Use of intracavernosal injection of autologous platelet rich plasma for the treatment of mild to moderate erectile dysfunction: A placebo controlled, parallel group, double blind randomized clinical trail

1. Erectile dysfunction (ED) is failing to develop or maintain a penile erection. It is a common health and psychological issue affecting 22%-49% of 40-70-year-old males and is predicted to affect about 300 million males worldwide by 2025. Male sexual dysfunction symptoms are commonly experienced, although they are less commonly screened by, or brought to the attention of, health care providers. There is a substantial body of evidence that male sexual dysfunctions have a clear negative impact not only on the sexuality but also on the psychological and general well-being of men afflicted with these disorders and often on their partners. Hence, there is a continuing medical need for the development of new efficacious and safe treatment options.

The main pathology of ED is endothelial dysfunction in the blood vessels of the corpora cavernosa, which reduces the endothelial nitric oxide release and impairs vasodilatation. A therapy targeting this pathology would be the most effective. Despite the variable therapeutic modalities available for ED, such as oral erectogenic drugs, intraurethral injection devices, intra-cavernosal injection, and penile prosthesis, the focus is directed towards the regenerative medicine that eliminates the pathology and not just improves erection hemodynamic.

Platelet-rich plasma (PRP) therapy is based on injecting a small amount of a patient’s blood after centrifugation to obtain plasma and platelet concentrate rich in growth factors like platelet-derived, vascular endothelial, insulin like, epidermal, and fibroblast growth factors. These factors have a major role in injured tissue regeneration. It is gaining

popularity and has been studied and approved in numerous medical and surgical disciplines. PRP has recently been used to treat ED through intra-cavernosal injections due to its angiogenic, vasculogenic, and regenerative properties. These properties made PRP a promising treatment for ED. PRP has been effective in many animal studies and is currently under evaluation in human trials. Recently few randomised control trials have been completed and are in various stages of publication. However, there is no published studies in Indian population.

Justification of the Study. We intend to do this study to see whether intracorporal injection of autologous platelet rich plasma really improves erectile function as compared to placebo in our subset of population. There is no published studies/RCT in Indian population as of now.