[Language, cultural adaptation and validation of the OABSS (Overactive Bladder Symptom Score) questionnaire in patients with overactive bladder].

AIM: To perform language and cultural adaptation and validation of the OABSS (Overactive Bladder Symptom Score) questionnaire among patients with overactive bladder (OAB), proposed as an effective tool for assessing the severity of symptoms and the efficiency of treatment in clinics of the Russian Federation. MATERIALS AND METHODS: In accordance with the protocols for carrying out such studies, the procedure of standardized forward-backward translation of the OABSS questionnaire was performed. Further, the intermediate Russian-language version was applied to 15 patients with subsequent correction of deficiencies and approval of the final Russian-language version of the questionnaire. In total, the study group included 176 patients of both sexes with OAB symptoms who filled out the questionnaire twice (test-retest) with an interval of 10-14 days. RESULTS: Based on the statistical analysis (Cronbach's alpha = 0.961), there was a significant degree of internal consistency of the sample. This fact is also supported by the very high retest reliability of the questionnaire (ICC >0.9). CONCLUSION: Our data showed that the Russian version of the OABSS questionnaire is a reliable and valid tool for subjective assessment of the severity of OAB symptoms.

[bobotulinum toxin A (Dysport) for the treatment of neurogenic detrusor overactivity].

Increasing of treatment efficiency in patients with neurogenic detrusor overactivity is an important medical and social problem. Its significance is determined not only by the high prevalence of neurogenic lower urinary tract dysfunctions, but also by the high risk of complications, among which an impaired renal function takes the leading place. Botulinum toxin therapy is considered as a second-line treatment and is carried out in case of insufficient efficacy, unsatisfactory tolerability or the presence of contraindications to anticholinergic therapy. Botulinum toxin therapy has been actively used in our country for more than 12 years. In 2022, abobotulinum toxin A (Dysport) was registered in the Russian Federation for the treatment of neurogenic detrusor overactivity. An overview of the results of clinical trials of Dysport, indicating its high efficacy and favorable safety profile, is presented in the article. The availability of botulinum toxin in the arsenal of a urologist, which has a high efficiency, opens up additional prospects for the treatment of patients with a neurourological profile.

[Epithelial protective therapy in comorbid diseases. Practical Guidelines for Physicians].

This document was produced with the support of the National Medical Association for the Study of Comorbidities (NASС). In 2021 the first multidisciplinary National Consensus on the pathophysiological and clinical aspects of Increased Epithelial Permeability Syndrome was published. The proposed guidelines are developed on the basis of this Consensus, by the same team of experts. Twenty-eight Practical Guidelines for Physicians statements were adopted by the Expert Council using the "delphic" method. Such main groups of epithelial protective drugs as proton pump inhibitors, bismuth drugs and probiotics are discussed in these Guidelines from the positions of evidence-based medicine. The clinical and pharmacological characteristics of such a universal epithelial protector as rebamipide, acting at the preepithelial, epithelial and subepithelial levels, throughout gastrointestinal tract, are presented in detail.

Primary myxoid leiomyosarcoma of renal pelvis: Case report and literature review.

Leiomyosarcoma arising from renal pelvis is a very rare disease. A patient was admitted to hospital with left renal colic due to nephrolithiasis, with a filling defect in renal pelvis that was considered to be a blood clot. Diagnosis of leiomyosarcoma was made after visual inspection and biopsy of the exophytic lesion. Laparoscopic radical nephrectomy was performed, histological and immunohistochemical investigation confirmed leiomyosarcoma with mixomatoid component. No adjuvant treatment was performed, the patient remains healthy 5 years after surgery without recurrence. Herein we provide literature review, discussion of the diagnosis and treatment scenario of the patient with renal pelvis leiomyosarcoma.

[Pharmacokinetic features of sildenafil spray in healthy men depending on food intake].

AIM: In order to evaluate the bioequivalence and benefits of a new dosage form of the type 5 phosphodiesterase inhibitor, sildenafil, two open-label studies in healthy male volunteers were carried out. MATERIALS AND METHODS: An open, randomized, crossover study to compare the pharmacokinetics after a single dose of sildenafil at a dosage of 50 mg on an empty stomach in a new spray form (test drug) and in a traditional tablet form (comparison drug) on 44 volunteers (18 to 43 years old) was done. To assess the effect of food intake on pharmacokinetics, an open, non-randomized study was conducted on 6 healthy male volunteers (from 23 to 35 years old) who received sildenafil (50 mg) after a meal in timely fashion: 1) spray, under the tongue, without drinking, 2) spray , in the mouth, drinking water and 3) the tablet form, drinking water. For pharmacokinetic analysis, blood was analyzed for 24 hours. Plasma concentration of sildenafil was determined by high performance liquid chromatography with tandem mass spectrometric detection (HPLC/TM/SD). The main parameters were the rate (maximum concentration; Cmax) and the degree of absorption (area under the pharmacokinetic curve "concentration-time" during the observation period; AUC0-t) after a single dose of drugs. In addition, the pharmacokinetic profiles of the bioavailability of sildenafil and its active metabolite, N-desmethyl sildenafil, as well as the safety of the different dosage forms, were evaluated. RESULTS: When comparing taking drugs on an empty stomach, the 90% confidence intervals (CI) of the ratios of the mean Cmax and AUC0-t values of sildenafil were 82-106% and 82-101%, respectively. An earlier achievement of the maximum concentration of sildenafil was detected when taking the test drug compared with the standard form (51 and 62 minutes, respectively, Z-value=-2.25, p-value=0.0244). In addition, it was shown that when taking Viagra after a meal, the determination of sildenafil in plasma was delayed (after 30 minutes) compared to the tested drugs (after 10 minutes), however, significant differences in Tmax between the dosage forms were not seen. In two studies, most adverse events were mild to moderate and resolved uneventfully. DISCUSSION: The bioavailability of the new dosage form, the sildenafil spray, is equivalent to the traditional form, however, it has an advantage in terms of onset of action. For example, when taking a spray, an earlier achievement of the maximum concentration of sildenafil and an earlier detection of sildenafil in plasma are shown compared to the traditional tablet form. CONCLUSIONS: Our results suggest that the new dosage form of sildenafil is a reliable alternative therapeutic option for the treatment of erectile dysfunction.

[Socio-economic aspects of neurogenic dysfunctions in urology].

AIM: to evaluate the medico-economic significance of neurogenic lower urinary tract dysfunction (NLUTD) in the Russian Federation, to calculate the economic burden of NLUTD in patients with targeted entities and to prepare suggestions for improving the methods of payment for the provision of medical care to patients with NLUTD in inpatient practice. MATERIALS AND METHODS: an analysis of the literature and an expert assessment of the prevalence of NLUTD in the Russian Federation were performed. Due to the various etiology of NLUTD, the following entities were considered: craniocerebral trauma, acute stroke, multiple sclerosis, spinal cord injury (hereinafter referred to as targeted entities), characterized by the highest rate of NLUTD and high social significance (damage to the working-age population): traumatic brain injury, acute stroke, multiple sclerosis, spinal cord injury. The calculations of the economic burden of NLUTD and its main complications (stage 5 of chronic kidney disease (CKD), urinary tract infection) in the Russian Federation (using mainly the normative method) were carried out, based on national statistics, regulatory legal acts and expert assessments of healthcare specialists. Proposals have been prepared for improving the reimbursement (tariffs of the KSG) for payment of NLUTD in the inpatient practice. RESULTS: according to the study, the number of patients with NLUTD due to the group of targeted entities is estimated at 910 000. The economic burden (excluding indirect and unaccounted costs) of the NLUTD is 33.3 billion rubles per year. The burden associated with secondary complications (stage 5 CKD, urogenital infection) due to ineffective diagnosis and treatment of NLUTD is 51.6 billion rubles. The total costs on the NLUTD is estimated at 84.9 billion rubles. Direct costs, calculated by the normative method based on the analysis of standards of medical care per patient are 36,546 rubles per year. Provision of medical care to patients with NLUTD in accordance with federal guarantees within the framework of the compulsory medical insurance is provided in accordance with the tariffs of KSG st30.005 (profile "urology"). The KSG tariff for 2019 (taking into account the established standards of financial costs for one case of hospitalization in the inpatient department and the established cost-intensity coefficients (CZ) established by the CG is 21,495.07 rubles, which is 58% of the minimum need, excluding the cost of treatment of complications, according to the normative method of calculation. The real estimate of the tariff for the payment of treatment of NLUTD in the constituent entities of the Russian Federation is 35-38% of the minimum need, excluding the cost of treatment of complications, according to the normative method of calculation. The real estimate of the costs for the treatment of NLUTD in regions is 35-38% of the minimum need, excluding the cost of treatment of complications, according to the normative method of calculation. To provide effective specialized urological care in the framework of compulsory medical insurance at the rates of the CSG for neuro-urological care (st30.005), expert calculations of the actual cost of NLUTD therapy were made. The proposed average cost of the CSG and the values of the cost intensity factors: CSG (min) st30.005.1 - 39,936 rubles, CZ - 1.65; CSG (max) st30.005.2 - 68,531 rubles, CZ - 2.75. The weighted average savings while expanding the availability of complex neuro-urological care for patients with NLUTD in accordance with the proposed payment rates is 9.4 billion rubles per year. CONCLUSIONS: Evaluation of the prevalence and burden of NLUTD showed the high medical and economic significance of NLUTD in the Russian Federation. The results of the study indicate a significant discrepancy between the requirements and the real costs within federal guarantees for the organization of medical care for patients with NLUTD. To provide effective specialized urological care in the compulsory medical insurance at the rates of CSG for neuro-urological care, it is necessary to increase funding, through the correction at the federal level of the cost-intensity coefficient from 1.65 to 2.75 for the CSG st30.005, which will ensure the increase in the cost for a case of treatment in inpatient department in form 39 936 to 68 531 rubles. The weighted average savings while expanding the availability of complex neuro-urological care for patients with NLUTD in accordance with the proposed payment rates is 9.4 billion rubles per year.

[Good urodynamic practice: consensus on the terminology].

In this publication a summary of the published manuscript "Good Urodynamic Practices and Terms 2016: Urodynamics, uroflowmetry, cystometry, and pressure-flow study" developed by a working group under the guidance of the Standardization Steering Committee of International Continence Society (ICS)1 is presented. The members of the working group were: Werner Schaefer, Gunnar Lose, Howard B. Goldman, Michael Guralnick, Sharon Eustice, Tamara Dickinson, Hashim Hashim and Peter F.W.M Rosier.

[Efficiency and safety of silodosin for treatment of lower urinary tract symptoms, associated of benign prostatic hyperplasia].

Benign prostatic hyperplasia commonly is the most common cause of bladder outlet obstruction and can result in storage and micturition symptoms in men older than 40 years. Nowadays the 1-adrenoreceptor antagonists are the first-line drug for treatment of the lower urinary tract symptoms (LUTS). However, 1-adrenoreceptors are known to be present in other tissues and this fact could be a reason of potential risk of adverse events, associated with changes in peripheral vascular tone, such as orthostatic hypotension, syncopal states, dizziness, etc., especially in patients of advanced age, and those affected by cardiovascular diseases and taking essential drugs. A highly selective -adrenergic blocker silodosin is characterized by a lower rate of mentioned adverse events, comparable with placebo. Silodosin is also highly effective in treating of both types of LUTS in these patients, both as monotherapy and in combination with other drugs. A detailed analysis of clinical data confirming the high efficacy and safety of silodosin is presented in this review of the literature.

[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.

[Ultrasound indicators of the prostate, urinary bladder and uroflowmetry parameters in the diagnosis of infravesical obstruction in men with benign prostatic hyperplasia].

RELEVANCE: Benign prostatic hyperplasia (BPH) is one of the most common urologic diseases of males. In patients who failed drug therapy of lower urinary tract symptoms (LUTS) caused by BPH, the most important indication for surgery is the presence of infravesical obstruction (IVO). IVO is detected by pressure-flow studies and is characterized by high detrusor pressure with decreased urinary flow rate. The invasiveness and high cost of this investigation has stimulated a search for non-invasive techniques that could reliably characterize the presence of IVO secondary to BPH. AIM: To determine the value of ultrasound indicators of the prostate, urinary bladder and uroflowmetry parameters in the diagnosis of IVO in men with BPH. MATERIALS AND METHODS: Seventy-six men with moderate and severe LUTS secondary to BPH underwent a comprehensive urological examination, including a clinical history, digital rectal examination, International Prostate Symptom Score (I-PSS), serum prostate-specific antigen (PSA), various ultrasound indicators of the prostate and urinary bladder, uroflowmetry and a pressure/flow study. RESULTS: Infravesical obstruction (IVO) was detected in 73.1% of men with BPH. IVO was found to have the strongest correlation with ultrasound signs of the intravesical prostatic protrusion (IPP, r = 0,667, p <0,05) compared with the prostate volume, prostate transition zone volume, prostate transition zone index, prostatic urethral angle, urethral length of the transition zone, estimated prostate circumference, prostate peripheral zone thickness, residual urine volume, weight of urinary bladder, the thickness of the detrusor, maximum and average urine flow rates and I-PSS score. The incidence of IVO increased in parallel with the increase of IPP. We established a cut-off value for IPP of 10 mm for the diagnosis of IVO with a sensitivity of 68.2%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 53.3%. CONCLUSION: The ultrasound findings of IPP measuring more than 10 mm strongly correlates with the IVO in men with LUTS and BPH as compared with other ultrasound parameters of the prostate, urinary bladder and urinary flow rates. The IPP is anatomical parameter that do not require urination, and is easily detected by both transabdominal and transrectal ultrasound. However, at the PPI values less than 10 mm, the main method for detecting IVO remains the pressure/ flow study.

[Intravesical prostatic protrusion in diagnosing infravesical obstruction in men with benign prostatic hyperplasia].

Infravesical obstruction (IVO) is an important characteristic of the functional state of male lower urinary tract. It is believed that IVO confirmed by pressure-flow study findings warrants switching from a medical to surgical management of lower urinary tract symptoms (LUTS). Intravesical prostatic protrusion (IPP) is a new indicator for detecting IVO secondary to benign prostatic hyperplasia (BPH). This indicator has several advantages over other non-invasive methods for evaluating IVO. The initial findings on the relationship between IPP and IVO suggest the feasibility of its clinical use as a screening tool in men with obstructive voiding symptoms.

[Comprehensive pharmacologic management of overactive bladder].

Overactive bladder (OAB) is a common and bothersome condition manifested by urgency, frequent urination, significantly impairing patients quality of life. The article presents an overview of the evidence on pharmacotherapy of neurogenic and idiopathic OAB. Selective M3 receptor blockers have been shown to be the medications of choice in treating these patients. Many studies have shown that solifenacin 10 mg is a starting dose for patients with OAB. Mirabegron (Betmiga) is the only 3-adrenergic receptor agonist approved for primary treatment of OAB patients refractory to anticholinergics or have their side effects. It seems promising to use this drug, both as monotherapy and concurrently with anticholinergic agents to improve treatment results in patients with idiopathic and neurogenic OAB.

[Transabdominal and transrectal ultrasound assessment of intravesical prostatic protrusion].

RELEVANCE: Benign prostatic hyperplasia (BPH) is one of the most common urological diseases among men. Despite the noticeable positive effects of pharmacotherapy on the quality of urination in BPH, the presence of an intravesical obstruction (IVO) leads to discontinuation of conservative treatment in favor of surgical interventions. One of the features of prostate enlargement is the degree of its intravesical growth (intravascular prostatic protrusion, IPP). According to some studies, IPP value of 10 mm or more is indicative of IVO in virtually all men. AIM: To compare transabdominal and transrectal ultrasound measurement of IPP in men with BPH. MATERIALS AND METHODS: The study comprised 108 men aged 69+/-10 years (43 to 93 years) with lower urinary tract symptoms and BPH. Patients underwent a standard urological examination. The shape of the prostate, prostate volume and the measurements of the IPP were assessed using transabdominal and transrectal ultrasound. RESULTS: The IPP measurements obtained using transabdominal and transrectal ultrasound were 9.8+/-5.7 mm (1.1 to 28 mm) and 9.3+/-5.3 mm (0.5 to 26 mm), respectively. The IPP measurements evaluated by transabdominal and transrectal ultrasound were found comparable regardless of the prostate volume. CONCLUSION: Similar results in assessing PPI by both ultrasound modalities allow them to be used equally effectively.

[Validation of urgency scale to detect and assess urgency in patients with overactive bladder].

INTRODUCTION: Urinary urgency is a hallmark symptom of overactive bladder (OAB). Several scales have been used to measure urgency. Taking into account the exceptional importance of these scales, it is important to determine their reliability, which depends directly on the accuracy of the wording and clarity to patients. AIM: To determine reliability of Russian-language translation of the Patient Perception of Intensity of Urgency Scale (PPIUS) in identifying and assessing urgency in patients with OAB. MATERIALS AND METHODS: The study included 50 patients (46 women and 4 men) aged 19 to 70 years (mean age 56.5 years). At the time of entering the study, all patients had symptoms of OAB and received anticholinergic therapy for at least 3 months with any drug approved for the use in Russia. PPIUS scale validation was performed by assessing reliability, absence of "habituation" effect of and indicators of convergent, divergent, and content validity. RESULTS: The Russian version of voiding diary with PPIUS scale was found to have good psychometric properties and besides the content validity also had significant signs of convergent and divergent validity. CONCLUSION: The Russian-language versions of urgency scales PPIUS and TUFS can be considered validated for using in clinical practice and in clinical and non-interventional studies in patients with OAB in Russia.

[High doses of trospium chloride in patients with idiopathic overactive bladder. Data of large-scale, multicenter observational program Resource].

PURPOSE: Evaluation of the efficacy and safety of different doses of trospium chloride in patients with idiopathic overactive bladder. MATERIALS AND METHODS: Large-scale observational program "Resource" included 669 patients with idiopathic OAB - 359 women and 310 men. At the first visit, all patients were assigned to use of trospium chloride at a standard dose of 45 mg per day. The results of treatment were evaluated during follow-up visits at 3, 6, 9 and 12 weeks. Depending on the results of examination, the dose was reduced in the presence of adverse events and increased in case of insufficient treatment effects. RESULTS: After 12 weeks, 102 patients have been receiving the drug at a dose of 30 mg/day, 241 - at a dose of 45 mg/day, 257 - at a dose of 60 mg/day, and 22 - at a dose of 75 mg/day. CONCLUSIONS: Individual approach to the selection of doses of trospium chloride in patients with idiopathic OAB can be quite effective and safe measure to achieve optimal clinical outcome with a good safety profile.

[NERVE GROWTH FACTOR IN THE URINE OF PATIENTS WITH IDIOPATHIC DETRUSOR OVERACTIVITY AND OVERACTIVE BLADDER WITHOUT DETRUSOR OVERACTIVITY].

The purpose was to determine the concentration of the neurotrophin nerve growth factor in urine to assess its possible role as a marker in the diagnosis of various forms of overactive bladder. The study included patients with urinary frequency and urgency: 21 patients with idiopathic detrusor overactivity, 18--with overactive bladder without detrusor overactivity and 11 healthy volunteers (control group). The level of nerve growth factor in the urine was determined in all participants of the study by the enzyme immunoassay (ELISA). In the control group the average ratio of nerve growth factor level to the level of urine creatinine was 0.2 ± 0.06, in patients with overactive bladder without detrusor overactivity -0.33 ± 0.06 (p > 0.05). In patients with idiopathic detrusor overactivity the rate was significantly higher and amounted to 6.04 ± 0.9 (p < 0.05). Therefore, measurement of the concentration of nerve growth factor in the urine may be used for differential diagnosis of the presence or absence of detrusor overactivity in patients with overactive bladder.

[INJECTION OF BOTULINUM TOXIN TYPE A IN THE BLADDER DETRUSOR AND SUBMUCOSA IN PATIENTS WITH OVERACTIVE BLADDER WITHOUT DETRUSOR OVERACTIVITY].

The objective of the study was to compare the efficacy and safety of injections of botulinum toxin type A in the submucosal layer of the bladder and in detrusor in patients who were refractory to anticholinergic therapy of overactive bladder without detrusor overactivity. 100 U botulinum toxin type A was diluted in 10 ml of 0.9% saline and injected with 0.5 ml (5 units) of this solution in 20 points of the bladder (the back and side walls except Letto triangle). In twenty-two patients (the first group) botulinum toxin was injected into the submucosal layer of the bladder, while in 34 patients (second group) - into the detrusor. In the first group after 1 and 3 months 3 (14%) patients and after 6 months 2 (9%) patients had positive treatment outcomes (improvement of symptoms in more than 50%). In 22 (65%) of the 34 patients of the second group positive results were observed at 1 and 3 months and in 17 (50%) - at 6 months. After 9 months, all patients had a relapse of urgent and frequent urination. Difficulties in emptying the bladder were observed in three (9%) of the second group patients who had to resort to periodic self-catheterization for 2-20 weeks. The obtained results allow us to state that the injections of 100 U of botulinum toxin type A in the submucosal layer of the bladder are ineffective in patients with overactive bladder without detrusor overactivity, whereas injections in the detrusor lead to a statistically significant improvement in symptoms of urgent and frequent urination for 6 months.

[Lower urinary tract symptoms in men].

Lower urinary tract symptoms (LUTS) are frequently encountered in clinical practice, especially in older men. The main focus in the primary treatment of men with complaints of violation of urination should be paid to assessing their severity on the basis of IPSS questionnaire. It is important to identify the predominant symptoms that determine treatment. In the absence of absolute indications for surgical treatment of clinical forms of benign prostatic hyperplasia (BPH), the drug treatment should be used. In cases of the prevalence of obstructive LUTS, first-line treatment is the use of alpha-adrenoblockers. In case of progression of BPH (prostate volume > or = 40 cm3, PSA > 1,5 ng/ml), it is useful to combine the alpha-adrenoblockers with 5alpha-reductase inhibitors. Combined medication in the form of alpha-adrenoblockers and M- cholinergic antagonists is justified in irritative LUTS in men with BPH.

[Long-term outcomes of the use of α-blockers tamsulosin in men with lower urinary tract symptoms and benign prostatic hyperplasia].

The retrospective evaluation of efficacy and safety of tamsulosin omnik (0.4 mg once a day) for 8 years in 17 patients with BPH and LUTS was performed. At the time of appointment of tamsulosin, mean age of patients was 61.9 years (range, 51 to 69 years). Efficacy of tamsulosin was evaluated based on the change of obstructive and irritative symptoms according to items of I-PSS scale, maximum urinary flow rate, residual urine volume and prostate volume. The study found that factors for favorable prognosis against the background of use of tamsulosin include moderate LUTS, small- or medium-sized BPH, maximum urinary flow rate of not less than 9 ml/s, and residual urine volume not more than 100 ml.

[Assessment of equivalence of the original tamsulosin and its generics].

Generics constitute a significant part of the modern pharmaceutical market. The use of generics in the case of their equivalence to the original drug allows to reduce the burden of health care costs. Often, however, the quality of generics does not match that of the original drug. The results of study suggest that the investigated generics of tamsulosin may not be fully recognized as pharmaceutically equivalent to the original drug.