Shockwave Therapy + Platelet Rich Plasma for Erectile Dysfunction
(COCKTAIL Trial)
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.12345
Is Shockwave Therapy combined with Platelet Rich Plasma safe for treating erectile dysfunction?
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.12345
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Platelet Rich Plasma (PRP)
- Shock Wave therapy (SWT)
Platelet Rich Plasma (PRP) is already approved in United States, European Union, Canada, Japan for the following indications:
- Orthopedic conditions including osteoarthritis, tendonitis, and meniscal tears
- Orthopedic conditions including osteoarthritis, tendonitis, and meniscal tears
- Orthopedic conditions including osteoarthritis, tendonitis, and meniscal tears
- Orthopedic conditions including osteoarthritis, tendonitis, and meniscal tears
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator