The following is a conglomeration of scientific articles which examine low-intensity extracorporeal shock wave therapy and related topics. While the potential benefits of radial waves and focused shock waves to enhance blood flow and stimulate regeneration have been demonstrated in multiple studies, Uroshock and UP, LLC don’t claim other investigator’s data as our own. Some of the studies feature equipment that may be different from Uroshock. The studies advocate for proof of concept rather than to imply that the outcomes cited will be identical with the Uroshock device. Our site was constructed for the edification of informed consumers. As such, we provide a diversity of research perspectives. This is not a cheerleading site for any one viewpoint. Always consult with your physician regarding any medical decisions.
LOW-INTENSITY SHOCKWAVE THERAPY
The FDA has approved a new over-the-counter cream for the treatment of erectile dysfunction. MED3000 (Eroxon), a topical gel treatment for ED has very few side effects (nausea in 3%, and headaches in 1%) It works in a novel fashion which results in activation of the nitric oxide pathway. This is likely to be a very useful adjunct or even primary treatment for many patients.
This is a link to the guidelines of the European Association of Urologists (EAU). This is an excellent guide that details the root causes of erectile dysfunction, and also discusses the array of treatment options available, including shockwave therapy. Of all the treatments reviewed, shockwave therapy is one of the few that offers the potential of cure.
The gold standard for medical research is a prospective, sham controlled study. This study evaluated improved blood flow evaluated by doppler ultrasound, comparing patients treated with shockwave therapy versus a sham group. It was determined that the treated group had improved blood flow compared to the sham group. There were no significant side effects.
This review article evaluated multiple studies and noted that there is a wide discrepancy between different types of machines, and especially protocols. Treatment sessions varied between 4 and 12, and total number of shocks varied between 6,000 and 80,000. Energy flux density ran between .05 and .25 mJ/mm2.
This prospective study demonstrated a lack of side effects on patients treated with radial waves, and also improvement in 21 out of 22 men treated with 4 treatments every 7 days. The one patient who did not respond actually had an improved ability to respond to pde5-inhibitors.
This is an interesting study in which patients with pressure ulcers were treated with a radial shockwave machine. The investigators found that treatment with a single session resulted in significant beneficial outcomes for patients.
This very interesting study compared patients treated with Tadalafil (Cialis) to patients treated with low intensity shockwave therapy. In this study, patients in the shockwave group were treated twice per week for six weeks. The two groups had similar response rates, but the group treated with medication had a much higher side effect rate (44% compared to 8% in the shockwave group.)
This study examined randomized controlled trials over a ten year period (over 1,000 participants.) Among those who were treated there was a significant improvement in erection hardness score (EHS), and patients with moderate erectile dysfunction benefited more than those with severe or mild ED.
Many patients who suffer from erectile dysfunction have cardiovascular disease, and are on antiplatelet therapy. This article reported on 138 patients who were on antiplatelet therapy and were treated with LiSWT. There were not any complications with bleeding, however, the energy used in this study was relatively low (0.05 or 0.1 mJ/mm2.
Linear Low-Intensity Extracorporeal Shockwave Therapy as a Method for Penile Rehabilitation in Erectile Dysfunction Patients after Radical Prostatectomy: A Randomized, Single-Blinded, Sham-Controlled Clinical Trial
This article provides important evidence that LiSWT not only assists in the repair of vascular insufficiency, but also has a neuroprotective and neuro-regenerative effect. LiSWT is one of the few potential interventions for patients who complain of lack of sensitivity of the penis during intercourse.
This article was recently published in the Journal Of Urology. The authors utilized a protocol in which patients were treated twice per week for 6 weeks. They compared SWT to a sham, and found that there was a significant improvement in the treated group (79%). There results were a little better than some studies in which patients were treated once per week for six weeks.
The authors compared the prospective outcomes of patients treated with either shockwave therapy or Tadalafil (Cialis) and found that the response rates were equivalent, but the patients treated with shockwave therapy had less side effects. In fact, 44% of the patients treated with Cialis had side effects.
Shockwaves have demonstrated the ability to facilitate tissue regeneration.
Benefits include new blood vessel formation and reduced inflammation.
This clinical trial in human patients confirmed benefit to patients with known cardiac disease who were treated with shockwave therapy.
2. There were no significant side effects from SWT. The investigators found the treatment to be safe and effective.
This study compared results of patients treated for CTS (carpal tunnel syndrome) and found that those treated with radial shockwaves had improvement in reduction of pain and functional recovery, while those treated with focused shockwaves did not.
In an animal model, a single-session application of focused low-energy shockwaves demonstrated an increase in skin thickness by stimulating collagen production and local microcirculation.
The authors found that shockwaves were successful in promoting nerve regeneration, and increased the thickness of the myelin sheath.
This article reiterates the concept of neovascularization, reduction of inflammation and ability to promote tissue regeneration.
2. The specific cellular pathways thought to be responsible for these benefits is detailed.
There are passionate proponents of both radial and focused shock waves for the treatment of erectile dysfunction. This well-constructed study determined that there was no significant difference in the outcomes between radial and focused shock waves.
Low-intensity shockwave therapy for erectile dysfunction in kidney transplant recipients. A prospective, randomized, double blinded, sham-controlled study with evaluation by penile Doppler ultrasonography
This study utilized radial waves to treat patients twice per week for three weeks (an outdated protocol). Subjectively, based upon a questionnaire, patients improved, although the penile doppler results did not demonstrate objective improvement.
This is an important laboratory study that confirmed that radial shockwaves can promote stem cell expression.
This article highlights two important points. Patients with the most severe cases of erectile dysfunction are less likely to respond to treatment. Also, the benefits may be transient, meaning some patients will require re-treatment.
This review article describes and illustrates the proposed mechanism of action of LiSWT, and compares focused versus linear delivery modes of treatment. Shock wave therapy offers the unique prospect of a cure, but there are still unanswered questions.
Favorable data for outcomes with LiSWT continue to accumulate. In this study patients were treated with two courses of treatment (18,000 shocks at .09 mJ/mm2.) The results confirmed both safety and efficacy.
This study evaluated patients with documented reduced blood flow to the penis. One group was treated with LI-ESWT while the other group had a sham procedure. This is a well-designed, prospective, controlled study; the gold standard. The results suggest improved blood flow in the group that was treated with shock waves.
In this study patients who failed to respond to pde5 drugs were treated with lieswt, and given repeat drugs. After lieswt about half were able to regain erectile function. While low intensity shock waves didn’t cure these patients, it demonstrated that it can potentially be of benefit even in severe cases.
If you are not satisfied with pde5 inhibitors, such as Viagra, you are not alone. 30 to 40% of ed patients are either unable to tolerate side effects, or unhappy with the results of these medications.
This important study that was published in the highly respected Journal of Urology found that the benefits of shock wave therapy persisted more than two years in most patients with mild erectile dysfunction, and in about half of patients with more severe forms.
This study used a metric commonly employed in urology, SHIM (sexual health inventory for men.) The study determined that liswt seemed to be effective, although less so for patients with more advanced age and more co-morbidities, which seems logical.
This study published in European Urology demonstrated that low intensity shock wave therapy was well tolerated, and capable of ridding some men of a need for pde5i. Other men still needed drugs such as Viagra, but had improved erections after treatment.
This study published in 2017 found that while the evidence of single-arm studies was supportive, the data derived from randomized trials were ambiguous, and suggested that further studies were needed.
This study examined erectile function and cellular changes in hypertensive rats treated with shock wave therapy. They found improved erections after shock wave treatment both with and without pde5 inhibitors. They also found evidence of vascularization, which is one of the proposed mechanisms to explain the improved erectile function seen in patients undergoing shock wave therapy.
Cavitation build up is one of the proposed mechanisms that help to stimulate regenerative processes which may account for repair of erectile dysfunction. Using sophisticated techniques including high speed imaging, the investigators demonstrated that some radial shock wave units can generate cavitation, a key element.
This study concluded that even patients with prolonged periods of erectile dysfunction could benefit from LiESWT. This is controversial, as other investigators have gone so far as to state, “You can’t raise the dead!”
This is one of the few studies with data based upon long term outcomes of LiSWT for ED (5 years.) The good news is that low intensity shock waves are associated with an excellent long-term safety profile. Over time, results seem to fade, and patients often require re-treatment to maintain their gains.
While there are still wide variances between different protocols and shock wave units, the most recent data suggests that lower power units generating energy flux density between .05-.1 mJ/mm2 may be as effective as more powerful units generating up to .25mJ/mm2. Meta analysis suggests that 3000 shocks per session may be optimal.
This is a great article, and anybody who is considering PRP, LiSWT, or any other form of regenerative therapy for treatment of ED should read this. There are a variety of studies with conflicting data, and the author feels that none of the studies are adequate to allow for definitive conclusions. There need to be more patients enrolled, and more long term data. Certainly the long-term benefits are not known, and many if not most patients require retreatment down the road.
This is the first article which examines combination therapy. Patients were treated with both daily Tadalafil (Cialis) and a three week course of LiSWT, with favorable results. While the goal of shock wave therapy is the elimination of a requirement for meds, certainly some patients benefit from receiving both modes of treatment.
There were no treatment complications observed either during treatment, or at follow-up.
This study utilized LiSWT for the treatment of stress incontinence in women. The treatment protocol was similar to those commonly used for treatment of men with ED. The study highlights the safety of shockwave therapy, as there were no reported complications observed.
This study confirmed positive outcomes from LiSWT and once again, there were no side effects, and no pain from the procedure.
This study was based upon different protocols in patients who were all responders to pde5-inhibitors. Patients treated once per week for 6 weeks responded 62% of the time, those treated twice per week responded 71% of the time, and those who received an additional 6 treatments in 6 months responded 83% of the time.
The authors note that LiSWT has a long history of safety and efficacy. In particular, patients who have mild to moderate ED, and a history of having responded to meds seem to do well with treatment, and “pretty much everyone gets an improvement in blood flow.” The Cleveland Clinic reported an overall success rate of 62%.
72% of the health experts at the European Society for Sexual Medicine found shockwave therapy effective treatment for erectile dysfunction.
While previous studies have supported the use of penis traction devices, this particular device was created in conjunction with the Mayo Clinic. Excellent results were obtained. Unlike other studies, the device was used for 30-90 minutes, making it a more practical alternative.
The only FDA approved treatment for PD is CCH, but the treatment is not without the risk of serious complications including penile fracture. Patients who undergo treatment are advised not to have sexual activity for 2 weeks, and the author suggests that this be extended to a 4 week moratorium on sexual activity.
This recent study found that patients treated with 6 sessions of shockwave therapy had nearly a 50% reduction in plaque size. Their interesting protocol used 4,000 shocks directed at the plaque from different directions. Combing pde5-inhibitors further improved their outcomes.
This recently published story, based upon a review of 73 articles, echoes the sentiment of most urologists. The study concluded that shockwave therapy-used as monotherapy- failed to improve the curvature of most patients.
A meta-analysis of 6 studies and over 400 patients led the authors to conclude that SWT may be helpful for reducing the size of the plaque, and pain reduction. However, there was little evidence to suggest that LiSWT improves curvature or sexual function in patients with PD.
This study determined that there was a significant decrease in curvature in patients treated with shockwave therapy, but no significant change in pain. (i.e. The exact opposite of the previously mentioned study!)
Randomized, controlled studies are usually recognized as the gold-standard, and this one concluded that shockwave therapy was helpful for patients with PD. Plaque size, curvature and erectile function improved in the treated group.
The most recent studies suggest that SWT does not reduce plaque size or curvature, but likely is effective in reducing pain. This article speculates that younger patients, in the early stages of PD may benefit from SWT. Traction therapy (use of a penile traction device) may compliment the use of SWT.
Bremelanotide is a melanocortin agonist that is well tolerated and suitable for treatment of male and female sexual dysfunction. In women it promotes improved sexual desire and response to stimulation.
Flibanserin, (Addyi) was approved by the FDA in 2015 for use in premenopausal women and has been shown to improve sexual function and desire. It results in the release of dopamine, norepinephrine, and decreased serotonin. It enhances sexual desire, probably at the level of the prefrontal cortex. It is administered orally. Its use preceded Bremelanotide, and it is not indicated for use in men. Bremelanotide induces dopaminergic neurons and is administered with a subcutaneous injection.
This article reported on the intranasal use of Bremelanotide in men. Results were favorable, resulting in erections without any physical stimulation. Side effects included flushing and nausea.
Vyleesi is a melanocortin receptor agonist that is FDA approved for premenopausal women with hypoactive sexual desire disorder. It is not approved for use in men at this time. It works by modulating brain pathways, which is completely different than pde5-inhibitors such as Viagra and Cialis. It is administered subcutaneously on-demand.
There are many effective therapies for the treatment of premature ejaculation which include SSRIs such as Paroxetine, pde5-inhibitors, tricyclic antidepressants such as Dapoxetine, opioid analgesics such as Ultram, topical anesthetics such as Ultram and behavioral therapies.
Constriction rings operate by correcting venous leak. They do not increase blood flow into the penis, and would not be expected to improve erections for patients who suffer from primary vascular insufficiency. The absolute best test to determine blood flow in the penis is dynamic infusion cavernosometry, which measures the pressure within the corpora cavernosa during an erection. Patients who had been diagnosed with venous leak by duplex sonography were later studied by cavernosometry, the gold standard. This study demonstrated that a tool more commonly used by urologists, duplex ultrasonography, often led urologists to overdiagnose venous leak.
NATURAL TESTOSTERONE AND ERECTION SUPPORT
This randomized, double blind, placebo controlled study made some interesting conclusions regarding the use of L-Arginine. They found evidence that this supplement was effective enough in mild to moderate ED patients that it might be considered as an alternative, or an adjunct to conventional pde5-inhibitors.
Nitric Oxide (NO) is a mediator of erections and is released by nerve endings in the corpora cavernosa.
Arginine induces endothelial NO. Patients who were treated with Sildenafil (Viagra) plus Arginine demonstrated more improvement than those treated with Sildenafil alone.
This was a summary of the validity of popular herbal supplements touted for treatment of erectile dysfunction compiled by the revered Mayo Clinic.
This study evaluated the 5 highest-ranking T boosters on Amazon and analyzed the objective data pertaining to the 10 most common ingredients present in those products. While they were able to find 191 studies, less than 20% of these involved human subjects. The investigators state that there was NO EVIDENCE of efficacy in the studies, and furthermore, questioned the authenticity of the publicized customer reviews.
Unlike the previously reviewed paper the investigators did find evidence supportive of some of the claims regarding components of testosterone boosters (about 25%.) However, they raised concerns that the same potential side effects seen in exogenous testosterone could occur with “natural” boosters-such as blood clots.
This paper considered the data from prospective controlled studies, which are the highest standard in research. They concluded that there was good evidence to support claims of testosterone enhancement by two herbal extracts: fenugreek seed and ashwagandha root.
In this randomized double-blind placebo-controlled trial subjects received Fenugreek at doses of 400 mg, 500mg, or a placebo. The subjects were later evaluated for health-related quality of life parameters, as well as aging male symptoms, anxiety levels, and grip strength. Those who received Fenugreek extract outperformed their nontreated cohorts.
The authors reviewed 17 published studies regarding penis enlargement. Most of the studies were of poor quality. They did find evidence of positive outcomes with penis extenders. They concluded that extenders were the preferred treatment choice for those patients that did opt for some form of intervention.
This article from the Journal of Sexual Medicine alerts readers to the condition of dysmorphobia; a false perception of inadequacy of their genitalia. It also references the popular view that extenders can increase length by 1.5 to 2.5 cm (about an inch.)
This abstract appeared in the highly respected Journal of Urology. Although there have been reported complications cited elsewhere, the abstract cited an obscure study in which over 80% of subjects who participated in a jelqing program experienced increases in length and girth.
This study from Brazil noted that 30% of patients who respond to pde5 inhibitors discontinue their use within 6 months. Interestingly, the authors referenced additional studies which reported that up to 50% of patients discontinue their use of pde5 inhibitors at 17 to 18 months follow-up.
STEM CELL SUPPORT
This interesting article suggests that diet, adequate sleep, and ketogenesis all play an important role in supporting stem cells and progenitor cells. These are the cornerstones of regenerative medicine, which is responsible for repair, restoration, and renewal.
ERECTILE DYSFUNCTION: CONTEMPORARY ISSUES
Vacuum erection devices have stood the test of time, having first been introduced 150 years ago. While cumbersome, they still serve a useful function, particularly as an adjunct to contemporary treatments for Peyronie’s disease and erectile dysfunction.
Specific lifestyle changes are detailed and include 1) dietary modification to address obesity 2) sodium restriction 3) aerobic activity 4)moderate alcohol consumption and 5)cessation of smoking.
It pays to watch your diet, and control diabetes. Anti-diabetic drugs had a protective effect on erectile dysfunction. Also, the Mediterranean diet was particularly helpful as well. The authors reviewed 61 articles, and found that diets that are rich in plant foods may increase the availability of nitric oxide.
This article suggests three different mechanisms for Covid related erectile dysfunction 1) endothelial dysfunction 2) testicular damage 3) psychologic trauma of having Covid.
Two unfortunate men who developed erectile dysfunction after being infected with Covid-19 had penile tissue removed at the time of implantation of penile prosthetics. The tissue was analyzed for endothelial Nitric Oxide Synthase (eNOS, a marker of endothelial function) and COVID-19 spike-protein expression. There was a reduction of the Nitric Oxide Synthase, and persistent evidence of Covid-19, suggesting a causal relationship.
Covid-19 has affected more than 7,500,000 people worldwide, and many of the survivors find themselves suffering from lingering consequences, among them erectile dysfunction and fertility issues. The virus affects both testicular function which may result in decreased testosterone production, as well as global inflammation that can result in endothelial dysfunction, the hallmark of ED.
According to this large international study the incidence of erectile dysfunction in young men may be as high as 30%. Clearly ED can no longer be considered just a disease of the aged man.
According to the American Journal of Preventive Medicine, e-cigarettes ( Electronic Nicotine Delivery Devices ENDS) increase the risk of ED, likely because of nicotine’s known consequences, which include reduced blood flow.
Based on a review of over 60000 patients the Italian study found that infection of Covid-19 resulted in a six-fold increase in erectile dysfunction.
According to the most recent data, it seems that watching porn does not cause erectile dysfunction. A confounding variable is refractory time. As men get older, the refractory time increases, meaning it takes more time to recover before one can engage in intercourse again.
PRP (PLATELET RICH PLASMA)
Some clinicians recommend the addition of PRP (platelet rich plasma) to LiSWT protocols. This study found that patients who underwent this additional procedure did not demonstrate increased gains in restoring erectile function.
FEMALE SEXUAL DYSFUNCTION
This prospective study compared the outcomes of women with chronic vulvar pain (PVD) who were treated with low intensity shockwave therapy against women who were treated with a sham protocol. The study found that women who were treated had reduced pain, and increased sexual function.
1. There is a 3 fold increase in MSD (male sexual dysfunction) in men who have partners who suffer from FSD (female sexual dysfunction).
1. By definition female sexual dysfunction must cause personal distress to the affected individual.
2. There are 4 different types of problems: desire, arousal, orgasm, and pain.
1. This article cited an incidence of FSD of 40%.
2. Risk factors include coronary artery disease, hypertension, diabetes mellitus, and dyslipidemia.
The authors report that there is a correlation between pelvic floor strength, and sexual function. Desire, arousal, lubrication and orgasm were stronger in women with greater pelvic floor strength. Women with greater pelvic floor strength had fewer sexual complaints.
Flibanserin (Addyi) is an FDA approved pill for the treatment of hypoactive sexual desire disorder in premenopausal women. (HSDD is defined as decreased desire to engage in sexual activity associated with personal distress.) This study found clinically meaningful improvement in patients (both premenopausal and postmenopausal) who took Flibanserin relative to those who took a placebo.
The authors developed a tool that has gained acceptance in the literature for reliably measuring the subjective experience of orgasm. As you might have guessed, they termed their creation the orgasmometer.