EN
The development of comprehensive non-drug technologies to treat patients with male reproductive system disorders and erectile dysfunction is of social and medical importance. It is known that changing natural and mechanical physical factors provides a significant hemodynamic improvement, decreasing the condition severity in patients with andrological diseases.
Modern physical therapy methods and devices allow for local healing effects and contribute to the more rapid stroma restoration of the disturbed physiological equilibrium and the formation of intrinsic compensatory reactions.
Over recent years, several studies have been devoted to the effectiveness of shock wave therapy (SWT) for chronic pelvic pain syndrome.
Today’s physical therapy is most often based on the compatibility principles of various factors and the optimal integrated exposure. As a result, the combination of prescribed medications, vacuum magnetic therapy, vacuum laser therapy, and other methods have been developed to treat patients with erectile dysfunction.
Of all the developed general methods, transcranial exposure to magnetic fields is the most effective one. During transcranial PEMF treatment, the traveling magnetic field is used to provide a range of adaptogenic, hypotensive, and bio-synchronization actions. The majority of these actions target the hypothalamus, pineal gland, antinociceptive brain system, as well as other brain parts and regions.
As part of transcranial PEMF treatment targeting the hypothalamus, it regulates the immune and endocrine systems, bringing about positive effects on the rest of the systems through them.
The most intense response is observed in the hypothalamus, including the cerebral cortex, specific and non-specific thalamic nuclei, hippocampus, and reticular formation of the brain medium.
Under the influence of therapeutic dosages for nitric fields in the electrical activity of different brain parts, the occurrence of reactive increases synchronization numbers of spindles and slows waves. High sensitivity resistance to the magnetic field of the nuclei of the hypothalamus, the complementary functions of the higher vegetative center, and the secretory activity of the anterior of the hypothalamus all explain the complex pattern and systemic body response to the action magnetic field.
The magnetic field induced the stimulation and synchronization of production-releasing factors, and the secretory cells of the anterior hypothalamus led to the increased synthesis of tropic hormones.
The end link of this chain is characterized by the increase in the hormone production of adrenal glands (cortisol) and other peripheral endocrine glands.
It is also proven that low-intensity magnetic fields have an anesthetic effect caused by the stimulation of antinociceptive patterns, in particular. The release into the blood and cerebrospinal fluid, as well as the sedative action, has a positive effect on sleep and emotional patterns.
Material and methods
In 2018-2019, the Federal State Budgetary Institution National Medi-Qing Rehabilitation Research and Balneology Center carried out a prospective domiciled study, which included 40 patients with vasculogenic ED receiving outpatient treatment.
- Inclusion criteria: vasculogenic ED, infectious and inflammatory diseases, reproductive system in remission, aged from 20 to 70 years.
- Non-inclusion criteria: aged over 70, the acute inflammatory process in the urinary system, active and latent phases of the inflammatory process in the organs of the urinary reproductive system, complications of chronic inflammation, the injection process in organs, complications of the chronic inflammation genitourinary process, prostate adenoma (Stage II-III), the anatomic deformity of the penis, hypo- and epi-recession and the presence of penile prostheses.
- Physiological contraindications to physical therapy: infectious and sexually transmitted diseases, mental illness, acute and chronic stages of blood diseases, malignant neoplasms, acute and chronic renal or hepatic nighttime failure.
According to the simple randomization method, patients were divided into 2 groups. The 1st group included 20 patients who received only up to 7 UVT procedures. The 2nd group comprised 20 patients treated with the complex physical therapeutic effect: UVT for topical use and pulsed magnetic fields for transcranial use.
Before and after the course of treatment, patients did general blood and urine tests, underwent the analysis of the gland secretion, and were up for the measurement of total testosterone and endothelial vascular growth factor levels.
The state of the genital microcirculation was assessed using the LDF method with a laser capillary blood flow analyzer LAK-02 (Moscow). The probe was installed at the base of the head member. The blood flow was assessed for 3 minutes. Using wavelet analysis, we calculated the amplitude and frequency of E-rhythms due to the secretory activity of endothelium, N-rhythms, M-rhythms (myogenic oscillations), D-rhythms (respiratory fluctuations), and C-rhythms (cardiac vibrations).
Treatment methods
UVT Therapy: used on the right and left cavernous bodies and spongy body according to the following method:
- ü exposure frequency – 4 Hz
- ü level of exposure intensity – 3-4 stage
- ü number of pulses – 1500
The procedures were carried out 2-3 times per week, with 7 procedures per course.
No temporary interval transcranial procedures were performed.
PEMF therapy:
- induction – 10 mT
- frequency – 25 Hz
- exposure duration – 20 min
The procedures were carried out 2-3 times per week, with 7 procedures per course (using the Diamag device).
The average age of the patients being examined was 59.2 ± 8.7 years, with the duration of the disease around 4.1 ± 0.9 years. The severity of complaints and subjective clinical manifestations in patients with ED were evaluated using the ICEF-5 scale.
After transcranial treatment, the results showed that the average score increased by 41.3% for the first question regarding the reduction of spontaneous and adequate erections. Additionally, the positive results were identified (by 39.7%) in the answers to the second question, which addressed the adequacy and intensity of erections. When answering the question “How often do you maintain an erection during sexual intercourse?”, the average score increased by 45.2%. Response Analysis to the fourth question “How often do you have difficulty maintaining an erection?” and the fifth question “How often do you feel satisfied with sexual intercourse?” also showed the upward trend (by 47.2 and 40.1%, respectively).
As a result of the UVT course in conjunction with transcranial PEMF therapy, ICEF-5 questionnaire results increased by 5.08 (135.5%) point (p <0.05). In patients who received UVT treatment only, the total score improved by 3.18 points (120.8%).
An increase in the quality of the Goldstein scale erection was reported after the completion of UVT in combination with transcranial PEMF therapy by 30% in FDI, while the results were 20.5% in patients of the comparison group. In general, a more significant decrease in the severity of clinical symptoms was reported when studying the state of microcirculation before the treatment: the increased myogenic tone of arterioles (10.5 ± 0.4%) was reported in 69% of patients with ED, while the remaining 31% reported the results within normal values.
When it comes to the endothelial vibrations associated with nitric oxide (NO), which is released from the endothelium of blood vessels and plays an important role in physiological pressure regulation and flow distribution, the values were 28% (p <0.05) higher than normal. All patients showed an increase in cardiac and respiratory fluctuations in the total level of flax emotions.
After the first procedure and a course of treatment, the neurogenic tone of arterioles was improved in patients of the primary group, as evidenced by the decrease in the rate (An / 3σ · 100%) from 23.4 ± 0.6 to 19.2 ± 0.7% (p <0.001) and up to 20.1 ± 0.5% (p <0.01), respectively. An improvement in the endothelial function after the first procedure and SWT rate – AE / 3σ · showed 100% approximation to normal values: from 22.97 ± 1.2 to 16.7 ± 1.1% and up to 17.1 ± 0.9% (p <0.001), respectively.
After the first procedure, the indicator (Am / 3σ · 100%) for the myogenic tone of arterioles increased from 10.5 ± 0.9 to 17.9 ± 1.1% (p <0.001).
As a result of the treatment, most patients with ED have been found to improve the neurogenic tone of arterioles. The decrease was noted (AN / 3 σ · 100%) from 23.4 ± 0.6 to 19.2 ± 0.7% (p <0.001) in patients who were treated with UVT only after the first procedure and up to 20.1 ± 0.5% (p <0.01) after the course of treatment.
In patients of the 2nd group, this indicator ranged from 23.5 ± 0.6 to 18.1 ± 0.6% (p <0.001) and up to 19.1 ± 0.1% (p <0.001), respectively. An improvement in the epithelial function was reported. In patients who were treated with UVT only, AE / 3 σ · 100% decreased from 22.97 ± 1.2 to 16.7 ± 1.0% after the first procedure and to 17.1 ± 0.9% (p <0.001) at the end of the course of treatment. In patients of the 2nd group, this indicator changed from 22.87 ± 1.2 to 15.8 ± 1.0% after the first procedures and up to 15.9 ± 0.9% (p <0.001) at the end of treatment. The positive effects concerning the (AM / 3 σ · 100%) indicator and the bacteriologic myogenic tone of arterioles were observed in both groups after the first procedure and at the end of treatment. There was also a decrease in the stagnation of the vein, as well as the microcirculatory bed.
In general, LDF indicators were unidirectional in patients of both groups with ED changes. The decrease in the initially increased fiery tone of arterioles, which is indicative of the vasodilation of precapillaries, and an increase in functioning capillaries and nutrient active blood flow were reported. There was an improvement in the endothelial function, which also led to a decrease in peripheral resistance and precapillary vasorelaxation. Thus, the course application of SWT as a monofactor, and in combination with PEMF therapy, brought about a profound corrective effect on microhemodynamics.
The analysis of LDF data showed that the endothelial oscillations of blood flow were sensitive to physical factors. The improved endothelial function led to the reduction of peripheral resistance and precapillary vasorelaxation.
However, there was a more significant improvement in the neurogenic tone of CA arterioles in ED patients who were exposed to complex UVT and transcranial PEMF therapy, as compared to patients who received UVT treatment only.
The activity of the inflammatory prostate process in patients with ED and concomitant prostatitis (CP) was evaluated according to the microscopic examination of the prostate gland secretion. Any significant changes in the number of leukocytes and lecithin grains in the secretions of the prostate glands were not identified in 17 (85.0%) patients of the comparison group and in 16 (80.0%) patients of the primary group. Three (3) patients showed an increase in the average number of leukocytes from 16.7 ± 2.4 to 26.4 ± 2.9 (p <0.1). The number of lecithin grains in the prostate secretion after therapy remained virtually unchanged (p> 0.1) in patients of both groups. The average number of leukocytes in the prostate secretion after completion of therapy increased from 18.4 ± 4.4 to 30.5 ± 3.7 without affecting the pain syndrome (p <0.1) in 3 patients of the comparison group and 1 patient of the other group.
It is important to note that the number of red blood cells did not increase in any case, which proves the safety of UVT at the given exposure parameters. Statistically significant changes in the main indicators were not identified during the analysis of general clinical laboratory tests (blood tests, general urine analysis) in the observed patients receiving UVT treatment. This fact can also be regarded as evidence of the absence of injury or the impact of shock waves on the gland and urethra.
As a result of complex therapy, 11 (55.0%) patients of the primary group showed improved blood testosterone levels. With the UVT-only group, testosterone levels did not change that drastically in 15 (75.0%) patients. On top of that, average testosterone levels decreased from 25.61 ± 4.21 to 16.40 ± 3.45 mmol / L in 4 patients of this group.
In the primary group, testosterone levels increased from 11.71 ± 0.87 / l to 14.80 ± 0.55 N mol / l (p <0.05), whereas the following values applied to the comparison group: from 11.23 ± 0.46 to 12.78 ± 0.37 N mol / L (p> 0.05).
This tendency can be explained by the fact that transcranial PEMF therapy has a certain effect on the hemodynamics of the thalamo-pituitary system, leading to the neurohumoral action on the gonads and adrenal glands and stimulating the endocrine function. The tendency to reduce hormonal imbalance contributes to improved therapeutic effects.
Glycoproteins, endothelial growth factor vessels (VEGF), are produced by cells to stimulate the ligation of vasculogenesis (the formation of the embryonic vascular system) and angiogenesis (the growth of new vessels in the existing vascular system). The glycoprotein of the VEGF-A family has the most important role in the human body. It has the following functions: angiogenesis, endothelial cell migration, endothelial cell mitosis, methane monooxygenase, integrin activity αVβ3, the creation of gaps in blood vessels, the creation of pores in endothelial cells, chemotaxis for macrophages and granulocytes, and vasodilation.
As a result of UVT, 11 (55.0%) patients with ED in Group 1 reported an increase in VEGF-A from 104.5 ± 5.8 to 118.7 ± 4.9 pg / ml (p <0.1). VEGF-A also increased from 96.9 ± 6.1 to 117.2 ± 6.9 pg / ml (p <0.05) in 12 (60.0%) patients of the 2nd group after the completion of complex therapy, which may testify to the stimulation tissues of the penis.
According to the aggregate assessment of treatment outcomes in Group 1, the improvement was reported in 14 (70.0%) patients, while the lack of positive results was reported in 6 (30.0%) patients. Group 2 patients, who received the combined effects of UVT with transcranial PEMF therapy, witnessed the improvement in 17 (85.0%) cases, with only 3 (15.0%) cases having no results altogether. The worsening of the erectile function condition after the treatment was not recorded.
Therefore, the studies obtained evidence that UVT, in combination with transcranial PEMF therapy in ED patients, brings about a curative effect due to the increased oscillations of myogenic, neurogenic, and endothelial areas. The activation of local mechanisms regarding tissue blood flow and increased factor production vascular endothelial growth resulted in the adequate microcirculatory dilation, improved volumetric characteristics, increased blood transport function, elimination of hypoxia, and congestion in the venular and precapillary links.
UVT, despite the mechanical factor nature, does not have a negative effect on the tissues of the urethra and penis. The combined treatment with PEMF transcranial therapy increases the levels of general testosterone and vascular endothelial growth factor VEGF-A. As a result of the UVT course, coupled with transcranial PEMF therapy, the ICEF-5 questionnaire score increased by 34.1% (p <0.05) in patients with ED in comparison with those who received only UVT ( 20.7%). The improved hardness quality (Goldstein erection) was observed by 30.9% in patients of the primary group, with 20.5% in patients of the comparison groups. High clinical results of UVT in combination with transcranial PEMF therapy FDI are based on the compensation of local blood treatment, which helps make up for the deficient blood supply by improving the tone of the arterial vessels and eliminating venous stagnation, according to LDM. The decrease was initially only about the myogenic tone of arterioles, while there were the precapillary vasodilation and the increased number of functioning capillaries, as well as nutritive blood flow. In addition, after the combined treatment, including transcranial PEMF therapy, the level of total testosterone, which leads to the neurohumoral effects on suprarenal glands, rendered a stimulating effect on their endocrine function, in connection with which there is an improvement in clinical symptoms and the quality of life in patients with ED. The obtained findings indicate the feasibility of including transcranial PEMF therapy along with UVT in the treatment of patients with ED.