NCT04350125已完成1 期
A Pilot Study Evaluating the Use of Autologous Platelet-rich Plasma (PRP) for the Treatment of Erectile Dysfunction
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Treatment-related adverse events
研究概览
简要总结
Researchers are trying to determine the safety and efficacy of Platelet Rich Plasma (PRP) in the treatment of Erectile Dysfunction (ED).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his informed and signed written consent
- •The patient has ED for longer than 1 year but less than 5 years.
- •The subject has a stable partner for at least 3 months.
- •The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- •IIEF-EF, EHS, SEP 2+3, and GAQ Domain score of 17-20 Mild to moderate vascular erectile dysfunction: PSV > 25 cm/sec
排除标准
- •The patient is participating in another study that may interfere with the results or conclusions of this study
- •History of radical prostatectomy or pelvic cancer surgery
- •Prior history of pelvic malignancies
- •Prior pelvic radiation therapy
- •Neurological disease which effects erectile function (Spinal cord injury, iatrogenic injury to the pelvic or cavernous nerves)
- •Psychiatric disease which effects erectile function
- •The patient is taking blood thinners
- •History of Diabetes Mellitus
- •History of Coronary Artery Disease
- •Evidence Based Criteria: Doppler Clinical Exam ( PSV < 25 cm/sec defined criteria for severe erectile dysfunction not likely to respond to approved medical therapies)
- •Biochemical evidence of Hypogonadism (total Testosterone < 300 ng/dL)
研究组 & 干预措施
Platelet Rich Plasma Treatment
Experimental
Male subjects diagnosed with Erectile Dysfunction (ED) will receive platelet rich plasma injections.
干预措施: Autologous Platelet Rich Plasma (Biological)
结局指标
主要结局
Treatment-related adverse events
时间窗: 35 weeks
Number of participants to experience treatment-related adverse events defined as reaction in the skin (e.g., swelling, erythema, and warmth), injection site discomfort, penile pain, change in penile appearance, novel sexual concerns and any systemic reactions seen by the investigators, or concerns expressed by patients.
次要结局
未报告次要终点
研究者
Gregory A. Broderick
Principal Investigator
Mayo Clinic
研究点 (1)
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