What side effects are associated with this type of intervention?

Common treatments for Erectile Dysfunction (ED) similar to Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) generally have mild side effects. SWT may cause mild pain, bruising, or numbness at the treatment site. PRP therapy can lead to pain at the injection site, bruising, and rarely, infection. Both treatments focus on improving erectile function through angiogenesis and tissue repair, but their long-term safety and efficacy are still being studied.

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), and vardenafil (Levitra). These drugs enhance the effects of nitric oxide, increasing blood flow to the penis. While these treatments differ from Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) in their mechanisms, they share the common goal of improving erectile function. SWT and PRP are investigational therapies that aim to promote angiogenesis and tissue repair through mechanical stimulation and growth factor release, respectively.

What other types of research exist?

Promising novel alternatives to Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for Erectile Dysfunction (ED) treatment in 2024 include: 1) Gene therapy, which involves the delivery of genes that encode for angiogenic factors directly into penile tissue to promote vascular growth and repair. 2) Stem cell therapy, particularly the use of mesenchymal stem cells, which have shown potential in regenerating damaged tissues and improving erectile function. 3) Combination therapies that integrate pharmacological agents like PDE5 inhibitors with emerging technologies such as low-intensity extracorporeal shockwave therapy (LI-ESWT) to enhance therapeutic outcomes.

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Platelet-Rich Plasma Therapy

Shockwave Therapy + PRP for Erectile Dysfunction (COCKTAIL-DM Trial)

Phase 1 & 2

Waitlist Available

Led By Thomas A Masterson, 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 older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at month 3 and at month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment combining sound waves and special blood components to help diabetic men with erectile dysfunction. The sound waves aim to improve blood flow, while the blood components help repair damaged tissues. The goal is to see if this combination can better restore erectile function compared to other treatments.

Who is the study for?

Men aged 30-80 with mild to moderate erectile dysfunction and diabetes (Type 1 or Type 2) are eligible for this trial. They must have a stable sexual relationship, making at least two attempts per month, and be willing to follow study procedures. Men with poorly controlled diabetes, previous penile surgery other than circumcision, abnormal testosterone levels, serious illnesses that affect study participation or safety, psychogenic ED, certain neurological conditions or psychiatric diseases are excluded.

What is being tested?

The COCKTAIL-DM trial is testing if Shockwave Therapy combined with Platelet Rich Plasma can improve erectile function in diabetic men by repairing microvascular issues caused by Erectile Dysfunction. Participants will receive both treatments and their effects on improving erections will be assessed.

What are the potential side effects?

Potential side effects may include pain at the injection site from PRP therapy, bruising, swelling, infection risk increase due to injections involved in PRP therapy; SWT might cause skin redness or soreness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at month 3 and at month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at month 3 and at month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 3 and at 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

Changes in Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs)

Changes in endothelial function markers

Changes in markers of neo-angiogenesis

+1 more

Secondary study objectives

Change in Penile Blood Flow

EDITS questionnaire scores

Incidence of Serious Adverse Events (SAEs)

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: Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) GroupExperimental Treatment2 Interventions

Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection.

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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

Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) are emerging treatments for Erectile Dysfunction (ED) that focus on improving vascular and tissue health. SWT uses mechanical pulses to stimulate angiogenesis, enhancing blood flow to the penile tissue, which is vital for achieving and maintaining erections. PRP involves injecting concentrated platelets from the patient's own blood into the penile tissue, releasing growth factors that promote tissue repair and regeneration. These treatments are significant for ED patients as they target the root causes of ED, potentially offering more sustainable and long-term benefits compared to conventional therapies that mainly provide temporary symptom relief.