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

The goal of this prospective pilot study is to learn about the Safety and Efficacy of Radiofrequency (RF) for the Treatment of Erectile Dysfunction. This research study is trying to determine if RF therapy is safe and effective in patients with symptoms of erectile dysfunction (ED).

Study Overview

• Status: Recruiting
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Device: Device treatment

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Shusterman; Phone Number: 9492396522; Email: maria.shusterman@inmodemd.com
• Study Contact Backup: Name: MEITAL MATALON; Phone Number: 9492396522; Email: meital.matalon@inmodemd.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Recruiting
      • LC Medical 140 W 58th St, Suite A New York, NY 10019
      • Contact: Lanna Cheuck; Phone Number: 929-492-2052
    • New York, New York, United States, 10032
      • Recruiting
      • Washington Heights Urology
      • Contact: Robert Valenzuela; Phone Number: 212-781-9696

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Treatment; Eligible subjects will receive 6 weekly treatments with the Forma Applicator according to the study protocol and will return for two follow up visits 1- and 3-months post treatment. Two further telephone feedback checks will be carried out 6 months and 12 months following the last treatment visit.	Device: Device treatment; 20 heterosexual males clinically diagnosed with Erectile Dysfunction will receive 6 weekly treatments with the Forma Applicator according to the study protocol and will return for two follow up visits 1- and 3-months post treatment. Two further telephone feedback checks will be carried out 6 months and 12 months following the last treatment visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ED symptoms, following the RF treatment	Change in ED symptoms, following the RF treatment measured by THE INTERNATIONAL INDEX OF ERECTILE FUNCTION - ERECTILE FUNCTION (IIEF-EF) questionnaire score. The IIEF-5 score is the sum of the ordinal responses to the 5 items.(1 to 5 ) 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sexual activity leading to optimal penetration	Change in sexual activity leading to optimal penetration measured by SEP- Sexual Encounter Profile questionnaire. The SEP questionnaire consists of 5 items addressing the sexual events and subject experiences when attempting intercourse. Efficacy of RF treatment evaluated using the change in percentage of "yes" responses to Sexual Encounter Profile (SEP) Questions 2 and 3	3 months
Evaluate efficacy of the RF treatment for erectile function	Proportion of subject responses to Global Assessment Questionnaire (GAQ) consisting of 2 questions (Yes or No): Question 1 'Has the treatment you have been taking improved your erectile function?' and if necessary, Question 2 'If yes, has the treatment improved your ability to engage in sexual activity?'.	3 months
Evaluate efficacy of the RF treatment for erectile function	Proportion of subject responses to Global Assessment Questionnaire (GAQ) consisting of 2 questions (Yes or No): Question 1 'Has the treatment you have been taking improved your erectile function?' and if necessary, Question 2 'If yes, has the treatment improved your ability to engage in sexual activity?'.	6 months
Evaluate efficacy of the RF treatment for erectile function	Proportion of subject responses to Global Assessment Questionnaire (GAQ) consisting of 2 questions (Yes or No): Question 1 'Has the treatment you have been taking improved your erectile function?' and if necessary, Question 2 'If yes, has the treatment improved your ability to engage in sexual activity?'.	12 months
Evaluate efficacy of the RF treatment for hardness of erection	To assess the effectiveness of RF treatment for erectile dysfunction with the Erectile Hardness Score (EHS) questionnaire The Erection Hardness Score is a self-reported tool that measures the hardness of an erection. It involves a scale report from 0 to 4, 4 being the best quality of erection.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring pain level during the procedure	NPRS is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	During the procedure

Collaborators and Investigators

• Sponsor: InMode MD Ltd.
• Investigators: Principal Investigator: Robert Valenzuela, MD; Principal Investigator: Lanna Cheuck, MD

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction
• Other Study ID Numbers: DO611503A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No