Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova

A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy Associated With Treating Patients Suffering From Erectile Dysfunction With Low Intensity Shockwaves by Renova

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.

Inclusion Criteria:

• Good general health
• Vascular ED for at least 6 months
• International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
• Positive response to PDE5-I (able to penetrate on demand=Responders)
• Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage = Non-responders)
• Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

• Hormonal, neurological or psychological pathology
• Past radical prostatectomy or extensive pelvic surgery
• Recovering from cancer during last 5 years
• Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
• Clinically significant chronic hematological disease
• Anti-androgens, oral or injectable androgens
• Past radiotherapy treatment of the pelvic region
• International normalized ratio (INR) > 3 for patients using blood thinners (such as Coumadin)