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临床试验/NCT02063061
NCT02063061已完成不适用

Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.

Grzegorz Fojecki2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
2
主要终点
International Index of Erectile Function (IIEF) outcome increases by 5 points

研究概览

简要总结

The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is an effective treatment for erectile dysfunction.

详细描述

Erectile dysfunction has a negative impact on quality of life and relationships. Thirty to sixty- five percent of men over 40 years of age have erection disorders. Current challenges of medical treatment are met with high costs and risks of side effects. Emerging new therapy with low-energy shock waves stimulate production of endothelial growth factor and nitrogen oxide which results in angiogenesis. It is our aim to assess efficaciousness of this method on potential to improve erectile dysfunction. We propose a prospective double-blind, randomised, cross-over, sham-controlled trial, to assess how effective shock waves therapy is for erectile dysfunction. Patients will receive one treatment per week for ten weeks. Subjects will be followed for up to one year after treatment. Standardized questionnaires will assess study endpoints for erectile dysfunction. We hypothesize that shock wave therapy could represent a low cost, low risk treatment for erectile dysfunction in men.

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
40 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Erectile dysfunction for at least 6 months
  • In relationships
  • Patient accept not to use any other therapy against erectile dysfunction

排除标准

  • Prostatectomy
  • Radiotherapy in pelvis
  • Hormonal therapy against prostate cancer
  • Anatomical penis disorder
  • Penile prosthesis
  • Treatment with anticoagulants (except acetylsalicylic acid 75 mg)
  • Psychiatric disorder
  • Hypogonadism
  • IIEF score higher than 25
  • Pregnant partner og delivered within last 12 months
  • Critical health disease
  • Neurological disorders

结局指标

主要结局

International Index of Erectile Function (IIEF) outcome increases by 5 points

时间窗: 1 year

次要结局

  • Erectile Hardness Scale (EHS) outcome is equal or higher than 3.(1 year)

研究者

发起方
Grzegorz Fojecki
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Grzegorz Fojecki

MD

University of Southern Denmark

研究点 (2)

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