[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.

[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.

[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.

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.

[ROLE OF KINETIC PERFORMANCE OF PSA IN SELECTION OF THE PATIENTS FOR CONDUCTION OF 11C-CHOLINE PET/CT AIMED TO REVEAL LOCAL RECURRENCES OF PROSTATE CANCER].

Given study was aimed to research a role of kinetic performance of PSA in selection of the patients for conduction 11C-choline PET/CT in order to reveal local recurrences in patient with prostate cancer after radiation therapy (RT) and radical prostatectomy (RP). The study included 185 patients with histologically distinctive prostate cancer and biochemical signs of tumor recurrence after RP (61 patients) or RT (124 patients). All the patients were examined using 11C-choline PET/CT in order to detect local relapses. Calculation of growth rate of the PSA level and PSA doubling time were made. According to results of 11C-choline PET/CT, recurrences of prostate cancer were detected in 124 out of 185 (65%). There were 22 patients out of 61 (36%) after RP and there were 102 patients out of 124 (82%) after RT. It was stated a correlation between PSA rates, growth rate of PSA level and presence or absence of relapse according to PET/CT results. PSA level and growth rate of PSA were indicated as the most significant predictive signs, which could influence on the selection of the patients for conduction of 11C-choline PET/CT in relation to detection of local recurrence after RT and RP.

[Determinants of risk of the development of erectile dysfunction in the Russian Federation: analysis of epidemiological studies].

According to the results of epidemiological studies of prevalence of erectile dysfunction in the Russian Federation, the search for the determinants of risk of its development was performed. It was found that the leading risk factors for the development of erectile dysfunction, in descending order of statistical significance, include the amount of accumulation of points according to the IPSS score, arterial hypertension, L(IPSS) quality of life index, age, diabetes, and overweight and obesity.

[Analysis of the results of epidemiological study on prevalence of erectile dysfunction in the Russian Federation].

With the aim of evaluation of prevalence of erectile dysfunction (ED) and other violations of the sexual function of men in the Russian Federation, anonymous questionnaire survey of 1400 men was performed. The study involved seven centers located in the most densely populated regions of the country. 1225 questionnaires were analyzed. It was found that ED symptoms were present in 1101 (89.9%) respondents. Age-related symptoms (by AMS questionnaire) were detected in 554 (45.2%) patients, most of whom were aged 45-59 years. The importance of active detection of ED in men, as it can be one of manifestation of a more serious disease, was demonstrated.

[Application of fibrinolysis inhibitor tranexam in transurethral resection of the prostate].

Prostatic surgery is often accompanied with increased intra- and postoperative bleeding which is caused, among other reasons, by enhancement of general and local fibrinolysis due to mechanical impact on prostatic tissue in operation. We proposed to inhibit enhanced fibrinolysis with preparation of tranexamic acid tranexam and tried it in 53 patients with prostatic adenoma undergoing transurethral prostatic resection (TUR). The comparison of bleeding severity in surgery with and without tranexam administration before, in and early after prostatic TUR showed that tranexam significantly lowers blood loss.

[Correction of erectile dysfunction in patients with chronic abacterial prostatitis].

A total of 76 patients with chronic abacterial prostatitis (CAP) in combination with erectile dysfunction were divided into two groups. Clinical symptoms of CAP and severity of erectile dysfunction were the same in both groups. Patients of the study group (n = 36) received pathogenetic treatment (vitaprost plus physiotherapy) and impase. The control group (n = 40) received vitaprost and physiotherapy. The results of the treatment showed that impase addition to combined treatment of CAP patients with erectile dysfunction significantly improves erectile function: 80.6% patients given impase raised their score by International Index of Erectile Function Scale to normal (26 points and higher). Impase efficacy increased with prolongation of the treatment from 4 to 12 weeks.

[Experience in phytotherapy in nephrolithiasis patients after extracorporeal shock-wave lithotripsy].

Our study of efficacy of Prolit-septo phytotherapy following extracorporeal shock-wave lithotripsy (ESWLT) in patients with nephrolithiasis has demonstrated that Prolit-septo noticeably reduces the time of evacuation from the urinary tract of the destructed stone fragments as well as renal colic incidence and renal inflammation exacerbation.

[Contact laser lithotripsy--an effective minimally traumatic method of treatment of cholelithiasis with calculi of the kidney, ureter and urinary bladder].

An experience with using contact laser lithotripsy is presented in treatment of such actual disease as cholelithiasis. This kind of modern minimally traumatic lithotripsy used in 73 patients has shown it to be effective independent of localization of the calculi: both in the urinary bladder and the kidney and ureter.

[Efficacy and safety of combined treatment of prostatic adenoma with 5-alpha reductase and alpha-adrenoblockers].

Pharmacotherapy of prostatic adenoma is based in present-day practice primarily on two basic groups of medicines--inhibitors of 5alpha-reductase and blockers of alphal-adrenoreceptors. Our trial included 98 patients with prostatic adenoma aged 59-79 years given combined treatment with finasteride (inhibitor of 5alpha-reductase) made in Hungary (prosteride, Gedeon Richter) and an uroselective blocker of alpha1-adrenoreceptors sonisin (Gedeon Richter, Hungary). Prosteride was given for 12 months, sonisine--for the first 6 months of combined treatment. Positive results were achieved in 97 (99%) of 98 patients. After 12-month combined treatment symptoms of the disease reduced by IPSS from 17.9 +/- 1.8 to 3.9 +/- 0.9 points, Qmax rose from 8.8 +/- 0.3 to 14.6 +/- 0.3, residual urine volume diminished from 91.7 +/- 8.5 to 31.7 +/- 4.4, the size of the prostate reduced from 72.4 +/- 2.9 to 50.6 +/- 3.7, quality of life improved 2-fold. Combined administration of finasteride (prosteride) and alpha1-adrenoblocker tamsulosine (sonisine) meet three principles of pharmacotherapy of prostatic adenoma: prevents progression of the disease and surgical treatment, relieves symptoms and improves quality of life.

[Finasteride preoperative preparation of patients with prostatic adenoma to transurethral prostatic resection].

Finasteride effect before transurethral resection (TUR) of the prostatic gland was studied in 88 patients with prostatic adenoma (PA). Forty seven patients received prosteride (Gedeon Richter), forty one patients - proscar (MSD) in a dose 5 mg/day for 3 months. Finasteride reduced blood flow in prostatic tissue, density of the vascular plexus, epithelium/stroma coefficient from 1.26 to 0.84. This decreased intraoperative blood loss, postoperative hematuria, TUR duration, postoperative rehabilitation, number of early and late TUR complications.

[Assessment of symptoms severity in patients with overactive bladder].

Symptoms severity was assessed in 533 patients with urinary bladder overactivity (mean age 56.4 +/- 0.6 years). All the patients kept urination diary for 3 days, some patients filled in KHQ questionnaire to find out quality of life, were examined urodynamically. Overactive bladder (OAB) symptoms were studied in 52 patients before and after 12 weeks of solifenacin treatment in a dose 5 mg/day. The statistical analysis identified three degrees of OAB symptoms. The severity was calculated according to the formula in points (S): S = 2 x number of urinations for 3 days + number of urges for 3 days + 1*(*--in the presence of urgent urine incontinence). In 62 points and less the diagnosis was "mild severity" of the symptoms (degree 1), in 63-80 points--"moderate severity" (degree 2), in 80 points and more--"great severity" (degree 3). Of 533 patients, 119 (22.3%) had symptoms of degree 1, 148 (27.8%)--of degree 2, 266 (49.9%)--of degree 3. The patients with more severe disease had more distinct changes in urodynamic indices and worse quality of life. Solifenacin treatment reduced severity of the symptoms in most patients treated. Before solifenacin administration degrees 1, 2 and 3 of the symptoms severity were detected in 12 (23.1%), 13 (25.0%) and 27 (51.9%) patients, respectively. After treatment--in 26 (50.0%), 16 (30.8%) and 6 (11.5%) patients, respectively. OAB symptoms were absent in 4 (7.7%) patients. Thus, it is shown that the proposed system of the system assessment reflects severity of OAB clinical symptoms, the degree of urodynamic disorders and deterioration of quality of life. This classification system can be used for follow-up assessment of OAB symptoms in the treatment process. It is simple and perspective for wide application.