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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06299332
• Other study ID #: DO611503A
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2023
• Est. completion date: May 2025

Study information

• Verified date: November 2023
• Source: InMode MD Ltd.
• Contact: MEITAL MATALON
• Phone: 9492396522
• Email: meital.matalon[@]inmodemd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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

Locations

Country	Name	City	State
United States	LC Medical 140 W 58th St, Suite A New York, NY 10019	New York	New York
United States	Washington Heights Urology	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
InMode MD Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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