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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
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
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
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
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.
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Who is running the clinical trial?
InMode MD Ltd.Lead Sponsor
24 Previous Clinical Trials
1,370 Total Patients Enrolled
Robert Valenzuela, MDPrincipal Investigator
Lanna Cheuck, MDPrincipal Investigator
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