Anasayfa » Comparative Analysis of Shockwave Therapy Treatment
Erectile dysfunction (ED) is a common male health problem. Inadequate sexual performance may result in high physical, emotional, and relationship-associated distress, ultimately influencing a man’s mental health. More advantages promised by the pelvic floor electrical stimulation devices caused advances in technology resulting in novel pulse wave therapy devices, PWT. Until now, strong evidence for known or experimental treatments for ED will be achieved. This paper outlines and compares the use of the two publicly known and widely spread aimed pulse wave therapies to treat erectile dysfunctions. Those are the shockwave therapy, SWT, which is already for a decade well used, and the pulse wave therapy, PWT, which is relatively novel. The main differences, pair-like studies results, and drawbacks with potential risks of using these methods are explained and discussed.
Background and Rationale: Up to 90% of all cases of ED are associated with organic disease. This pathology is diagnosed in about 150 million men of reproductive age worldwide. Thanks to the introduction of PDE-5 inhibitors, intracorporal injections, and penile prostheses, iatrogenic and surgical treatments are successfully carried out. However, the genesis of the disease has not been thoroughly studied. Over the past 10 years, interest in the physiology of the release of stem cells from the bone marrow and the beneficial effect of their tissue distribution on the effects of ST on the erectile tissue of the penis enhances our understanding of the disease. Stem cells are actively observed in the cavernous tissue 7 days after ST, and then their activity decreases. It is established that stem cell implantation also has a beneficial effect on erection. ST stimulates the activation of stem cells in the corpus cavernosum by suppressing apoptosis and autophagy. Similar anti-apoptotic and anti-inflammatory effects of ST on cells were demonstrated in a rabbit model of myocardial infarction after the direct injection of ST-treated endothelial progenitor cells into the infarction region. ST activates stem cells by suppressing apoptosis and autophagy.
Up to 90% of all cases of erectile dysfunction are associated with organic disease, so it is necessary to have penile, vasculogenic, and other diagnostic methods. Diagnosis of vasculogenic erectile dysfunction is especially important for planning treatment. A comparative analysis of shockwave (ST) and pulse wave therapies (PWT) was performed for the treatment of erectile dysfunction (ED).
Recent advances in treating patients with vasculogenic ED have not only significantly increased the effectiveness and shortened the time frame, but also allowed such treatment methods to be used more and more widely. ABAT is a pulsed wave technology with the same stimulating effect on penile neuropathy, angiogenesis, neurogenesis, and vascular regeneration, while inducing fewer adverse and side effects related to the acoustic energy. It is the only non-invasive technology that uses pulsed wave technology. In addition, the mechanotransduction effect of pulse wave therapy allows for the use of AC waves for the very first time.
The purpose of the article is to compare the effectiveness of shock wave therapy and pulse wave therapy (Accelerated Bio-Activation Therapy) for the treatment of patients with vasculogenic erectile dysfunction. This article is the first to be published as a scientific study comparing the effectiveness of these two technologies that use different types of acoustic waves to treat patients with vasculogenic erectile dysfunction. The article presents the long-term clinical results after a single course of shock wave therapy (SWT) and a scientific study of the effectiveness of a game-changing technology for the treatment of men with vasculogenic erectile dysfunction – Accelerated Bio-Activation Therapy (ABAT).
An erection is initiated by excitement, either physical or mental, and involves the release of nitric oxide from the nerve endings associated with the corpus cavernosum (a type of endothelium) and the parasympathetic nerves that supply it. This then activates the guanylate cyclase enzyme in the vascular smooth muscle to produce cyclic monophosphate guanosine. In turn, this allows for the free diffusion of calcium ions within the cells, reducing the overall level of intracellular calcium, activating calmodulin, and promoting the release of nitric oxide, leading to the erection. This phenomenon is a product of a chain of biochemical reactions initiated by nerve impulses from the brain and genital areas. Once the desired state is achieved, the sympathetic spinal system is triggered, and the cavernous bodies are contracted under the influence of arteriolar resistance, like two sponge-like tissues. During this process, the neurotransmitter noradrenaline is released.
Erectile dysfunction (ED) is defined as the consistent or recurrent inability to attain and/or maintain a penile erection sufficient for sexual satisfaction and/or ejaculation. It can also be associated with insufficient rigidity of the penile tissue, premature ejaculation, reduced libido, and dysfunctional orgasm. Studies have shown that as many as 52% of men aged 40-70 years old suffer from erectile dysfunction, with a global prevalence of up to 28%. This can have a profound effect on a man’s self-esteem, emotional health, and interpersonal relationships, as well as the quality of life of his partner. It can lead to negative feelings of guilt, worry, depression, and symptoms related to stress.
Today there are two main representative types of the mechanism of erectile dysfunction treatment with SWT or PWT: the repair mechanisms. Even referring to the same shockwave effect, there is a significant difference in the SWT and PWT names that brings confusion to the community of urologists who are trying to use this method for erectile dysfunction treatment. At the same time, the physical characteristics of the waves produced by shockwave therapy or pulsating wave therapy are also different. Beyond the real clinical efficiency of SWT or PWT, we would like to know and emphasize their molecular mechanism of action. Therefore, we carried out a search of the various factors associated with erectile function and the treatment of erectile dysfunction in databases such as PubMed, Web of Science, Embase, Cochrane, China National Knowledge Infrastructure, Wan Fang Data, and Chinese BC Journal. All available English and Chinese literature published until September 2021 were included. We summarized the current understanding of the mechanisms of both therapies in the molecular and cellular aspects.
The purpose of this issue is to be aware of and compare the abilities of shockwave therapy (SWT) and pulsewave therapy (PWT) for the treatment of erectile dysfunction at the molecular and cellular level. The success of the treatment of erectile dysfunction with both methods was confirmed according to the results of numerous past studies, and many reviews were also published based on these studies. However, the molecular and cellular mechanism of the effect of SWT and PWT have not been fully elucidated. There are two main figures of the limitation faced by SWT and PWT: small number of clinical trials and absence of attention at the molecular and cellular level. The first one means that only a few controlled, randomized, longitudinal trials support the conclusion that SWT and PWT are more effective than placebo, and in general, only positive retrospective studies of the effectiveness of therapy are advertised more often than not. The second one means that it is quite interesting to be aware of the molecular and cellular effect that is the basis of positive clinical effects found.
Diabetes is also strongly associated with low levels of testosterone. Low levels of total and free (bioavailable) testosterone are related to many symptoms of sexual disorders in diabetes-affected males such as the low levels of sexual desire, low coitus frequency, and high levels of hypoactive sexual desire. The prevalence of erectile dysfunction can be three times higher in patients with diabetes compared to people who are not affected by this condition. However, the development of ED, because of the presence of diabetes, often occurs 10-15 years earlier in life. According to research, diabetes also has a significant impact on the incidence of cardiovascular diseases. About 70% of male patients who were affected by erectile dysfunction were found to have significant coronary artery disease when scanned for symptoms of coronary artery disease. There is also a significant correlation between diabetes and obstructive coronary artery disease. These data may be important because they highlight the necessity for a proactive search for coronary artery disease in diabetic males, especially those who showed symptoms typical of heart disease. According to research, about 30-70% patients with diabetes suffer from erectile dysfunction. Each of the aforementioned factors has an individual effect on the endothelium. However, it is common for ED to coexist alongside at least one of the aforementioned problem factors.
ED is often a secondary indication of major cardiovascular diseases. ED can be the most visible sign of silent or manifest heart disease. Endothelial dysfunction exacerbates many systemic diseases or combines diseases such as arterial hypertension, diabetes, metabolic syndrome, obesity, hyperlipidemia, smoking, and inactive lifestyle. Many reduction factors are established, such as the action of physiologically active substances of a process nature, which causes the dilatation or occlusion of the cavernous body and combined diseases that are exacerbated by psychosocial and environmental factors. It appears that the vasculature organ used for sexual activity is a vanguard of the atherosclerosis process. Erectile dysfunction may appear long before symptoms of heart disease, such as angina pectoris, myocardial infarction, or chronic heart failure. This may call the early care necessary to face these ischemic diseases. Dyslipidemia and diabetes are the two main causes of ED development. These phenomena are essentially related to the reduction of nitric oxide production in endothelia. Their production reduction action will create vasospasm or arterial stenoses. The relationship between testosterone, metabolic syndrome, and hypogonadism is not yet entirely established. However, some studies come to the conclusion that hypogonadism leads to metabolic syndrome increase in elderly people or in those already affected by some chronic disease.
Currently, the most commonly employed type of shockwave therapy for erectile dysfunction is the linear-focused electromagnetic type known as energy wave therapy for erectile dysfunction using the Cellstar and Aries medical devices, the Swiss-made Duolith device, and the device made by the Chinese company, Vasta Medical. The potential contradictory effects of electromagnetic shockwaves on the physiological systems in the tissue and subsequent possible generation of secondary pathological responses suggest the inclusion of information concerning how physically destructive or active that shockwaves may be in other therapeutic procedures, which differ from cell stimulation using lower energy levels that trigger biostimulatory effects. In that regard, another type of electromagnetically produced focused shockwave therapy, described also as linear shockwave source, in an erectile dysfunction treatment application, emits trigger impulses that differ from prior continuous shockwave generation found for piezoelectric devices.
The application of shockwave therapy for measures to restore erectile function originates from well-documented and successful clinical experiences in the use of shockwaves for treatment of urolithiasis. The original hypothesis is that those same physical mechanisms affecting the stone may also stimulate neovascularization and initiate processes to heal damaged and atherosclerotic tissues that can re-establish healthy sexual function. Various clinical and experimental studies implemented the hypothesis and the penis of an estimated 2,500 men so far has thus been exposed to the effects of shockwaves for treatment of their erectile dysfunction. These procedures have established variations in treatment protocols, including the parameters of shockwave intensity, numbers of shockwaves, duration and improvement of the effect, degree of patient discomfort, and emergence of adverse effects.
Electromagnetic shock wave therapy devices differ from the products based on the Marangoni liquid jets effect; the principles of their operation are similar to acoustic shock wave generators. Since the levels of tissue strain followed by the application of three types of EDSWTs are comparable, potential effectiveness is arbitrary: only the ability to provide a high level of passive tissue strain at the FFZ contributes. Their common limitation, increasing risk by inducing the cavitation effect, does not allow further raising boundary values (P+ = 100max), and thus the enhancement of efficacy and safety seem impossible. Therefore patient sensitivity might be the last safety factor, and potential discomfort seems to be the limiting point of EDSWT efficacy.
The working principle is based on non-elastic ‘loading’ of passive components of human tissues (collagen and elastin in particular) following the application of both acoustical and electromagnetic pressure waves. Acoustic shock waves penetrate up to 8-16 cm (focal size is 2-6 mm at pressure P+), whereas focused shock waves have a penetration of up to 12-20 cm within human axial tissues. Tissues located at an apex of a sound lens could be loaded by an unlimited amount of energy. The level of traction forces applied with a focused shock wave over 1-2 minutes is 1000-2000 times higher than forces necessary to achieve the same tissue distension during an extended period of a sexual act.
The first method of patient assessment was the use of questionnaires that were conducted before each cycle of 7 and 14 PW therapeutic procedures, 14-21 days and 6 months after the completion of therapy. Assessment of the results was made based on a general self-assessment of the condition based on the International Index of Erectile Function (IIEF-5). The degree and speed of the effect, as patients and doctors noted, are stronger and more clinically significant in the PW group than in the SW group. We established statistically significant differences between the two methods in favor of the PW group both in the beginning of treatment, at each of its stages, and on long-term terms. In general, this difference was 1.5 times.
Recommended Regimen
To achieve the optimal effect and to sustain the durable results, FSWTs are recommended to be administered in a series of 5 to 8 sessions over 9-12 weeks and are typically performed once weekly. After the initial sessions, patients are closely followed up and their progress is assessed. Additional sessions may be administered to yield further improvements or to sustain long-term outcomes.
Potential Benefit
Initially, studies of Men’s Clinics reported that potent and smooth erections will sustain for more than 12 months in patients with vasculogenic impotence. FSWT enhances neovascularization, increases smooth muscle cells, and increases cytokine/chemokine production and differentiation, with the overall result being a reversal of corporal fibrosis. It is presumed that FSWT restores the self-regenerating potential of the endogenous mesenchymal stem cells population over the long term. These benefits mainly address the aging population where, apart from atherosclerosis-suppressed nitric oxide release, there is a proliferation-suppressed baseline toward normal blood flow conditions.
Potential Limitation
Thus, chronic PDE5i users may appreciate the need to “detox” after achieving satisfactory erection and may discontinue for a period of 3-12 months based on the progress of treatment. In competitive sports, following treatment, one must check and make sure that no peptide hormones are washed into the body through the neovascularization process ever work as a controlled substance. Early termination or preventing further PDE5i medication usage with the hope of restarting at a future given date should be conveyed and well understood.
The shear stress imposed by LV-SWT increases the secretion of autocrine growth factors that could promote tissue remodeling. These data suggest there is a consistent pattern in the literature on the role of neurogenesis. The shock wave regenerated and rescues damaged nerves partly by increasing the expression of GAP-43, S100β, c-RET. Recent studies have shown that electroshock waves (EWS) also enhance endothelial cell activation, elevate endothelial NO levels by increasing eNOS activity, and induce transdifferentiation of smooth muscle cells (SMCs). In the supplementary bilaterally cavernosa of diabetic rats, a long-term effect of ESW or ESW combined with mesenchymal stem cells was observed, indicated by increased relaxation of corporal smooth muscle, increased expression of norepinephrine and VIP in nerve, recovery of the neurogenic ratio, and increased expression of VEGFalpha1.
The exact mechanism through which ESWT improves erectile function is unknown. Currently, it is believed that LV-SWT works through a mechanical vascularization effect as well as an angiogenesis effect. The mechanical shear stress that was generated by ESWT can increase the release of angiogenic growth factors necessary for a good recovery of the nerves and blood vessels damaged by radical pelvic surgery. This was consistent with our previous study, which demonstrated that ESWT was able to upregulate angiopoietin-1, VEGFR2, p-AKT, and NOS3 levels in radical prostatectomy-induced erectile dysfunction (RP-ED) rats. Also, other articles explained that low-energy shock wave therapy (LESWT) could result in the activation of telocytes by promoting secretion of extracellular vesicles from mesenchymal cells. Consequently, the levels of growth factors, such as SDF1, EGF, HGF, and VEGF-A, increased after ESWT treatment.
LSWT is a relatively widespread and well-studied physical effect. The authors mention some controversial points, such as the necessity of touch-sensitivity during the early treatment stage. Some clinical studies of PWT application in ED have been previously described and reported in the advanced phase of the trial. Seven in vitro cultured corporal tissues from patients were treated with PWT. PWT significantly improved the adenosine triphosphate release, which is believed to play a major role in mediating the effects of PWT. This study shapes the field of PWT application for ED treatment. The authors showed a significant improvement in the erectile response in a 28% penis arterial stenosis rat model, as well as a significant and dose-dependent decrease in penile apoptosis in a diabetes-induced erectile dysfunction rat model.
Efficacy studies compared low-intensity shockwave therapy (Li-SWT) and pulsewave therapy (PWT) effects on the erectile response in animals. Although the results of these preclinical studies showed that the peak pressure produced by shockwave devices is significantly greater than by pulsewave devices and that shockwave energy may result in more consistent vessel wall damage, the final conclusions are not well supported. Regardless of obvious dissimilar increments of pressure, the shockwave and pulse-wave devices had a significant difference in their therapeutic potential for cell repair joint to the animals’ injury with a minimum optical power of 0.25 W. It was also determined that PWT enhances the effect of peripheral nerve stimulation by broadband pulse currents and improves erectile function in patients due to smooth muscle and microvascular function enhancement. Deposition of peripheral nerve stimulation procedures gives the possibility to overcome the risk factors associated with the use of PDE5 inhibitor drugs and enables the use of PWT for complex ED treatment in patients.
The first method of patient assessment was the use of questionnaires that were conducted before each cycle of 7 and 14 PW therapeutic procedures, 14-21 days and 6 months after the completion of therapy. Assessment of the results was made based on a general self-assessment of the condition based on the International Index of Erectile Function (IIEF-5). The degree and speed of the effect, as patients and doctors noted, are stronger and more clinically significant in the PW group than in the SW group. We established statistically significant differences between the two methods in favor of the PW group both in the beginning of treatment, at each of its stages, and on long-term terms. In general, this difference was 1.5 times.
Recently, interest in mechanical technology, which includes shock wave therapy, high and low-intensity focused ultrasound lithotripsy, extracorporeal magnetic innervation, and others, has been growing. These mechanical technologies represent potential noninvasive means of influencing penile tissue and partial nerve regeneration and functional recovery in various pathophysiological conditions, including erectile dysfunction (ED). The lack of uniform treatment of patients with ED highlights the need to widen the therapeutic spectrum by introducing new less invasive methods. The use of the pulse wave therapy has expanded rapidly in modem medicine, especially with the advances in the scientific understanding of the biological variations related to the energy waves. Therapy with the use of the energy waves might be considered a good choice for patients in whom rapidness of treatment results should be combined with the noninvasiveness of the treatment itself.
In this research, we compared one of the best medical devices utilizing the technology of shock wave therapy with a developing painless technology called pulse wave therapy. The comparative work was conducted healthily on a group of 20 people, and the selected parameters were erectile function questionnaire, nocturnal penile tumescence, quality of erection, and penile Doppler examination. The results of the examined data revealed the similarity of these two different technologies in the treatment of erectile dysfunction. It was observed that the frequency applied in shock wave therapy is 60 or 36 Hz. However, the pulse wave therapy applied 3 Hz in this study. The clinical assessment of our study showed that pulse wave therapy is safe and well tolerated, and it is a useful and effective noninvasive treatment option for patients with erectile dysfunction. This study aims to evaluate and compare the efficacy of one session that lasts 20 minutes of shock wave therapy and pulse wave therapy in the treatment of erectile dysfunction. The result achieved in this treatment method shows that pulse wave therapy is a viable treatment option for patients who do not respond to the initial attempt of shock wave therapy and phosphodiesterase type 5 inhibitors.
So, it is easy to accept that the more developed technology is, the more advanced device can be. Then, it will make sense to have a comparison between top class technologies and the reply would not keep you waiting. It is necessary to say that it is unlikely to find a similar concept in this field, so it has the right to be initial in xo space. This concerns the using a piezoceramic effect and a gentle enough therapy for patients with erectile dysfunction. For sure, the ease of use, patient friendliness, the possibility of using in not expensive devices and others from the SW Lite family and capital invested are the technologies that can come into the implementation in the SW MSK ED.
In our previous publications, we described the main differences in technology of generating and damages to the emitting surfaces according to several quantitative features in Tiryaki and Tirsi Uro which was the next generation. Generally, this technology was based upon electrohydraulic effect for generation of the shock wave and bubbles collapse upon the treated surface for its damages. And while SW Lite is based upon piezoceramic effect for generating focused shock wave, it applies mechanical damages to the ceramic’s surface. Nowadays, Aries is the best example of the next generation of the electrohydraulic shock wave. This system is no doubt the lightest, the easiest to use, the fastest, the most bang for your buck in the history of medical devices.
After 4 weeks, despite none of the treatment modalities caused significantly different improvements compared with the sham group, a beneficial effect was still reported. In contrast to our perspective, Lee et al. stated that treatment of the Dornier device (Duolith SD1 T-Top, Dornier MedTech) led to significant improvement in the IIEF-15 and EHS scores, while the placebo group failed to show any improvements. Terlecki et al. published the results of a study with 147 men in the USA, with the goals of demonstrating the superiority of a higher energy level compared with a sham group with a higher number of shocks for the Tissue Ablation device (GainsWave; DirexGroup, Vernon Hills, IL, USA). Keskin et al. claimed that all ED patients treated with the Urogold 100, 300, and 500 Dornier device had significant improvements in the IIEF-EF scores at the first, second, and third months compared with the control (sham) group. The authors indicated that higher success rates were observed in the Urogold 100 group at the 1-year follow-up visit, which was significantly higher than the sham cohort. In contrast, the Urogold 300 and 500 groups showed no significant differences in outcome measures compared with the sham group on the first, second, third, 6th, and 12th months. Another Western single-center, randomized, and double-blind study performed by Alomran’s group with 128 men compared the efficacy of a placebo group with the Dornier device (Dornier ModS MTS, Dornier MedTech). No differences between the placebo and active groups were seen after 4 weeks of follow-up.
Large-scale multicenter randomized studies are indispensable because therapy efficacy and selectivity results might be affected due to the absence of control groups in the majority of published previous studies. Men’s health centers in Europe, Canada, and the USA are working in collaboration to overcome the aforementioned problems. The patients were included in the study if they had at least two International Index of Erectile Function (IIEF-5) scores of <21 in the six months preceding randomization. Patients with a penile curvature >45°, Peyronie’s disease symptoms, current priapism or a history of priapism in the last year, problems of penile anatomical deformity, known hypersensitivity of any of the used shockwave therapy devices, and coagulation disorders were excluded. The patients were randomized into three groups for treatment with one of three types of devices.
The aim of this work was the comparative analysis of shockwave therapy and pulsewave therapy in the treatment of erectile dysfunction. It was found out that patients experiencing organic erectile dysfunction showed the best results concerning the improvement of the genital organ blood supply, as well as the functions related to relaxation and the elastic properties of the cavernous bodies under the combined effect of the impulse and resonant energy. The proposed therapy can correct the penile reflexes, contributing to the normalization of the central and peripheral regulation systems. This type of therapy is safe and noninvasive. It helps to heal chronic post-inflammatory edema and connective tissue dysplasia of the genital organ, which stimulates the release of elastin and collagen fibers. The peptidase effects on bradykinin contribute to hemodynamic equilibrium and the improvement of the trophic status of the corpus cavernosum tissue. The body undergoing the shockwave-pulsewave therapy presents a high level of nitric oxide synthase, iNOS, the enzyme responsible for the vascular smooth muscle cell relaxation. The patient’s improvement in sexuality is achieved eight weeks after the beginning of the treatment, with a minimal contribution of rehabilitation medications. These techniques can successfully treat patients.
As penile hemodynamics are essentially the major discrepancy between physiologic and organic ED, we believe six treatments (or three sessions of Li-ESWT) might suffice. No major adverse events were reported in the 11 included trials, and apparently, ESWT and Li-ESWT are inclined to be safe. While Li-ESWT is increasingly suggested as the preferable form, the evidence revealed from sham-controlled trials so far is far from solid since no significant benefit of Li-ESWT over sham control were modeled. These implications should inform the policy-makers in decision-making concerning the prudent allocation of resources. There is also an urgent need to improve and harmonize outcome measures and time points. We recommend more high-quality sham-controlled trials of ESWT and Li-ESWT for vasculogenic ED that report response rates, cure rates, and adverse events.
This paper systematically reviewed the current evidence comparing the efficacy, tolerability, and safety of extracorporeal shockwave therapy (ESWT) and Li-ESWT with other interventions in men with ED. It identified eleven RCTs involving 877 participants. The current evidence suggested a potentially greater effect with ESWT and Li-ESWT on core outcomes, such as IIEF-EF domain and EHS as measures of efficacy compared with placebo (sham) control in men with vasculogenic ED. There is a need for future high-quality trials examining the effect of ESWT and Li-ESWT compared to current medications such as phosphodiesterase type 5 inhibitors (PDE5is), other ED therapies, and evaluating other outcomes such as response rate and curing ED at the last follow-up visit. Additionally, trials on Li-ESWT are also needed to compare the effect of different shockwave parameters, such as intensity, energy, and number of sessions.
Only a few randomized, prospective, and large-scale studies on shockwave therapy for the treatment of ED are available. Additional long-term studies covering the functionality and optimal patient therapy might also need to be performed. Possible results might include the development of new therapy protocols, possibly combining other therapeutic choices, such as PDE5 inhibitors, and the possible inclusion of therapeutic devices in the suggested post-RP erectile rehabilitation in case of nerve sparing. Further research on the possible role of shockwave therapy in the management of patients with Peyronie’s disease, chronic prostatitis, and general chronic pelvic pain is warranted, particularly in light of the poor therapeutic outcomes obtained by current standard therapies in these subjects.
Generally, it is declared that low-intensity shockwave therapy is one of several effective and noninvasive methods, both in terms of action and pleasure, that can be used to treat erectile dysfunction. The current guidelines indicate that shockwave therapy can be recommended only in specific clinical cases, such as Peyronie’s disease, particularly in cases where fibrosis has not completely developed. Evidence is scarce for these patient groups, highlighting the importance of future research in this field. Pulse wave therapy offers the added benefit over shockwave therapy in the same clinical indications by being more flexible in adjusting the shot movement to the patient’s pain threshold and generally causing less distress for the patient. Due to this improved performance, it can be used in a wider clinical context, which is useful for patients with contraindications or negative expectations regarding the use of PDE5 treatment. This broader flexibility will also be helpful for those subjects for whom the penile rehabilitation protocol is recommended, regardless of penile rehabilitation protocols. We believe that observing and measuring the therapeutic effects of pulse wave therapy, as well as its ease of implementation and efficacy, will soon be recommended by worldwide guidelines as the first therapeutic choice in the clinical context in which it is being studied.