Shockwave Therapy + Platelet Rich Plasma for Erectile Dysfunction

(COCKTAIL Trial)

Overseen By Manuel Molina, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: University of Miami

Must not be taking: SSRI, Psychotropics

Disqualifiers: Penile surgery, Priapism, Hypogonadism, others

Compensation: Varies

Number of Visits: 8

Duration: 5 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using certain hormone treatments or medications for psychiatric conditions, you may not be eligible to participate.

What data supports the effectiveness of the treatment Shockwave Therapy + Platelet Rich Plasma for Erectile Dysfunction?

Research shows that combining shockwave therapy with platelet-rich plasma (PRP) can improve erectile function and prolong the time before ejaculation in men with erectile dysfunction. Studies found that patients receiving this combination treatment had better sexual outcomes compared to those who did not, and it was considered safe. ^{1 2 3 4 5}

Is Shockwave Therapy combined with Platelet Rich Plasma safe for treating erectile dysfunction?

Research indicates that combining Shockwave Therapy with Platelet Rich Plasma is generally safe for treating erectile dysfunction, with studies reporting no significant severe side effects. ^{1 2 3 5 6}

How is the combination of shockwave therapy and platelet-rich plasma unique for treating erectile dysfunction?

This treatment is unique because it combines shockwave therapy, which uses sound waves to improve blood flow, with platelet-rich plasma (PRP) injections, which use components from your own blood to promote healing and tissue growth. This combination aims to enhance erectile function more effectively than either treatment alone, offering a novel approach for those who haven't responded to standard medications. ^{1 2 3 4 5}

Research Team

Emad Ibrahim, MD

Principal Investigator

University of Miami

Eligibility Criteria

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.

Inclusion Criteria

Be able to provide written informed consent

I am between 30 and 80 years old.

I am male.

Exclusion Criteria

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

I use injections for erectile dysfunction treatment.

I have tried ED medications without success.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person)

Treatment Details

Interventions

• Platelet Rich Plasma (PRP)
• Shock Wave therapy (SWT)

Trial Overview 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.

Participant Groups

Group I: SWT plus PRP Group Experimental Treatment 2 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 Group Placebo Group 2 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.

Platelet Rich Plasma (PRP) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Platelet-rich plasma for:

• Orthopedic conditions including osteoarthritis, tendonitis, and meniscal tears

Approved in European Union as Platelet-rich plasma for:

• Orthopedic conditions including osteoarthritis, tendonitis, and meniscal tears

Approved in Canada as Platelet-rich plasma for:

• Orthopedic conditions including osteoarthritis, tendonitis, and meniscal tears

Approved in Japan as Platelet-rich plasma for:

• Orthopedic conditions including osteoarthritis, tendonitis, and meniscal tears

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

The combination of low intensity external shock wave therapy (Li-ESWT) and platelet-rich plasma (PRP) therapy significantly improved outcomes in patients with acute Peyronie's disease, including reductions in plaque size and penile curvature, as well as enhancements in erectile function and pain scores.

This treatment was found to be safe, with no reported side effects such as ecchymosis or hematoma at the injection sites, indicating a favorable safety profile for early intervention in Peyronie's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new alternative approach to management of acute phase Peyronie's disease: low intensity extracorporeal shockwave therapy and platelet-rich plasma. Karakose, A., Yitgin, Y.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma intracavernosal injections for the treatment of primary organic erectile dysfunction: a systematic review and meta-analysis of contemporary controlled studies. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of low-intensity shock wave therapy and its combination with platelet-rich plasma in patients with erectile dysfunction. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Platelet Rich Plasma (PRP) Growth Factor Concentration Varies in Men With Erectile Dysfunction. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Rationale and Design for the COCKTAIL Trial: A Single-center, Randomized, Double-blind, Sham-controlled Study Combining Shockwave Therapy and Platelet-rich Plasma for Erectile Dysfunction. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

A new alternative approach to management of acute phase Peyronie's disease: low intensity extracorporeal shockwave therapy and platelet-rich plasma. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The impact of shock wave therapy at varied energy and dose levels on functional and structural changes in erectile tissue. [2008]