A Prospective Trial of Autologous Platelet-rich Plasma Injection in Erectile Dysfunction Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- International Index of Erectile Function(IIEF-5)
研究概览
简要总结
RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. In theory, it is possibility of curing ED.
详细描述
There are many reasons of erectile dysfunction(ED). If left untreated, there is a major impact on relationships, self-esteem, and overall health. RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. Its mechanism is to promote the regeneration of blood vessels in the cavernous body of the penis, increase blood circulation, and then help erection, increase penile stiffness and improve the phenomenon of premature ejaculation. The main purpose of this study is to study the safety and effectiveness of PRP injection for the treatment of ED.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Between 20 and 70 years old
- •Sexual dysfunction exists for at least 6 months
- •IIEF-5 score 8-2
- •Sign an informed consent form
排除标准
- •Ever radical prostatectomy or extensive pelvic surgery
- •Radiation therapy to the pelvic area within 12 months before recruiting
- •Nervous system diseases that affect erectile function
- •Have any blood disease
- •History of coronary artery disease
结局指标
主要结局
International Index of Erectile Function(IIEF-5)
时间窗: Change from 0 week at 4,8,12,24,48 weeks
The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild (12-21), and no ED (22-25).
次要结局
- Erection Hardness Score(EHS)(Change from 0 week at 4,8,12,24,48 weeks)
- Duplex - Peak systolic velocity(PSV)(0,16 weeks)
- Duplex - Resistance index(RI)(0,16 weeks)