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What is
Li-ESWT?

Extracorporeal shockwave therapy (ESWT) is a non-invasive therapeutic approach that uses acoustic waves to break down tissue or to promote healing and repair.  It was developed during the 1960’s and 1970’s.  It gained wide acceptance in the 1980’s as a non-invasive way to break up kidney stones.  During the 1990’s to 2000’s it was adapted to address several musculoskeletal issues such tendinopathies and bone disorders.  It has since been adapted to treat erectile dysfunction (ED) as well as coronary artery disease.

1) Mayo Clinic. The evolving use of extracorporeal shock wave therapy in managing musculoskeletal and neurological diagnoses. February 4, 2022. Accessed December 20, 2023. https://www.mayoclinic.org/medical-professionals/physical-medicine-rehabilitation/news/the-evolving-use-of-extracorporeal-shock-wave-therapy-in-managing-musculoskeletal-and-neurological-diagnoses/mac-20527246. 2) Takakuwa, Y., Sarai, M., Kawai, H., Yamada, A., Shiino, K., Takada, K., Nagahara, Y., Miyagi, M., Motoyama, S., Toyama, H., & Ozaki, Y. (2018). Extracorporeal Shock Wave Therapy for Coronary Artery Disease: Relationship of Symptom Amelioration and Ischemia Improvement. Asia Oceania journal of nuclear medicine & biology, 6(1), 1–9. 3) Graber, M., Nägele, F., Hirsch, J., Pölzl, L., Schweiger, V., Lechner, S., Grimm, M., Cooke, J. P., Gollmann-Tepeköylü, C., & Holfeld, J. (2022). Cardiac Shockwave Therapy - A Novel Therapy for Ischemic Cardiomyopathy?. Frontiers in cardiovascular medicine, 9, 875965.

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How does Li-ESWT help ED?

1) Yahata, K., Kanno, H., Ozawa, H., Yamaya, S., Tateda, S., Ito, K., Shimokawa, H., & Itoi, E. (2016). Low-energy extracorporeal shock wave therapy for promotion of vascular endothelial growth factor expression and angiogenesis and improvement of locomotor and sensory functions after spinal cord injury. Journal of neurosurgery. Spine, 25(6), 745–755. 2) Huang TH, Sun CK, Chen YL, et al. Shock Wave Enhances Angiogenesis through VEGFR2 Activation and Recycling. Mol Med. 2017;22:850-862.

Shockwave therapy works by triggering the body’s innate healing mechanisms to stimulate the growth and development of new blood vessels in the penis. Research has shown that shockwaves induce the release of vascular endothelial growth factor (VEGF) and nitrous oxide (NO) which signal to the body to make new blood vessels and repair old ones.  It also breaks up calcium deposits in damaged arteries. These new, healthy blood vessels are responsible for the development and sustaining of an erection. Therefore, it addressed the underlying problem of ED.  It is so effective that it is being adopted as an alternative to treat coronal artery disease in place of surgery.

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Does Li-ESWT really regenerate blood vessels?

Extracorporeal Shockwave Therapy for erectile dysfunction has not been studied as thoroughly as it has been for other conditions.  However, research has repeatedly demonstrated that extracorporeal shockwave therapy stimulates the production of new blood vessels through the release of vascular endothelial growth factor (VEGF) and nitrous oxide production (NO).  

1) Main Line Health. New technology helps patients with coronary disease avoid surgery. September 12, 2022. Accessed December 22, 2023. https://www.mainlinehealth.org/blog/shockwave-therapy-for-coronary-artery-disease 2) Qiu, Q., Chen, S., Qiu, Y., & Mao, W. (2022). Cardiac Shock Wave Therapy in Coronary Artery Disease: A Systematic Review and Meta-Analysis. Frontiers in Cardiovascular Medicine, 9, 932193.

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What results can I expect from Li-ESWT?

1) Lu, Z., Lin, G., Reed-Maldonado, A., Wang, C., Lee, Y. C., & Lue, T. F. (2017). Low-intensity extracorporeal shock wave treatment improves erectile function: a systematic review and meta-analysis. European urology, 71(2), 223-233. 2) Sokolakis, I., & Hatzichristodoulou, G. (2019). Clinical studies on low intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic review and meta-analysis of randomised controlled trials. International journal of impotence research, 31(3), 177-194.

Results will vary based on the existing underlying medical conditions that affect the blood vessels of the penis.  For research purposes, subjective results are measured using the International Index of Erectile Function (IIEF) and Erection Hardness Score (EHS) to measure the strength of an erection.  Objective results are obtained by measuring the increase in blood flow to penile blood vessels before and after treatment as measured by doppler ultrasound.  

 

A 2017 literature review of 14 studies (seven of which were randomized controlled trials), including 833 patients, “suggests that Low-Intensity Extracorporeal Shockwave Therapy could significantly improve the International Index of Erectile Function (IIEF) and Erection Hardness Score (EHS) of erectile dysfunction patients. … There was evidence that these men experienced improvements in their erectile dysfunction following Low-Intensity Extracorporeal Shockwave Therapy.” 1

A 2019 literature review of ten randomized controlled trials including 873 patients “showed that low-intensity extracorporeal shockwave therapy (LI-ESWT) could significantly improve erectile function in men with ED regarding both patient-subjective outcomes (IIEF-EF and EHS) and patient-objective outcomes (blood flow measurements of penile blood vessels). In conclusion, the present meta-analysis provided results showing that LI-ESWT significantly improves erectile function in patients with vasculogenic ED.” 2

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How many treatment sessions are required?

There is no official consensus from the American Urological Association on this subject.  We follow the protocol published in the World Journal of Men’s Health, April 2020, which consists of a total of 12 treatments.  Two treatments every week for 3 weeks, a 3-week resting period, followed by another 3 weeks of treatments.  

We also offer a 6 treatment package to accommodate those on a budget.

1) Kim KS, Jeong HC, Choi SW, Choi YS, Cho HJ, Ha US, Hong SH, Lee JY, Lee SW, Ahn ST, Moon DG, Bae WJ, Kim SW. Electromagnetic Low-Intensity Extracorporeal Shock Wave Therapy in Patients with Erectile Dysfunction: A Sham-Controlled, Double-Blind, Randomized Prospective Study. World J Mens Health. 2020 Apr;38(2):236-242.

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What settings do you use?

There is no official consensus from the American Urological Association on this subject.  A 2022 review of 16 randomized controlled trials including 1,064 participants concluded that “treatment plans with an energy density of 0.09 mJ/mm2 and pulses number of 1,500 to 2,000 are more beneficial to IIEF in ED patients.”  We follow those guidelines.

1) Yao, H., Wang, X., Liu, H., Sun, F., Tang, G., Bao, X., ... & Ma, J. (2022). Systematic review and meta-analysis of 16 randomized controlled trials of clinical outcomes of low-intensity extracorporeal shock wave therapy in treating erectile dysfunction. American Journal of Men's Health, 16(2), 15579883221087532.

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Is Li-ESWT safe?

Treatment of erectile dysfunction uses low intensity shockwaves to break up calcified arteries and stimulate the release of vascular endothelial growth factor (VEGF) and nitrous oxide (NO).  It is not a high intensity shockwave used to break up kidney stones.  It is non-invasive and is done without any anesthesia.  Side effects are generally limited to mild redness, swelling or occasional bruising which is temporary.   

1) Reddy, B., Nehra, A., Kirubakaran, R., Sindhwani, P., Tharyan, P., & Jung, J. H. (2018). Extracorporeal shockwave therapy for the treatment of erectile dysfunction. The Cochrane Database of Systematic Reviews, 2018(11), CD013166.

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What about in-home shockwave devices?

Devices marketed for in-home use are Class I medical devices and therefore limited in the power of the shockwave that they can produce.  As Class I devices, they are exempt from the FDA regulatory process and their companies choose not to disclose their device specifications.  Therefore, there is no way of knowing how much therapeutic energy is being delivered during treatment.  A certain threshold of energy is required to stimulate blood vessel repair and regrowth. In-home treatments are underpowered.  Using them is like trying to boil an egg in a bathtub.  No amount of time is sufficient to achieve the desired result.  It is similar to in-office professional teeth whitening vs. in-home teeth whitening products.  Dentists are permitted to use a stronger product than is allowed with over-the-counter in-home kits so the results will always be superior. 

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Is Li-ESWT FDA approved to treat ED?

Low-Intensity Extracorporeal Shockwave is not yet approved by the FDA for the treatment of ED.  This makes its application to ED an off-label use. In medical practice “off-label use is common, accounting for approximately 10% to 20% of prescriptions.”  The American Urological Association considers low-intensity extracorporeal shock wave therapy investigational treatment options.   

1) Fitzgerald AS, O’Malley PG. Staying on track when prescribing off-label. Am Fam Physician. 2014;89(1):4-5. 2) Burnett AL, Nehra A, Breau RH, et al. Erectile dysfunction: AUA guideline. J Urol. 2018;200:633.

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How much does it cost?

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