"This is a phase 1 clinical trial, so we're primarily looking at safety and adverse events. We’ve had none in the 46 participants that we have so far," says David Alejandro Velasquez.
In this video, David Alejandro Velasquez, Ranjith Ramasamy, MD, and Manuel Leyba Molina, MD, highlight the background and preliminary findings from the study, “Safety and Feasibility of the COCKTAIL (Combining Shockwave Therapy and Platelet-Rich Plasma for Erectile Dysfunction) Trial: A Single Center, Randomized, Double-Blind, Sham-Controlled Study Update,” which will be presented at the 2023 SMSNA Annual Meeting in San Diego, California.
Ramasamy: The COCKTAIL trial (NCT05048667) is an NIH funded study that we're doing for men with erectile dysfunction. Specifically, we're looking at men with mild to moderate erectile dysfunction, and it's a combination clinical trial. Men received both a combination of PRP, platelet rich plasma, and shockwave therapy for erectile dysfunction. This is the first study in the United States that's being done using the combination therapy of both shockwave therapy and PRP together.
Velasquez: This is a phase 1 clinical trial, so we're primarily looking at safety and adverse events. We’ve had none in the 46 participants that we have so far. Slightly, we're looking at efficacy, and preliminary findings have shown some kind of difference between the treatment group, PRP and shockwave, compared to the sham group. However, the power is not too significant yet. We're going to wait until we enroll every single participant.
Molina: This is a very interesting clinical trial, because in the recent years, there has been an increased trend of utilization of restorative therapy in men's health, including shockwave therapy, PRP, or stem cells. Now, this is the first time that we put 2 of the main restorative therapies together, including PRP and shockwave therapy for this condition.
This transcription has been edited for clarity.