Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction

A Prospective Multicenter Pilot Study to Assess the Safety and Efficacy of Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' in Patients With Erectile Dysfunction

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

Inclusion Criteria:

• Good general health
• Vasculogenic 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:

• Psychogenic ED
• Neurological pathology
• Hormonal pathology
• Past radical prostatectomy
• 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
• Radiotherapy in pelvic region