Low Intensity Shockwaves Therapy for the Treatment of Erectile Dysfunction. 12- Month Follow-Up

Randomized Control Trial of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction. 12- Month Follow-Up of a Double-Blinded, Sham-Controlled Study.

The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.

Inclusion Criteria:

• The patient must be able willing and able to provide informed consent.
• The patient is a male between 30 and 70 years of age (inclusive).
• The patient has erectile dysfunction (ED) based of IIEF scores.
• The patient has been in a stable relationship for over 3 months prior to enrollment.
• A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by International Index of Erectile Dysfunction (IIEF)
• The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient.
• IIEF-EF score between 16 and 25.
• Testosterone level 300-1000 ng/dL within 1 month prior to enrollment. A1C level ≤ 7% within 1 month prior to enrollment

Exclusion Criteria:

• The patient is currently or has participated in another study within the past three months that may interfere with the results or conclusions of this study.
• The patient is under judicial protection (prison or custody).
• The patient is an adult under guardianship.
• The patient refuses to sign the consent.
• History of radical prostatectomy or extensive pelvic surgery.
• Evidence of venous leak.
• Past radiation therapy of the pelvic region within 12 months prior to enrollment.
• Recovering from any cancer within 12 months prior to enrollment.
• Neurological disease such as Alzheimers or Parkinson's disease which affects erectile function at the discretion of the investigator.
• Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator.
• Anatomical malformation of the penis, including Peyronie's disease.
• Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
• A1C level > 7% within 1 month prior to enrollment or history of Insulin dependent diabetes.
• The patient is taking blood thinners and has an international normalized ratio >3.
• Received shockwave treatment at least 6 months before enrollment.