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Medispec
Omnispec ED1000
EDSWT
low-intensity shock wave therapy
EdSWT, that is low-intensity shock wave therapy - LI-ESWT, is a new treatment modality used for the treatment of organic erection problems commonly seen in men over the ages of 45-50. The potential benefits of this treatment modality are especially noteworthy compared to the use of performance-enhancing PDE5i medications (sildenafil, tadalafil) because LI-ESWT offers long-term or even therapeutic resolutions. Scientific and clinical studies about EdSWT are continued to be performed. Benefiting from EdSWT varies greatly depending on the severity and duration of erectile dysfunction (ED), the age of the patient; the presence and severity of diabetes, heart diseases, and hypertension, and the smoking status of the individual.
History of EdSWT:
EdSWT (or LI-ESWT) is a treatment modality that sends shock waves to the target organ (penis), aiming to generate restorative biological reactions at the cellular level. The first scientific publication about ESWT was published in 2010 by Vardi Y et al. in the European Journal of Urology. Later, many types of ESWT devices were introduced for use and many scientific studies were performed to investigate the use of these devices. Currently, there are over 30 scientific studies and over 2000 patient experiences available in the literature. However, it is agreed that the number of patients in these studies is low and there is still a need to conduct well-designed randomized controlled studies on large patient series. The most obvious point with an established consensus is the side-effect-free profile of EdSWT. No side effects have been demonstrated in association with the use of EdSWT on so many patients in 10 years of experience. Besides its use for the treatment of erectile dysfunction, LI-ESWT is used for the treatment of Peyronie's disease and chronic pelvic pain syndrome in urology practice.
Efficacy of EdSWT in clinical trials
It would be much more accurate to interpret the actions of EdSWT through review studies. The most important review study about this subject was published by Sokolokis et al. in the journal “The Journal of Sexual Medicine” in January 2019. A total of 10 randomized controlled trials (RCT) were included in that study. Naturally, RCTs are significantly reliable studies because these studies have at least two arms; a treatment arm and a sham group. Data obtained from a total of 872 patients with vasculogenic erectile dysfunction (ED) were examined. IIEF (The International Index of Erectile Function) scores increased by a mean value of +3.97 in patients undergoing ESWT. The likelihood of attaining an increase of ≥3 points in EHS (erection hardness score) was found 4.5 times higher with the ESWT treatment. The objective measures of the blood flow by ultrasonography demonstrated an increase of +4.12 units in the mean peak flow. In the conclusion section, EdSWT has been found effective in the treatment of vasculogenic erectile dysfunction (ED) and it has been stated that it can be recommended to patients as a first-line treatment option. Conditions affecting treatment success were determined to be the patient's age and the severity of the disease. It should be noted that Omnispec ED1000 device was used in 5 of the 10 RCTs included in this review study. Other devices of different trademarks were used in the other 5 studies. In this respect, the data obtained with the use of the Omnispec ED1000 device are more decisive for us to comment on the efficacy of the EdSWT treatment.
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Choosing the right patient for EdSWT:
The most important point is to identify the right patient to undergo EdSWT. Sexual activity and sexual problems essentially comprise an extremely complex infrastructure. Erection problems do not occur solely due to organic causes. Even if the onset of ED is triggered by organic factors, psychogenic factors or relation problems necessarily add to its manifestations. Considering sexual activity as the interplay only between the penis and the vagina is the biggest mistake that could be made at the beginning. If possible, sexual problems of the individual should be addressed in detail during a detailed anamnesis interview in the presence of the spouse. The factors aggravating erection problems and the associated secondary gains should be revealed. It would be a big mistake to make a diagnosis of an organic ED in all patients over the age of 45. We consider that this is the main factor underlying the failure of EdSWT. On the other hand, it is very important for the success of the treatment to motivate the patient with organic ED to engage him in the treatment, instill hope, and initiate some behavioral changes. When these are not possible, achieving solid treatment success will not be easy even in patients with improved blood circulation inside the penis. Those patients become demotivated over time and keep experiencing erectile dysfunction due to the fear of not attaining an erection. In summary, whatever the reason is, systematic investigation of factors that are potentially associated with erection problems and the provision of tailor-made solutions for the individual are critical to achieve treatment success with EdSWT. Relational problems and emotional dynamics should be reviewed besides organic pathologies. Psychogenic support should be provided to patients before and after the treatment when necessary.
Mechanism of Action of EdSWT:
Shock waves (SW) cause many effects to occur at the cellular level. These effects have been scientifically proven in non-human clinical trials. Every year, interesting pieces of information are added to the existing pile of knowledge. Shock waves create therapeutic effects on endothelial cells lining intravenous surfaces, smooth muscle cells, and even nerve cells inside the penis. EdSWT primarily induces vascular endothelial cells to produce growth factors called VEGF. Secondly, it increases the production and release of the enzyme NOS (nitric oxide synthase) and NO (nitric oxide). Consequently; vasodilation occurs, the formation of new vessels (neovascularization) is induced, and the regeneration of internal structures of blood vessels begins. Thirdly; shock waves activate stem cells, too, causing them to accumulate in the areas of injury and be transformed into healthy and young muscle and vascular cells. Over time, rigid collagen fibers in the muscle tissue are replaced by flexible elastin fibers. Fourthly, inflammatory cell reactions and oxidative stress levels are alleviated in the penile tissue. Finally, shock waves are involved in the restoration and repair of nerve cells. In summary; EdSWT allows for the rejuvenation and restoration of the entire system in the penis, directing them to a healthy way of regeneration. These are all objectively measurable effects proven in scientific studies.
EdSWT with Omnispec ED1000 device
The major reason for obtaining different results about the efficacy of EdSWT is the use of different devices utilizing completely different energy sources. Moreover, the way of energy emission by those devices and the treatment protocols used in those studies are different between studies. In conclusion; many undefined and intertwining factors come into play, increasing the confusion about the benefits of treatment. Mednispec's Omnispec ED1000 device is the most widely used brand in clinical practice. It is equipped with an electrohydraulic generator that sends energy focused to the target organ. The treatment protocol includes 2-3 sessions of therapy per week with 1500 beats at each session. After the first 6 sessions followed by a 3-week interval, the remaining 6 sessions are applied. In total, 12 sessions are performed with a total of 18,000 shock waves applied to patients. Scoring is made after one month of treatment to test the treatment efficacy. This is the protocol that we exactly use in our clinic, achieving quite satisfying results.
Maintenance of EdSWT Treatment Success:
Another curiosity arising issue is the length of time during which the benefits obtained by EdSWT are maintained. An important study about this subject was published by Kitrey et al. in the Journal of Urology in 2018. Kitrey et al. reported that 76% of patients continued benefiting from the treatment after 2 years when they suffered from ED of mild severity. When that ratio is calculated by including all patients in the study population, a rate of around 53% is found. In patients with severe ED, recurrences occur in more patients and they are observed earlier. Therefore, it is concluded that mild and short-term ED is associated with a higher likelihood of obtaining long-term benefits from EdSWT.
Who should not undergo EdSWT:
The main indication for the use of EdSWT is vasculogenic erection problems. EdSWT does not provide any benefits in psychogenic, neurogenic or hormonal ED. Therefore, diagnostic tests should be performed well. The success rates with EdSWT are very low in individuals; who underwent pelvic surgery or radiotherapy or who have serious anatomical problems in the penis. Naturally, it will not be possible to foresee success rates in men with no sexual partners. Psychogenic causes should be investigated in ED with an abrupt onset. In summary, the primary criteria for attaining treatment success with EdSWT are to have the diagnosis of vasculogenic ED and to investigate concomitant diseases that might exist in the patient.
Success rate and criteria with EdSWT:
Success is often a subjective concept. If we draw conclusions based on symptom scores (IIEF, EHS), we can say that EdSWT is successful in 50-70% of patients in general. What we mean by success is described as follows: To increase the erection quality of the patient to a level (EHS ≥3) that will enable to complete the coitus (sexual intercourse) adequately without the use of PDE5i medications; or to enable sexual intercourse with the use of PDE5i medications for patients, who were unable to do so previously. In other words, obtaining treatment response in drug-unresponsive patients indicates a significant success. Another major treatment target is undoubtedly to eliminate the need for using PDE5i drugs. Also, we can easily measure objective success parameters by using penile Doppler ultrasonography. A significant increase in Peak Systolic Flow (PSV) values compared to pretreatment data as evidenced by penile Doppler ultrasonography documents that considerable improvement has been achieved.
Conclusion:
EdSWT, or shock wave therapy, is definitely a very valuable and effective treatment option when applied to the right patient. We observe the effectiveness of EdSWT in our clinical practice in many of our patients with vasculogenic erection problems. EdSWT should be performed in experienced clinics under the supervision of a urologist. The main principle for obtaining successful results is undoubtedly the selection of the right patient.