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临床试验/NCT04416802
NCT04416802招募中不适用

A Clinical Study of the Combined Treatment of Platelet-rich Plasma and Low-intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction

Taipei Medical University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年12月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
The Change in Erectile Function

研究概览

简要总结

The purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.

详细描述

According to statistics from the Taiwan Society of Andrology, 18 to 25 years old male population in Taiwan having erectile dysfunction (ED) trouble is as high as 5 to 10 percent. At the same time, statistics from the Taiwan Sexual Dysfunction Counseling Training Committee show that as many as 50 percent of men between 40 and 70 years old have erectile dysfunction. Erectile dysfunction is the most common sexual dysfunction in men and is believed to be related to nerve or blood vessel damage, and often significantly affects the patients' quality of life.

PRP is the abbreviation of "platelet-rich plasma". It can release growth factors and cytokines in the body to further promote tissue repair. The results of pre-clinical and clinical trials show that PRP can promote the repair of cavernous tissue, protect erection function of nerve, and stimulate the regeneration of nerve.

Low-intensity extracorporeal shockwave therapy (Li-ESWT) is a non-invasive treatment. Under this treatment, it will help body producing angiogenesis-related proteins, stimulating the formation of small blood vessels, generating new blood vessels at the site to be treated, and increasing the perfusion flow of local tissues. Li-ESWT has been clinically shown to have a significant effect on erectile dysfunction.

The purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.

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
30 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Impotence for more than three months
  • International index of erectile function, (IIEF) less than 21( including 21)
  • Erectile hardness score, (EHS) less than 3( including 3)
  • Age over 30 years old

排除标准

  • Hypogonadism
  • Bleeding tendency
  • Could not cooperate with the treatment
  • AIDS, syphilis and condyloma victim
  • Received radical prostatectomy
  • Prostate cancer or pelvis malignant tumor victim
  • Gonad dysfunction
  • Penis deformities
  • Penile prosthesis implantation
  • Psychiatric disease victim
  • Neural disease ( multiple myeloma , brain atrophy, etc)
  • Pacemaker implantation
  • Not suitable join this trial judged by Investigator
  • Alcohol or drug abuse

结局指标

主要结局

The Change in Erectile Function

时间窗: Baseline, the 4th week, 8th week, and 12th weeks

Using the International Index of Erectile Function (IIEF) questionnaire.

次要结局

  • Incidents of Side Effects(the 4th week, 8th week, and 12th weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ming-Che Liu, MD

Director of Clinical Research Center

Taipei Medical University Hospital

研究点 (2)

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