Feasibility and safety of laparoscopic radical cystectomy for male octogenarians with muscle-invasive bladder cancer.

This study was designed to evaluate the safety and feasibility of laparoscopic radical cystectomy (LRC) for male octogenarian patients with muscle-invasive bladder cancer (MIBC). Briefly, a total of 57 male octogenarian patients (A group) with bladder carcinoma were enrolled and underwent LRC and intracorporeal pelvic lymph node dissection with bilateral cutaneous ureterostomy from May 2016 to December 2022. Besides, 63 male patients (age < 80 years old) with bladder carcinoma undergoing LRC and 17 octogenarian male patients with bladder carcinoma undergoing open radical cystectomy (ORC) were enrolled in B and C groups as control. All perioperative clinical materials and outcomes of long-term follow-up, and complication were collected. The specific results were shown as follows. Compared with C group, the operation time and resected lymph node in A group was increased, and the estimated blood loss, the number of transfusion needed, duration of pelvic drainage and hospital stay after surgery was decreased. The death rate and ileus complication rate were higher in A group (12 cases) than in C group (15 cases). The cases of ureteral stricture in A group (13 cases) was decreased compared with that in C group. Overall, LRC and bilateral cutaneous ureterostomy are safe, feasible and better choices for the treatment of male octogenarian patients with MIBC. The octogenarian receiving cutaneous ureterostomy heals slowly and exists certain incomplete intestinal obstruction after surgery.

Application of a three-dimensional visualization model in intraoperative guidance of percutaneous nephrolithotomy.

OBJECTIVES: To establish a three-dimensional visualization model of percutaneous nephrolithotomy, apply it to guiding intraoperative puncture in a mixed reality environment, and evaluate its accuracy and clinical value. METHODS: Patients with percutaneous nephrolithotomy indications were prospectively divided into three-dimensional group and control group with a ratio of 1:2. For patients in three-dimensional group, positioning markers were pasted on the skin and enhanced computed tomography scanning was performed in the prone position. Holographic three-dimensional models were made and puncture routes were planned before operation. During the operation, the three-dimensional model was displayed through HoloLens glass and visually registered with the patient's body. Puncture of the target renal calyx was performed under three-dimensional-image guiding and ultrasonic monitoring. Patients in the control group underwent routine percutaneous nephrolithotomy in the prone position under the monitoring of B-ultrasound. Deviation distance of the kidney, puncture time, puncture attempts, channel coincidence rate, stone clearance rate, and postoperative complications were assessed. RESULTS: Twenty-one and 40 patients were enrolled in three-dimensional and control group, respectively. For three-dimensional group, the average deviation between virtual and real kidney was 3.1 ± 2.9 mm. All punctures were performed according to preoperative planning. Compared with the control group, the three-dimensional group had shorter puncture time (8.9 ± 3.3 vs 14.5 ± 6.1 min, P < 0.001), fewer puncture attempts (1.4 ± 0.6 vs 2.2 ± 1.5, P = 0.009), and might also have a better performance in stone clearance rate (90.5% vs 72.5%, P = 0.19) and postoperative complications (P = 0.074). CONCLUSIONS: The percutaneous nephrolithotomy three-dimensional model manifested acceptable accuracy and good value for guiding puncture in a mixed reality environment.

Bilateral adrenal hemorrhage after hip arthroplasty: an initially misdiagnosed case.

BACKGROUND: Bilateral adrenal hemorrhage (BAH) is a rare but potentially catastrophic condition. Its clinical manifestation is often non-specific and sometimes difficult to be diagnosed in time. A 57-year-old woman, who presented with severe fatigue, nausea and vomiting after left hip arthroplasty due to her femoral neck fracture in a local hospital, was transferred to our medical center. Laboratory results revealed significant hyponatremia, low serum cortisol and elevated serum ACTH. Computed tomography (CT) showed a bilateral adrenal mass, measured 3.6 × 2.7 cm on the left and 3.4 × 2.3 cm on the right. Further magnetic resonance imaging (MRI) confirmed the diagnosis of BAH. The patient was prescribed with oral prednisolone acetate, 5 mg, tid, and her condition improved gradually. Nine months after, the patient was in good condition with 5 mg prednisolone acetate per day. CT revealed a clearly shrunken adrenal mass compared with 9 months ago. CONCLUSIONS: This case illustrates the difficulty in making the diagnosis of BAH with atypical presentation. Such cases necessitate greater alertness on the part of the clinician and require rapid diagnosis and prompt glucocorticoid replacement for better clinical outcomes.

Surface-projection-based transperineal cognitive fusion targeted biopsy of the prostate: an original technique with a good cancer detection rate.

BACKGROUND: To report a new standardized cognitive fusion technique on transperineal targeted biopsy (TB) of prostate, and to evaluate its efficacy for cancer detection combined with systematic biopsy (SB) . METHODS: We present a retrospective review of consecutive patients undergoing multiparametric magnetic resonance (mpMRI) imaging of the prostate with subsequent transperineal prostate biopsy from January 2016 to December 2018. A free-hand 12-core SB was performed for each patient. PI-RADS 3-5 lesions were further targeted for biopsy with our TB technique. Firstly, a central point of suspicious lesion (B') was registered cognitively on a transverse section of transrectal ultrasound (TRUS). Then, biopsy gun punctured vertically through a fixed pioneer site (A) on skin of perineum, and deep into the TRUS section to get A'. Next, targeted site (B), the surface-projection of B', would be determined on skin of perineum by A and distance from B' to A'. Finally, puncture through B to reach B'. Pathological findings of SB and TB were analyzed. RESULTS: A total of 126 patients underwent transperineal prostate biopsy (47 SB only, 79 SB + TB). The age of the patients was 68.7 ± 9.2 years. The median preoperative PSA value was 11.8 ng/mL. Preoperative prostate volume was 60.5 ± 50.0 mL. The numbers of patients with PI-RADS scores of 1 through 5 were 4, 43, 27, 21 and 31, respectively. The overall detection rate of cancer was 61/126 (48.4%), and it was significantly higher in the combination cohort (56/79, 70.9%) compared with the SB only cohort (5/47, 10.6%, p<0.001). When focused on the combination cohort, TB detected a similar overall rate of PCa (53/79, 67.1% vs 52/79, 65.8%; p = 0.87) compared with SB. The clinically significant PCa (csPC) detection rate was 52/79 (65.8%), while for TB and SB the csPC/PC rate was 51/53 (96.2%) and 48/52 (92.3%), respectively(p = 0.44). TB demonstrated a better sampling performance (positive rate for each core) compared with SB (51.0% vs 31.3%, p < 0.001). CONCLUSIONS: Surface-projection-based transperineal cognitive fusion targeted biopsy of the prostate has a good efficacy in detecting PCa.

[A dosage regimen of M-receptor blocker after TURP for severe BPH with predominant urine storage symptoms].

OBJECTIVE: To study the dosage regimen of oral M-receptor blocker following transurethral resection of the prostate (TURP) for severe benign prostate hyperplasia (BPH) with predominant urine storage period symptoms (USPSs) and its clinical effect. METHODS: Severe BPH patients with predominant USPSs received oral tolterodine (2 mg q12d or 4 mg qd) 6 hours after TURP for 4 weeks. The medication continued for another 2 weeks in case of recurrence of USPSs or until the 12th week in case of repeated recurrence. Before and at 1, 4, 8 and 12 weeks after TURP, we analyzed the International Prostate Symptoms Score (IPSS), quality of life (QoL) score, maximum urinary flow rate (Qmax), and postvoid residual volume (PVR) of the patients. RESULTS: Complete clinical data were collected from 106 cases, of which 33 achieved successful drug withdrawal with no aggravation of USPSs at 4 weeks after TURP, 51 at 6－8 weeks, 13 at 10－12 weeks, and 9 needed medication after 12 weeks. Before and at 1, 4, 8 and 12 weeks after TURP, the total IPSSs were 25.33 ± 3.45, 19.33 ± 3.62, 11.56 ± 2.45, 8.38 ± 2.0 and 7.74 ± 1.87, those in the urine storage period were 11.97 ± 1.53, 10.76 ± 1.82, 6.16 ± 1.22, 4.08 ± 1.19 and 3.91 ± 1.15, those at urine voiding were 9.80 ± 1.60, 5.59 ± 1.45, 3.40 ± 0.92, 2.85 ± 0.71, and 2.61 ± 0.67, and the QoL scores were 4.70 ± 0.78, 3.92 ± 0.75, 2.55 ± 0.74, 1.83 ± 0.72 and 1.66 ± 0.75, respectively, with statistically significant differences between the baseline and the scores at 1 and 4 weeks (P <0.01) but not at 8 or 12 weeks (P >0.05). Qmax and PVR were improved progressively and significantly at 1 and 4 weeks (P <0.01) but not at 8 or 12 weeks (P >0.05). CONCLUSIONS: Four to eight weeks of oral administration of M-receptor blocker may be an effective dosage regimen for severe BPH with predominant USPSs after TURP.

Evaluation of three-dimensional printing for laparoscopic partial nephrectomy of renal tumors: a preliminary report.

OBJECTIVES: To investigate the impact of three-dimensional (3D) printing on the surgical planning, potential of training and patients' comprehension of minimally invasive surgery for renal tumors. METHODS: Patients of a T1N0M0 single renal tumor and indicated for laparoscopic partial nephrectomy were selected. CT data were sent for post-processing and output to the 3D printer to create kidney models with tumor. By presenting to experienced laparoscopic urologists and patients, respectively, the models' realism, effectiveness for surgical planning and training, and patients' comprehension of disease and procedure were evaluated with plotted questionnaires (10-point rating scales, 1-not at all useful/not at all realistic/poor, 10-very useful/very realistic/excellent). The size of resected tumors was compared with that on the models. RESULTS: Ten kidney models of such patients were fabricated successfully. The overall effectiveness in surgical planning and training (7.8 ± 0.7-8.0 ± 1.1), and realism (6.0 ± 0.6-7.8 ± 1.0) were reached by four invited urologists. Intraoperative correlation was advocated by the two performing urologists. Patients were fascinated with the demonstration of a tactile "diseased organ" (average ≥ 9.0). The size deviation was 3.4 ± 1.3 mm. CONCLUSIONS: Generating kidney models of T1N0M0 tumors with 3D printing are feasible with refinements to be performed. Face and content validity was obtained when those models were presented to experienced urologists for making practical planning and training. Understandings of the disease and procedure from patients were well appreciated with this novel technology.

Validation of a novel non-biological bench model for the training of percutaneous renal access.

PURPOSE: The percutaneous renal access (PRA) is the most critical step of percutaneous renal surgery (PRS). For the training of PRA in the lab, a novel non-biological bench model was developed and set for validation test. MATERIALS AND METHODS: Experts in PRS (> 60 cases) and novices were included to perform fluoroscopy guided PRA on the model. Overall time, X-ray exposure time and puncture attempts were recorded to establish construct validity. After accomplishment, the experts rated the model using a standardized questionnaire for face and content validity based on a 5-point Likert scale, with 1 denoting very bad and 5 as excellent. Baseline and post-training data of novices were analyzed for skill acquisition. RESULTS: 9 experts and 30 novices were finally included. The overall appraisal was 4 by the experts, and consensus of all experts was reached for the model as an excellent training tool. Significant difference between experts and novices was detected with the experts using less total time 183.11 ± 29.40 vs. 278.00 ± 50.30 seconds (P < 0.001), shorter X-ray exposure time 109.22 ± 19.93 vs. 183.13 ± 38.83 seconds (P < 0.001), and fewer attempts 1.28 ± 0.44 vs. 2.35 ± 0.65 (P < 0.001). After training, the novices demonstrated significant skill improvement in total and fluoroscopy time, and number of attempts (P < 0.001). CONCLUSIONS: Our non-biological model provides a new method for PRA training. The face, content and construct validity were demonstrated. This model allows contact with PRA skills and could be applied to the first step in the learning curve.

Comparison of doublet and triplet therapies for metastatic hormone-sensitive prostate cancer: A systematic review and network meta-analysis.

Background: The best choice of first-line treatment for metastatic hormone-sensitive prostate cancer (mHSPC) is unclear. We aimed to compare the effectiveness and safety determined in randomized clinical trials of doublet and triplet treatments for mHSPC. Methods: Medline, Embase, Cochrane Central and ClinicalTrials.gov were searched from inception through July 01, 2022. Eligible studies were phase III randomized clinical trials evaluating androgen deprivation treatment (ADT) alone, doublet therapies [ADT combined with docetaxel (DOC), novel hormonal agents (NHAs), or radiotherapy (RT)], or triplet therapies (NHA+DOC+ADT) as first-line treatments for mHSPC. Outcomes of interest included overall survival (OS), progression-free survival (PFS) and grades 3-5 adverse events (AEs). Subgroup analyses were performed based on tumor burden. The effects of competing treatments were assessed by Bayesian network meta-analysis using R software. Results: Ten trials with 12,298 patients comparing nine treatments were included. Darolutamide (DARO) +DOC+ADT ranked best in terms of OS benefits (OR 0·52 [95% CI 0·39-0·70]), but its advantages were all statistically insignificant compared with other therapy options except for DOC+ADT (OR 0·68 [95% CI 0·53-0·88]) and RT+ADT (OR 0·57 [95% CI 0·40-0·80]). In terms of PFS, enzalutamide(ENZA)+DOC+ADT (OR 0·32 [95% CI 0·24-0·44]) and abiraterone and prednisone (AAP) +DOC+ADT (OR 0·33 [95% CI 0·25-0·45]) ranked best. For patients with high volume disease (HVD), low volume disease (LVD), and visceral metastases, the optimal therapies were AAP+DOC+ADT (OR 0·52 [95% CI 0·33-0·83]), apalutamide+ADT (OR 0·52 [95% CI 0·26-1·05]) and DARO+DOC+ADT (OR 0·42 [95% CI 0·13-1·34]), respectively. For safety, AAP+DOC+ADT (OR 3·56 [95% CI 1·51-8·43]) ranked worst with the highest risk of grade 3-5 AEs. Conclusions: Triple therapies may further improve OS and PFS but may be associated with a decrease in safety. Triplet therapies could be suggested for HVD patients, while doublet combinations should still be preferred for LVD patients. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPEROFILES/303117_STRATEGY_20220202.pdf, identifier CRD4202303117.

[Effects of modification of transferrin on cytotoxicity and intracellular delivery of paclitaxel loaded PLGA nanoparticles].

OBJECTIVE: To evaluate the effects of modification of transferrin on cytotoxicity and intracellular delivery of paclitaxel loaded Poly (lactide-co-glycolide) (PLGA) nanoparticle (NPs). METHODS: PLGA NPs were formulated with microemulsion method, Polyvinyl alcohol (PVA) was used as surfactant (PVA NPs). Transferrin (Tf) was used to modify the NPs (Tf NPs). The cytotoxicity of paclitaxel solution and paclitaxel loaded PVA NPs and Tf NPs were measured in bladder cancer cell line J-82. The intracellular delivery of two kinds of NPs was measured. RESULTS: The half maximal inhibitory concentration (IC50) of paclitaxel loaded PVA NPs and Tf NPs was (44 ± 7) and (49 ± 11) ng/ml respectively and significantly lower than that of paclitaxel solution, which was (81 ± 18) ng/ml (both P < 0.05). The uptake of PVA NPs and Tf NPs by J-82 cells after 2 hours was (89 ± 19) µg/mg cellular protein and (76 ± 16) µg/mg cellular protein. The uptake of two kinds of NPs had no significantly difference. The intracellular level of NPs decreased significantly upon the withdrawal of NPs in medium. However, it became stable 2 hours later and 11.3% PVA NPs and 18.0% Tf NPs remained. The intracellular level of PVA NPs and Tf NPs had no significantly difference at any time point. NPs were distributed in cytoplasm after endocytosis. CONCLUSIONS: PLGA NPs can significantly improve the anti-neoplastic effect of paclitaxel on bladder cancer. However, modification of Tf does not change the intracellular dynamics.

[Maximal androgen blockade little influences bone mineral density in prostate cancer patients].

OBJECTIVE: To determine the influence of maximal androgen blockade (MAB) on bone mineral density (BMD) in men with prostate cancer. METHODS: We enrolled 40 men with prostate cancer treated by MAB for 7 to 12 months. We obtained the laboratory results of PSA, testosterone, serum calcium and phosphorus, 24-h urine calcium and phosphorus, alkaline phosphatase, and parathyroid hormone, measured the BMD of the lumbar spine and femoral neck by dual energy X-ray absorptiometry, recorded pain scores, and compared the results before and after the treatment. RESULTS: Before MAB treatment, 5 (12.5%) of the patients met the BMD criteria of lumbar spine (L2-4) osteopenia, 8 (20%) lumbar spine (L2-4) osteoporosis, 13 (32.5%) left femoral neck osteopenia, and 15 (37.5%) left femoral neck osteoporosis. The PSA and testosterone levels were decreased from (52.9 +/- 69.9) microg/L and (18.9 +/- 6.5) nmol/L before MAB to (1.5 +/- 1.6) microg/L and (1.9 +/- 1.3) nmol/L after it (P<0.05). There were no statistically significant differences before and after MAB in the levels of serum calcium and phosphorus, 24-h urine calcium and phosphorus, alkaline phosphatase, and parathyroid hormone (P>0.05), nor in the BMD levels of the lumbar spine ([1.1 +/- 0.1] vs [1.1 +/- 0.2] g/cm2) and femoral neck ([0.8 +/- 0.2] vs [0.8 +/- 0.1] g/cm2), nor in the pain score ([0.6 +/- 0.2] vs [0.7 +/- 0.1], P>0.05). CONCLUSION: MAB treatment (range from 7 to 12 months) has no significant influence on BMD in men with prostate cancer, but BMD should be measured before MAB.

[Value of laparoscopic virtual reality simulator in laparoscopic suture ability training of catechumen].

OBJECTIVE: To investigate the value of laparoscopic virtual reality simulator in laparoscopic suture ability training of catechumen. METHODS: After finishing the virtual reality training of basic laparoscopic skills, 26 catechumen were divided randomly into 2 groups, one group undertook advanced laparoscopic skill (suture technique) training with laparoscopic virtual reality simulator (virtual group), another used laparoscopic box trainer (box group). Using our homemade simulations, before grouping and after training, every trainee performed nephropyeloureterostomy under laparoscopy, the running time, anastomosis quality and proficiency were recorded and assessed. RESULTS: For virtual group, the running time, anastomosis quality and proficiency scores before grouping were (98 ± 11) minutes, 3.20 ± 0.41, 3.47 ± 0.64, respectively, after training were (53 ± 8) minutes, 6.87 ± 0.74, 6.33 ± 0.82, respectively, all the differences were statistically significant (all P < 0.01). In box group, before grouping were (98 ± 10) minutes, 3.17 ± 0.39, 3.42 ± 0.67, respectively, after training were (52 ± 9) minutes, 6.08 ± 0.90, 6.33 ± 0.78, respectively, all the differences also were statistically significant (all P < 0.01). After training, the running time and proficiency scores of virtual group were similar to box group (all P > 0.05), however, anstomosis quality scores in virtual group were higher than in box group (P = 0.02). CONCLUSION: The laparoscopic virtual reality simulator is better than traditional box trainer in advanced laparoscopic suture ability training of catechumen.

The effects of psychological distance on spontaneous justice inferences: A construal level theory perspective.

Objective: The aim of this study was to examine the effects of psychological distance on spontaneous justice inferences. Methods: Two experiments were conducted using the probe recognition paradigm to directly examine whether psychological distance affects spontaneous justice inferences. In Experiment 1, the spatial distance of justice actions from the perceivers was manipulated. In Experiment 2, temporal distance was manipulated. Results: Consistent with our expectations, the results of Experiments 1 and 2 (for spatial distance and temporal distance, respectively) consistently demonstrated the effect of psychological distance on spontaneous justice inferences. In concrete terms, participants made stronger spontaneous justice inferences when confronted with situation descriptions of justice-implying events occurring in a spatially distant location than in a proximal location (Experiment 1) and in the distant-future condition than in the near-future condition (Experiment 2). Conclusion: These findings indicate that psychological distance can influence influence simplicity, unintentional processing of justice inferences.

Detecting and monitoring bladder cancer with exfoliated cells in urine.

Current methods for the diagnosis and monitoring of bladder cancer are invasive and have suboptimal sensitivity. Liquid biopsy as a non-invasive approach has been capturing attentions recently. To explore the ability of urine-based liquid biopsy in detecting and monitoring genitourinary tumors, we developed a method based on promoter-targeted DNA methylation of urine sediment DNA. We used samples from a primary bladder cancer cohort (n=40) and a healthy cohort (n=40) to train a model and obtained an integrated area under the curve (AUC) > 0.96 in the 10-fold cross-validation, which demonstrated the ability of our method for detecting bladder cancer from the healthy. We next validated the model with samples from a recurrent cohort (n=21) and a non-recurrent cohort (n=19) and obtained an AUC > 0.91, which demonstrated the ability of our model in monitoring the progress of bladder cancer. Moreover, 80% (4/5) of samples from patients with benign urothelial diseases had been considered to be healthy sample rather than cancer sample, preliminarily demonstrating the potential of distinguishing benign urothelial diseases from cancer. Further analysis basing on multiple-time point sampling revealed that the cancer signal in 80% (4/5) patients had decreased as expected when they achieved the recurrent-free state. All the results suggested that our method is a promising approach for noninvasive detection and prognostic monitoring of bladder cancer.

[Viviperception on renal vessel variation by retroperitoneal laparoscopy a report of 525 cases].

OBJECTIVE: To study the variation of renal vessels with retroperitoneal laparoscopy so as to increase the safety of retroperitoneal laparoscopic surgeries. METHODS: A total of 525 patients underwent retroperitoneal laparoscopic nephrectomy or partial nephrectomy at our hospital between January 2004 and June 2008. There were 316 males and 209 females with a mean age of (58 ± 13) years old. The procedures were as follows: (1) patients lay on one side with their waist up and the retroperitoneal cavity was established with our institutional method; (2) gerota's fascia was separated widely along the ventral surface of major psoas muscle; (3) the tissues around renal arteries and veins were isolated by ultrasonic scalpel. Careful observation was performed to explore if there were duplicated or accessory renal vessels; (4) renal vessels were cut by Endo-GIA/Hem-o-lok or blocked by bulldog clamps; (5) whole or partial kidney was finally resected (remaining procedures omitted). RESULTS: Among all patients, 58 patients (11.0%, 58/525) had a variation of renal vessels. There were double renal arteries on one side (n = 18), double renal veins (n = 10), 3 renal veins (n = 1) and double arteries and veins on one side (n = 3). Twenty-five patients (4.8%, 25/525) had one accessory renal artery on one side while 19 (76.0%, 19/25) accessory renal arteries went toward the upper kidney pole. The diameter of one patient's left spermatic vein was similar with that of renal vein and they were joined by lumber vein. CONCLUSION: The variation of renal artery is more common than that of renal vein. The accessory renal arteries are common and usually go toward the upper kidney pole. The variation of renal vessels should be considered before and during a laparoscopic procedure.

[Nanometer silver dressing alleviates pain after circumcision].

OBJECTIVE: Postoperative pain is a common problem in male circumcision. We investigated the effect of nanometer silver dressing (Shenzhen AGT Pharm. Co. Ltd.) in relieving pain following male circumcision. METHODS: Sixty patients undergoing circumcision in the outpatient department were randomized into an experimental and a control group, the incision covered with nanometer silver dressing in the former and with vaseline dressing in the latter. None of the patients received any analgesics or other pain-killing therapies after surgery. The postoperative pain intensity was accessed using the modified numeric pain intensity assessment scale at 1, 2, 3, 5 and 7 days after the operation, and statistical analyses were performed using SPSS 12.0 software. RESULTS: The patients averaged (31.13 +/- 13.94) years in age, and had no significant differences in age and body mass index (BMI) between the two groups. At 1, 2, 3 and 5 days, postoperative pain intensity was significantly lower in the experimental than in the control group (P > 0.05). Multiple regression analysis revealed that postoperative pain score was not correlated with patients' age, BMI and types of disease, but with the types of dressing. CONCLUSION: Nanometer silver dressing can significantly alleviate postoperative pain of circumcision, and is particularly applicable to such moist parts as the perineum, genitals, and urethra.

A multicenter retrospective study on evaluation of predicative factors for positive biopsy of prostate cancer in real-world setting.

OBJECTIVE: This study aimed to evaluate the predictors for positive biopsy in prostate cancer (PCa) patients and develop a risk-stratification score model for positive biopsy rate in patients with prostate specific antigen (PSA) in the gray zone. METHODS: In this retrospective, multicenter, real-world study, Chinese patients receiving prostate biopsy for the first time were included. The study evaluated the positive biopsy rate, predictors for positive biopsy and a risk prediction model for PSA 4-10 ng/mL PCa was developed. The univariate and multivariate logistic regression analyses were used to identify the risk factors. RESULTS: A total of 2426 patients were included in the study. The biopsy positive rate was 47.57%, 25.77%, and 60.57% among overall patients, total PSA (t-PSA) 4-10 ng/mL patients, and PSA > 10 ng/mL patients respectively. Elderly age 60-74, ≥75, multi parametric magnetic resonance imaging (MP-MRI), pre-operative PSA > 10 and PSA density (PSAD) significantly increased the positive rate in overall population, and elderly age, MP-MRI, positive digital rectal examination and f-PSA were significant predictors for positive biopsy in PSA 4-10 ng/mL population. A risk prediction model for positive biopsy rate in patients with PSA in the gray zone was developed. Area under curve (AUC) was associated with low accuracy for all the variables used such as tPSA (0.53), PSAD (0.57), frequency of puncture (0.53) and MP-MRI (0.64) in prediction of biopsy positive rate. CONCLUSION: Our study evaluated the significant predicative factors for positive biopsy and the PCa risk prediction model developed might help Clinicians to avoid unnecessary biopsy in patients with PSA in gray zone.

Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study.

INTRODUCTION: Dapoxetine on demand has been approved for premature ejaculation (PE) management in China; however, studies on the efficacy and safety of this treatment in the Chinese population are scarce. AIM: The aim of this study was to evaluate the safety and effectiveness of dapoxetine 30 mg and 60 mg on demand in Chinese men with PE. METHODS: Phase IV real-world study on 1,252 patients with PE. If men reported no response to dapoxetine 30 mg after 4 weeks treatment, dapoxetine has been uptitrated at 60 mg for 4 weeks more. MAIN OUTCOME MEASURE: Self-reported data were collected for demographics, general and sexual health characteristics, PE severity, and treatment safety and effectiveness, as measured by the PE profile questionnaire. RESULTS: Adverse events (AEs), such as nausea, thirst, headache, and dizziness, similarly to previous literature, were detected. The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively). No new safety concerns were observed. The overall effectiveness rates were 88.2% in subjects using 30 mg of dapoxetine, whereas a rescue from the previous failure was in 55.7% in the patients who received 60 mg after the initial 30 mg. Overall, 83.2% responded to dapoxetine at dosages equal to or lower than 60 mg. CONCLUSION: The results in this study demonstrated in a large Chinese population that on-demand dapoxetine is a safe and effective symptomatic treatment in patients with PE. J Peng, L Yang, L Liu, et al. Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study. Sex Med 2021;9:100296.

Single-Use Digital Flexible Ureteroscopes as a Safe and Effective Choice for the Treatment of Lower Pole Renal Stones: Secondary Analysis of a Randomized-Controlled Trial.

Objective: To compare the efficacy and safety of a single-use digital flexible ureteroscope (FURS) and a reusable FURS for the treatment of lower pole stones (LPS) smaller than 20 mm. Patients and Methods: We analyzed the data of 49 patients with LPS from our previous multicenter, randomized, open-label clinical trial in four hospitals in China. All patients underwent FURS for LPS with a single-use FURS ZebraScope™ (trial group) or a reusable FURS URF-V (control group). The efficacy endpoints assessed were the 1-month postsurgical stone-free rate (SFR), operative time, length of postoperative hospital stay, and mean reduction in hemoglobin level. The safety outcomes assessed were the presence of adverse events (AEs), severe AEs (SAEs), and postoperative complications. Results: The demographic and preoperative parameters were comparable between the two groups. The 1-month SFR was 84.00% for the ZebraScope group and 58.33% for the reusable flexible ureteroscope (URF-V) group (p < 0.05). There was no difference between the two groups in the operative time (p = 0.665), length of hospital stay (p = 0.308), presence of postoperative complications (p = 0.307), presence of AEs (p = 0.483), and the presence of SAEs (p = 0.141). Conclusions: This study demonstrates that single-use digital FURS is a safe and effective option and can offer higher SFR than the reusable FURS in the treatment of LPS smaller than 20 mm. We recommend single-use digital FURS as an alternative to reusable FURS for the treatment of LPS. The Clinical Trial Registration number: ChiCTR1900021615.

[Analysis of safety and efficacy of laparoscopic and open partial nephrectomy for small renal cell carcinoma].

OBJECTIVE: To compare the safety and efficacy of laparoscopic and open partial nephrectomy for small renal cell carcinoma. METHODS: To collect and analyze the data such as operation time, warm ischemia time, complications, recovery and surgical margins of 110 patients of small renal carcinoma (T1aN0M0) from January 2004 to March 2009, 52 of which underwent laparoscopic partial nephrectomy (LPN) and the other 58 patients underwent open partial nephrectomy (OPN). RESULTS: The mean operation time of LPN group and OPN group were 177.8 min and 126.7 min (t = 3.973, P < 0.01), respectively. The warm ischemia time of the two groups were 28.3 min and 21.9 min (t = 4.627, P > 0.05), respectively. Two cases in LPN group and 1 case in OPN group (3.8% vs 1.7%, chi(2) = 0.010, P > 0.05) needed blood transfusion. The increment of creatine after operation were 4 micromol/L in LPN group and 6 micromol/L in OPN group (t = -2.018, P > 0.05). Six cases (11.5%) in LPN group and 8 cases (13.8%) in OPN group needed collection system repairing (chi(2) = 0.130, P > 0.05)and the same data of hematuria after operation was observed. There was no urinary fistula or other severe complications in all patients. The hospital stay after operation was 10.6 d and 12.9 d (t = -3.244, P < 0.01) in the two groups, respectively. All surgical margins were negative. CONCLUSION: LPN and OPN have the same safety and efficacy, LPN primary treatment can be used for selected patients of T1aN0M0 renal cell carcinoma because of its fast recovery.

Single-Use Versus Reusable Digital Flexible Ureteroscopes for the Treatment of Renal Calculi: A Prospective Multicenter Randomized Controlled Trial.

Objective: To compare the efficacy and safety of a single-use digital flexible ureteroscope (f-URS) and a reusable digital f-URS (URF-V) for the treatment of renal stones in adults. Patients and Methods: In this randomized open-label noninferiority trial, we randomly selected patients with renal stones to receive ureteroscopy through a single-use digital f-URS (ZebraScope™; Happiness Workshop, Beijing, China) or a URF-V (Olympus, Tokyo, Japan). The primary endpoint was the 1-month postsurgical stone-free rate (SFR). The secondary efficacy endpoints assessed were the high-quality rate of images, the eligible rate of operability, the operative time, and the length of hospital stay. The safety outcomes assessed were the presence of postoperative complications, adverse events (AEs), and serious AEs (SAEs). The noninferiority margin was set at -10%. Results: In total, 126 patients completed the study (i.e., 63 patients in each group). The demographic and preoperative parameters were comparable between the two groups. The 1-month SFR was 77.78% for the ZebraScope group and 68.25% for the URF-V group (two-sided 95% confidence interval [CI]: -5.95 to 25.01). The high-quality rate of images and the eligible rate of operability were 100% in both groups (two-sided 95% CI: -5.27 to 5.35). There was no difference between the two groups in the operative time (p = 0.687), the length of hospital stay (p = 0.430), the presence of postoperative complications (p = 0.310), the presence of AEs (p = 0.709), and the presence of SAEs (p = 0.648). The most important and fatal SAE was acute urinary tract obstruction. Conclusion: The single-use digital f-URS (ZebraScope) appears to be at least noninferior to URF-V regarding the 1-month SFR, the high-quality rate of images, and the eligible rate of operability. Single-use digital f-URSs are an effective and safe alternative to URF-V.