Shockwave Therapy + Platelet Rich Plasma for Erectile Dysfunction
(COCKTAIL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether combining Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) can improve blood flow and function in men with organic erectile dysfunction (ED), a condition caused by physical factors. Researchers aim to determine if these treatments together enhance blood vessel function more effectively than when used alone. Participants will receive either the active treatments or a placebo for comparison. Men who have experienced ED for at least six months and are in a stable, heterosexual relationship may be suitable candidates for this study. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this innovative therapy.
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 prior data suggests that Shock Wave Therapy and Platelet Rich Plasma are safe for treating erectile dysfunction?
Research has shown that using Shock Wave Therapy (SWT) with Platelet Rich Plasma (PRP) is generally safe for treating erectile dysfunction (ED). Several studies have found no harmful effects from this treatment.
For example, one study reported no negative side effects when PRP was used with SWT. Another study confirmed the safety of these combined treatments but noted that the benefits might be difficult to observe due to the small number of participants.
In summary, early research suggests that this combination treatment is well-tolerated, with no major safety concerns reported.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Shockwave Therapy (SWT) combined with Platelet Rich Plasma (PRP) for treating erectile dysfunction because it offers a novel approach compared to standard treatments like oral medications or injections. Most traditional treatments focus on temporarily boosting blood flow, but this combination aims to promote natural tissue repair and regeneration. SWT uses sound waves to stimulate the growth of new blood vessels, while PRP employs growth factors from the patient's own blood to enhance healing. This method could potentially provide longer-lasting improvements with fewer side effects.
What evidence suggests that this trial's treatments could be effective for erectile dysfunction?
This trial will compare the effectiveness of Shock Wave Therapy (SWT) combined with Platelet Rich Plasma (PRP) against a sham treatment. Research has shown that using SWT with PRP may help treat erectile dysfunction (ED). Studies have found that PRP improves erectile function scores more than SWT alone. Specifically, men using both treatments reported better results in their sexual health scores. PRP is considered safe for men with mild to moderate ED. Adding PRP to SWT might enhance the treatment's effectiveness, especially for those with blood flow-related ED.56789
Who Is on the Research Team?
Emad Ibrahim, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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:
- 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
Published Research Related to This Trial
Citations
The efficacy of platelet-rich plasma (PRP) alone or in ...
PRP demonstrated a better efficacy in treating ED, especially during a follow-up period of 6 months. Compared with using Li-SWT alone, the addition of PRP ...
Full article: The efficacy of platelet-rich plasma (PRP) alone ...
Subgroup analysis revealed that adding PRP regimen can considerably improve IIEF scores of ED patients compared to using Li-SWT alone (p < 0.0001). Conclusion.
Erectile dysfunction treatment by platelet-rich plasma and ...
Extracorporeal shock wave therapy and the combination of platelet-rich plasma plus are effectiveness methods for correcting erectile dysfunction.
Combined Treatment of Platelet-rich Plasma (PRP) and ...
Li-ESWT has been clinically shown to have a significant effect on erectile dysfunction. The purpose of this clinical study is mainly to use platelet-rich plasma ...
Is platelet rich plasma a promising treatment for erectile ...
Platelet-Rich Plasma appears to be a safe and promising long-term therapeutic option for men with mild to moderate erectile dysfunction. In this ...
Clinical Effects and Safety Outcomes of Platelet-Rich ...
Studies combining PRP with low-intensity shock wave therapy showed enhanced efficacy. Conclusions: PRP therapy appears promising for ...
Clinical Effects and Safety Outcomes of Platelet-Rich ...
PRP therapy led to significant short-term (after one month) improvements in erectile function, with 80% of patients recovering responsiveness to ...
P2-10 COMBINED SHOCKWAVE THERAPY AND ...
Initial findings indicate that combined use of PRP and SWT is safe, yet its clinical efficacy in treating ED may be insignificant due to small sample size.
(151) Safety and Feasibility of the COCKTAIL (Combining ...
The combination of PRP and SWT appears to be safe, as no adverse events were reported. Although preliminary data do not show differences between ...
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