Some heavy-hitter urologists are testing a promising novel procedure known as shockwave therapy that could become a noninvasive, pill-free, game-changing fix in the treatment of erectile dysfunction (ED).
Extracorporeal Shock Wave Therapy ESWT is a non-invasive treatment that works by emitting high energy sound waves into the body at target areas. They were first used over three decades ago to disintegrate kidney stones and have now been used in many other areas of medicine, including pain relief. Low-Intensity Extracorporeal Shock Wave Therapy (LI-ESWT) Low-intensity extracorporeal shock wave therapy (LI-ESWT) is a novel modality that has recently been developed for treating erectile dysfunction (ED). Set an Appointment. Scheduling your appointment with us is easy!
ED is a frustrating condition that experts say affects some 50 percent of men between the ages of 40 and 70.
Officially called low-intensity extracorporeal shockwave therapy (Li-ESWT), the procedure is more commonly known as shockwave therapy.
Treatment consists of noninvasive low-intensity sound waves that pass through erectile tissue, restoring natural erectile function by clearing plaque out of blood vessels and encouraging the growth of new blood vessels. The shockwave treatment offers a cure in that it reverses the problems that cause the dysfunction in the first place — the most desired win-win outcome coveted by men with ED.
But board-certified urologists are urging men seeking help for ED to do their homework before jumping into novel treatments that aren’t yet FDA approved.
Society warns men shockwave treatment isn’t FDA approved
On March 22, the Sexual Medicine Society of North America, Inc. (SMSNA) released a position statement warning men seeking ED treatment that new treatments being offered around the country aren’t FDA approved. “The Society recognizes the need for adequately powered, multicenter, randomized, sham/placebo-controlled trials in well-characterized patient populations to ensure that efficacy and safety are demonstrated for any novel ED therapy.”
They went on to list some of the unproven treatments, besides shockwave therapy, that are being offered: stem cell therapy; platelet-rich plasma (PRP), also known as the P-shot or the Priapus shot; and other agents, such as amniotic fluid.
The SMSNA believes that these therapies could potentially restore natural function and “regenerate erectile tissues.”
“There exists robust basic science evidence… supporting the ability of shockwave therapy and stem cell therapy to improve erectile function; however, to date, there is an absence of clinical trial data supporting their efficacy and long-term safety in humans.”
Any therapy available to help men with ED issues would have an undeniable quick-fix kind of appeal, but experts warn that the technology is in its infancy stages of research in the United States and isn’t ready for prime time until numerous clinical trials are wrapped up.
Given the current lack of regulatory agency approval for any restorative therapies for the treatment of ED and until such time as approval is granted, SMSNA believes the use of shock waves, stem cells, and platelet-rich plasma is experimental and should be conducted under research protocols in compliance with Institutional Review Board approval.
Bob Dole breakthrough
Let’s back up. It was former U.S. Senator and 1996 presidential candidate Bob Dole who came into our living rooms 20 years ago as the first Viagra pitchman for Pfizer.
Already known for his daunting rehabilitation from wounds he received in World War II, Dole had undergone a prostatectomy in 1991 while serving as a senator from the state of Kansas. The personal ED issues he discussed — to the chagrin of those watching television with their parents or grandparents — was a result of the surgery.
“You know, it’s a little embarrassing to talk about ED, but it’s important to millions of men and their partners,” he said in describing why he was speaking publicly about the condition.
How far have we come in the past two decades?
Blue pills aren’t a panacea
Irwin Goldstein, MD, board-certified urologist, director of sexual medicine at Alvarado Hospital in San Diego and the director of San Diego Sexual Medicine, is a trailblazer in the field of men’s sexuality. He explained that Viagra, the ubiquitous blue pills that serve as the current treatment for ED, aren’t a panacea.
“Pills do not work for everyone, and they’re incredibly expensive,” said Dr. Goldstein. “They [interfere] with certain health conditions, and many men discontinue their use for different reasons. But most importantly, they’re temporary, and they do not change the underlying pathophysiology of the condition.”
Dr. Goldstein explained the motivation for researchers to find a safe and appropriate alternative to pill therapy. “Through shockwave therapy, we are introducing a new paradigm of ED treatment that appears effective in changing the health of the penile tissue.”
He drove home the point that shockwave therapy for treating ED hasn’t received approval from the U.S. Food and Drug Administration (FDA), but he is working toward conducting a clinical trial later this year.
His center has nine trials ongoing in various areas of sexuality, and it has already completed a pilot study on men with ED in open-label context with the shockwave device, the Dornier Aries, made by Dornier MedTech Systems out of Germany. It’s still not approved for use in the United states outside of clinical trial use.
For the next step, Dr. Goldstein said, the FDA would require a multi-institutional sham-control trial with numerous institutions participating.
Like all of the board-certified urologists Healthline spoke to for this article, Dr. Goldstein urged readers to be wary of rogue operators who claim to be using FDA-approved shockwave therapy.
“There are healthcare providers offering treatments similar to shockwave, but there is no safety and efficacy data available and there’s absolutely no oversight as to the energy level provided to patients; theoretically, there could be harm with different energy levels,” said Dr. Goldstein. “It’s out of control and very sad, and desperate patients are caught in the middle. We take an oath to do no harm. So how would you know you are not causing harm until you’ve done the studies?”
FDA says shockwave tech for ED not approved
Stephanie Caccomo, a spokesperson from the FDA, confirmed that at this time, the only shockwave technology approved by the Center for Devices and Radiological Health (CDRH) of the FDA was the Sanuwave dermaPACE System, a Class II device, for use on conditions such as diabetic foot ulcers.
It delivers acoustic shock waves into the wound tissue to stimulate healing. Any device must be specifically approved for the condition being treated. Otherwise, it’s being used off-label, they said.
“If the public has concerns about unapproved products being marketed in inappropriate ways, we encourage consumers to file reports on our webpage for allegations of regulatory misconduct ,” said Caccomo.
The sole clinical trial using shockwave therapy in the United States
Ranjith Ramasamy, MD, assistant professor and director of reproductive urology at the University of Miami, is the principle investigator on the only ongoing clinical trial in the United States.
The study is titled “Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction.”
“Current nonsurgical ED treatment options include PDE-5 inhibitors (PDE5-i), such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra); vacuum erection devices; intracevernosal injections (P-shots); intraurethral suppositories; and penile implants,” said Dr. Ramasamy.
“All of these various treatments attempt to improve erectile function without really treating the underlying pathophysiology of ED, which leaves the question pending as to whether we can actually heal the dysfunctional penis.”
“The protocol schedule that we are using now is 10 minutes a day for either five days in a row — Monday, Tuesday, Wednesday, Thursday, Friday — with a follow-up at one month, three months, and then again at six months. Or we use Monday, Wednesday, Friday for two weeks,” Ramasamy said.
In that quest to learn if this treatment will be viable in the long run, Dr. Ramasamy said that his clinical trial was designed for 80 men and that he currently has 66 patients enrolled at their University of Miami site.
“Patients are paying $3,000 for non-FDA-approved treatments, and if they qualify for our trial, it’s free of charge,” he said, although the trial isn’t industry-funded. Dr. Ramasamy said that this current trial is being supported by private donors and philanthropic support, although two devices were given to him by the manufacturer, Direx Medical Systems Ltd., out of Israel.
To qualify for the trial, potential participants must meet the following criteria:
- be a male between 30 and 80 years of age
- have ED lasting for over six months but not more than five years
- have had a stable sexual relationship for over three months prior to enrollment
When asked if the 80-year-old mark for qualification was a bit on the high side, and also about “Mrs. Eighty,” Dr. Ramasamy was quick to respond: “That’s not true; we live in Miami, where sex is of paramount importance to all men regardless of their age. We have had irate patients who are 84 and 85 years of age call us asking why the cutoff is 80, and I feel bad for them, but that’s in our clinical trial criteria. Maybe in the next trial, we could design it to go to 90.”
Dr. Ramasamy said that his next trial will be a placebo trial where the participant will hear a sound, but the actual shock waves won’t get delivered. “We wanted to do this trial first to make sure it works — and it does,” he said.
Differences in wave energy
Shockwave therapy for treating ED, he noted, is quite different from extracorporeal shockwave lithotripsy (ESWL) used to treat kidney stones, a procedure that people have either had done in the last three decades or have at least heard about.
“ESWL has a smaller focal volume and the energy is concentrated to one spot, as opposed to ED where the shock waves are radial, the area is larger, and the energy is spread over that greater area,” Dr. Ramasamy explained. “In fact, the energy is about 10 percent of what we use for ESWL for kidney stones.”
Dr. Ramasamy was asked if it was possible that the machine could titrate the dosage up on its own or whether it had a built-in governor that would keep the energy at a certain level, the 10 percent of what is used for kidney stones. “We keep all maintenance records in an FDA-required format,” he said. “The device has a shut-off point. You can keep turning the dial as much as you want and there will be no higher intensity. The machine will cut off — like a hot water heater in your house.”
At the end of the numerous clinical trials that will be conducted by urological centers in the United Stated, Dr. Ramasamy said that an ideal regimen will be known, but only after a lot of documented study on a lot of subjects.
“Meanwhile, men seeking ED treatment should be very wary of non-doctors and chiropractors treating patients with what they say is shockwave therapy but is actually an acoustic vibrator,” he said. “Men are vulnerable and will do anything to have sex; men are willing to do anything to achieve an erection. It’s important for doctors and the medical community to keep an eye on what is correct.”
Shockwave therapy is the only current treatment on the horizon for ED that might offer a cure, which is the most desired outcome for men with ED. Shockwave therapy has also been suggested to improve the effect of pill therapy in nonresponders, reducing the need for more invasive treatments. Several single-arm trials have shown the benefit of shockwave therapy on patient-reported erectile function scores. Data from randomized trials appear to be conflicting, however, so questions remain to be answered before this therapy can routinely be offered to people.
Extracorporeal shockwave therapy | |
---|---|
ICD-10-PCS | 6A93 |
ICD-9-CM | 98.5 |
[edit on Wikidata] |
Extracorporeal shockwave therapy (ESWT) is a treatment mostly used to treat kidney stones and in physical therapy and orthopedics.[1][2]
Medical uses[edit]
Some of the passed fragments of a 1-cm calcium oxalate stone that was smashed using lithotripsy.
The most common use of extracorporeal shockwave therapy (ESWT) is for lithotripsy to treat kidney stones[3] (urinary calculosis) and biliary calculi (stones in the gallbladder or in the liver) using an acoustic pulse. It is also reported to be used for salivary stones[4] and pancreatic stones.[5]
In the UK, NICE has found that the evidence for ESWT in the majority of indications is conflicting, as such ESWT should only be used where there are special arrangements for clinical governance and audit.[6] Two 2017 reviews had similar findings, with moderate level evidence at best.[7][8]
Extracorporeal shockwave therapy is used as a second line measure to treat tennis elbow,[9][10] shoulder rotator cuff pain,[11][12]achilles tendinitis,[13][14]plantar fasciitis,[15][16] and greater trochanteric pain syndrome.[17]
ESWT is also used to promote bone healing and treat bone necrosis.[18] It is an effective alternative to surgical treatment of non-healing fractures.[19]
ESWT is used for wound healing and has shown positive results in short-term and long-term outcomes in diabetic patients suffering from foot ulcers.[20] Randomised controlled trials into the use of ESWT for healing venous leg ulcers are needed as there is a lack of evidence in this area.[21]
Procedure[edit]
The lithotriptor attempts to break up the stone with minimal collateral damage by using an externally applied, focused, high-intensity acoustic pulse. The patient is usually sedated or anesthetized for the procedure in order to help them remain still and reduce possible discomfort.[22] Sedation is not required in its application for soft tissue injuries.
History[edit]
Beginning in 1969 and funded by the German Ministry of Defense, Dornier began a study of the effects of shock waves on tissue. In 1972, on the basis of preliminary studies performed by Dornier Medical Systems, an agreement was reached with Egbert Schmiedt, director of the urologic clinic at the University of Munich. The development of the Dornier lithotripter progressed through several prototypes, ultimately culminating in February 1980 with the first treatment of a human by SWL.The production and distribution of the Dornier HM3 lithotripter began in late 1983, and SWL was approved by the U.S. Food and Drug Administration in 1984.[23]
In the 1980s people using ESWT for kidney stones noticed that it appeared to increase bone density in nearby bones, leading them to explore it for orthopedic purposes.[24]
Research[edit]
In response to concerns raised by NICE, in 2012 a study called the Assessment of the Effectiveness of ESWT for Soft Tissue Injuries was launched (ASSERT).[6]
As of 2018 use of ESWT had been studied as a potential treatment for chronic prostatitis/chronic pelvic pain syndrome in three small studies; there were short term improvements in symptoms and few adverse effects, but the medium term results are unknown, and the results are difficult to generalize due to low quality of the studies.[25]
Veterinary use[edit]
ESWT is commonly used for treating orthopedic problems in horses, including tendon and ligament injuries, kissing spine, navicular syndrome, and arthritis. The evidence for these uses is weak.[24]
See also[edit]
- Laser lithotripsy : effective for larger stones (> 2 cm) with good stone-free and complication rates.[26]
References[edit]
- ^Wang, Ching-Jen (2012). 'Extracorporeal shockwave therapy in musculoskeletal disorders'. Journal of Orthopaedic Surgery and Research. 7 (1): 11. doi:10.1186/1749-799X-7-11. PMC3342893. PMID22433113.
- ^Chung, Bryan; Wiley, J. Preston (2002). 'Extracorporeal Shockwave Therapy'. Sports Medicine. 32 (13): 851–865. doi:10.2165/00007256-200232130-00004. PMID12392445.
- ^Srisubat, A; Potisat1, S; Lojanapiwat, B; Setthawong, V; Laopaiboon, M (24 November 2014). 'Extracorporeal shock wave lithotripsy (ESWL) versus percutaneous nephrolithotomy (PCNL) or retrograde intrarenal surgery (RIRS) for kidney stones'. The Cochrane Library. 11: CD007044. doi:10.1002/14651858.CD007044.pub3. PMID25418417.
- ^'Salivary duct stones: MedlinePlus Medical Encyclopedia'.
- ^Hayes JM, Ding SL (September 2012). 'Pancreatic stone and treatment using ERCP and ESWL procedures: a case study and review'. N. Z. Med. J. 125 (1361): 89–97. PMID22960720.
- ^ abMaffulli G, Hemmings S, Maffulli N (2014). 'Assessment of the Effectiveness of Extracorporeal Shock Wave Therapy (ESWT) For Soft Tissue Injuries (ASSERT): An Online Database Protocol'. Translational Medicine. 10: 46–51. PMC4140430. PMID25147767.
- ^Korakakis, V; Whiteley, R; Tzavara, A; Malliaropoulos, N (27 September 2017). 'The effectiveness of extracorporeal shockwave therapy in common lower limb conditions: a systematic review including quantification of patient-rated pain reduction'. British Journal of Sports Medicine. 52: 387–407. doi:10.1136/bjsports-2016-097347. PMID28954794.
- ^Steuri, R; Sattelmayer, M; Elsig, S; Kolly, C; Tal, A; Taeymans, J; Hilfiker, R (September 2017). 'Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs'. British Journal of Sports Medicine. 51 (18): 1340–7. doi:10.1136/bjsports-2016-096515. PMC5574390. PMID28630217.
- ^'Extracorporeal shockwave therapy for refractory tennis elbow'. Interventional procedures guidance. National Institute for Health and Clinical Excellence. August 2009. IPG313.
- ^Thiele S, Thiele R, Gerdesmeyer L (2015). 'Lateral epicondylitis: This is still a main indication for extracorporeal shockwave therapy'. International Journal of Surgery. 24: 165–70. doi:10.1016/j.ijsu.2015.09.034. PMID26455532.
- ^'Extracorporeal shockwave lithotripsy for calcific tendonitis (tendinopathy) of the shoulder'. Interventional procedures guidance. National Institute for Health and Clinical Excellence. November 2003. IPG21.
- ^Louwerens JK, Sierevelt IN, van Noort A, van den Bekerom MP (2014). 'Evidence for minimally invasive therapies in the management of chronic calcific tendinopathy of the rotator cuff: a systematic review and meta-analysis'. Journal of Shoulder and Elbow Surgery. 23 (8): 1240–9. doi:10.1016/j.jse.2014.02.002. PMID24774621.
- ^'Extracorporeal shockwave therapy for refractory Achilles tendinopathy'. Interventional procedures guidance. National Institute for Health and Clinical Excellence. August 2009. IPG312.
- ^Wiegerinck JI, Kerkhoffs GM, van Sterkenburg MN, Sierevelt IN, van Dijk CN (2013). 'Treatment for insertional Achilles tendinopathy: a systematic review'. Knee Surgery, Sports Traumatology, Arthroscopy. 21 (6): 1345–55. doi:10.1007/s00167-012-2219-8. PMID23052113.
- ^'Extracorporeal shockwave therapy for refractory plantar fasciitis'. Interventional procedures guidance. National Institute for Health and Clinical Excellence. August 2009. IPG311.
- ^Yin MC, Ye J, Yao M, Cui XJ, Xia Y, Shen QX, Tong ZY, Wu XQ, Ma JM, Mo W (2014). 'Is extracorporeal shock wave therapy clinical efficacy for relief of chronic, recalcitrant plantar fasciitis? A systematic review and meta-analysis of randomized placebo or active-treatment controlled trials'. Archives of Physical Medicine and Rehabilitation. 95 (8): 1585–93. doi:10.1016/j.apmr.2014.01.033. PMID24662810.
- ^'Extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome'. Interventional procedures guidance. National Institute for Health and Clinical Excellence. January 2011. IPG376.
- ^Cheng JH, Wang CJ (2015). 'Biological mechanism of shockwave in bone'. International Journal of Surgery. 24: 143–6. doi:10.1016/j.ijsu.2015.06.059. PMID26118613.
- ^Kong FR, Liang YJ, Qin SG, Li JJ, Li XL (2010). '[Clinical application of extracorporeal shock wave to repair and reconstruct osseous tissue framework in the treatment of avascular necrosis of the femoral head (ANFH)]'. Zhongguo Gu Shang (in Chinese). 23 (1): 12–5. PMID20191955.
- ^Wang CJ, Cheng JH, Kuo YR, Schaden W, Mittermayr R (2015). 'Extracorporeal shockwave therapy in diabetic foot ulcers'. International Journal of Surgery. 24: 207–9. doi:10.1016/j.ijsu.2015.06.024. PMID26079500.
- ^Cooper, Ben; Bachoo, Paul (2018-06-11). 'Extracorporeal shock wave therapy for the healing and management of venous leg ulcers'. The Cochrane Database of Systematic Reviews. 6: CD011842. doi:10.1002/14651858.CD011842.pub2. ISSN1469-493X. PMID29889978.
- ^'Lithotrypsy' National Kidney Foundation, Accessed February 6, 2017
- ^'Gastroenterology and Urology Devices; Reclassification of the Extracorporeal Shock Wave Lithotripter AGENCY: Food and Drug Administration, HHS ACTION: Proposed rule'. Federal Register (US Government). February 8, 1999. Retrieved February 6, 2017.
- ^ abChamberlain, GA; Colborne, GR (2016). 'A review of the cellular and molecular effects of extracorporeal shockwave therapy'. Veterinary and comparative orthopaedics and traumatology : V.C.O.T. 29 (2): 99–107. doi:10.3415/VCOT-15-04-0057. PMID26846274.
- ^Franco, JV; Turk, T; Jung, JH; Xiao, YT; Iakhno, S; Garrote, V; Vietto, V (26 January 2018). 'Non-pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome'. The Cochrane Database of Systematic Reviews. 1: CD012551. doi:10.1002/14651858.CD012551.pub2. PMID29372565.
- ^Aboumarzouk OM, Monga M, Kata SG, Traxer O, Somani BK (Oct 2012). 'Flexible ureteroscopy and laser lithotripsy for stones >2 cm: a systematic review and meta-analysis'. J Endourol. 26: 1257–63. doi:10.1089/end.2012.0217. PMID22642568.
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