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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Grzegorz Fojecki

Current Primary Outcome: International Index of Erectile Function (IIEF) outcome increases by 5 points [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Erectile Hardness Scale (EHS) outcome is equal or higher than 3. [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: University of Southern Denmark

Dates:
Date Received: January 9, 2014
Date Started: February 2014
Date Completion:
Last Updated: December 23, 2016
Last Verified: December 2016