NCT02063061

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Grzegorz Fojecki · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Sham treatment	Patients will receive simulated treatment, with the same ESWT unit as in other arm. Placebo gel-pad is design to prevent shockwaves emission. Looks identical as active gel-pad.
DEVICE	ESWT treatment	ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-08-01
• Completion: 2015-12-01
• First posted: 2014-02-14
• Last updated: 2016-12-28

Locations

1 site across 1 country: Denmark