Effectiveness of prophylactic antimicrobial levofloxacin against postureteroscopic lithotripsy infection: A multicenter prospective open-label randomized controlled trial.

BACKGROUND: To verify the appropriate prophylactic agent to prevent ureteroscopic lithotripsy infection, which is safe, effective, convenient, reasonable, and with best pharmacoeconomic benefit ratio, to provide evidence for clinical practice. METHODS: This study is a multicenter, open-label, randomized, positive drug-controlled trial design. From January 2019 to December 2021, patients with ureteral calculi who were going to undergo retrograde flexible ureteroscopic lithotripsy were selected from urology departments in 5 research centers. The patients enrolled were randomly divided into the experimental group and the control group according to the random number table by blocking randomization. In the experimental group (Group A), 0.5 g levofloxacin was given 2 to 4 hours before surgery. In the control group (Group B), cephalosporin was injected 30 minutes before surgery. The infectious complications, the incidence of adverse drug reactions and the economic benefit ratio were compared between the 2 groups. RESULTS: A total of 234 cases were enrolled. There was no statistically significant difference between the 2 groups at baseline. Postoperative infection complications were 1.8% in the experimental group, which was significantly lower than 11.2% in control group. The type of infection complication in both groups was asymptomatic bacteriuria. The cost of drugs in the experimental group was 19.89 ± 13.11 yuan, which was significantly lower than cost of drugs in the control group of 41.75 ± 30.12 yuan. The levofloxacin application had favorable cost-effectiveness ratio. The difference in safety between 2 groups was not significant. CONCLUSION: The application of levofloxacin is safe, effective, and low-cost regimen for postureteroscopic lithotripsy infection prevention.

The antibiotic strategies during percutaneous nephrolithotomy in China revealed the gap between the reality and the urological guidelines.

BACKGROUND: Correct perioperative antibiotic strategies are crucial to prevent postoperative infections during percutaneous nephrolithotomy (PCNL). We aimed to compare the realistic antibiotic strategies applied in China with current urological guidelines. METHODS: Between April and May 2020, urologists from China were invited to finish an online cross-sectional survey. The questionnaire was designed according to the current urological guidelines and literatures. RESULTS: 3393 completed responses were received. 61.1% (2073/3393) respondents had urological experience of more than 10 years. 72.4% urologists chose multiple-dose antibiotics for patients with both negative urine culture (UC-) and negative urine microscopy (UM-) preoperatively. Respondents in central China (OR = 1.518; 95% CI 1.102-2.092; P = 0.011), east China (OR = 1.528; 95% CI 1.179-1.979; P = 0.001) and northeast China (OR = 1.904; 95% CI 1.298-2.792; P = 0.001) were more likely to prescribe multiple-dose antibiotic for UC-UM- patients. Notably, the respondents who finished PCNL exceeded 100 cases per year were in favor of single-dose administration (OR = 0.674; 95% CI 0.519-0.875; P = 0.003). There are only 8.3% urologists chose single-dose antibiotic for UC-UM+ patients, whereas 65.5% administered antibiotics for 1-3 days. Meanwhile, for UC+ patients, 59.0% of the urologists applied antibiotics shorter than 1 week, and only 26.3% of the urologists carried out routine re-examination of UC. Moreover, postoperative antibiotics were frequently prescribed for 3-6 days (1815; 53.5%). Finally, although 88.2% urologists considered stone culture important for management of postoperative antibiotics as the guideline recommended, only 18.5% performed it routinely. CONCLUSIONS: The antibiotic strategies are different between current practice in China and the urological guidelines. The dissimilarities suggested that further studies should be conducted to investigate the reasons of the differences and standardize the application of antibiotics.

A multicenter, double-blind, placebo-controlled parallel study to evaluate the role of Yinhua Miyanling tablets in the prevention of bacterial biofilm formation on ureteral stents: a randomised trial.

BACKGROUND: Yinhua Miyanling tablet (YMT) not only has the functions of clearing away heat and toxin, dredging drenching and diuresis, but also has antibacterial activity. The formation of bacterial biofilm in ureteral stent and its related infection have plagued the clinic. Antibacterial traditional Chinese medicine is a potential method. METHODS: This multicenter, randomized, double-blind, placebo-controlled study was designed to enroll patients who underwent ureteroscopic lithotripsy associated with indwelling ureteral stents at six centers between March 2019 and June 2020. The eligible patients were randomly assigned to the experimental group to take YMT 2 g qid orally or the control group to take dummy YMT 2 g qid orally from the first day after the operation according to a random number table. The unused drugs were recalled 14±3 days after the operation and record the body temperature. Relevant laboratory tests (urinalysis and urine culture) were performed before extubation. The ureteral stent was removed. The specimen was collected for scanning electron microscopy (SEM). Biofilm formation, USSQ scores, postoperative infectious complications, stone formation, and adverse drug reactions were compared between the two groups. RESULTS: Of the 211 patients enrolled, 165 were included in the per-protocol set (PPS), including 86 in the control group and 79 in the experimental group. No significant difference was found between the two groups in baseline parameters (P>0.05). The prevalence of biofilm formation in the control group (47%) was significantly higher than that in the experimental group (22.7%, P=0.001). There was no significant difference in total USSQ score and domain score between the two groups (all P>0.05). There were more patients with symptomatic urinary tract infection (UTI) in the control group (12.9%) than in the experimental group (2.6%, P=0.017). The incidence of other complications did not show a significant difference between the two groups (all P>0.05). The incidence of stone formation on the ureteral stent surface and adverse drug reactions did not show a significant difference between the two groups (all P>0.05). CONCLUSIONS: YMT is helpful to reduce the formation of bacterial biofilms on ureteral stents and the incidence of symptomatic UTIs related to ureteral stenting after surgery for ureteral calculi. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000041399.

Ultrasonography Can Replace CT Scans as the Initial Imaging Examination of Ureteral Calculi.

OBJECTIVE: To study the feasibility of ultrasonography (US) as a replacement for CT during the diagnosis of ureteral calculi (UC). MATERIALS AND METHODS: Clinical and imaging data of patients with UC between January 2013 and December 2017 were retrospectively analyzed. According to the imaging method, patients were divided into 3 groups: Group A, CT alone; Group B, CT and US, Group C, US alone. Age, location, and the size of stones were compared among the groups. According to the maximum diameter (MD) measured by using CT in Group B, patients were subdivided into 3 groups (subgroup 1-3): MD <0.5 cm, 0.5 cm ≤ MD ≤1.0 cm, and MD >1.0 cm. The MD measured by US and CT were compared in the subgroups. RESULTS: A total of 1,289 patients with UC were admitted. The use of CT correlated with age (p = 0.000) and stone location (p = 0.004). The sensitivity and specificity of US were 71.3 and 100%. Positive US results correlated with stone size (p = 0.008), but not location (p = 0.861). The mean MDs of the calculi measured by US and CT: in subgroup 1:  0.80 ± 0.31 and 0.35 ± 0.05 cm (p = 0.000); in subgroup 2: 0.94 ± 0.32 and 0.72 ± 0.16 cm (p = 0.000); in subgroup 3: 1.75 ± 0.68 and 1.59 ± 0.52 cm (p = 0.094). CONCLUSIONS: US confirmed that UC do not require confirmatory CT. US can replace CT as the initial imaging examination of UC.

New-onset metabolic risk factors and the incidence of kidney stones: a prospective cohort study.

OBJECTIVE: To examine the association of kidney stones with new-onset hypertension, diabetes and obesity. PARTICIPANTS AND METHODS: This prospective cohort study included participants in the Qingdao Port Cardiovascular Health Study who were aged ≥18 years and had abdominal ultrasonography results in 2013 that were negative for kidney stones. Multivariable Cox regression models with time-dependent covariates were used to estimate the effects of new-onset hypertension, diabetes and obesity on the incidence of kidney stones. RESULTS: There were 9667 participants without kidney stones in 2013 (mean age 46.2 years; 75.6% men). During a mean (range) follow-up of 33.5 (6-42) months, 676 (7.0%) incident cases of kidney stones were identified. Kidney stones were more frequent among those who had new-onset of a metabolic factor vs those who did not (hypertension: 7.7 vs 6.0%; diabetes: 8.4 vs 6.6%; obesity: 7.4 vs 6.8%). Adjusted Cox models identified that increased risk of kidney stones was associated with new-onset hypertension (adjusted hazard ratio [HR] 1.69, 95% confidence interval [CI] 1.25-2.27), new-onset diabetes (HR 1.78, 95% CI 1.07-2.96), and new-onset obesity (HR 1.78, 95% CI 1.15-2.74). CONCLUSIONS: New-onset of hypertension, diabetes and obesity were all strongly associated with an increased risk of kidney stones in this prospective cohort study. Results suggest that a substantial proportion of kidney stones are potentially preventable by appropriate control of these metabolic risk factors.

Uroseptic Shock Can Be Reversed by Early Intervention Based on Leukocyte Count 2 h Post-operation: Animal Model and Multicenter Clinical Cohort Study.

This study investigated whether early intervention based on leukocyte count (WBC) of less than 2.85 × 109/L obtained within 2 h post-operatively may ameliorate the uroseptic shock induced by upper urinary tract endoscopic lithotripsy (UUTEL). Urosepsis was induced in 30 rabbits and assigned to three groups: Control-I, WBC-I, and Shock-I. Control-I: Non-intervention control. WBC-I: Immediate resuscitation when there was a drastic drop of WBC within 2 h post-operatively but without signs or symptoms of shock. Shock-I: Resuscitation only when there were signs or symptoms of shock. In total, 107 patients whose WBC were less than 2.85 × 109/L within 2 h after UUTEL were retrospectively analyzed. Patients were assigned into two groups based on the time of the intervention. Shock-II included 59 patients who were started on the resuscitation bundle when there were signs or symptoms of shock. WBC-II included 48 patients who were started immediately on the resuscitation bundle when the WBC decreased drastically. All Control-I rabbits developed shock within 72 h and died. None of the WBC-I rabbits developed shock and all survived for 72 h. In total, 60% of Shock-I died within 72 h. Overall, 43 patients in Shock-II and six patients in WBC-II experienced uroseptic shock. The average lengths of hospitalization for Shock-II and WBC-II were 17.8 ± 9.7 days and 7 ± 4.2 days, respectively. Six patients in the Shock-II and none in WBC-II died of the uroseptic shock. Early intervention based on WBC measured within 2 h post-operatively might avert the uroseptic shock induced by UUTEL.

Evaluation of perioperative prophylaxis with fosfomycin tromethamine in ureteroscopic stone removal: an investigator-driven prospective, multicenter, randomized, controlled study.

PURPOSE: To compare efficacy, safety, and cost-effectiveness of fosfomycin tromethamine with other standard-of-care antibiotics in patients undergoing ureteroscopic lithotripsy. METHODS: This study was a prospective, multicenter, randomized, controlled trial. Eligible patients scheduled for ureteroscopic lithotripsy were randomly assigned to receive either fosfomycin (fosfomycin group, N = 101 patients) or standard-of-care antibiotic therapy as prophylaxis (control group, N = 115 patients). The incidence of infectious complications and adverse events was analyzed between the two groups, as well as the cost-benefit analysis. RESULTS: The incidence of infections following lithotripsy was 3.0% in the fosfomycin group and 6.1% in the control group (p > 0.05). Only asymptomatic bacteriuria was reported in fosfomycin group. In the control group was reported asymptomatic bacteriuria (3.5%), fever (0.9%), bacteremia (0.9%), and genitourinary infection (0.9%). The rate of adverse events was very low, with no adverse event reported in the fosfomycin group and only one in the control group (forearm phlebitis). The average cost per patient of antibiotic therapy with fosfomycin was 151.45 ± 8.62 yuan (22.7 ± 1.3 USD), significantly lower compared to the average cost per patient of antibiotics used in the control group 305.10 ± 245.95 yuan (45.7 ± 36.9 USD; p < 0.001). CONCLUSIONS: Two oral doses of 3 g fosfomycin tromethamine showed good efficacy and safety and low cost in perioperative prophylaxis of infections following ureteroscopic stone removal.

Establishment and Evaluation of Patient-Specific Virtual Ureteroscopy in Assisting Flexible Ureteroscopy for Urolithiasis.

OBJECTIVES: To establish virtual ureteroscopy (VU) through computed tomography urography (CTU) data from patients with upper urinary tract (UUT) stones indicated for flexible ureteroscopy (fURS) and to validate its effectiveness. METHODS: Patient-specific VU generation was accomplished through incorporating CTU data into specialized software (Crusher) developed on the open access Visualization Tools Kit (VTK). These were then presented to fURS experts and novice urologists for evaluation and comparison using modified Likert-type questionnaire of 10-point rating scales (1 = not at all useful/not at all realistic/poor, 10 = very useful/very realistic/ excellent). RESULTS: Face and content validation of VU from 5 fURS experts in 3 different centers: overall usefulness 7.4 ± 0.5, graphics 7.4 ± 0.5, intrarenal anatomy 8.4 ± 0.5, stone details 7.8 ± 0.4, usefulness in surgical planning and training 7.6 ± 0.9. Significant increase of detection in the number of calyces and stones was found from using CTU only to CTU-VU combined in the novice group ( P = .000). Before VU observation, novices found much fewer calyces and stones than experts ( P = .004 and .000, respectively). However, this gap disappeared after VU observation ( P = .327 and .292, respectively). VU feedback from the novices was superb. CONCLUSIONS: Establishing patient-specific VU through CTU data from renal stone patients is feasible. The present VU can significantly improve novice urologists' comprehension of intrarenal anatomy and stone information before fURS procedures. Face and content validity is also proved. This novel modality may serve as an important tool for fURS surgical planning, navigation, and training.

Early drastic decrease in white blood count can predict uroseptic shock induced by upper urinary tract endoscopic lithotripsy: a translational study.

PURPOSE: Uroseptic shock is a life threatening complication after upper urinary tract endoscopic lithotripsy. Prompt diagnosis and treatment are paramount for patient survival. We identified a practical predictor of upper urinary tract endoscopic lithotripsy induced uroseptic shock in an animal model. We validated the results by retrospectively reviewing multicenter clinical records. MATERIALS AND METHODS: We ligated the rabbit ureter and injected Escherichia coli solution in the renal pelvis to create a uroseptic shock model. White blood count and other parameters were measured at different intervals and bacterial concentrations. Results were compared with clinical findings in 48 patients who experienced uroseptic shock after upper urinary tract endoscopic lithotripsy at a total of 8 medical centers. We used a ROC curve to evaluate the predictive value of parameters for uroseptic shock. RESULTS: We established a stable rabbit model by injecting 9.0 × 10(8) cfu/ml E. coli in the renal pelvis at a dose of 2 ml/kg. In patients and rabbits with uroseptic shock the white blood count decreased in the first 2 hours after the procedure. The ROC curve showed that the white blood count threshold within the first 2 hours of uroseptic shock was 2.85 × 10(9)/L. Sensitivity and specificity for predicting uroseptic shock were 95.9% and 92.7%, respectively. CONCLUSIONS: The white blood count decreased drastically within the first 2 hours during the development of uroseptic shock. This could be an ideal predictor of uroseptic shock after upper urinary tract endoscopic lithotripsy. In patients with high risk factors for uroseptic shock the white blood count should be measured within 2 hours after upper urinary tract endoscopic lithotripsy.

From angiomyolipoma to malignant epithelioid angiomyolipoma of the kidney, a case report with a history of eight years.

Epithelioid angiomyolipoma (EAML) is a rare subtype of angiomyolipoma (AML) with potential has malign tendency. UP to now, the biological association between EMAL and typical AML is not well known. In the present study, we reported a case of EMAL arose in AML seven years post AML operation. A 34-year-old man with bilateral kidney AML was operated with an open cytoreductive surgery of both sides. After seven years, the left nephrectomy was performed due to a new neoplasm was found in the left kidney. The pathology diagnosis and inmmunohistochemical staining suggested the new neoplasm was EAML. Finally the patient developed metastases to liver and retroperitoneum and died 19 months post the last operation. After reviewing the history of the patient, we thought that the EAML might be developed from a little amount of EMAL accompany with AML in the small lesson that was missed by the CT scan. The results revealed that a carefully screening for the epithelioid cells in the typical AML specimen should be made to avoid missing the important EAML.

Characteristics of urinary tract infection pathogens and their in vitro susceptibility to antimicrobial agents in China: data from a multicenter study.

OBJECTIVE: This study assessed the characteristics of pathogens identified in clinical isolates from patients with urinary tract infection (UTI) and their in vitro sensitivity to commonly used antibiotics in the clinical setting in China. DESIGN AND SETTING: Multicenter study was conducted between January and December 2011 in 12 hospitals in China. PARTICIPANTS: Urine samples were collected from 356 symptomatic patients treated in the study hospitals for acute uncomplicated cystitis, recurrent UTI or complicated UTI. PRIMARY AND SECONDARY OUTCOME MEASURES: Minimal inhibitory concentrations (MICs) were measured using broth microdilution according to the Clinical and Laboratory Standards Institute 2011 guidelines. Thirteen antimicrobial agents were tested: fosfomycin tromethamine, levofloxacin, moxifloxacin, cefdinir, cefixime, cefaclor, cefprozil, cefuroxime, amoxicillin/clavulanic acid, cefotaxime, azithromycin, nitrofurantoin and oxacillin. Escherichia coli isolates were screened and extended spectrum ß-lactamases (ESBL) production was confirmed by a double-disk synergy test. RESULTS: 198 urine samples were culture-positive and 175 isolates were included in the final analysis. E coli was detected in 50% of cultures, followed by Staphylococcus epidermidis (9%), Enterococcus faecalis (9%) and Klebsiella pneumoniae (5%). The detection rate of ESBL-producing E coli was 53%. Resistance to levofloxacin was the most common among all the isolates. Nitrofurantoin and fosfomycin tromethamine had the greatest activity against E coli; overall, 92% and 91% of isolates were susceptible to these antimicrobials. E faecalis had the highest susceptibility rates to fosfomycin tromethamine (100%). CONCLUSIONS: The most frequently identified pathogens in our patients were ESBL-producing E coli and E faecalis. Fosfomycin tromethamine and nitrofurantoin showed a good antimicrobial activity against UTI pathogens. They may represent good options for the empiric treatment of patients with UTI.

Evaluation of three-dose fosfomycin tromethamine in the treatment of patients with urinary tract infections: an uncontrolled, open-label, multicentre study.

OBJECTIVE: To evaluate the clinical and microbiological efficacy and safety of three doses of 3 g fosfomycin tromethamine administered orally to treat lower urinary tract infections. DESIGN AND PARTICIPANTS: This prospective, uncontrolled, open-label study was conducted in 12 medical centres in China, between January and December 2011. According to the diagnosis criteria of Chinese Guidelines on Urological Infections, patients (18-70 years) with acute uncomplicated cystitis, recurrent lower urinary tract infection or complicated lower urinary tract infection received three doses of 3 g fosfomycin tromethamine orally, at days 1, 3 and 5. PRIMARY AND SECONDARY OUTCOME MEASURES: Efficacy endpoints (clinical efficacy, microbiological efficacy and overall efficacy) were evaluated on day 15. Clinical symptoms, physical signs, urinalysis, liver and kidney function, patient records and evaluation of adverse events (AEs) and serious AEs up to day 15 were evaluated for analysis of safety. RESULTS: 361 patients were included in the full analysis set, 356 in the safety analysis set and 335 in the per-protocol set (PPS). In the PPS, the clinical efficacy rates at day 15 for acute uncomplicated cystitis, recurrent lower urinary tract infection and complicated lower urinary tract infection were 94.71% (179/189), 77.22% (61/79) and 62.69% (42/67), respectively. The microbiological efficacy rates (day 15) were 97.65% (83/85), 94.44% (34/36) and 83.87% (26/31), respectively. The overall efficacy rates (day 15) were 95.29% (81/85), 77.78% (28/36) and 64.52% (20/31), respectively. 20/356 (5.6%) patients reported drug-related AEs, the most common being diarrhoea. No serious drug-related AEs were reported. CONCLUSIONS: This fosfomycin tromethamine dosing regimen showed clinical and microbiological efficacy with some AEs and good tolerability in patients with acute uncomplicated cystitis, recurrent lower urinary tract infection and complicated lower urinary tract infection.

Fusion between TMPRSS2 and ETS family members (ERG, ETV1, ETV4) in prostate cancers from northern China.

In this study we evaluated the frequency of fusion between TMPRSS2 and ETS family members (ERG, ETV1, ETV4) in prostate cancers in patients from northern China in order to explore differences in fusion rates among regions in northern and southern China, other parts of Asia, Europe, and North America. We examined 100 prostate cancer patients, diagnosed by means of prostate biopsy; fluorescence in situ hybridization (FISH) was used to detect the expression of TMPRSS2, ERG, ETV1 and ETV4 in cancer tissue. Differences in gene fusion rates among different ethnics groups were also analyzed. Of the 100 prostate cancer patients, 55 (55%) had the fusion gene. Among the patients with the fusion gene, 46 (83.6%) patients had the TMPRSS2:ERG fusion product, 8 (14.8%) patients had TMPRSS2:ETV1 fusion, 1 (1.6%) patient had TMPRSS2:ETV4.

[The indication of bone scan for patients with newly diagnosed prostate cancer].

OBJECTIVE: To investigate the indication of bone scan for patients with newly diagnosed prostate cancer. METHODS: The clinical data of continual 95 patients with newly diagnosed prostate cancer was involved between January 2006 and December 2010. The relationship between age, PSA, Gleason scores, clinical stage and positive bone scans was respectively compared. RESULTS: The 33 patients (34.7%) with positive bone scans and 62 patients (65.3%) with negative bone scans. The mean age was (74±7) years and (76±7) years respectively in 2 groups respectively. PSA was (70.7±38.1) ng/ml and (28.4±27.2) ng/ml respectively, the difference was significant (t=-5.499, P=0.000). Clinical stage had positive correlation with positive bone scan, the OR value was 4.684. If the Gleason score>7, the sensitivity, specificity, positive predictive value and negative predictive value of positive bone scan was 64%, 63%, 48% and 77% respectively. If PSA>50 ng/ml, sensitivity, specificity, positive predictive value and negative predictive value was 67%, 86%, 71% and 83% respectively. If Clinical stage>T2, sensitivity, specificity, positive predictive value and negative predictive value was 82%, 81%, 69% and 89% respectively. CONCLUSIONS: For patients with PSA≤10 ng/ml or simultaneously PSA≤50 ng/ml and Gleason score≤7 and clinical stage≤T2, bone scan is not necessary. Patients with newly diagnosed prostate cancer and PSA>50 ng/ml or Gleason score>7 or clinical stage>T2 should undergo bone scan.