What side effects are associated with this type of intervention?

Common treatments for Erectile Dysfunction (ED) that focus on tissue regeneration and blood flow enhancement include Shock Wave Therapy (SWT) and Platelet Rich Plasma (PRP). SWT is generally well-tolerated, with side effects being minimal and may include mild pain, bruising, or swelling at the treatment site. PRP therapy, which involves injecting concentrated platelets to promote tissue repair, also has a favorable safety profile. Minor and transient side effects of PRP can include pain, bleeding, tenderness, swelling, and bruising at the injection site. Both treatments are considered safe with no significant adverse effects reported in clinical trials.

What prior FDA approvals exist?

The FDA has approved several treatments for erectile dysfunction, primarily focusing on phosphodiesterase-5 inhibitors (PDE5Is) such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra), which enhance blood flow to the penis. While these medications do not directly promote tissue regeneration, they improve erectile function by increasing blood flow. In contrast, investigational approaches like Shock Wave Therapy (SWT) and Platelet Rich Plasma (PRP) aim to treat ED by promoting tissue regeneration and enhancing blood flow and tissue repair. These methods are still under study and have not yet received FDA approval for ED treatment.

What other types of research exist?

Promising novel alternatives to Shock Wave Therapy (SWT) and Platelet Rich Plasma (PRP) for Erectile Dysfunction patients include: 1) Gene therapy, which involves the use of transforming growth factor-beta-1 (TGF-β1) expressing chondrocytes to enhance tissue repair and regeneration. 2) Cell-mediated therapies, such as stem cell therapy, which have the potential to regenerate damaged tissues and improve erectile function. 3) Low-level laser therapy (LLLT), which has shown potential in improving healing and symptoms related to tissue damage. These alternatives are still under investigation and should be discussed with a healthcare provider for suitability and availability.

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Platelet Rich Plasma

Shockwave Therapy + Platelet Rich Plasma for Erectile Dysfunction (COCKTAIL Trial)

Phase 1

Waitlist Available

Led By Emad Ibrahim, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

Be 30 to 80 years of age (inclusive)

Be Male

Must not have

Patients using Intracavernosal Injection (ICI) for management of ED

History of consistent treatment failure with Phosphodiesterase Type 5 (PDE5) inhibitors for therapy of ED

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 3, month 6

Summary

This trial is testing a combination of sound wave therapy and special injections to treat erectile dysfunction caused by poor blood flow in small vessels. The goal is to improve blood flow and repair blood vessels, enhancing erectile function. This approach targets patients who do not respond well to typical ED treatments.

Who is the study for?

Men aged 30-80 with organic erectile dysfunction (ED) for at least 6 months, in a stable heterosexual relationship, willing to have regular intercourse without alcohol/drugs influence. Must not have psychological ED causes, significant penile abnormalities or surgeries, severe psychiatric disorders, uncontrolled diabetes, abnormal testosterone levels or use certain medications.

What is being tested?

The study tests if Shock Wave Therapy (SWT) combined with Platelet Rich Plasma (PRP) can improve blood flow and repair blood vessel function in the penis. Participants will be randomly assigned to receive SWT + PRP, SWT alone, PRP alone or placebo treatments.

What are the potential side effects?

Potential side effects may include pain at the injection site from PRP treatment and discomfort from SWT. There might also be bruising or swelling after the procedures. The severity of side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

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

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I am between 30 and 80 years old.

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I am male.

Exclusion Criteria

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

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I use injections for erectile dysfunction treatment.

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I have tried ED medications without success.

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I have a physical or nerve condition in my genital area that affects my sex life.

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I have a condition like severe diabetes, multiple sclerosis, or Parkinson's affecting my nerves.

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My testosterone levels are either below 300 ng/dL or above 1197 ng/dL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 3, month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 3, month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3, month 6 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 IIEF-EF Scores

Circulating Angiogenic Factor levels

Penile Blood Flow

+1 more

Secondary study objectives

Number of participants reporting a decrease or discontinue in use of PDE5 inhibitors

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SWT plus PRP GroupExperimental Treatment2 Interventions

Participants will receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks. SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. PRP will be administered on Week 1 and Week 5.

Group II: Sham SWT plus Placebo Saline GroupPlacebo Group2 Interventions

Participants will receive weekly Sham Shockwave Therapy (SWT) and Placebo Saline Intracavernosal Injection (ICI) for 5 weeks. Sham SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. Placebo Saline ICI will be administered on Week 1 and Week 5.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platelet Rich Plasma (PRP)

2015

Completed Phase 4

~330

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

Common treatments for Erectile Dysfunction (ED) include Shock Wave Therapy (SWT) and Platelet Rich Plasma (PRP). SWT works by promoting tissue regeneration and improving blood flow through the induction of neovascularization, which is the formation of new blood vessels. This is crucial for ED patients as improved blood flow is essential for achieving and maintaining an erection. PRP, on the other hand, enhances tissue repair and regeneration by delivering high concentrations of growth factors that stimulate cellular repair processes. This can help in the recovery of damaged tissues in the penile region. Additionally, phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, work by increasing blood flow to the penis by inhibiting the enzyme that breaks down cyclic GMP, a molecule that relaxes smooth muscle cells. These treatments are important for ED patients as they address the underlying issues of poor blood flow and tissue damage, thereby improving erectile function.