NCT01814852

Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction

A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy of Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' in Patients With Erectile Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Initia · Industry
• Sex: Male
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.

Detailed description

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety and efficacy of the control sham patients. Patients are randomized in a 1:1 ratio of Renova to the sham control group.

Conditions

• Vasculogenic Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Shockwave system
DEVICE	Sham treatment	Sham treatment that looks, sounds and feels like real LI-ESWT treatment by Renova.

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-03-20
• Last updated: 2015-05-12

Locations

1 site across 1 country: Israel