[Evaluation of long-term results of using the drug Fertiwell: impact on the likelihood of conception and pregnancy outcome].

INTRODUCTION: Current methods of treating male infertility have limited efficiency, since they are aimed to individual stages of the pathogenesis. Preparations based on testicular regulatory polypeptides are the most physiological and universal, owing to a complex effect on the self-regulation of testicular tissue. AIM: To study the delayed efficiency and safety of therapy with Fertiwell in patients with pathospermia and to assess the frequency of conception and pregnancy outcome in their partners based on the collection, analysis and interpretation of medical data. MATERIALS AND METHODS: A telephone survey of patients participating in the phase III clinical trial was carried out. The fact of conception in a couple was assessed over a period of 1 to 9 months after completion of therapy, as well as time from completion of the course to conception, pregnancy outcomes, newborn health outcomes. RESULTS: In the period from 1 to 9 months after completion of therapy, pregnancy occurred in 17 out of 34 couples (50%) in the Fertiwell group and in 13 out of 42 couples (30.95%) in the placebo group. This difference was statistically and clinically significant (p<0.05). All pregnancies resulted in a live birth. The median time from completion of the course to conception was 4 months in Fertiwell group and 6 months in the placebo group. There were no significant differences in anthropometric parameters of newborns between the two groups (p>0.05). CONCLUSION: When using the drug Fertiwell, pregnancy and live birth rate was significantly higher (2.23 times) compared to the control group. There was a trend toward earlier pregnancies in partners of men receiving Fertiwell. Thus, this drug can be recommended for the treatment of men with idiopathic infertility as monotherapy, as well as in combination with assisted reproductive technologies.

[Efficiency and safety of Prostatex in patients with chronic prostatitis/chronic pelvic pain syndrome. Results of the phase IV PRESTIGE trial].

INTRODUCTION: A large number of both preclinical and clinical studies demonstrates the efficiency of bioregulatory peptides for the treatment of prostatitis and chronic pelvic pain syndrome (CPPS). A relatively new drug in this group is Prostatex, the active ingredient of which is bovine prostate extract. AIM: To evaluate the effect of taking Prostatex on the intensity of CPPS, the sexual function, and the results of microscopy of expressed prostate secretions and urinalysis. MATERIALS AND METHODS: A cohort of patients aged 25-65 years with chronic abacterial prostatitis and complaints of chronic pelvic pain was analyzed. The abacterial type of prostatitis was confirmed by bacteriological examination of expressed prostate secretions. The patients received Prostatex for 30 days according to the following scheme: 1 suppository rectally 1 time per day. The follow-up was 30 days. Before starting the drug and at the end of the 30-day course, patients completed the Chronic Prostatitis Symptom Index (NIH-CPSI) and the sexual function questionnaire. In addition, urinalysis and microscopic study of expressed prostate secretions was performed. RESULTS: A total of 1700 patients were included in the study. While taking the drug, there was a significant decrease in pain during digital rectal examination, as well as in the intensity of pain as a symptom of CPPS. The severity of symptoms after treatment was lower in all domains of NIH-CPSI. Microscopic study of the expressed prostate secretions during treatment showed a decrease in the number of patients with excessive number of leukocytes. The sexual function improved, while urinalysis and microscopy of expressed prostate secretions returned to the reference values. CONCLUSION: The use of Prostatex for the treatment of patients with CPPS reduces the severity of pain and other symptoms of chronic prostatitis, increases sexual function and normalizes the expressed prostate secretions and urinalysis. In order to obtain data of a higher level of evidence, it is necessary to carry out randomized, blind, placebo-controlled studies.

[Assessment of the safety and efficacy of medicinal product PPR-001 based on regulatory polypeptides of the testes].

OBJECTIVE: Evaluation of the effectiveness and safety of the drug PPR-001 (lyophilizate) in comparison with placebo in men with impaired spermatogenesis. MATERIALS AND METHODS: This study was a randomized, double-blind, placebo-controlled, prospective, multicenter, parallel-group research. RESULTS: It was found that the drug has clinical efficacy and a positive effect on the concentration of spermatozoa in the ejaculate, the percentage of progressively mobile forms and the number of morphologically normal forms of spermatozoa was increased in the group of PPR-001. The primary end point was defined as a proportion of patients who had a therapeutic response (TO) at Visit 3. TO meant at least 20% increase in the concentration and/or progressive motility of spermatozoa compared to the baseline level. The hypothesis of Superiority of PPR-001 over placebo based on primary end point was confirmed (the limit of Superiority was more than 27%). In total, AEs were identified in 65 patients out of 100 (34 patients in the PPR-001 group and 31 patients in the placebo group). When assessing the number of patients who had AEs, there were no statistically significant differences between the groups. All identified AEs were of mild severity; during the study. No negative dynamics was found according to the results of the assessment of vital functions, biochemical and clinical blood tests, clinical urinalysis, ECG indicators. CONCLUSION: The study demonstrated the superiority of PPR-001 over placebo in terms of increasing concentration and motility of spermatozoa in the ejaculate. A significant increase in the number of morphologically normal forms of spermatozoa in the PPR-001 group was also revealed.

[Medical treatment of patients with benign prostatic hyperplasia with 5-reductase inhibitors].

The results of studies comparing the therapy of benign prostatic hyperplasia with 5-reductase inhibitors and 1-blockers are presented in the article. Benign prostatic hyperplasia is a common disease in older men. Pathogenetic treatment allows to block a progression of prostatic hyperplasia and is of greatest interest in the treatment of this disease. The obtained data reliably demonstrate the advantage and safety of long-term pathogenetic therapy with dutasteride compared with symptomatic tamsulosin monotherapy with regard to quality of life and subjective symptoms. In addition, pathogenetic therapy provides better results in preventing the progression of benign prostatic hyperplasia.

[Current opportunities for symptomatic treatment of dysuria].

Dysuria is the one of the most common conditions in urology. Although dysuria is not an independent disease, it accompanies a wide range of urological diseases of both infectious and non-infectious origin. Dysuria is traditionally understood as a feeling of discomfort, a burning sensation, or a sensation of pain during urination. Despite a significant reduction in the quality of life of this category of patients, pathogenetic treatment of the underlying cause is often performed in routine clinical practice, while the dysuria itself can remain without proper attention. The current possibilities of symptomatic relief of dysuria are reviewed in this article.

[Issues of spectrum and local sensitivity of E. coli in female patients with acute uncomplicated lower urinary tract infection a review of M. Seitz study and own observations].

RELEVANCE: Acute uncomplicated lower urinary tract infections (AULUTI) are one of the most common diseases in urological practice. The management of cystitis is commonly based on antibacterial therapy. Despite the high efficiency, inadequate prescription of antibiotics leads to an increase in microorganisms resistance. In light of these matters, the selection of antibacterial agents to which the sensitivity of bacteria is the highest is becoming increasingly challenging. AIM: To estimate the spectrum and local sensitivity of E. coli in patients with AULUTI. MATERIALS AND METHODS: The present study analyzed the results of bacterial culture sampled from 45 patients with AULUTI. The mean age of the patients was 44+/-17 years. All bacterial cultures were obtained in out-patient settings in the framework of a multicenter initiative study on the prevention of recurrent AULUTI with d-mannose. RESULTS: Microbiological studies of the urine of patients with AULUTI revealed the growth of E. coli in concentrations ranging from 104 to 107 CFU/ml. Assessment of sensitivity demonstrated 100% sensitivity of Escherichia coli to fosfomycin trometamol. CONCLUSION: According to the findings of microbiological studies, the patients with the AULUTI retain the highest sensitivity level of E.coli to phosphomycin trometamol, which allows it to be used as a first-line drug.

[Results of a comparative multi-center randomized clinical study of efficacy and safety of EFFEX Tribulus and Tribestan in patients with erectile dysfunction].

RELEVANCE: Erectile dysfunction (ED) is a common condition. Pharmacological management of ED involves medications produced by chemical synthesis. Despite high efficiency, their use is often accompanied by some side effects. Considering this, herbal preparations with sufficient efficacy and greater safety have received much attention. AIM: To compare the efficacy and safety of two herbal preparations (EFFEX Tribulus and Tribestan) based on Tribulus Terrestris herb dry extract in patients with ED. MATERIALS AND METHODS: A total of 173 patients were enrolled in the study, of whom 87 (group I) and 86 (group II) received EFFEX Tribulus and Tribestan, respectively. The mean age of patients was 42.2+/-11.5 years in group I and 42.8+/-11.2 years in group II. One hundred fifty two patients completed the study. The follow-up was 13 weeks (the herbal preparation dose was titrated at week five after the treatment initiation). The effectiveness of treatment was assessed on five follow-up visits using the IIEF, AMS, MSF, GAQ questionnaires, and a complex of diagnostic and laboratory studies. RESULTS: At visit five compared to visit 1, the mean IIEF erectile function domain score increased by 5.7+/-4.6 and 5.2+/-4.3 points in group I and II, respectively. In both groups, all other IIEF domain scores demonstrated a statistically significant increase. The AMS scores decreased from 32.93+/-10.04 to 25.02+/-7.62 points in group I and 31.78+/-10.37 to 24.55+/-7.31 points in group II. The SMF scores increased from 22.36+/-4.85 to 27.16+/-4.80 points in group I and from 22.13+/-3.69 to 26.10+/-5.69 points in group II. Besides, the use of the herbal preparations was associated with a decrease in the serum cholesterol level, more pronounced with increasing patient age (correlation coefficient -0.06, p=0.41). CONCLUSION: The herbal preparations EFFEX Tribulus and Tribestan have a similar efficacy and safety profiles.

[Endoscopic enucleation of the prostate: a short term trend or a new treatment standard?]

Endoscopic enucleation of the prostate (EEP) techniques such as HoLEP (holmium laser enucleation of the prostate), ThuLEP (thulium laser enucleation of the prostate) and electroenucleation (mono- or bipolar) are highly effective and safe. They have been endorsed by the latest version of the European Association of Urology guidelines as an alternative to not only open adenomectomy but also transurethral resection of the prostate (EAU Guidelines on Treatment of Non-neurogenic Male LUTS 2018). Therefore, many urologists face the possibility of replacing the treatments of BPH. In this article, we analyze the history of EEP techniques, both their pros and cons and, what are they today - just a popular trend or a new standard procedure for the surgical treatment of BPH?

[Comparative analysis of the effectiveness of various techniques of endoscopic prostate enucleation in a single center]. / Sravnitel'nyi analiz éffektivnosti razlichnykh metodik éndoskopicheskoi énukleatsii prostaty.

AIM: To compare electro- and laser enucleation (thulium, holmium) of prostate hyperplasia. MATERIAL AND METHODS: 693 prostate hyperplasia patients were enrolled. 489 patients underwent holmium enucleation (HoLEP), 51 - monopolar enucleation, 153 - thulium enucleation (ThuLEP). Prostate volume was 91.7 (50-250) cm3. There were no significant differences in preoperative variables between both groups (I-PSS, QoL, Qmax, residual urine volume) (p>0.05). RESULTS: Mean time of HoLEP was 97.0±42.2 min, monopolar enucleation - 112.9±36.3 min, ThuLEP duration was significantly less (77.4±36.3 min, p<0.01). An efficacy of all methods was confirmed in 6 months after surgery by significant (p<0.01) improvement of functional parameters (I-PSS, QoL, Qmax, residual urine volume). CONCLUSION: High efficiency of thulium and holmium enucleation allows to consider them as 'gold standard' of prostate hyperplasia management. Despite higher incidence of complications an efficacy of monopolar enucleation is comparable to that in laser techniques.

[Experience of using phytolysin in combination therapy of chronic cystitis in patients with urate nephrolythisis].

AIM: To evaluate the effectiveness of the herbal preparation Phytolysin in the comprehensive management of urate nephrolithiasis against the background of chronic cystitis exacerbation. MATERIALS AND METHODS: The study comprised 21 patients aged 19 to 57; 11 of them (the study group) received ciprofloxacin 500 mg once daily for 7 days, Phytolysin (for 1 month) and Blemaren (for 3 months), while 10 patients of control group were treated with antibacterial therapy and Blemaren. The clinical evaluation of the patients included laboratory testing and ultrasound imaging. RESULTS: The combination therapy resulted in a decrease in leukocyturia and bacteriuria. There was no tendency to relapse. The occurrence of relapse was identified by dysuria, urgent and frequent urination, suprapubic pain and results of laboratory testing (leukocyturia, bacteriuria >103) on days 15, 29, 57, 85 and 112 of the study. CONCLUSIONS: The findings suggest that the use of Phytolysin can be an effective and safe way to prevent exacerbation of chronic cystitis in patients with urate nephrolithiasis.

[Combination therapy for benign prostatic hyperplasia in the light of clinical guidelines].

The article reviews clinical trials on the effectiveness of combination therapy with 5-reductase inhibitors and -blockers in men with benign prostatic hyperplasia (BPH). These trials have demonstrated a significant improvement in the symptoms and quality of life in this group of patients. The authors outline main strategies offered by the Russian clinical guidelines for BPH patients.

[Current laser technologies for the surgical treatment of prostatic hyperplasia].

The first medical application of lasers dates back to the mid-60s of the XX century. Since then, laser systems have undergone significant changes. No longer a science fiction, lasers are used in many medical fields as an indispensable tool in the hands of the modern physician. The article outlines advances in laser techniques (from the idea of laser radiation to the modern laser systems used as effective surgical tools). We also present our experience in using laser surgical techniques in treating patients with prostatic hyperplasia.

[RATIONAL THERAPY FOR RECURRENT INFECTIONS OF THE LOWER URINARY TRACT. THE RESULTS OF A PROSPECTIVE OBSERVATIONAL PROGRAM TO ASSESS THE EFFECTIVENESS AND SAFETY OF CEFORAL®, SOLUTAB®* AND URO-VAKSOM® IN PATIENTS WITH RECURRENT UNCOMPLICATED LOWER URINARY TRACT INFECTIONS (FLORA)].

Remaining generally unchanged, urinary tract infection (UTI) treatment protocols require continuing monitoring due to growing antibiotic resistance and lowered immune status of the majority of patients. The article presents the results of a prospective observational program carried out the Russian Federation in to assess the effectiveness and safety of Ceforal®, Solutab® and Uro-Vaksom® in patients with recurrent uncomplicated lower urinary tract infections (FLORA). The results of the program suggest that Ceforal® Solutab® and Uro-Vaksom® administered as a part of routine clinical practice contribute to a significant reduction in the number of UTI recurrences and have a good safety profile. These findings support recommendation to use this treatment protocol in patients with recurrent UTI, taking into account individual and epidemiological features.

[REVIEW OF CLINICAL STUDIES ON COMBINATION THERAPY OF 5α-REDUCTASE INHIBITORS AND α1-BLOCKERS IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA].

The review presents the results of studies on combination therapy of 5α-reductase inhibitors and α-blockers in patients with benign prostatic hyperplasia (BPH). These data demonstrate a significant advantage of the combination therapy versus monotherapy in terms of quality of life and subjective symptoms as well as the safety, better results in the prevention of BPH progression and acute urinary retention, and reduced need for surgery.

[On prevention of post-surgery acute urinary retention].

The article highlights the issues of prevention of acute urinary retention after surgery. The authors present results of a study on the efficacy and safety of 1-blockers for the prevention of acute urinary retention after surgery. The results imply that the use of 1-blockers in pre- and postoperative period can significantly reduce the risk of postoperative ischuria, contribute to independent urination after a single urinary catheterization in patients who experience urinary retention, improve the postoperative period and promote recovery of patients.

[The results of the 10-year study of efficacy and safety of Serenoa repens extract in patients at risk of progression of benign prostatic hyperplasia].

The article presents the results of an open, noncomparative, observational study of the efficacy and safety of continued use of the Serenoa repens (prostamol uno) plant extract at a dose of 320 mg 1 time a day for 10 years in 38 patients with early manifestations of BPH and the risk of its progression. The results of study showed the absence of progression, both on subjective criteria (IPSS, and QoL scores), and objective criteria (prostate volume, the rate of urination, residual urine volume). Furthermore, patients had no undesirable effects directly related to the use of this drug.

[Efficacy and safety of use of likoprofit in patients with chronic prostatitis and prostatic adenoma].

The article summarizes the results of the clinical trials on application of likoprofit in patients with a chronic prostatitis and prostate adenoma, which were conducted by the Russian urologists for the last 8 years. Application of likoprofit in patients after TURP contributes to significantly earlier and effective restoration of microcirculation, which decreases the risk of development of postoperative complications and accelerates rehabilitation of patients. Studies in which likoprofit was applied in patients with a chronic prostatitis and prostate adenoma, proved that likoprofit also has antiedematous effect, improves the urination act, improves ejaculate parameters, positively impacts on sexual function, and has a high safety profile.

[Treatment of chronic prostatitis in prophylaxis of prostatic adenoma].

The results of a retrospective study of efficacy of prostamol uno in a standard single dose of 320 mg/day in prevention of chronic prostatitis recurrences and prostatic adenoma used for 5 years as an adjuvant to standard therapy of chronic prostatitis exacerbations were compared with those of standard course antibacterial and anti-inflammatory treatment alone. The analysis demonstrated that prostamol uno (Serenoa repens extract) in a dose 320 mg/day improves both subjective symptoms (data of IPSS, QoL scale) and objective ones (the absence of the disease progression and adverse effects, enhancement of the erectile function). Prostamol uno is effective for prevention of both recurrences of chronic prostatitis exacerbations and development of prostatic adenoma.