Recovering from cancer during last year
- •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
IIEF-EF- International Index of Erectile Function questionnaire score
时间窗: 1 month post treatment
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
IIEF-EF questionnaire score
时间窗: 6 months post treatment
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
次要结局
- GAQ- Global Assessment Questions(1, 3 and 6 months post treatment)
- SEP- Sexual Encounter Profile: Questions 2 and 3(1, 3 and 6 months post treatment)
- EHS- Erection Hardness Score(1, 3 and 6 months post treatment)
研究者
研究点 (1)
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