New Therapies Currently Under Investigation
Several new innovations are on the horizon in the treatment of ED. These novel therapies are considered rejuvenative therapies and show potential for the future. However, they have not yet had sufficient research to determine if and who they may benefit (which etiology of ED), or how they may be delivered with minimal side effects or harm. The American Urological Association (AUA), the Sexual Medicine Society of North America (SMSNA), and the FDA have taken a very strong stance to say these therapies are off-label, lack adequate research, and are not approved by the FDA. They should only be performed under an Institutional Review Board (IRB)-approved study.
Stem cell therapy, low-intensity extracorporeal shock wave therapy, and plasma rich protein therapy for ED represent potential restorative modalities to promote cell rejuvenation. Each treatment is designed to possibly regenerate erectile tissue. Animal studies show promise for some treatments, but human studies have been very small and limited, and in some cases, no human studies have been published.
In particular, there are no randomized controlled human studies of plasma-rich protein therapy, which is sometimes referred to as the "P shot." Clinicians should caution men who seek this treatment that there are no published scientific human studies.
There are a few small randomized studies for stem cell therapy and for short-term extracorporal shock wave therapy. The exact mechanism of action of stem cell therapy is not understood, but it is thought to be due to immune modulation leading to secretion of cytokines and growth factors to decrease inflammation and promote healing. Animal studies show promise with stem cell therapy, but there are only four small published studies on using it for ED. In men post-radical prostatectomy, there are no randomized placebo-controlled studies, but only two small studies (Matz, Terlecki, Zhang, Jackson, & Atala, 2018). Low-intensity shock wave therapy for ED is another treatment being investigated. The mechanism is still being determined, but it is thought to decrease inflammation while causing cell membrane micro-trauma, resulting in the release of blood flow-promoting factors. It has been used for ED caused specifically by blood flow problems (vasculogenic ED). From the limited small studies, it seems to work best in mild vasculogenic ED, and younger patients do better with the treatment (Lu et al., 2017; Zou et al., 2017). There was only one study (not a randomized controlled study) using the therapy in men after radical prostatectomy, with small improvement in erectile function scores at one month after treatment and very minimal improvement in the average score one year after treatment (Frey, Sønksen, & Fode, 2016). Given the lack of any randomized placebo-controlled studies in men treated for prostate cancer, further research is needed to determine if this treatment will have any positive effect on erectile function in these men, and there is no good evidence to support this to date.
Urol Nurs. 2019;39(5):262-264. © 2019 Society of Urologic Nurses and Associates