Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction

Exclusion Criteria

• •1. Evidence of co-existing Neurological disease or other systemic disease conditions such as Alzheimer or Parkinson disease which affects erectile function (at the discretion of the investigator)
• •2. History of radical prostatectomy or extensive pelvic surgery ever
• •3. Psychiatric diagnosis or medications such as antidepressants which affects erectile function or any other medications at the discretion of the investigator.
• •4. Anatomical malformation of the penis, including Peyronie's disease.
• •5. Testosterone level \<300 or \>1000 ng/dL within 1 month prior to enrollment.
• •6. Diabetes type I
• •7. Diabetes Type II with A1C level \> 8.5% within 1 month prior to enrollment.
• •8. Unwillingness to abstain from systemic medications known to cause ED for the study duration.
• •9. Internal defibrillator, pacemaker or any other implanted electrical device anywhere in the body
• •10. Permanent metal implant in the treatment area
• •11. Any surgery in the treatment area in the last 3 months
• •12. Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles in the facial area
• •13. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
• •14. Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
• •15. Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction
• •16. Any active condition in the treatment area, such as but not limited to open sores, psoriasis, eczema, vitiligo, herpes and rash.
• •17. History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin
• •18. Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
• •19. Use of Isotretinoin (Accutane®) within 30 days prior to treatment.
• •20. Participation in another study within 30 days prior to screening.
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