Restorative Therapies for Erectile Dysfunction: Position Statement From the Sexual Medicine Society of North America (SMSNA)

Abstract

Introduction: Current non-invasive treatments for erectile dysfunction (ED) include oral medications, intracavernosal injections, and vacuum-assisted devices. Though these therapies work well for many, a subset of patients have contraindications or are unsatisfied with these options. Restorative therapies for ED are a new frontier of treatments focused on regenerating diseased tissue and providing a potential "cure" for ED. Aim: The aim of this position statement is to examine existing clinical trial data for restorative therapies and identify elements that require further research before widespread adoption. Methods: A literature review was performed to identify all clinical trials performed with regenerative therapy for ED. This includes treatments such as stem cell therapy (SCT), platelet rich plasma (PRP), and restorative related technologies like low-intensity shockwave therapy (LiSWT). Main Outcome Measures: Most clinical trials in restorative therapies were assessed for safety, feasibility, or efficacy. This included recording adverse events, changes in sexual function and erectile function questionnaires, and diagnostics measures. Results: To date there is an absence of robust clinical data supporting the efficacy of restorative therapies regarding ED, though technologies such as LiSWT have established relative safety. Conclusions: Restorative therapies are a promising technology that represents a new frontier of treatment geared towards reversing disease pathology rather than just treating symptoms. However, current published clinical studies are limited. Future work needs to be adequately powered, multi-center, randomized, sham/ placebo-controlled trials in well-characterized patient populations to ensure safety and demonstrate efficacy. Until these studies are done, restorative therapies should be reserved for clinical trials and not offered in routine clinical practice. Liu JL, Chu KY, Gabrielson AT, et al. Restorative Therapies for Erectile Dysfunction: Position Statement From the Sexual Medicine Society of North America (SMSNA).

Assessing the quality and readability of online content on shock wave therapy for erectile dysfunction

“…LI‐SWT is an emerging regenerative therapy gaining support for its potential use in treating ED, by restoring underlying mechanisms to allow for normal erections (Gruenwald et al, 2013). Currently, patients have been increasingly seeking information and utilising regenerative therapies for ED, including LI‐SWT, stem cell therapy (e.g., stromal vascular fraction), and platelet‐rich plasma therapy (Liu et al, 2021; Shahinyan et al, 2022). As many ED patients either have no success with currently available treatments or find them unpleasant, many clinics are providing shock wave therapy and advertising it as an effective, harmless treatment (Liu et al, 2021; Pastuszak, 2014).…”

“…Currently, patients have been increasingly seeking information and utilising regenerative therapies for ED, including LI‐SWT, stem cell therapy (e.g., stromal vascular fraction), and platelet‐rich plasma therapy (Liu et al, 2021; Shahinyan et al, 2022). As many ED patients either have no success with currently available treatments or find them unpleasant, many clinics are providing shock wave therapy and advertising it as an effective, harmless treatment (Liu et al, 2021; Pastuszak, 2014). There are also relatively few known side effects, such as pain during treatment and mild hematoma, but no severe complications tend to occur if the procedure is carried out correctly (Auersperg & Trieb, 2020).…”

Low‐intensity extracorporeal shockwave therapy for diabetic men with erectile dysfunction: A systematic scoping review

“…Despite promising data, national guidelines remain restrictive in their endorsement of Li-ESWT, stating that it should only be considered as an investigational therapy. 4,45 Nevertheless, interest in this technology continues to increase, with approximately 38% of uro-andrologists performing Li-ESWT in their routine practice in 2019, compared to 14% in 2016. 6 Men with diabetes have a 3.5-fold higher risk of having ED compared to healthy controls, and yet there continues to be a paucity of literature examining the use of Li-ESWT in this patient population.…”

Erectile Dysfunction, Surgical and Regenerative Therapy

“…More impor-tantly, few studies have demonstrated an enhancement in penile haemodynamic at penile doppler after LI-SWT. Likewise, several reports suggest that LI-SWT could improve erectile function even in severe ED men who are PDE5Is non-responders, thus dropping the urgent need for second-line treatments like injection or penile implant insertion [31].…”

“…On the other hand, high-quality prospective randomize trials with long follow-up are needed to provide urologists and sexual medicine clinicians with more assurance concerning the efficacy of LI-SWT. Further clarity is also needed in defining treatment protocols that can result in greater clinical benefits [31].…”