What is the mechanism of action of this treatment?

The most common treatments for Erectile Dysfunction (ED) include phosphodiesterase type 5 (PDE5) inhibitors and penile implants. PDE5 inhibitors, such as sildenafil and tadalafil, work by blocking the enzyme PDE5, which increases levels of cGMP, leading to smooth muscle relaxation and enhanced blood flow to the penis, facilitating erection. Penile implants involve surgically placing devices into the penis, which can be either inflatable or malleable, allowing men to manually control erections. Understanding these mechanisms is important for ED patients to select the most suitable treatment based on their specific condition and preferences.

What side effects are associated with this type of intervention?

Common treatments for erectile dysfunction include PDE-5 inhibitors (e.g., sildenafil, tadalafil), intracavernosal injections, and penile implants. PDE-5 inhibitors can cause headaches, flushing, nasal congestion, and visual disturbances. Intracavernosal injections may lead to pain at the injection site, priapism (prolonged erection), and penile fibrosis. Penile implants, while generally effective, carry risks such as infection, mechanical failure, and pain during the healing process. Each treatment has its own risk profile, and patients should discuss these with their healthcare provider to choose the most appropriate option.

What prior FDA approvals exist?

The FDA has approved several treatments for Erectile Dysfunction (ED), including oral medications like sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra), which are phosphodiesterase type 5 (PDE5) inhibitors. For patients who do not respond to these medications, surgical options such as penile implants are available. Penile implants, including inflatable and malleable prostheses, have been FDA-approved and are considered effective for men with ED who have not had success with less invasive treatments. These implants are designed to provide rigidity for intercourse and are typically considered when other treatments have failed.

What other types of research exist?

Promising novel alternatives to penile implant surgery for erectile dysfunction patients in 2024 include: 1) Low-intensity extracorporeal shockwave therapy (Li-ESWT), which promotes neovascularization and improves blood flow to the penis. 2) Platelet-rich plasma (PRP) injections, which use growth factors to enhance tissue repair and regeneration. 3) Stem cell therapy, which aims to restore erectile function by regenerating damaged tissues. 4) New oral medications and formulations, such as dissolvable films or sublingual tablets, that offer faster onset and fewer side effects. 5) Advanced vacuum erection devices (VEDs) with improved comfort and efficacy.

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Wound Healing Protocols for Erectile Dysfunction Post-Surgery

N/A

Waitlist Available

Led By Tariq Hakky, MD

Research Sponsored by Vivex Biomedical, Inc.

Eligibility Criteria Checklist

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

Must have

The patient is undergoing penile implant surgery for the first time

The patient is a male between 30 and 70 years of age

Must not have

The patient is an adult under guardianship

The patient is taking blood thinners and has an international normalized ratio >3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up surgery to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special healing membrane called VIAGENEX Max on men having their first penile implant surgery for Erectile Dysfunction. The membrane is placed over the surgical wound to help it heal better and faster.

Who is the study for?

Men aged 30-70 with erectile dysfunction (ED), planning their first penile implant surgery, and in a stable relationship for over 3 months. They must have an IIEF-EF score of 16-25, at least two sexual attempts per month, normal testosterone levels (300-1000 ng/dL), and controlled blood sugar (A1C </=7%). Exclusions include recent participation in other studies, certain medical conditions like venous leak or pelvic radiation therapy within the last year, insulin-dependent diabetes with high A1C (>7%), or use of psychiatric medications affecting ED.

What is being tested?

The trial is testing VIAGENEX Max treatment versus a Hibiclens wash regimen on wound healing after first-time penile prosthesis implantation. It's a prospective study where patients are randomly assigned to either active treatment or sham group in a ratio of 2:1.

What are the potential side effects?

Potential side effects may include skin irritation from the treatments applied to the surgical area. Since this trial focuses on post-surgical care rather than systemic medication, widespread side effects are less likely but can vary based on individual reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am having my first penile implant surgery.

Select...

I am a man aged between 30 and 70.

Exclusion Criteria

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

Select...

I am an adult with a legal guardian.

Select...

I am on blood thinners and my blood clotting rate is high.

Select...

I do not agree to sign the consent form.

Select...

I have had major surgery on my prostate or in my pelvic area.

Select...

My A1C level was over 7% recently or I need insulin for my diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ surgery to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~surgery to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and surgery to 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

Penile implant activation

Secondary study objectives

Pain after undergoing penile prosthesis surgery

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Viagenex MaxExperimental Treatment1 Intervention

VIAGENEX Max graft will be placed in the incision at the end of surgery prior to closing.

Group II: Standard of careActive Control1 Intervention

Hibiclens wash will be performed.

0 / 7Eligibility 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

The most common treatments for Erectile Dysfunction (ED) include phosphodiesterase type 5 (PDE5) inhibitors and penile implants. PDE5 inhibitors, such as sildenafil and tadalafil, work by blocking the enzyme PDE5, which increases levels of cGMP, leading to smooth muscle relaxation and enhanced blood flow to the penis, facilitating erection. Penile implants involve surgically placing devices into the penis, which can be either inflatable or malleable, allowing men to manually control erections. Understanding these mechanisms is important for ED patients to select the most suitable treatment based on their specific condition and preferences.

A Systematic Review of the Role of Penile Rehabilitation in Prostate Cancer Patients Receiving Radiotherapy and Androgen Deprivation Therapy.The management of stuttering priapism.Management of erectile dysfunction post-radical prostatectomy.