Clinical evidence for low intensity extracorporeal shock wave therapy (Li-ESWT)
Low intensity extracorporeal shock wave therapy has been studied extensively and a number of double blind studies have been undertaken, with more underway, to investigate its potential to treat erectile dysfunction in various cohorts. Studies are registered with the National Institutes of Health on ClinicalTrials.gov here. Over 19 studies involving shock waves have been registered and are listed here. The therapy is currently approved in over 20 countries and many hundred clinics worldwide. The protocols and the type of device are significant – see the devices/technologies here. Focused and radial shock waves have different effects.
Relevant papers are as follows:
Shockwave Therapy for Erectile Dysfunction: Which Gives the Best Results? A Retrospective National, Multi-Institutional Comparative Study of Different Shockwave Technologies
Jamil Ghahhari, MD, Alessio Faieta, Urological Nurse, Luca Cindolo, MD, PhD, Department of Urology, Private Hospital Villa Stuart, Rome, Italy , Cosimo De Nunzio, MD, Assistant Professor of Urology, Riccardo Lombardo, MD, Department of Urology, “Sant’Andrea” Hospital, “La Sapienza” University, Rome, Italy, Riccardo Ferrari, MD, Department of Urology, University of Modena and Reggio Emilia, Modena, Italy, Giovanni Ferrari, MD, Professor of Urology, Lorenzo Gatti, MD, Nicola Ghidini, MD, Rosario Calarco Piazza, MD, Department of Urology, Hesperia Hospital, CUrE Group, Modena, Italy – 31 March 2022
A retrospective national, multi-institutional study was performed to compare the effects of different shockwave technologies in ED patients.
All of the subjects underwent 8 consecutive weekly physical treatments with SWT under either a focused or non-focused regimen: 3,000 shocks per session at 0.09 mJ/mm2 and 10,000 shocks per session at 15 Hz and 90 mJ, respectively.
Conclusions: SWT is a clinically effective and safe treatment for ED that is independent of the generator type, source, shockwave morphology emitted, type of ED and perhaps treatment protocol.
Analysis of the Impact of Clinical Factors on Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction
Natalie Oginski, Hendrik Apel, Mario Richterstetter, Verena Lieb, Christian Fiebig, Peter J Goebell, Bernd Wullich, Danijel Sikic – Feb 2022
Li-ESWT was performed in 50 patients suffering from ED by applying 3,000 shock waves once a week over a period of 6 weeks. Treatment success was defined as an increase in the International Index of Erectile Function 5 (IIEF-5) score by ≥5 points or an Erectile Hardness Score (EHS) of ≥3 points. IIEF-5 and EHS were measured at baseline and at 3 and 6 months of follow-up. A significantly improved IIEF-5 score could be achieved in men with cardiovascular risk factors (p = 0.026) and in men with antihypertensive medication (p = 0.009). Men without cardiovascular risk factors showed no therapeutic benefit from Li-ESWT
Evaluation of Long-Term Clinical Outcomes… Minimum 5-Year Follow-Up on a Prospective Open-Label Single-Arm Clinical Study
Eric Chung, Ross Cartmill – August 2021
This long-term study showed the observed clinical improvement in EF continues to deteriorate but appears to plateau at 40% clinical efficacy at 48–60 months after completion of LIESWT. The absence of penile pain and deformity at 5-year follow-up supports the long-term safety data of LIESWT in men with ED.
Men’s Power-Pressure Wave Erectile Regeneration-Therapy: an Early Assessment
Jason Perelman and Vaughan Daniels Hepnar – 2017
This study was to evaluate low intensity extracorporeal shockwave therapy (LISWT) for Erectile Dysfunction (ED) used as a first line treatment in many parts of the world as a viable alternative to oral, on-demand, phosphodiesterase type 5 inhibitors (PDE5i). It concluded that non-invasive low intensity shockwave therapy (LISWT) has been shown to significantly improve erectile function in men previously PDE5i dependent.
Efficacy of low-intensity shock wave therapy for erectile dysfunction: A systematic review and meta-analysis.
Angulo, Arance, de Las Heras, Meilán, Esquinas, Andrés – October 2017
Meta-analysis of literature concludes that treatment with LISW for erectile dysfunction is effective, both in the short and medium term. LISW has been described as more effective than placebo in the short term. The long-term efficacy data are insufficient.
Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis
Safety and Efficiency of Low-intensity Extracorporeal Shockwave in the Treatment of Vasculogenic Erectile Dysfunction: a Multi-center, Double-blind, Randomized Sham-controlled Clinical Trial
Zhongcheng Xin, Ruili Guan, Wanshou Cui, Xiaodong Zhang, Long Tian, Yi Xie, Hongen Lei, Jihong Liu, Tao Wang – April 2017
This study was to evaluate the safety and efficacy of Low-intensity Extracorporeal Shockwave (LI-ESWT) in the Treatment of Vasculogenic Erectile Dysfunction. It concluded that LI-ESWT in patients with mild or moderate Vasculogenic ED is a feasible, noninvasive and effective way for improving male ED.
Effect of Extracorporeal Shockwave Therapy on Erectile Dysfunction from Vascular Causes: A single-centered, randomised, prospective study – Turkish Study
Abdulkadir Özmez, Asgar Garayev, Ateş Kadıoğlu, Istanbul University School of Medicine, Andrology Department. Presented at the 26th National Congress of Urology 2017
CONCLUSION: Short-term results of ESWT showed significant increase of IIEF-EF score in mild-to-moderate vascular ED. A positive effect of ESWT on ED shows that it can be used as an alternative treatment to traditional methods.
Recent advances in the treatment of erectile dysfunction
David F Mobley, Mohit Khera, Neil Baum – July 2017
This article will briefly discuss the diagnosis and management of Erectile Dysfunction (ED). In addition, emerging concepts in ED management will be discussed, such as the use of testosterone to treat ED, the role of the endothelium in men with ED and treating the partner of the man with ED. Finally, future potential therapies for ED will be discussed.
Effects of Next-Generation Low-Energy Extracorporeal Shockwave Therapy on Erectile Dysfunction in an Animal Model of Diabetes
Hyun Cheol Jeong, et al, November 2017
Research into the effectiveness of treatments of ED using ESWT can be more systematic using animal models. This study using three cohorts of 10 individuals conducted in Korea demonstrated that electromagnetic cylinder ESWT, the technology utilized in SONICWAVE treatment, helps restore smooth muscle function. Histological and immunohistochemical study shows restored levels of vascular endothelial growth factor (VEGF), endothelial nitric oxide synthase (eNOS), platelet endothelial cell adhesion molecule-1, cyclic guanosine monophosphate, and neuronal nitric oxide synthase (nNOS) expression levels.
Low-Intensity Shockwave Therapy Improves Hemodynamic Parameters in Patients With Vasculogenic Erectile Dysfunction: A Triplex Ultrasonography-Based Sham-Controlled Trial.
D. Kalyvianakis, I. Mykoniatis, July 2017
A double-blinded, randomized, sham-controlled trial of forty-six patients with ED thirty of whom underwent low-intensity extracorporeal shockwave therapy (LI-ESWT). The study confirmed the beneficial effect of LI-ESWT on penile hemodynamics and the beneficial effect of this treatment up to 12 months. The result is objective and subjective documentation of the value of this treatment modality for men with vasculogenic ED.
Full article available for download here (payment required).
Shockwaves for erectile dysfunction
A review in Nature of a study published in the Journal of Urology December 2015 by Kitrey, N. D. et al. on Penile low intensity shockwave treatment showing a shift of PDE5i non-responders to responders in a double blind sham-controlled study of 58 patients.
After treatment, 20 patients (54.1%) in the LIST group achieved erection hardness adequate for penetration compared with no patients in the sham group. A month after sham treatment, patients in the sham group were offered active treatment; 16 of these patients completed treatment and nine of them (56.3%) achieved erections.
Evaluation of clinical efficacy, safety and patient satisfaction rate after low-intensity extracorporeal shockwave therapy for the treatment of male erectile dysfunction: an Australian first open-label single-arm prospective clinical trial
Eric Chung*† and Ross Cartmill* 2015
LiESWT appears to improve erectile function, is safe and potential plays an important role in penile rehabilitation in men whom failed medical therapy.
Can low-intensity extracorporeal shockwave therapy improve erectile dysfunction? A prospective, randomized, double-blind, placebo-controlled study
Anne B. Olsen, Marie Persiani, Sidsel Boie, Milad Hanna & Lars Lund, Dec 2014
This placebo-controlled study over 5 weeks shows that 57% of the men who suffered from erectile dysfunction had an effect from LI-ESWT. After 24 weeks, seven (19%, active group) and nine (23%, active placebo group) men were still able to have intercourse without medication. This study shows a possible cure in some patients, but more research, longer follow-up in the placebo group and an international multicentre randomized study are needed.
Low intensity extracorporeal shockwave therapy for erectile dysfunction: a study in an Indian population.
Srini VS1, Reddy RK, Shultz T, Denes B. 2015
In this double-blind, placebo-controlled study, LI-ESWT demonstrated a positive long term clinical effect with improvement in erectile function of Indian men with vasculogenic ED who were prior responders to PDE5i therapy. The efficacy and tolerability of this treatment, coupled with its long term benefits and rehabilitative characteristics, make it an attractive new therapeutic option for men with vasculogenic erectile dysfunction.
Sound wave therapy is first alternative to Viagra in 15 years
New Scientist February 2016
Sound wave therapy is first alternative to Viagra in 15 years
Linear shock wave therapy in the treatment of erectile dysfunction
Pelayo-Nieto M, Linden-Castro E, Alias-Melgar A, Espinosa-Pérez Grovas D, Carreno-de ˜ la Rosa F, BertrandNoriega F, et al. Terapia de ondas de choque lineales en el tratamiento de la disfunción eréctil. Actas Urol Esp. – 2015.
A study of 15 patients concludes, the feasibility and tolerability of this treatment, and rehabilitation potential features, make it this an attractive new treatment option for patients with ED.
Safety and efficacy of low intensity shockwave (LISW) treatment in patients with erectile dysfunction
A. Ruffo, M. Capece, D. Prezioso, G. Romeo, E. Illiano, L. Romis, G. Di Lauro, and F. Iacono – Sepr/Oct 2015
A study of 31 patients that concludes, we can affirm that LISW is a confirmed therapeutic approach to erectile dysfunction that definitely needs more long-term trials to be clarified and further verified.
Penile Low-Intensity Shock Wave Therapy: A Promising Novel Modality for Erectile Dysfunction
Yasmin Abu-Ghanem, corresponding author* Noam D. Kitrey,* Ilan Gruenwald,1 Boaz Appel,1 and Yoram Vardi
LIST is a promising novel therapeutic modality for restoring erectile function in men with vasculogenic ED. It is a safe and non painful treatment with a long-lasting effect on erectile function. Additional well-designed, randomized, large-scale studies are necessary to confirm these findings and to outline the optimal treatment protocol and the suitable candidates. 2014
Does Low Intensity Extracorporeal Shock Wave Therapy Have a Physiological Effect on Erectile Function? Short Term Results of a Randomized, Double-Blind, Sham Controlled Study
THE JOURNAL OF UROLOGY, 2012, Vol. 187, 1769-1775
Vardi Y, et al.
This is the first randomized, double-blind, sham controlled study to our knowledge that shows that low intensity extracorporeal shock wave therapy has a positive short-term clinical and physiological effect on the erectile function of men who respond to oral phosphodiesterase type 5 inhibitor therapy. The feasibility and tolerability of this treatment, coupled with its potential rehabilitative characteristics, make it an attractive new therapeutic option for men with erectile dysfunction.