What side effects are associated with this type of intervention?

Common treatments for erectile dysfunction include PDE5 inhibitors (e.g., sildenafil), vacuum erection devices, and penile injections. PDE5 inhibitors can cause headaches, flushing, indigestion, nasal congestion, dizziness, and visual disturbances. Vacuum erection devices may lead to penile bruising, pain, numbness, and difficulty ejaculating due to the constriction ring. Penile injections can result in pain at the injection site, prolonged erections (priapism), and fibrosis. Device-based therapies like the VERTICA® treatment are generally well-tolerated but can cause discomfort, bruising, and, in rare cases, infection.

What prior FDA approvals exist?

The FDA has approved several treatments for Erectile Dysfunction, primarily focusing on pharmacologic agents such as phosphodiesterase-5 (PDE5) inhibitors, including sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra). Device-based therapies, like vacuum erection devices (VEDs) and penile implants, have also been approved and are commonly used. The VERTICA® treatment, currently under study, represents a novel device-based approach, potentially adding to the existing array of mechanical interventions for ED.

What other types of research exist?

Promising novel alternatives to VERTICA® treatment for erectile dysfunction in 2024 include: <ol> <li>Phosphodiesterase-5 Inhibitors (PDE5Is): These remain a mainstay in ED treatment, with ongoing improvements in formulations and delivery methods.</li> <li>Alprostadil: Available as an injection, urethral suppository, or topical cream, it continues to be a reliable option for those who do not respond to PDE5Is.</li> <li>Stem Cell Therapy: Emerging research suggests potential in regenerating erectile tissue and improving function.</li> <li>Platelet-Rich Plasma (PRP) Therapy: This involves injecting PRP into the penis to promote tissue regeneration and improve erectile function.</li> <li>Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT): This non-invasive treatment uses shockwaves to improve blood flow and has shown promising results in clinical trials.</li> <li>Gene Therapy: Experimental but potentially transformative, targeting the underlying causes of ED at the genetic level.</li> </ol>

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Procedure

VERTICA Device for Erectile Dysfunction

N/A

Recruiting

Research Sponsored by OHH-MED Medical Ltd

Eligibility Criteria Checklist

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

Must have

Subjects diagnosed with organic ED for at least 3 months, according to the American Urology Association (AUA) Guideline Statement 1 (as described in Section 8.1.1 of the study protocol)

Adult, heterosexual, males between 22 and 85 years of age

Must not have

History of urothelial or colorectal cancer

Anatomic penile deformations or penile prosthesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial involves using a device called VERTICA® to help adults with mild to moderate erectile dysfunction (ED). Participants will use the device at home for several months and report their experiences. The goal is to see if the device can improve their ability to achieve and maintain an erection.

Who is the study for?

This trial is for heterosexual male adults aged 22-85 with mild to moderate erectile dysfunction (ED) for at least 3 months. Participants must have a steady relationship, be sexually active, and own a smartphone. They can't join if they've had certain pelvic treatments or conditions, take specific medications, have major neurological issues, psychiatric disorders including premature ejaculation and substance abuse problems, or if their partner is pregnant.

What is being tested?

The VERTICA® RF Device's safety and effectiveness in treating ED are being tested. Men will randomly receive either the real device or a sham (fake) version to use at home for six months. They'll try sexual activity regularly and log each event while attending monthly check-ups where safety checks and more efficacy tests happen.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from using the device or skin irritation at the site of application based on similar devices' profiles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with erectile dysfunction for at least 3 months.

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I am a heterosexual male aged between 22 and 85.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had bladder or colorectal cancer in the past.

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I have a physical deformity of the penis or a penile implant.

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I have had treatment that targeted my entire prostate.

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I have had surgery or radiotherapy in my pelvic area.

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I do not have major neurological conditions like Alzheimer's or Parkinson's.

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I am currently on blood thinners.

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I have a serious heart or lung condition.

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I have low testosterone due to aging or treatment.

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I am currently undergoing or have undergone antiandrogen therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

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

Treatment Details

Study Objectives

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

Primary study objectives

A significant change from baseline in the mean International Index of Erectile Function - Erectile Function domain (IIEF-EF) scores at 12 weeks, within the VERTICA Active treatment group.

A significant difference in the mean change from baseline in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) scores at 12 weeks, between the treatment groups.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention

Group II: ShamPlacebo Group1 Intervention

0 / 11Eligibility criteria met

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 type 5 inhibitors (PDE5-Is), vacuum erection devices (VEDs), and newer device-based therapies like the VERTICA® RF Device. PDE5-Is, such as sildenafil (Viagra), work by increasing blood flow to the penis by inhibiting the enzyme that breaks down cGMP, a molecule that relaxes smooth muscle. VEDs create a vacuum around the penis, drawing blood into the erectile tissue and maintaining the erection with a constriction ring. Device-based therapies like the VERTICA® RF Device use radiofrequency energy to improve erectile function by enhancing blood flow and tissue health. These treatments are crucial for ED patients as they address the underlying vascular and tissue issues, improving the ability to achieve and maintain an erection, thereby enhancing sexual function and quality of life.

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