What side effects are associated with this type of intervention?

Common treatments for erectile dysfunction include phosphodiesterase type 5 (PDE-5) inhibitors (such as sildenafil and tadalafil), vacuum erection devices, penile injections, and penile implants. PDE-5 inhibitors can cause headaches, flushing, nasal congestion, and visual disturbances. Vacuum erection devices may lead to bruising and discomfort. Penile injections can cause pain at the injection site and prolonged erections. Penile implants carry risks of infection and mechanical failure. Radiofrequency Therapy, which uses electromagnetic waves to improve blood flow and tissue function, is being studied for its safety and efficacy. Known side effects from similar treatments include mild discomfort and, rarely, skin burns or tissue damage.

What prior FDA approvals exist?

The FDA has approved several treatments for erectile dysfunction, primarily focusing on phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra), and avanafil (Stendra). These medications work by enhancing blood flow to the penis. While the provided context does not mention FDA-approved treatments that use electromagnetic waves like radiofrequency therapy, it does highlight the ongoing research into such innovative treatments. Radiofrequency therapy aims to improve blood flow and tissue function, potentially offering a new avenue for ED treatment pending further studies and approvals.

What other types of research exist?

Promising novel alternatives to Radiofrequency Therapy for Erectile Dysfunction patients include: 1) Phosphodiesterase-5 (PDE-5) inhibitors, which can be used on-demand or as daily low-dose therapy. 2) Intracavernosal injections (ICI) or intraurethral (IU) suppositories for those who do not respond to oral PDE-5 inhibitors. 3) Pulsatile administration of exogenous GnRH for stimulating endogenous gonadotropin secretion and improving erectile function. These alternatives have shown efficacy in clinical settings and may offer viable options for ED treatment in 2024.

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Procedure

Radiofrequency Therapy for Erectile Dysfunction

N/A

Recruiting

Led By Robert Valenzuela, MD

Research Sponsored by InMode MD Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, RF treatments may potentially cause skin irritation, discomfort or pain at the treatment site, and temporary changes in sensation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in ED symptoms, following the RF treatment

Secondary study objectives

Change in sexual activity leading to optimal penetration

Evaluate efficacy of the RF treatment for erectile function

Evaluate efficacy of the RF treatment for hardness of erection

Other study objectives

Measuring pain level during the procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Device TreatmentExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Device treatment

2022

N/A

~40

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Erectile Dysfunction (ED) include Phosphodiesterase-5 (PDE5) inhibitors, vacuum erection devices, penile injections, and lifestyle modifications. PDE5 inhibitors, such as sildenafil (Viagra), work by blocking the enzyme PDE5, which results in increased levels of cyclic guanosine monophosphate (cGMP). This leads to relaxation of smooth muscle and increased blood flow to the penis, facilitating an erection. Vacuum erection devices create a vacuum around the penis, drawing blood into the corpora cavernosa. Penile injections involve injecting vasodilators directly into the penis, which also increases blood flow. Lifestyle changes, such as exercise and diet, improve cardiovascular health and blood flow. Understanding these mechanisms is crucial for ED patients as it helps them make informed decisions about their treatment options, ensuring they choose therapies that best address their specific physiological issues.