[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.

[Infection of the lower urinary tract: new possibilities of herbal medicine].

The review article is devoted to using modern combined herbal remedies for the treatment and prevention of urinary tract infections. From current point of view, the mechanisms of the pharmacological action of the components of Phytolysin preparations, paste for the preparation of a suspension for oral administration and Phytolysin capsules, are described in detail. The pathogenetic explanations of using herbal preparations in urological patients is given. The results of clinical studies are presented, confirming the efficiency of the use of drugs for the treatment and prevention of lower urinary tract infections. The new dosage form Phytolysin in the form of capsules does not differ in composition from the paste. Pharmacological effects and pathogenetic bases for the use of Fitolizin suggest that the new dosage form (capsules) is identical to the traditional, previously used one (paste).

[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.

[Antiadhesive strategy for non-antibacterial prophylaxis of recurrent lower urinary tract infections].

INTRODUCTION: The importance of recurrent lower urinary tract infection (LUTI) is associated with its high frequency, a significant decrease in the quality of life and insufficient efficiency of currently available treatment methods. Due to the high antibiotic resistance of uropathogens, the role of alternative therapeutic strategies increases, including substances with antiadhesive properties. AIM: to evaluate the efficiency of a biologically active additive (BAA) "Ecocystin" containing D-mannose and inulin for the prevention of recurrent LUTI in women. MATERIALS AND METHODS: A total of 74 women aged 21 to 75 years (mean 47.4+/-13.6 years) with recurrent LUTI were included in the study. After the initial treatment of LUTI all the patients were divided into two groups. Patients of the main group (n=44) received BAA "Ecocystin", containing D-mannose with antiadhesive properties and inulin, which is a prebiotic, to prevent recurrence of LUTI. Ecocystin was prescribed 1 sachet packet 2 times a day for the first 3 days, and then 1 sachet packet 1 time a day for 6 months. The Ecocystin sachet contains 1.5 g of D-mannose and 1.5 g of inulin. In the control group (n=30) were not prescribed Ecocystin. Clinical indicators were assessed on the 3rd day, as well as after 3 and 6 months from the beginning of the study. RESULTS: During the first 3 months, recurrent LUTI were diagnosed in 51.7% of patients in the control group and only in 15.9% of patients in the main group (p=0.002). By the 6th month of follow-up, relapses were seen in 75.9% and 29.5% of patients, respectively (p<0.001). In the main group a significant increase in the time interval before the onset of recurrence was found. During the first three months of follow-up, the recurrence of LUTI in the main group developed on average after 43.4+/-14.3 days compared to 28.2+/-13.5 days in the control group (p=0.026). In addition, severity and duration of recurrent LUTI in patients of the main group were less pronounced than in the control group. CONCLUSION: Our results showed that Ecocystin is an effective drug for the prevention of recurrences in patients with recurrent LUTI. Considering antiadhesive properties of D-mannose, which is part of Ecocystin, this drug can be recommended as a pathogenetically justified alternative to the antibacterial drugs.

[Recurrent lower urinary tract infection in women: treatment and prevention].

INTRODUCTION: Antibiotics represent the main drugs for the treatment and prevention of recurrent lower urinary tract infections (UTIs). At the same time, there is no consensus regarding the duration of therapy and the interval between courses. MATERIAL AND METHODS: A total of 50 women aged 18 to 65 years (mean age 44.6+/-13.2 years) with recurrent lower UTIs in the acute stage were treated. All patients were prescribed fosfomycin trometamol (Fosfomycin Esparma, Esparma GmbH, Germany) at a dose of 3 g once every 10 days for 3 months. The changes of clinical and laboratory parameters were evaluated on the 3rd day after the first administration of fosfomycin, and then after 1, 3 and 6 months from the start of treatment. RESULTS: A decrease in the severity of clinical manifestations of cystitis was seen on the next day after first administration of fosfomycin. By the 3rd day, the ACSS score decreased from the initial 9.2+/-2.1 to 1.4+/-1.0 (p<0.001), while the average urinary frequency changed from 12.3+/-2.3 to 7.5+/-1.4 (p<0.05). After 3 months of therapy, the clinical results virtually did not differ from results on the 3rd day. The therapy was well tolerated; adverse events were noted in 10 patients, but they didnt result in discontinuation of the drug. During follow-up for 3 months after the completion of therapy, 47 (94%) women didnt have recurrence of lower UTI. CONCLUSION: the results of the study suggest a high efficiency and good tolerability of fosfomycin when it is prescribed according to specific scheme for the treatment and prevention of recurrent lower UTIs in women.

[D-mannose for prevention and treatment of lower urinary tract infection: pathogenetic basics and clinical results].

Non-antibacterial methods of prevention and treatment of lower urinary tract infection are described in the article. The current view on the mechanism of treatment effect of D-mannose is presented, which contributes to the prevention of bacterial invasion. Pathogenetic concepts for using D-mannose as specific antiadhesin or a competitive blocker of bacterial invasion is provided. In addition, we discussed the results of basic and clinical studies, proving the efficiency of D-mannose for prevention and treatment of lower urinary tract infection.

[Lower urinary tract symptoms in young adult men: analysis of prevalence, profile and relationship with metabolic syndrome risk factors].

AIM: To evaluate LUTS prevalence and characteristics of lower urinary tract symptoms in young men and to investigate the relationship between LUTS and metabolic syndrome risk factors. MATERIALS AND METHODS: One hundred and one male student (age between 19 and 29, mean 21,2+/-1,5 years) of St Petersburg universities (63 (62,4%) students of First State Pavlov Medical University and 38 (37,6%) students of National Research University Higher School of Economics) were anonymously questioned. Students were asked about their height, weight, metabolic syndrome risk factors and interviewed by I-PSS and QoL questionnaire. The obtained data was analyzed in order to find significant relationship. RESULTS: Lower urinary tract symptoms (I-PSS>0) were found in 84 (84%) men, mild and moderate LUTS - in 77 (77%) and 7 (7%) men, respectively. 39 (39%) men had both storage and voiding symptoms, storage only and voiding only symptoms were found in 31 (31%) and 14 (14%) students respectively. I-PSS score was higher in men with hypertension, diabetes, chronic stress and unmotivated fatigue (p=0,032, p=0,027, p=0,015 and p=0,003, respectively). In regression model (R2=0,268) I-PSS score was associated with diabetes (p<0,001), chronic stress (p=0,002) and hypertension (p=0,020). CONCLUSION: LUTS prevalence in young men is high. The relationship between LUTS and metabolic syndrome risk factors in young adult men can be considered as a reason for clinical investigation.

[Fosfomycin for treatment of uncomplicated lower urinary tract infection].

In this article the current data on using of antibacterial drug Fosfomycin for treatment of lower urinary tract infection are reviewed. The distinct features of pharmacodynamics and pharmacokinetics of fosfomycin, as well as the spectrum of its antimicrobial activity are thoroughly discussed. The current information on the resistance of uropathogens, including those that produce extended-spectrum -lactamase, are presented.

[Bladder hydrodistension in treating patients with interstytial cystitis/ bladder pain syndrome].

This study aimed to evaluate the effectiveness of bladder hydrodistension in the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS), depending on the duration of the procedure. MATERIALS AND METHODS: The study comprised 71 women aged 51.6+/-8.3 years with a 5.2+/-2.3 year history of IC/BPS. All patients underwent bladder hydrodistension (BH). Depending on the duration of BH, patients were divided into 4 groups. The distension time in group 1 (n=10), group 2 (n=20), group 3 (n=20) and group 4 (n=21) was 1 min, 2 min, 4 min and 6 min, respectively. The treatment effectiveness was assessed 1 month after BH by subjective assessment of patients, Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale questionnaire, a visual analog pain scale (VAS), and voiding diaries. RESULTS: At one month after BH, positive effect was observed in 32 (45.1%) patients. In groups 1, 2, 3 and 4 the treatment was effective in 20%, 55%, 45% and 47.6% of patients, respectively. Clinical effectiveness of BH with distension time of 1 min was significantly lower than that of 2, 4, and 6 min. At the same time, we did not find significant differences in the effectiveness of this procedure with distension time of 2, 4 and 6 min. CONCLUSION: The results of this study suggest that BH is an effective treatment in patients suffering from IC/BPS. At the same time, they show that the distension time of 2 min. is optimal from the point of view of clinical effectiveness, since the longer duration of the procedure is excessive, and the shorter time is insufficient.

[NefroCAPS phytolysin in complex management of women with chronic recurrent cystitis].

RELEVANCE: Recurrent lower urinary tract infections (UTI) in women are one of the most challenging problems of modern urology, which is associated both with their high incidence and increasing resistance of uropathogens to antibacterial drugs. Due to this fact, the phytotherapy of infectious and inflammatory diseases of the urinary tract has received increased attention. AIM: To investigate the effectiveness of Phytolysin nefroCAPS in the complex management of women with chronic recurrent cystitis. MATERIALS AND METHODS: 50 women with chronic recurrent cystitis underwent a complex examination. They were divided into two groups depending on the treatment they received. Patients of the 1st group (n=27) received a combination therapy: fosfomycin (monural) 3 g (single dose) and Phytolysin nefroCAPS one capsule three times daily for three months. Patients of the 2nd group (n=23) were administered a single 3-g dose of fosfomycin (monural). RESULTS: Follow-up examinations were performed 1, 3 and six months after initiation of the treatment. In patients of the 1st group, clinical manifestations of the disease disappeared earlier, and they had fewer recurrences than the patients of the 2nd group. Also, bacteriological study of urine showed a more persistent antimicrobial effect among patients of the 1st group. CONCLUSION: In patients with chronic recurrent cystitis, plant-based preparation Phytolysin nefroCAPS administered concurrently with an antibacterial drug is more effective than antibiotic monotherapy.

[Quality of life in patients with lower urinary tract symptoms after TURP for benign prostatic hyperplasia].

INTRODUCTION: To date, the gold standard for the surgical management of BPH is transurethral resection of the prostate (TURP). Most patients who undergo TURP for BPH experience immediate effects and complete relief of lower urinary tract symptoms and do not need further urological care. However, some patients after this operation have some level of persistent residual lower urinary tract symptoms, which may require additional therapy. AIM: To investigate voiding function and the need for medical therapy in patients who underwent TURP for LUTS due to BPH. MATERIALS AND METHODS: This study was performed as an anonymous survey among male patients presenting to a urology clinic. During the visit, the patients were offered to fill out I-PSS and SF-36 questionnaires. Also, they were asked about their socio-economic status, history of BPH, their perception of surgery and the postoperative period up to the day of the interview, presence or absence of symptoms of voiding dysfunction and any drug therapy at the time of the interview or after surgery. The patients also rated the severity of the symptoms using the IPSS questionnaire. The study comprised patients after 12 months to 3 years following successful TURP for LUTS due to BPH. A total of 1100 questionnaires were forwarded to researchers for interviewing patients who underwent TURP for prostatic hyperplasia. RESULTS: After collecting and reviewing all the questionnaires, 921 questionnaires were found eligible. The findings of the survey showed that a significant proportion of patients who underwent TURP require a long-term postoperative medical therapy. At the same time, in the Russian Federation, there are no standard approaches to medical management of this category of patients.

[Imidafenacin for treatment of overactive bladder and urgent urinary incontinence: the results of open-label multicenter randomized controlled clinical trial].

INTRODUCTION: The analysis of the results of a multicenter, open, randomized comparative phase III clinical trial on the use of imidafenacin for treating patients with OAB was carried out. A clinical study was conducted according to GCP standards in 12 urological centers of the Russian Federation with the support of company AO "R-Pharm". MATERIALS AND METHODS: A total of 296 patients (men and women) aged from 18 to 65 years with OAB and urgent urinary incontinence were included in the study. All patients were randomized into two groups. In Group 1 (n=148) patients received -cholinoblocker imidafenacin 1 tablet (0,1 mg) twice a day. Group 2 patients (n=148) were prescribed a comparison drug tolterodine 1 tablet (2 mg) twice a day, as well. The duration of treatment was 12 weeks. RESULTS: The analysis of results showed a significant decrease in the OAB symptoms in both groups. In Group 1 a decrease of episodes of urge urinary incontinence was more pronounce compared to Group 2, as well as amount of day-time and night-time of episodes of urge urinary incontinence by the 2nd, 4th, 8th and 12th weeks of treatment in comparison with baseline scores. There were no differences between two groups in the severity of reducing average urinary frequency per day. Reducing the severity of urinary disturbances in patients of both groups was accompanied by an improvement in the quality of life. There was a significant and similar decrease in the average total score of both OAB Awareness Tool and EQ-5D questionnaires. Tolerability of treatment was satisfactory in both groups and there were no differences in the adverse events in Group 1 and 2. CONCLUSION: Imidafenacin showed high clinical efficacy for treating patients with OAB, which is not inferior, and in some values, is superior in comparison to tolterodine. Both drugs had a similar safety and tolerability profile.

Prevalence and risk factors for erectile dysfunction and lower urinary tract symptoms in Russian Federation men: analysis from a national population-based multicenter study.

An analysis of prevalence and associated common risk factors of ED and lower urinary tract symptoms (LUTS) was performed in Russian Federation by cross-sectional multicenter survey. International Index of Erectile Function (IIEF) score and International Prostate Symptom Score (IPSS) were used for data collection in 1225 men between 20 and 77 years interviewed in six regions of Russian Federation. In addition, each participant's social, demographic, lifestyle, sexual and medical history was taken with special emphasis on risk factors for ED. Upon the basis of IIEF erectile domain score interpretation, ED was found in 530 (48.9%) men, consisting of mild and mild to moderate, moderate and severe ED in 375 (34.6%), 78 (7.2%) and 77 (7.1%) respondents, respectively. According to IPSS assessment, LUTSs were present in 649 (59.9%) responders; inclusive 370 (34.2%), 216 (19.9%) and 63 (5.8%) men with mild, moderate and severe LUTS, respectively. Men with both ED and LUTS shared common co-morbidities and lifestyle risk factors with age-adjusted odds ratio between 1.2 and 5.2. In logistic regression model (R(2)=0.361), the strongest associated with ED factor found was IPSS symptom score, followed by hypertension, IPSS-related quality of life, age, diabetes mellitus, obesity and unmotivated fatigue.

[The pathochemical characteristics of oligomeric forms of Tamm-Horsfall protein under urolithiasis].

The role of Tamm-Horsfall protein in pathogenesis of urolithiasis was analyzed. The study of oligomeric forms of protein was carried out using technique of dynamic light scattering. The sampling of 57 patients with urolithiasis and 51 patients of control group of comparative age and gender were examined. The degree of purification of Tamm-Horsfall protein was controlled using denaturant electrophoresis in polyacridine amyl gel. The reversing change of oligomeric form of protein with molecule size 2 Mda in polymeric form 28 Mda under impact of guanidinhydrochloride. Under urolithiasis, the form of protein associated with non-organic components and with size of macromolecular complex larger than 1500 nm was detected. The diagnostic criterion of urolithiasis was proposed based on totality of biochemical and biophysical analyses of urine.

EXPERIENCE OF 424 ROBOT-ASSISTED OPERATIONS IN ST-PETERSBURG: RADICAL PROSTATECTOMY, PARTIAL AND RADICAL NEPHRECTOMY.

The article presents the results of 257 robot-assisted radical prostatectomies, 135 partial nephrectomies and 32 radical nephrectomies at the period from 2010 to 2016. The operations were performed on robotic complex da Vinci S. The mean operative time was 170±50 min, 158,4±72,2 min and 143,3±67,3 min, the mean blood loss was 130±35 ml, 213,0±102,2 ml and 141,4±49,0 ml for robotic radical prostatectomy, partial and radical nephrectomy, respectively. The mean time of warm ischemia consisted of 13,1±2,7 min. Five-year cancer-specific survival rate was 100%, 100% and 98%. The overall survival rate was 97,5%, 87% and 92% for robotic radical prostatectomy, partial and radical nephrectomy, respectively.

[Litholytic therapy for urate nephrolithiasis].

AIM: To evaluate the effectiveness of ESWL combined with litholytic therapy in patients with uric acid kidney stones. MATERIALS AND METHODS: A total of 59 patients with urate nephrolithiasis were observed at the Department of Urology, First Pavlov SMU of St. Peterburg. The patients were divided into two groups according to the treatment regimen. The study group comprised 30 patients who were administered litholytic therapy before ESWL. The comparison group included 29 patients with nephrolithiasis who underwent ESWL without prior litholytic therapy. RESULTS: After 4 weeks of treatment with Blemaren, in 60% of patients of the study group a decrease in the calculus size was noted; in 83.3% of patients according to MSCT there was a decrease in calculus density. Disintegration of kidney stones after a single ESWL session was achieved in 86.7% of patients of the study group and in 65.5% of patients of the control group. CONCLUSION: The results of this study allow us to recommend a 4-week course of Blemaren to treat patients with urate nephrolithiasis to prepare for ESWL.

[SIGNIFICANCE OF DOPPLER-GRAPHIC RESEARCHES FOR DIAGNOSTICS OF PROSTATE CANCER].

An analysis of the Doppler-graphic results was made in transrectal ultrasound in 98 patients. Prostate cancer was detected in 44 cases. Priority zones for bioptic injection were determined. There were high probabilities of adenocarcinoma detection. The index of systolic speed of blood flow is significant for diagnostics.

[NEW METHOD OF PARTIAL NEPHRECTOMY WITH SELECTIVE PARENCHYMA CLAMPING].

The authors suggested a new method of performance of open, laparoscopic and robot-assisted partial nephrectomy using specially developed instruments for selective parenchyma clamping in order to improve the functional results of renal cell carcinoma treatment. The operation with clamping of renal vessels was carried out in 86 cases and clamping of renal parenchyma was used in 24 cases. It was shown, that the open, laparoscopic and robot-assisted partial nephrectomy could be safely performed in conditions of selective ischemia of the renal parenchyma without clamping of renal vessels.

[URINARY DISCOMFORTS IN PATIENTS AFTER RADICAL PROSTATECTOMY].

The authors showed the result of complication treatment of lower urinary tracts in 128 patients with localized prostate cancer. The patients underwent radical prostatectomy. Urinary discomforts included enuresis, urinary incontinence in postoperative period. Abnormalities of urine outflow due to urethral stricture were revealed in 6 (4,6%) patients by the 6 month after operation. These complications required surgical treatment. Urinary incontinence was noted in 20 (15,6%) patients in this period. It was stressful urinary incontinence in 16 (12,6%) and urgent - in 4 (3%). Patents with stressful urinary difficulty were advised to use the conservative treatment (pelvic floor muscle training and electrostimulation), but in case of inefficiency - surgical treatment.

[Prevalence of lower urinary tract symptoms among male population in Russian Federation: analysis of population study results].

The purpose of the present research is to study the incidence and severity of lower urinary tract symptoms (LUTS) in male population of the Russian Federation and to establish the relationship with the most common diseases. Based on the materials of population survey of 1083 men (mean age - 42,8±14,1 years) held in the Russian Federation in 2011-2012 the relationship between age, weight, height, sexual activity, addictions, co-morbidities and the answers to the questionnaire IPSS with the assessment of quality of life in relation with existing disorders of urination (QoL) was studied in six federal districts. 649 (59.9%) respondents had urinary system disorders (IPSS>0), the mean (±SD) of the sum IPSS questionnaire score was 5,0±7,0. LUTS severity was greater in: older men (τB=0,441; p<0,001); in men who had undergone surgeries of the pelvic organs (τB=0,242; p<0,001); in the presence of coronary artery ischaemic disease (τB=0,242; p<0,001), arterial hypertension (τB=0,255; p<0,001); diabetes mellitus (τB=0,154; p<0,001); obesity (τB=0,148; p<0,001); depression (τB=0,126; p<0,001); and sexual disorders (τB=-0,425; p<0,001). The prevalence of LUTS in men of the Russian Federation is high, their relationship with age and comorbidities require a comprehensive approach to prevention, diagnosis and treatment.