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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if radiofrequency (RF) therapy is a safe and effective treatment for erectile dysfunction (ED). Participants will undergo six weekly treatments with a device that uses RF energy and attend follow-up visits to monitor progress. Ideal candidates are men who have experienced ED for more than six months but less than five years, can maintain an erection with medication, and are in a stable heterosexual relationship. As an unphased trial, this study provides participants the chance to contribute to pioneering research in RF therapy for 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.

What prior data suggests that this radiofrequency therapy is safe for treating erectile dysfunction?

Research has shown that radiofrequency (RF) therapy might help treat erectile dysfunction (ED). One study involved 32 men with mild to moderate ED who used a handheld RF device and reported significant improvements in achieving erections. This finding suggests RF therapy could benefit others with similar issues.

RF treatments have been used safely in other areas, such as women's health. In a study with 102 women, RF therapy for sexual dysfunction was well-tolerated, with no major side effects reported. This outcome is encouraging for those considering RF therapy for ED.

While specific safety data for RF therapy in men with ED is still being collected, the use of RF in other conditions provides some reassurance. This trial, in its early stages, aims to determine both the safety and effectiveness of the treatment. Although RF therapy appears promising, more research is needed to confirm its safety specifically for ED. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for erectile dysfunction, which often include medications like Viagra or Cialis that temporarily increase blood flow, the Bi-Polar Radiofrequency therapy offers something new. This approach uses radiofrequency energy delivered through a specialized device to potentially improve erectile function by stimulating tissue remodeling and increasing blood flow over time. Researchers are excited because this treatment might provide longer-lasting results without the need for ongoing medication. Additionally, the non-invasive nature of this therapy could mean fewer side effects compared to oral medications.

What evidence suggests that Radiofrequency Therapy might be an effective treatment for erectile dysfunction?

Research has shown that bi-polar radiofrequency therapy, which participants in this trial will receive, can help men with mild to moderate erectile dysfunction (ED) improve their erectile function. In one study, 32 men experienced significant improvements after using a handheld radiofrequency device. Another study found that this therapy helped maintain and enhance sexual function over time. These results suggest that radiofrequency therapy could effectively improve erectile function and support sexual performance. ^{1 2 3 5 6}

Who Is on the Research Team?

Robert Valenzuela, MD

Principal Investigator

Lanna Cheuck, MD

Principal Investigator

Are You a Good Fit for This Trial?

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

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

Subject has at EHS score ≥ 1 (natural tumescence during sexual stimulation)

I am a man aged between 40 and 80.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06299332

Safety and Efficacy of Bi-Polar Radiofrequency for the ... The goal of this prospective pilot study is to learn about the Safety and Efficacy of Radiofrequency (RF) for the Treatment of Erectile Dysfunction.

2. withpower.com withpower.com/trial/phase-erectile-dysfunction-5-2023-e3b6a

Radiofrequency Therapy for Erectile Dysfunction A study involving 32 men with mild to moderate erectile dysfunction showed that using a handheld radiofrequency device significantly improved erectile function, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10035145/

The efficacy and safety of temperature controlled dual-mode ... The improved sexual dysfunction in 102 women after temperature controlled dual-mode radiofrequency (RF). Note: A: Comparison of the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S009042951731155X

Convective Radiofrequency Thermal Therapy ... Sexual function was preserved; erectile function remained improved and durable in the subset of sexually active subjects. Notable is the reproducibility of ...

5. mdpi.com mdpi.com/1424-8247/17/5/622

Bipolar Radiofrequency and Non-Crosslinked Hyaluronic ... Effect of Single-Session, Cryogen-Cooled Monopolar Radiofrequency Therapy on Sexual Function in Women with Vaginal Laxity: The VIVEVE i Trial.

6. liebertpub.com liebertpub.com/doi/10.1089/gyn.2023.0142

Bipolar Radiofrequency Treatment of the Vaginal Canal in ... The FsFI final instrument ranged with scores from 1 to 36, with a score <26 indicating sexual dysfunction. The ANOVA test was statistically ...