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

Eligibility Criteria

• 1. Adult male between ≥40 and ≤80 years of age
• 2. Subjects with a history of self-reported erectile dysfunction lasting for over 6 months and not more than 5 years.
• 3. The subject is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
• 4. The subject has been in a stable heterosexual relationship for over 3 months prior to enrollment.
• 5. A minimum of 4 sexual attempts during the last two weeks prior to enrollment.
• 6. Abstinence from taking PDE5 for two weeks (washout) after enrolment and 2 weeks before each follow up visit/call.
• 7. IIEF-EF score between 11 and 25.
• 8. Testosterone level 300-1000 mg/dL within 1 month prior to the enrollment/baseline.
• 9. A1C level ≤ 8.5% within 1 month prior to enrollemnt/baseline.
• 10. Subject has at EHS score ≥ 1 (natural tumescence during sexual stimulation).
• 11. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and are willing to sign the Informed Consent Form
• 12. If the FirmTech Ring is provided, the participants must be willing to use the ring according to the instructions.
• 13. The subjects should be willing to comply with the study procedure and schedule, including follow up visits.
• 14. Agreement/ability to abstain from erectile dysfunction medications or any device treatments for the duration of the study, i.e., the time between the treatment visit and the final study visit.
• 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.