Using radiofrequency to treat erectile dysfunction

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

This study is testing if a new radiofrequency treatment can help men aged 40 to 80 with long-term erectile dysfunction feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 40 Years to 80 Years
• Sex: Male
• Sponsor: InMode MD Ltd. (Industry-sponsored)
• Locations: 2 sites (New York, New York and 1 other locations)
• Trial ID: NCT06299332 on ClinicalTrials.gov

What this trial studies

This prospective pilot study aims to evaluate the safety and efficacy of bi-polar radiofrequency therapy for men experiencing erectile dysfunction (ED). The study will involve adult males aged 40 to 80 who have a history of ED lasting over six months. Participants will undergo treatment with a radiofrequency device and will be monitored for their response and any side effects. The goal is to determine if this innovative approach can provide a reliable solution for men struggling with ED.

Who should consider this trial

Good fit: Ideal candidates are adult males aged 40 to 80 with a history of erectile dysfunction who are responsive to PDE5 inhibitors.

Not a fit: Patients who have not experienced erectile dysfunction for more than six months or those who do not respond to PDE5 inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, non-invasive option for men suffering from erectile dysfunction.

How similar studies have performed: While the use of radiofrequency for ED is a relatively novel approach, similar studies have shown promising results in other areas of urology.

Eligibility criteria

Inclusion 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.

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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Where this trial is running

New York, New York and 1 other locations

• LC Medical 140 W 58th St, Suite A New York, NY 10019 — New York, New York, United States (Recruiting)
• Washington Heights Urology — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Robert Valenzuela, MD
• Study coordinator: Meital Matalon

Conditions Erectile Dysfunction