Radiofrequency Therapy for Erectile Dysfunction

Recruiting at 1 trial location

Overseen By MEITAL MATALON

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: InMode MD Ltd.

Must be taking: PDE5 inhibitors

Must not be taking: Antidepressants, Isotretinoin

Disqualifiers: Neurological disease, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is studying the safety and effectiveness of using radiofrequency (RF) therapy to treat erectile dysfunction (ED). RF therapy uses controlled heat from radio waves to improve blood flow and tissue health. The goal is to see if this method can help patients with ED.

Will I have to stop taking my current medications?

Yes, you will need to stop taking erectile dysfunction medications for the duration of the study, including a two-week period before and after certain visits. Additionally, you must abstain from any systemic medications known to cause erectile dysfunction.

How is Bi-Polar Radiofrequency Therapy different from other treatments for erectile dysfunction?

Bi-Polar Radiofrequency Therapy is unique because it uses radiofrequency energy to renew and restore the structure of collagen fibers in the penis, potentially improving erectile function at the tissue level. This self-applied, handheld device is simple to use and has shown promising results without reported side effects, making it a novel approach compared to other treatments like shockwave therapy or vacuum devices. ^{1 2 3 4 5}

Research Team

Robert Valenzuela, MD

Principal Investigator

Lanna Cheuck, MD

Principal Investigator

Eligibility Criteria

This trial is for men experiencing erectile dysfunction (ED). Specific eligibility criteria are not provided, but typically participants would need to be adults with a clinical diagnosis of ED.

Inclusion Criteria

I am a man aged between 40 and 80.

A1C level ≤ 8.5% within 1 month prior to enrollment/baseline

I have attempted sex at least 4 times in the last two weeks.

Exclusion Criteria

Internal defibrillator, pacemaker or any other implanted electrical device anywhere in the body

Permanent metal implant in the treatment area

My testosterone level is either below 300 or above 1000 ng/dL.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Eligible subjects will receive 6 weekly treatments with the Forma Applicator according to the study protocol

6 weeks

6 visits (in-person)

Follow-up

Participants will return for two follow-up visits 1- and 3-months post-treatment and two further telephone feedback checks at 6 and 12 months

12 months

2 visits (in-person), 2 visits (telephone)

Treatment Details

Interventions

• Bi-Polar Radiofrequency

Trial Overview The study is testing the safety and effectiveness of a device that uses Bi-Polar Radiofrequency (RF) therapy on patients with erectile dysfunction. It's a prospective pilot study, which means it's preliminary research to gather initial data.

Participant Groups

Group I: Device Treatment Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

InMode MD Ltd.

Lead Sponsor

Trials

26

Recruited

1,500+

Findings from Research

Extracorporeal shock wave therapy (ESWT) and vacuum erectile devices (VED) both showed significant improvements in erectile function, with treatment success rates of 73.3% for ESWT and 67.7% for VED after 4 weeks of therapy.

Both treatments resulted in similar increases in erectile function scores (IIEF-5) and other measures, indicating that ESWT is as effective as VED for managing erectile dysfunction in the studied population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of extracorporeal shock wave therapy and a vacuum erectile device on penile erectile dysfunction: a randomized clinical trial. Qi, T., Ye, L., Wang, B., et al.[2021]

Internet-based sex therapy significantly improved erectile functioning and overall sexual satisfaction in men with erectile dysfunction, with 48% of participants reporting much or somewhat improved sexual functioning.

For men with premature ejaculation, the therapy did not show superiority over a waiting list, although some improvements in sexual desire and satisfaction were noted, indicating that the treatment may not be as effective for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based brief sex therapy for heterosexual men with sexual dysfunctions: a randomized controlled pilot trial. van Lankveld, JJ., Leusink, P., van Diest, S., et al.[2015]

Low-intensity extracorporeal shockwave therapy (LI-ESWT) shows potential as a complementary treatment for erectile dysfunction (ED), with evidence suggesting benefits for patients, although the overall confidence in the studies is critically low due to methodological flaws.

The therapy appears to have no significant side effects, but the effectiveness may vary based on the number of treatments and energy levels used, highlighting the need for more rigorous studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity extracorporeal shockwave therapy for erectile dysfunction: an overview of systematic reviews. Yuan, F., Wang, Y., Ma, Z., et al.[2022]

A study involving 32 men with mild to moderate erectile dysfunction showed that using a handheld radiofrequency device significantly improved erectile function, with many participants achieving normal erectile function after treatment.

The treatment was safe, with no reported side effects, and participants found the device easy to use and comfortable, indicating its potential as a practical option for managing erectile dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency energy in the treatment of erectile dysfunction-a novel cohort pilot study on safety, applicability, and short-term efficacy. Gruenwald, I., Appel, B., Shechter, A., et al.[2023]

Radio wave electrotherapy at 448 kHz significantly improved erectile function in men with organic erectile dysfunction, as evidenced by higher IIEF-5 scores (19.5 vs. 15.1) and SEP scores (3.6 vs. 2.4) compared to a control group after 9 weeks of treatment.

The treatment was safe, with no reported complications or adverse events, indicating that radio wave electrotherapy could be a viable option for patients with organic erectile dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radio wave electrotherapy with a radiofrequency of 448 khz for the treatment of patients with organic erectile dysfunction: a prospective, randomized, blind, Sham-controlled, parallel-group study]. Chuvalov, LL., Korolev, DO., Azilgareeva, KR., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of the effects of extracorporeal shock wave therapy and a vacuum erectile device on penile erectile dysfunction: a randomized clinical trial. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Internet-based brief sex therapy for heterosexual men with sexual dysfunctions: a randomized controlled pilot trial. [2015]

3. China pubmed.ncbi.nlm.nih.gov

Low-intensity extracorporeal shockwave therapy for erectile dysfunction: an overview of systematic reviews. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Radiofrequency energy in the treatment of erectile dysfunction-a novel cohort pilot study on safety, applicability, and short-term efficacy. [2023]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Radio wave electrotherapy with a radiofrequency of 448 khz for the treatment of patients with organic erectile dysfunction: a prospective, randomized, blind, Sham-controlled, parallel-group study]. [2022]