Autologous Slings in Female Stress Urinary Incontinence Treatment: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION AND HYPOTHESIS: The aim of this study is to evaluate the efficacy and safety of autologous fascial slings (AFS) compared with other surgical methods for female stress urinary incontinence (SUI) treatment. METHODS: The search was performed on studies published before September 2023 to identify articles assessing the effectiveness and safety of AFS compared with other surgical methods in female SUI. Inclusion criteria were randomized controlled trials (RCTs) and adult women with SUI. Exclusion criteria were other urinary incontinence types, combined pharmacological treatment, pregnancy, and lactation. This systematic review was conducted according to the Population, Intervention, Comparison, and Outcome framework, Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 checklist, and was registered in the Prospective Register of Systematic Reviews. RESULTS: Twenty RCTs were included in the systematic review and 10 RCTs in the meta-analysis. Comparison between AFS and synthetic midurethral slings (SMUS) did not show any statistically significant differences in the cure rate, frequency of urinary retention, or self-catheterization. SMUS showed more long-term postoperative complications (RR = 0.12, 95% CI: 0.03 to 0.50, p = 0.004), AFS had more in de novo urgency cases: (RR = 2.84, 95% CI: 1.13 to 7.10, p = 0.03). Operation time of SMUS was lower: (RR = 2.87, 95% CI: 2.56 to 3.19, p < 0.00001, I2 = 97%). SMUS showed significantly lower hospital stay duration: (RR = 1.92, 95% CI: 1.44 to 2.41, p < 0.00001). CONCLUSIONS: In this systematic review and meta-analysis, autologous slings demonstrated the same efficacy in comparison with SMUS in the management of SUI in women. AFS showed lower incidence of long-term postoperative complications. SMUS demonstrated lower operation time, hospital stay and de novo urgency.

Adjustable slings versus other surgical methods in female stress urinary incontinence: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to evaluate the efficacy and safety of different adjustable slings compared to other surgical methods for the treatment of stress urinary incontinence (SUI) among women. METHODS: The inclusion criteria were as follows: randomized controlled trials (RCTs) and non-RCTs assessing adult women with SUI. The exclusion criteria were as follows: other types of urinary incontinence, studies that combined conservative interventions and pharmacological treatment, pregnant and lactating patients. Databases were searched up to November 2022 to identify articles evaluating the effectiveness and safety of different adjustable slings compared to other surgical methods for the treatment of SUI among women. The systematic review was conducted in accordance with the PRISMA 2020 checklist and registered in PROSPERO. Risk-of-bias assessment tools recommended by the Cochrane Society were used to evaluate the risk of bias in the included studies. RESULTS: Eighteen clinical trials were included in this systematic review, and 11 studies were included in the meta-analysis. Fourteen studies were RCTs, and four were retrospective studies. Only RCTs were included in the meta-analyses. There was no statistically significant difference in the objective cure rate, subjective cure rate, or long-term postoperative complication rate between Ajust single-incision mini-slings (SIMS) and standard mid-urethral slings (SMUS) or MiniArc SIMS. However, the operation time in the adjustable SIMS group was significantly shorter (RR = -4.20, 95% CI: [-7.51, -0.89], p = 0.01). CONCLUSIONS: This systematic review and meta-analysis revealed that adjustable SIMS is equally effective when compared with SMUS for the treatment of SUI among women. Moreover, the operation time for the adjustable SIMS was shorter. However, additional well-designed studies with standard outcome measures and complete follow-up periods will help to increase confidence in the choice of different options for treating SUI among women.

Autoimmune Effect of Antibodies against the SARS-CoV-2 Nucleoprotein.

COVID-19 caused by SARS-CoV-2 is continuing to spread around the world and drastically affect our daily life. New strains appear, and the severity of the course of the disease itself seems to be decreasing, but even people who have been ill on an outpatient basis suffer post-COVID consequences. Partly, it is associated with the autoimmune reactions, so debates about the development of new vaccines and the need for vaccination/revaccination continue. In this study we performed an analysis of the antibody response of patients with COVID-19 to linear and conformational epitopes of viral proteins using ELISA, chip array and western blot with analysis of correlations between antibody titer, disease severity, and complications. We have shown that the presence of IgG antibodies to the nucleoprotein can deteriorate the course of the disease, induce multiple direct COVID-19 symptoms, and contribute to long-term post-covid symptoms. We analyzed the cross reactivity of antibodies to SARS-CoV-2 with own human proteins and showed that antibodies to the nucleocapsid protein can bind to human proteins. In accordance with the possibility of HLA presentation, the main possible targets of the autoantibodies were identified. People with HLA alleles A01:01; A26:01; B39:01; B15:01 are most susceptible to the development of autoimmune processes after COVID-19.

Pentosan polysulfate in patients with bladder pain syndrome/interstitial cystitis with Hunner's lesions or glomerulations: systematic review and meta-analysis.

Background: Bladder pain syndrome/interstitial cystitis (BPS/IC) is a persistent pain perceived in the urinary bladder region, accompanied by at least one symptom, such as pain worsening with bladder filling and daytime or nighttime urinary frequency without any proven infection or obvious pathology. The aim of this study is to evaluate the efficacy and safety of pentosan polysulfate (PPS) in patients with BPS/IC. Methods: Systematic search was performed by PRISMA checklist. Electronic databases, including PubMed and Cochrane library, were checked until 2021 using keywords: 'pentosan polysulfate', 'pain syndrome', 'interstitial cystitis', and bibliography of relevant papers was checked. Inclusion criteria: Patients with confirmed diagnosis of BPS/IC and cystoscopy criteria - Hunner's lesions. Exclusion criteria included hypersensitivity, pregnancy, lactation, and oral therapy for BPS/IC in the period of 1 month before the study and abstracts or unpublished papers. Results: In total, 13 clinical trials were included in systematic review and 7 were included in meta-analysis. Studies evaluated the effectiveness and safety of oral PPS versus placebo or other treatment options. In the first meta-analysis, three studies compared oral PPS with placebo: [relative risk (RR) = 2.07, 95% confidence interval (CI): 1.37-3.13, p = 0.0006]. The second meta-analysis of two studies compared oral PPS with another treatment options (intravesical liposome and CyA): (RR = 0.44, 95% CI: 0.10-1.93, p = 0.28). The third meta-analysis of two studies included intravesical regimen of PPS compared with intravesical placebo: (RR = 1.09, 95% CI: 0.54-2.22, p = 0.80). The majority of studies do not report any particular serious side effects. Conclusion: PPS treatment has a statistically significant effect over placebo on the subjective improvement of patients with BPS/IC. There was no difference between PPS and other treatment options. Intravesical regimen of PPS had no significant impact on response rates. None of included studies reported severe side effects after intervention.

Anatomical and functional outcomes of non-obstetric urogenital fistula repair.

INTRODUCTION AND HYPOTHESIS: Studies on non-obstetric urogenital fistulas (NOUGFs) provide limited information on predictive outcome factors. This study was aimed at specifying and analyzing the risk factors for long-term anatomical and functional results. METHODS: A cross-sectional study of surgical repair for non-obstetric urogenital fistula was performed. From 2012 to 2020, a total of 479 patients with urogenital fistulas were treated in two tertiary centers. Patients with isolated ureteral fistulas and rectal injuries were excluded. For evaluation of the long-term results, patients with vesicovaginal and urethrovaginal fistulas with at least 12 months of follow-up were identified and contacted by phone and/or examined in the clinic. The anatomical outcome was assessed by resolution of symptoms and/or clinical examination. The Urinary Distress Inventory (UDI-6) was used for the functional outcomes. RESULTS: Overall, 425 patients were studied (mean age was 49.8; BMI 27.5; mean fistula size 1.4 cm, mean follow-up was 12 months). Vesicovaginal fistula affected 73% of patients. Hysterectomy without radiation was the most common etiology (66.3%), followed by hysterectomy with subsequent radiation (16%) and pelvic radiotherapy (12.2%). The transvaginal approach was used in 54.4%, abdominal in 12.4%, transvesical in 22.4%, and a combined approach in 10.8%. The successful closure rate was 92.9% for primary cases, 71.6% for secondary cases, and 66.7% for radiation fistulas. A high risk for relapse was found for NOUGFs with ureteral involvement (RR 2.5; 95% CI 1.3-4.5; p = 0.003), radiation fistulas (RR 2.1; 95% CI 1.3-3.5, p = 0.003); and combined radiation and hysterectomy cases (RR 2.9; 95% CI 1.8-4.6; p = 0.0001). In multifactorial analysis, fistula size >3.0 cm, pelvic radiation, and previous vaginal surgeries were associated with a higher risk for failure or lower urinary symptoms. CONCLUSIONS: Factors for successful NOUGF closure are fistula size less than 3.0 cm, absence of pelvic radiation, and previous vaginal surgeries.

Suburethral Synthetic Adjustment-controlled Tape Compared with Conventional Treatment for Female Stress Urinary Incontinence: A Randomized Controlled Trial.

BACKGROUND: Urinary incontinence (UI) is a urological problem in women. Currently, suburethral slings are the standard of surgical treatment for stress UI in the female population. OBJECTIVE: To prove the feasibility of an operating technique using suburethral adjustment-controlled tape (SACT) placement. DESIGN, SETTING, AND PARTICIPANTS: A single-center comparative randomized controlled trial included patients randomized according to the CONSORT checklist from April to October 2018 and from November 2018 to April 2019. The inclusion criteria were women from 21 to 81 yr, stress and mixed UI forms, and positive cough test. The exclusion criteria were pregnancy, lactation, neurogenic bladder dysfunction, recurrent forms of UI, radiation therapy and pelvic surgery in anamnesis, genital prolapse (Pelvic Organ Prolapse Quantification system >2), urinary infection, and obstructive urination. INTERVENTION: The first group (50 patients) was using synthetic SACT and the second group (75 patients) a transobturator tape (TOT) midurethral sling (MUS). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Subjective efficacy of 96% was established in group 1 and 86% in group 2, with a median follow-up of 12 mo. According to gynecological examination results, the objective surgical treatment efficiency was 96% in group 1 and 90.7% in group 2. This statistically significant indicator was evaluated in each group. However, when comparing both groups, no statistical difference was revealed. According to urodynamic studies, 1 mo after surgery in group 1, terminal and phase detrusor overactivity signs were 18% (n = 9) and 12% (n = 6), respectively. In group 2, these were 14.7% (n = 11) and 12% (n = 9), respectively. RESULTS AND LIMITATIONS: The block approach was used to randomize patients into groups. A total of 125 patients (50 in the main group and 75 in the control group) were analyzed. CONCLUSIONS: Our results prove the efficacy and safety of SACT in treating UI in women. The subjective and objective effectiveness results of treating patients in the study group show the possibility of using SACT in the same row with TOT MUS. PATIENT SUMMARY: Our purpose was to standardize the surgery stage for urinary incontinence, and evaluate the effectiveness and safety of suburethral adjustment-controlled tape placement. We analyzed women with urinary incontinence and used two different surgical methods. Our results prove the efficacy and safety of suburethral adjustment-controlled tape in treating urinary incontinence in women.

16S rRNA gene sequencing data of the upper respiratory tract microbiome in the SARS-CoV-2 infected patients.

The SARS-CoV-2 pandemic is a big challenge for humanity. The COVID-19 severity differs significantly from patient to patient, and it is important to study the factors protecting from severe forms of the disease. Respiratory microbiota may influence the patient's susceptibility to infection and disease severity due to its ability to modulate the immune system response of the host organism. This data article describes the microbiome dataset from the upper respiratory tract of SARS-CoV-2 positive patients from Russia. This dataset reports the microbial community profile of 335 human nasopharyngeal swabs collected between 2020-05 and 2021-03 during the first and the second epidemic waves. Samples were collected from both inpatients and outpatients in 4 cities of the Russian Federation (Moscow, Kazan, Irkutsk, Nizhny Novgorod) and sequenced using the 16S rRNA gene amplicon sequencing of V3-V4 region. Data contains information about the patient such as age, sex, hospitalization status, percent of damaged lung tissue, oxygen saturation (SpO2), respiratory rate, need for supplemental oxygen, chest computer tomography severity score, SARS-CoV-2 lineage, and also information about smoking and comorbidities. The amplicon sequencing data were deposited at NCBI SRA as BioProject PRJNA751478.

Effectiveness and safety of bulking agents versus surgical methods in women with stress urinary incontinence: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the efficacy and safety of bulking agents compared with surgical methods for female stress urinary incontinence. METHODS: Inclusion and exclusion criteria: women with stress urinary incontinence. Bulking agents versus any surgical treatment as a comparison. Patients with other types of incontinence and treatment were excluded. Electronic databases (PubMed, MEDLINE, and the Cochrane Library) were searched from 2000 until 2021 to identify articles evaluating the effectiveness and safety of urethral bulking agents versus surgical methods. Risk-of-bias assessment tools recommended by the Cochrane Society were used to evaluate the risk of bias in the studies included. RESULTS: Six studies were included in the quantitative synthesis for a total of 710 patients. Our systematic review and meta-analysis showed that bulking agents are less effective than surgical procedures according to subjective improvement after treatment (RR = 0.70, 95% CI: 0.53 to 0.92, p = 0.01). There was no statistically significant difference between these two methods with regard to complications after the intervention (RR = 1.30, 95% CI: 0.30 to 5.66, p = 0.73). CONCLUSION: The main limitation of this systematic review and meta-analysis was the absence of a common objective outcome measure to evaluate effectiveness. However, it shows that bulking agents are less effective than surgical procedures in subjective improvement. Safety analysis showed no significant difference between these methods. Hence, we believe that the first and final surgery is considered to be the best.

Lasers in laparoscopic and robotic surgery: is there a need for them.

PURPOSE OF REVIEW: The application of lasers in treating urological disorders is a developing area. In the laparoscopic and robotic surgery, laser energy is not so popular as in the treatment of stone disease and benign prostatic hyperplasia. The aim of this review is to clarify the current status of laser applications in laparoscopic and robotic urology. RECENT FINDINGS: Laser welding of the pyeloureteral anastomosis is not performed in routine clinical practice. Most investigation of laser applications in laparoscopic and robotic urology has centered on laparoscopic partial nephrectomy and robot-assisted partial nephrectomy. Much less work has been done with regard to lower tract laser laparoscopic and robotic applications. However, laser laparoscopic radical prostatectomy has been investigated. SUMMARY: Current literature regarding lasers in laparoscopic and robotic surgery is extremely limited. Available data consist mostly of small cohorts providing a low level of evidence. Even though initial studies with currently available laser modalities demonstrated promising results, several drawbacks in each technique need to be addressed before being widely accepted as a standard care. Despite investigation, laser usage during laparoscopic and robotic urological procedures has not gained widespread acceptance and remains experimental at this time.

Robotic sacrocolpopexy in pelvic organ prolapse: a review of current literature.

PURPOSE OF REVIEW: Recently, robotic sacrocolpopexy has become the gold standard for treating genital prolapse. Despite this, there is still much interest in this procedure, and many questions remain unanswered. This review focuses on the most critical articles on this issue that have been published in the last 2 years. RECENT FINDINGS: A summary of 23 articles is provided. There were no differences in total postoperative complications, postoperative stress incontinence, mesh erosion, and the success of the two surgical techniques in long-term investigations. Obesity modestly increases robotic approach difficulty and does not raise the mesh erosion rate or prolapse recurrence rate. Ultra-light and preprepared meshes with alternative fixation techniques can be applied with these procedures. Another emerging trend is alternative robotic approaches and the use of single-port surgery. SUMMARY: For women with pelvic organ prolapse, especially the elderly and obese, robotic sacrocolpopexy is well tolerated and effective. Despite highly restricted and heterogeneous data, recent investigations have included single incision methods and new mesh/fixation materials. Randomized trials with large sample size and excellent quality are necessary before the practical implementation of new techniques.

Safety and efficacy of pentosan polysulfate in patients with bladder pain syndrome/interstitial cystitis: a multicenter, double-blind, placebo-controlled, randomized study.

INTRODUCTION: Bladder pain syndrome/interstitial cystitis (BPS/IC) is a condition that is characterized by urgency, frequency and/or pelvic pain. The disease occurs mainly in women. BPS/IC can be severe enough to have a significant impact on patients' quality of life, but it can also be associated with moderate symptoms that are equally debilitating.The aim of this article was to evaluate the possibility of the use of pentosan polysulfate sodium in patients in the complex treatment of BPS/IC. MATERIAL AND METHODS: A multicenter, double-blind, placebo-controlled, randomized study was conducted in parallel groups in 7 Russian medical centers. RESULTS: Efficacy and safety have been established as the main criteria. A total of 93 patients were screened. Statistical analysis was performed. It has been shown that pentosan therapy is more effective than in the placebo. Average change in the number of points on the scale O'Leary-Santa Interstitial Cystitis Symptom Index compared to baseline data in the pentosan group 4.93 ±3, 03, in the placebo group 1.66 ±3.19 (p = 0.014), and the adverse events and safety of pentosan are comparable to the placebo group. CONCLUSIONS: Oral glycosaminoglycan (pentosan polusulfate sodium) is an effective and safe drug and should be included in the complex treatment of patients with bladder pain syndrome/interstitial cystitis.

Collagen type 3A1 and 1A1 polymorphisms in women with pelvic organ prolapse and urinary incontinence assessed with Sanger sequencing method.

INTRODUCTION: This case-control trial investigates the prevalence of COL3A1 and COL1A1 gene polymorphisms in female patients suffering pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in comparison with controls. MATERIAL AND METHODS: Inclusion criteria were having one or more risk factors for SUI and POP. Exclusion criteria were hereditary connective tissue diseases as well as surgeries for POP/SUI for the control group. The rs1800255 polymorphism in COL3A1 gene was considered as a local substitution of guanine (G) for adenine (A). The rs1800012 polymorphism in COL1A1 gene was considered as a local substitution of guanine (G) for thymine (T). Genotyping was performed by Sanger sequencing method, followed by estimation of sensitivity and specificity for POP and SUI. RESULTS: Fifty-two patients with POP and SUI (mean age 64.4 years) and 21 women were included in the control group (mean age 63.2 years). Homozygous genotype (AA) in COL3A1 was found in 10% of patients suffering from POP or SUI. No women in the control group had this genotype. The single nucleotide polymorphism (SNP) had high specificity (1.0) for POP/SUI, but low sensitivity (0.1). Heterozygous genotype (AG) in COL3A1 had a sensitivity equal to 0.47 and specificity of 0.62. Homozygous genotype (TT) in COL1A1 was found in only 2% of patients with POP/SUI, but was not found in controls. Heterozygous genotype (TG) in COL1A1 has sensitivity equal to 0.25 and specificity of 0.74. CONCLUSIONS: POP/SUI patients have specific SNPs in COL1A1 and COL3A1 sequenced by Sanger method.

Management of patients who opt for radical prostatectomy during the coronavirus disease 2019 (COVID-19) pandemic: an international accelerated consensus statement.

OBJECTIVE: Coronavirus disease-19 (COVID-19) pandemic caused delays in definitive treatment of patients with prostate cancer. Beyond the immediate delay a backlog for future patients is expected. The objective of this work is to develop guidance on criteria for prioritisation of surgery and reconfiguring management pathways for patients with non-metastatic prostate cancer who opt for surgical treatment. A second aim was to identify the infection prevention and control (IPC) measures to achieve a low likelihood of coronavirus disease 2019 (COVID-19) hazard if radical prostatectomy (RP) was to be carried out during the outbreak and whilst the disease is endemic. METHODS: We conducted an accelerated consensus process and systematic review of the evidence on COVID-19 and reviewed international guidance on prostate cancer. These were presented to an international prostate cancer expert panel (n = 34) through an online meeting. The consensus process underwent three rounds of survey in total. Additions to the second- and third-round surveys were formulated based on the answers and comments from the previous rounds. The Consensus opinion was defined as ≥80% agreement and this was used to reconfigure the prostate cancer pathways. RESULTS: Evidence on the delayed management of patients with prostate cancer is scarce. There was 100% agreement that prostate cancer pathways should be reconfigured and measures developed to prevent nosocomial COVID-19 for patients treated surgically. Consensus was reached on prioritisation criteria of patients for surgery and management pathways for those who have delayed treatment. IPC measures to achieve a low likelihood of nosocomial COVID-19 were coined as 'COVID-19 cold' sites. CONCLUSION: Reconfiguring management pathways for patients with prostate cancer is recommended if significant delay (>3-6 months) in surgical management is unavoidable. The mapped pathways provide guidance for such patients. The IPC processes proposed provide a framework for providing RP within an environment with low COVID-19 risk during the outbreak or when the disease remains endemic. The broader concepts could be adapted to other indications beyond prostate cancer surgery.

Identification of Clinically Significant Prostate Cancer by Combined PCA3 and AMACR mRNA Detection in Urine Samples.

PURPOSE: Preclinical evaluation of PCA3 and AMACR transcript simultaneous detection in urine to diagnose clinical significant prostate cancer (prostate cancer with Gleason score ≥7) in a Russian cohort. PATIENTS AND METHODS: We analyzed urine samples of patients with a total serum PSA ≥2 ng/mL: 31 men with prostate cancer scheduled for radical prostatectomy, 128 men scheduled for first diagnostic biopsy (prebiopsy cohort). PCA3, AMACR, PSA and GPI transcripts were detected by multiplex reverse transcription quantitative polymerase chain reaction, and the results were used for scores for calculation and statistical analysis. RESULTS: There was no significant difference between clinically significant and nonsignificant prostate cancer PCA3 scores. However, there was a significant difference in the AMACR score (patients scheduled for radical prostatectomy p=0.0088, prebiopsy cohort p=0.029). We estimated AUCs, optimal cutoffs, sensitivities and specificities for PCa and csPCa detection in the prebiopsy cohort by tPSA, PCA3 score, PCPT Risk Calculator and classification models based on tPSA, PCA3 score and AMACR score. In the clinically significant prostate cancer ROC analysis, the PCA3 score AUC was 0.632 (95%CI: 0.511-0.752), the AMACR score AUC was 0.711 (95%CI: 0.617-0.806) and AUC of classification model based on the PCA3 score, the AMACR score and total PSA was 0.72 (95%CI: 0.58-0.83). In addition, the correlation of the AMACR score with the ratio of total RNA and RNA of prostate cells in urine was shown (tau=0.347, p=6.542e-09). Significant amounts of nonprostate RNA in urine may be a limitation for the AMACR score use. CONCLUSION: The AMACR score is a good predictor of clinically significant prostate cancer. Significant amounts of nonprostate RNA in urine may be a limitation for the AMACR score use. Evaluation of the AMACR score and classification models based on it for clinically significant prostate cancer detection with larger samples and a follow-up analysis is promising.

Outreach and Influence of Surgical Societies' Recommendations on Minimally Invasive Surgery During the COVID-19 Pandemic-An Anonymized International Urologic Expert Inquiry.

OBJECTIVE: To assess the outreach and influence of the main recommendations of surgical governing bodies on adaptation of minimally invasive laparoscopic surgery (MIS) procedures during the coronavirus disease 2019 (COVID-19) pandemic in an anonymized multi-institutional survey. MATERIALS AND METHODS: International experts performing MIS were selected on the basis of the contact database of the speakers of the Friends of Israel Urology Symposium. A 24-item questionnaire was built using main recommendations of surgical societies. Total cases/1 Mio residents as well as absolute number of total cases were utilized as surrogates for the national disease burden. Statistics and plots were performed using RStudio v0.98.953. RESULTS: Sixty-two complete questionnaires from individual centers performing MIS were received. The study demonstrated that most centers were aware of and adapted their MIS management to the COVID-19 pandemic in accordance to surgical bodies' recommendations. Hospitals from the countries with a high disease burden put these adoptions more often into practice than the others particularly regarding swabs as well as CO2 insufflation and specimen extraction procedures. Twelve respondents reported on presumed severe acute respiratory syndrome coronavirus 2 transmission during MIS generating hypothesis for further research. CONCLUSION: Guidelines of surgical governing bodies on adaptation of MIS during the COVID-19 pandemic demonstrate significant outreach and implementation, whereas centers from the countries with a high disease burden are more often poised to modify their practice. Rapid publication and distribution of such recommendation is crucial during future epidemic threats.

A comparison among PCNL, Miniperc and Ultraminiperc for lower calyceal stones between 1 and 2 cm: a prospective, comparative, multicenter and randomised study.

BACKGROUND: Conventional Percutaneous Lithotripsy (PCNL) has been an effective, successful and easy approach for especially > 1 cm sized calyceal stones however risks of complications and nephron loss are inevitable. Our aim is to compare the efficacy and safety of PCNL, MiniPerc (MP) and UltraMiniPerc (UMP) for lower calyceal stones between 1 and 2 cm with a multicenter prospective randomized study. METHODS: Between January 2015 and June 2018, 132 consecutive patients with single lower calyceal stone were enrolled. Patients were randomized in three groups; A: PCNL; B: MP; C: UMP. 44 patients for the Group A, 47 for Group B and 41 for Group C. Exclusion criterias were the presence of coagulation impairments, age of < 18 or > 75, presence of infection or serious comorbidities. Patients were controlled with computerized tomography scan after 3 months. A negative CT or an asymptomatic patient with stone fragments < 3 mm size were the criteria to assess the stone-free status. Patient characteristics, stone free rates (SFR) s, complications and re-treatment rates were analyzed. RESULTS: The mean stone size were 16.38, 16.82 and 15.23 mm respectively in Group A, B and C(p = 0.34). The overall SFR was significantly higher in Group A (86.3%) and B (82.9%) as compared to Group C (78%)(p < 0.05). The re-treatment rate was significantly higher in Group C (12.1%) and complication rates was higher in Group A (13.6%) as compared to others(p < 0.05). The hospitalization was significantly shorter in Group C compared to Group A (p = 0.04). CONCLUSIONS: PCNL and MP showed higher efficacy than UMP to obtain a better SFR. Auxiliary and re-treatment rates were higher in UMP. On the other hand for such this kind of stones PCNL had more complications. Overall evaluation favors MP as a better indication in stones 1-2 cm size.

First-in-human study of anticancer immunotherapy drug candidate mobilan: safety, pharmacokinetics and pharmacodynamics in prostate cancer patients.

Toll-like receptor 5 (TLR5) controls endogenous immune responses to pathogens and is a promising target for pharmacological stimulation of anti-tumor immunity. Mobilan is an innovative gene therapy agent consisting of a non-replicating bicistronic adenovirus directing constitutive expression of human Toll-like receptor 5 (TLR5) and the secreted flagellin-based TLR5 agonist, 502s. In mice, Mobilan injection into prostate tumors resulted in autocrine TLR5 signaling, immune system activation, and suppression of tumor growth and metastasis. Here we report a first-in-human placebo-controlled clinical study of Mobilan aimed at evaluating safety, tolerability, pharmacokinetics and pharmacodynamics of a single intra-prostate injection of Mobilan in early stage prostate cancer patients. Mobilan was safe and well-tolerated at all tested doses; thus, the maximum tolerated dose was not identified. Injection of Mobilan induced signs of self-resolving inflammation not present in placebo-injected patients, including transient elevation of PSA and cytokine (G-CSF, IL-6) levels, and increased lymphoid infiltration in prostate tissue. The highest dose of Mobilan (1011 viral particles) produced the best combination of safety and pharmacodynamic effects. Therefore, Mobilan is well-tolerated and induces the expected pharmacodynamic response in humans. These results support further clinical development of Mobilan as a novel immunotherapy for prostate cancer.

Distribution and antibiotic resistance profile of key Gram-negative bacteria that cause community-onset urinary tract infections in the Russian Federation: RESOURCE multicentre surveillance 2017 study.

BACKGROUND: Urinary tract infections (UTIs) are among the most common bacterial infections in clinical practice. This RESOURCE (pathogen distribution and antibiotic RESistance prOfile of key Gram-negative bacteria caUsing community-onsEt URinary traCt) study aimed to determine the antimicrobial resistance profile of Gram-negative bacteria isolated from outpatient urine samples collected across the Russian Federation. METHODS: A total of 96 781 urine samples were collected from 520 cities in the Russian Federation between 01 January 1 and 31 December 2017. Antibiotic susceptibility was performed using semi-automated analysers. The mean age of the study population was 40.9 years; 80.2% were female and 19.8% were male. RESULTS: Of the uropathogens that were isolated, 64.2% were Gram-negative bacteria. Among these, Escherichia coli (E. coli) was the most common (49.1%) followed by Klebsiella pneumoniae (9.5%), Proteus mirabilis (2.9%), Pseudomonas aeruginosa (1.7%), and Enterobacter spp. (1.0%). Of the antibiotics that were tested, 50% of the isolated E. coli strains were resistant to ampicillin, 30.3% to co-trimoxazole, 26.2% to aztreonam, 28.8% to levofloxacin, and 21% to cefuroxime. Conversely, E. coli was highly susceptible to imipenem (0.7% resistant strains isolated), amikacin (0.9%), nitrofurantoin (4.5%), and fosfomycin (1.2%). The most active antimicrobials against Klebsiella pneumoniae were imipenem (6.8% resistant strains) and colistin (0.5%), while piperacillin/tazobactam (4.2%), cefoperazone/sulbactam (3.1%) and imipenem (0%) were the most active agents against Proteus mirabilis. The antimicrobials showing the highest activity against Pseudomonas aeruginosa were colistin (10.7% resistant strains) and aztreonam (0%), while piperacillin/tazobactam (7.1%) and cefoperazone/sulbactam (2.3%) showed the highest activity against Enterobacter spp. CONCLUSION: The prevalence of fluoroquinolone and cephalosporin resistance among common UTI-causing Gram-negative bacteria highlights the growing challenge of successfully treating community-onset UTIs.