Optimizing outcome reporting after robotic flexible ureteroscopy for management of renal calculi: Introducing the concept of tetrafecta.

Robotic flexible ureteroscopy (RFURS) has shown encouraging results in terms of stone free rate (SFR) and better ergonomics compared to conventional FURS. However, few studies have reported its outcomes. The goal of this study was to report our initial results of RFURS, furthermore we proposed a novel metrics for composite outcome reporting named tetrafecta. A retrospective analysis of electronic records of 100 patients treated with RFURS for renal stones between 2019 till 2023 was performed. Tetrafecta criteria included, complete stone removal after a single treatment session, without auxiliary procedures, absence of high-grade complications (GIII-V) and same-day hospital discharge. Mean patient age and stone size were 40.7 ± 9.2 and 11.7 ± 5.8 mm, respectively. Median stone volume was 916 (421-12,235) mm3. Twenty-eight patients had multiple renal stones. Staghorn stones were seen in 12 patients. Preoperative DJ stent was fixed in 58 patients. Median operative time and stone treatment time were 116 min (97-148) and 37 (22-69) min. The median stone treatment efficiency (STE) was 21.6 (8.9-41.6). A strong positive correlation between stone volume and STE (R = 0.8, p < 0.0001). Overall, 73 patients were stone free after the initial treatment session while tetrafecta was achieved in 70 patients. Univariate analysis showed that the stone size (p = 0.008), acute infundibulopelvic angle (p = 0.023) and preoperative stenting (p = 0.017) had significant influence on achieving tetrafecta. Multivariate analysis identified preoperative stenting (OR 0.3, 95% CI 0.1-0.8, p = 0.019) as the only independent predictor of tetrafecta achievement. A comprehensive reporting methodology for reporting outcomes of RFURS is indicated for patient counseling and comparing different techniques. Tetrafecta was achieved in 70% of cases. Presence of significant residual stones ≥ 3mm was the leading cause of missing tetrafecta. Absence of preoperative stent was the only predictor of missing tetrafecta.

Greenlight laser (XPS-180watt) prostatectomy for treatment of benign prostate obstruction, Pursuit of durability.

Objectives: To report 5-year outcomes, need and predictors of retreatment post greenlight laser photoselective vaporization (GL.PVP) and vapo-enucleation (GL.PVEP), as long-term data on safety and efficacy of GL.PVP and GL.PVEP and on the prostate using XPSTM system are still pending. Patients and methods: Primary outcome was the need for retreatment (medical treatment and reintervention) for recurrent BOO. Time-to-event (retreatment) analysis, perioperative events, change in the urinary outcome measures at different follow-up visits, early and late complications and PSA kinetics were reported. Results: Between September 2014 and April 2017, 248 patients underwent GL/XPS procedures. GL.PVP and GL.PVEP were carried out for 157 (63.3%) and 91 (36.7%) patients with mean prostate sizes of 60 ± 18 and 100 ± 22 cc, respectively. After a mean duration of 62 ± 9-month follow-up, overall retreatment rate (medical and interventional) was 23% (57 patients). It was comparable between both GL.PVP and GL.PVEP cases: 38 (24.2%) and 19 (20.9%) patients, P = 0.5, respectively. Significantly more surgical reintervention rate was reported after GL.PVP compared to GL.PVEP (P = 0.03). In retreatment group, more intraoperative bleeding (P = 0.02), early postoperative hematuria (P = 0.03), higher median preoperative PSA (P = 0.02) and less postoperative one-year percent PSA reduction (P = 0.02) were detected. Lower postoperative one-year percent PSA reduction independently predicts retreatment with a cut-off point of 64.2% (58.2% sensitivity, 73.4% specificity, AUC 0.647, 95% CI 0.52-0.76).Median (range in months) time to event was 20 (1-60) for all cases and 13.5 (1-42) and 30 (18-60), P = 0.7, for GL.PVP and GL.PVEP groups, respectively. Conclusion: Greenlight laser XPS is an effective, durable and versatile tool in treating benign prostatic obstruction. Durability of the outcome is predictable with more postoperative PSA reduction.

Randomized trial to assess the potential role of ascorbic acid and statin for post-contrast acute kidney injury prevention.

PURPOSE: To evaluate the effect of using statins and ascorbic acid for the prevention of post-contrast acute kidney injury (PC-AKI) in patients undergoing urologic diagnostic elective contrast-enhanced computed tomography (CECT). METHODS: This registered trial (NCT03391830) was for statin naïve patients underwent elective CECT. Patients were randomized allocated to two groups: the first group received atorvastatin 80-mg the day before the study and atorvastatin 40-mg two hours before the CECT and for continue on atorvastatin 40-mg two days after CECT; plus ascorbic acid 500 mg with atorvastatin. The other group received two tablets of placebo once/daily before the procedure and for another 3 days. The primary outcome was to assess the incidence PC-AKI. RESULTS: The baseline parameters were comparable between both groups. The final median (interquartile range "IQR") serum creatinine were 0.80 (0.60, 1.00) and 0.80 (0.60, 1.00), respectively, with insignificant p-value (p = 0.8). The median (IQR) final estimated GFR were 95.2 (72.8, 108.1) and 88.6 (71.9, 111.0) mL/min in placebo and statin plus ascorbic acid groups, respectively (p = 0.48). The eGFR difference median (IQR) were - 6.46 (- 11.72, - 4.18) and - 6.57 (- 13.38, - 3.82) ml/min in placebo and statin plus ascorbic acid groups, respectively (p = 0.58). PC-AKI occurred in 11 patients (9.8%) in placebo group and in 3 patients (3%) in statin plus ascorbic acid group (p = 0.04). CONCLUSIONS: Statin and ascorbic acid did not statistically improve neither serum creatinine nor eGFR values in patient underwent CECT. However, it can decrease the incidence of the clinically insignificant PC-AKI.

Can we offer additional BCG therapy for three-month BCG refractory high grade/T1, Tis bladder cancer patients?

Background: We lack tools to predict treatment and survival outcomes in patients receiving additional BCG therapy as a bladder-preserving therapy in high grade/T1, Tis NMIBC patients who showed persistent/recurrent tumors at three-month follow-up. Objectives: To assess the predictors of additional BCG response in patients who experienced persistent/recurrent tumors at three-month follow-up after BCG induction. Patients and methods: We retrospectively analyzed database for NMIBC. Between 2000 and 2019, 231 patients with high-grade T1/Tis NMIBC showed persistent/recurrent tumors at 3-month after BCG-induction, refused or were unfit to radical cystectomy (RC) and were offered additional intravesical BCG as bladder-preserving treatment. Predictors of the outcome after additional BCG were studied using univariate and multivariate logistic regression analysis. Kaplan Meier curve was utilized to estimate the recurrence-free survival (RFS) and progression-free survival (PFS). COX regression analysis was performed to identify independent predictors or RFS and PFS. Results: During a median (range) of 148 (24-224) months, poor response to additional BCG (tumor recurrence and/or progression) was noted in 112 (48.5%) patients. On multivariate logistic regression analysis, 3-month tumor features (persistent T stage, persistent grade and persistent/new CIS) significantly predicted poor response to additional BCG (OR: 3.4, 95%CI: 1.3-10.8, p = 0.021, OR: 2.1, 95%CI: 1.1-4.1, p = 0.02 and OR: 16.6, 95%CI: 4.5-109, p=<0.001, respectively). The mean RFS was 26 (9-152) months with identified 3-month tumor features (persistent T stage and persistent/new CIS) as independent predictors of RFS (HR = 11.5, 95%CI = 2.7-48.3, p = 0.001 and HR = 2.5, 95%CI = 1.5-4.1, p=<0.001, respectively) on multivariate COX regression analysis. In addition, 3-month tumor features (persistent/new CIS, non-papillary shape and bladder neck involvement) were identified to significantly predict PFS (HR = 6.2, 95%CI = 3.4-11.5, p=<0.001 and HR = 2.3, 95%CI = 1.3-4.3 p = 0.001 and HR = 2.1, 95%CI = 1.2-3.8, p=<0.005, respectively). Conclusions: Three-month tumor features could be utilized as a tool to predict treatment outcomes and survival benefits when additional intravesical BCG is utilized as a bladder-preserving treatment in patients with recurrent/persistent tumors at three-month follow-up.

Greenlight laser (XPSTM) 180W prostatectomy for treatment of benign prostate hyperplasia in patients with uncorrectable bleeding tendency.

Objectives: Safety of GreenLight™ laser prostatectomy (GL-LP) in patients with ongoing blood thinners has been proven. Yet, the possibility of drug manipulation makes it a less challenging situation compared to treating patients with uncorrectable bleeding tendency. Herein, we aim at evaluating the outcomes of XPS™-180 W GL-LP for treatment of BPH in patients who had uncorrectable bleeding tendency due to hepatic dysfunction. Methods: A prospectively maintained database for all patients who underwent GL-LP for symptomatic BPH was reviewed. Patients were divided into two groups based on the degree of hepatic dysfunction using Fib-4 index: Group 1 (indexed patients; low-risk Fib-4) and Group 2 (non-indexed patients; intermediate-high-risk Fib-4) included those who had chronic liver disease associated with either thrombocytopenia and/or hypoprothrombinemia. Primary outcome was the difference in perioperative bleeding complications between the two groups. Other outcome measures included all perioperative findings and complications as well-functional outcome measures. Results: The study included 140 patients (93 indexed patients and 47 non-indexed). There were no significant differences between both groups in operative time, laser time and energy, auxiliary procedures, catheter time, hospital stay, and hemoglobin deficit. The need for blood transfusion was significantly more in group 2 (two patients (4.3%) versus no patients in group 1, P = 0.045). Perioperative and late postoperative complications were comparable for both groups (P = 0.634 and 0.858, respectively). There were no significant differences in the postoperative uroflow, symptoms score, and PSA reduction between the two groups (P = 0.57, 0.87, and 0.05, respectively). Conclusions: XPS™-180 W GL-LP is a safe and effective technique for treatment of BPH in patients with uncorrectable bleeding tendency due to hepatic dysfunction.

A randomized trial of adjuvant tamsulosin as a medical expulsive therapy for renal stones after shock wave lithotripsy.

Adjuvant medical expulsive therapy (MET) for shock wave lithotripsy (SWL) is controversial. With limited use of the computed tomography (CT), the stone free rate (SFR) become overestimated. Herein we evaluate tamsulosin post-SWL for renal stone using the CT to assess SFR. A randomized controlled trial (NCT05032287) was carried out for renal stone patients amenable for SWL. Patients were allocated after 1st session of SWL to receive tamsulosin 0.4 mg or placebo once daily from the 1st day of SWL and for 3-months or becoming stone free. The primary outcome was SFR, defined by presence of residual fragments (RF) ≤ 3 mm (3C-SFR). The 3C-SFR were 73.8% and 59.6% in tamsulosin and placebo groups, respectively (p = 0.03). The median (IQR) pain scores were 3 (3, 5) and 5 (3, 6) in tamsulosin and placebo groups, respectively (p = 0.04), However, the post-SWL complication and add-on analgesia needed showed no significance differences between groups. The median time for stone free were 30 days (95% CI: 27.29-32.71) in tamsulosin arm, and 36 days (95% CI: 31.01-40.99) in placebo arm, HR = 1.42 (95% CI: 1.02-1.98). Tamsulosin has more reversible adverse effect, compared to placebo (p = 0.03). In our study, the use of tamsulosin as MET following SWL facilitates expulsion of retained residual fragments. Tamsulosin shortens time to reach stone free, decreases pain scores. However, tamsulosin does not affect the add-on IV analgesics and have more reversible adverse effect, compared to placebo.

Oncologic Outcomes of Squamous Cell Carcinoma Versus Urothelial Carcinoma With Squamous Differentiation After Radical Cystectomy for Bladder Carcinoma.

INTRODUCTION: In this study we aim to compare clinicopathological characteristics and cancer specific survival between patients treated with radical cystectomy for pure squamous cell carcinoma (SCC) and urothelial carcinoma with squamous differentiation (SqD). PATIENTS AND METHODS: We reviewed data of 1737 consecutive patients treated with radical cystectomy and urinary diversion between January 2004 and February 2014. Only patients with pure SCC or SqD were included in the analysis. Squamous differentiation was defined as intercellular bridges or keratinization in the tumor. Clinicopathological data and recurrence free survival (RFS) were compared between patients diagnosed with SCC and SqD. RESULTS: SCC and SqD were found in 318 and 223 patients, respectively. Mean age was 57 ± 8.3 years in SCC and 58.8 ± 7.8 in SqD (P = .008). A higher proportion of female patients was observed in SCC group compared to SqD (31.8% vs. 22% P < .0001). Patients with SqD were more likely to have extravesical (58.3% vs. 46.2%: P = .006) and nodal positive disease (34.5% vs. 14.5%: P < .0001) than pure SCC patients. Bilharzial eggs were found in 61% of SCC vs. 46% of SqD (P = .001).; The median (IQR) follow up period for SCC and SqD was 63 (12-112) months and 23 months (9-74.7), respectively. The 5-year RFS for SCC and SqD were 77% and 59.8 %, respectively (P < .0001).; Multivariate cox regression analysis identified advanced pT stage (OR: 1.9, 95% CI: 1.3-2.86, P = .0001), nodal positive disease (OR: 1.6, 95% CI: 1.1-2.48, P = .01) and SqD histology (OR: 1.6, 95% CI: 1.14-2.31, P = .007 as independent predictors of 5-year RFS. CONCLUSION: Patient with SCC had significantly higher 5-year RFS in comparison to SqD. The higher rate of extravesical disease and lymph node metastasis in SqD patients is indicative of aggressive behavior of this histologic type.

Predictors and survival benefit of achieving pentafecta in a contemporary series of open radical cystectomy.

BACKGROUND: Pentafecta provides a comprehensive approach for standardized reporting of surgical and oncologic outcomes after radical cystectomy and urinary diversion. We aimed to report the rate, predictors of achieving pentafecta and its impact on long-term survival in a contemporary series of open radical cystectomy (ORC). METHODS: A retrospective analysis of a computerized database of patients treated with ORC between 2004 till 2014 was performed. Pentafecta criteria included negative soft tissue surgical margin (STSM), retrieval of ≥16 lymph nodes, absence of clinical recurrence within 12 months after surgery, absence of high-grade complication (GIII-V) within 90 days after surgery, and absence of urinary diversion related complications at 12 months follow-up. Multivariate analysis was used to identify predictors of achieving pentafecta. RESULTS: Pentafecta was achieved in 545 (33.6%) patients out of 1624 included in the study. Absence of ≥16 LN yield was the first cause of missing pentafecta (49.5%). Multivariate analysis identified: ASA Score grades ≥III (OR=0.7, 95%CI 0.6-0.9, P=0.04), BMI≥35 (OR=0.5, 95%CI 0.3-0.8, P=0.007), perioperative blood transfusion (≥4 units) (OR=0.5, 95%CI 0.3-0.7, P=0.001), and ileal conduit (OR=0.7, 95%CI 0.5-0.9, P= 0.01) as independent predictors of missing pentafecta. Patients who achieved pentafecta had higher estimated 5-year RFS than their counterparts (81.7% vs. 62.5%; P<0.0001). CONCLUSIONS: Pentafecta was achieved in nearly one third of patients after ORC. Achievement of pentafecta was associated with better long-term recurrence-free survival. Obesity (class II, III), perioperative blood transfusion (>4 units), associated comorbidities, and ileal conduit were independent predictors of missing pentafecta.

Clinical efficacy of mebeverine for persistent nocturnal enuresis after orthotopic W-neobladder.

OBJECTIVES: To investigate the efficacy of mebeverine for nocturnal incontinence in male patients with an ileal orthotopic bladder substitute (OBS). PATIENTS AND METHODS: A randomised controlled trial was carried out for adult male patients who were nocturnal incontinent. Patients were allocated to receive mebeverine 200 mg or placebo once a day in the evening for 3 months. The primary outcome was to compare the continence status between groups, assessed by the urinary domain of the Bladder Cancer Index (BCI) and pad usage. The secondary outcomes were to assess the safety of mebeverine. RESULTS: There were 55 patients in the placebo group and 58 in mebeverine group who completed the follow-up. The median (interquartile range) interval between OBS surgery and starting treatment was 9 (4-13) years in the placebo group and 9 (6-13) years in the mebeverine group. The mean (SD) 3-month urinary domain score of the BCI was 70.8 (5.6) and 86.4 (14.2) in the placebo and mebeverine groups, respectively (P < 0.001). At 3 months, 54 (98.2%) and 26 (44.8%) patients required the use of a night-time pad in the placebo and mebeverine groups, respectively. Mebeverine reduced the risk of pad use by 53.4% (95% confidence interval 40.1-66.6; P < 0.001). Constipation occurred in one (2.1%) and three (5.8%) patients in the placebo and mebeverine groups, respectively; abdominal distention occurred in two (3.8%) of the patients in the mebeverine group (P = 0.25). CONCLUSION: Mebeverine decreases night-time pad use and improves the quality of life in male patients with an ileal OBS and is associated with minimal adverse events.

Predictive value of immunological markers after bacille Calmette-Guérin induction in bladder cancer.

OBJECTIVES: To investigate the predictive value of different immunological markers on treatment outcomes after bacille Calmette-Guérin (BCG) induction in high-risk non-muscle-invasive bladder cancer (NMIBC). PATIENTS AND METHODS: Patients who underwent transurethral resection of bladder tumour for NMIBC were assessed for study eligibility. Urine and blood samples were taken from patients at baseline (immediately before first dose of induction) and after induction (4 h after last [sixth] dose). Urine samples were evaluated for interleukin (IL)-2 and IL-10 by solid-phase enzyme-linked immunosorbent assay. Blood samples were evaluated for tumour necrosis factor α (TNF-α), cytotoxic T-lymphocyte antigen 4 (CTLA-4) and transcription factors (TFs) (GATA-binding protein 3 [GATA3], T-box expressed in T cells [T-bet], and forkhead box protein 3 [FoxP3]) using quantitative reverse transcriptase-polymerase chain reaction analysis. Change pattern and fold change of each evaluable marker was assessed in relation to different treatment outcomes (initial complete response [ICR]/recurrence/progression). RESULTS: Between July 2013 and May 2019, 204 patients were included. Among evaluable markers, urinary IL-2 and serum TNF-α increased in all patients, serum CTLA-4 and FoxP3+ showed a predominant decreased pattern in 188 (92.2%) and 192 (94.1%) patients, respectively. An ICR was achieved in 186 (91.2%) patients. Serum TNF-α fold change and urinary IL-10 change pattern were significantly associated with an ICR (P = 0.001 and P = 0.03, respectively). At a median (range) follow-up of 37 (20-88) months, 104 (56%) patients developed recurrence. Urinary IL-10, serum CTLA-4, T-bet+ , FoxP3+ change patterns and GATA3+ /T-bet+ ratio were significantly associated with tumour recurrence (P = 0.001, P = 0.001, P = 0.02, P = 0.009 and P = 0.001, respectively). Tumour progression occurred in 34 (18.3%) patients. Urinary IL-10, serum CTLA-4, serum T-bet+ change patterns and GATA3+ /T-bet+ ratio were independent predictors of tumour progression (P = 0.001, P = 0.001, P = 0.02 and P = 0.001, respectively). CONCLUSIONS: Urinary IL-10 and serum TNF-α can significantly predict ICR. Moreover, change pattern of urinary IL-10, serum CTLA-4, TFs (GATA3, T-bet and FoxP3) and GATA3+ /T-bet+ ratio after BCG induction can independently predict further BCG response. These markers could be implemented in clinical practice when management options are discussed or in systems with severe BCG shortage.

Prognostic influence of microsatellite alterations of muscle-invasive bladder cancer treated with radical cystectomy.

OBJECTIVE: To examine the prognostic effect of microsatellite instability (MSI) and loss of heterozygosity (LOH) on cancer-specific survival (CSS) in patients with muscle-invasive bladder cancer (MIBC). PATIENTS AND METHODS: The liquid nitrogen-preserved specimens of 220 patients between March 2009 and December 2012 were analyzed for the presence of MSI and LOH in 12 loci (ACTBP2, D16S310, D16S476, D18S51, D4S243, D9S162, D9S171, D9S747, FGA, INF-α, MBP, MJD) using polymerase chain reaction. MSI was defined as MSI-stable, MSI-Low, or MSI-High if instability was detected in 0, 1, or 2 or more of the examined markers, respectively. The association between MSI-High and LOH and CSS was analyzed using uni- and multivariate analyses and the degree of agreement between tumor and urine samples were determined. RESULTS: MSI were found in 1030 (39%) and 1148 (43.5%) in tumor and urine specimens, respectively (Kappa = 0.77). On the other hand, LOH was found in 163 (6.2%) of tumor tissues and 44 (1.7%) in urine specimens (Kappa = 0.34). Microsatellite alterations were significantly associated with worse CSS at 1- and 5-year in tumor tissue (95% and 83.7% vs. 65.8% and 3.5%, respectively; P < 0.001) and in urine sample (90% and 64% vs. 46.5% and 9.3%, respectively; P < 0.001). MSI and/or LOH was an independent predictor of CSS (HR: 9.8; 95%CI: 5.1-18.9; P < 0.001). CONCLUSIONS: Microsatellite alterations were potentially an independent predictor of CSS in patients with MIBC. The agreement was good between tumor and urine MSI but weak for LOH.

Validation of the Arabic linguistic version of the Danish Prostatic Symptom Score for benign prostatic hyperplasia associated with lower urinary tract symptoms.

Objective: To validate an Arabic version of the Danish Prostatic Symptom Score (DAN-PSS), a self-administered quality-of-life questionnaire. Patients and methods: The reliability of the Arabic DAN-PSS was assessed by determining the internal consistency (Cronbach's α coefficient) and by assessing the test-retest reliability (Kappa [κ] test). Inter-domain associations were examined using Spearman's correlation coefficient (r). The discrimination validity was evaluated using receiver operating characteristic (ROC) curves. The sensitivity to change of the questionnaire and its individual items was assessed before and after intervention using a paired t-test. Results: In all, 106 men (55 patients with BPH and 51 without BPH symptoms) were included. A high level of internal consistency amongst the three domains of the answered Arabic DAN-PSS questionnaire was observed (Cronbach's α > 0.70). Also, there was a good correlation between storage and voiding (r = 0.75; P < 0.001) and post-micturition symptoms domains (r = 0.51; P < 0.001). Voiding and post-micturition symptoms domains also had a good correlation (r = 0.51; P < 0.001). The agreement between the test and retest scores had a κ value of 0.83 (P < 0.001). The ROC curve had an area under the curve of 0.98. The sensitivity to change comparing patients with BPH who received medical or surgical intervention revealed Arabic DAN-PSS mean (SD) scores of 34.7 (17.7) and 17 (8.7) before and after the intervention, respectively (P < 0.001). Conclusion: The Arabic DAN-PSS is a clear questionnaire, valid, reliable, and responsive that can be used for BPH associated with lower urinary tract symptoms assessment and follow-up in clinical practice and research in Arabic-speaking patients. Abbreviations: AUC: area under the curve; BPH: benign prostatic hyperplasia; CI: confidence interval; DAN-PSS: Danish Prostatic Symptom Score; DRE: digital rectal examination; ICIQ-MLUTS: International Consultation on Incontinence Male LUTS Questionnaire; ICS: international continence society; IPSS: international Prostatic Symptom Score; IPSS-Arb: Arabic version of the IPSS; LUTS: lower urinary tract symptoms; PSA: prostatic specific antigen; PSS: prostatic symptom score; QoL: quality of life; ROC: receiver operating characteristic; UTI: urinary tract infection.

Holmium Laser En-bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle-invasive Bladder Cancer: A Randomized Clinical Trial.

BACKGROUND: En-bloc resection of bladder tumors achieves complete tumor removal, improves the quality of resection, decreases perioperative complication, and potentially improves recurrence rates. OBJECTIVE: To assess the efficacy and safety of holmium laser en-bloc resection (HolERBT) versus conventional transurethral resection of bladder tumor (cTURBT). DESIGN, SETTING, AND PARTICIPANTS: Between September 2015 and September 2018, 100 patients with non-muscle-invasive bladder cancer were randomly allocated to cTURBT or HolERBT. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was detection of residual tumor in reTURBT specimens at 4 wk after the primary resection. Operative parameters, specimen quality, perioperative complications, and recurrence-free survival (RFS) were compared. Independent sample t tests, χ2 tests, and Kaplan-Meier curves were used, as appropriate. RESULTS AND LIMITATIONS: The patient and tumor baseline characteristics were comparable between the groups. Residual tumors were detected in 7% and 27.7% of cases after HolERBT and cTURBT, respectively (p=0.01). Detrusor muscle was sampled in 98% of HolERBT and 62% of cTURBT cases (p<0.001). Lamina propria invasion substaging was feasible in only 68.2% of HolERBT and 18.4% of cTURBT cases (p<0.001). Following HolERBT, catheterization time (p<0.001) and hospital stay (p=0.001) were shorter when compared to cTURBT. Immediate postoperative instillation of chemotherapy in indicated cases was feasible for 100% of the HolERBT group and 91.5% of the cTURBT group (p=0.04). After follow-up of 20 ± 9.9 mo (13-36), RFS was 31.76 mo (95% confidence interval [CI] 28.67-34.86) in the HolERBT group and 28.25 mo (95% CI 24.87-31.64) in the cTURBT group (hazard ratio 0.43, 95% CI 0.17-1.1; p=0.07). However, this study was not powered to detect a difference in RFS. CONCLUSIONS: Compared to cTURBT, HolERBT is a safer procedure for bladder tumor resection. It fulfills the oncological criteria of optimized resection with less residual tumor and better specimen quality. PATIENT SUMMARY: En-bloc resection of bladder cancer tumors using a holmium laser is safer than the conventional technique. It has the advantages of less residual tumor and better specimen quality, with a similar tumor recurrence rate. This study is registered at ClinicalTrials.gov as NCT02555163.

Development and validation of a simple stone score to estimate the probability of residual stones prior to percutaneous nephrolithotomy.

BACKGROUND: The aim of the present study was to develop and internally validate a simple stone score (SSS) to estimate the probability of clinically significant residual fragments (CSRF) prior to percutaneous nephrolithotomy (PNL). METHODS: The files of 1170 PNL procedures between January and December 2015 were evaluated. CT-derived stone characteristics were examined. Caliceal stone distribution (CSD) was assigned three grades based on the number of calices involved regardless of the renal pelvis (I = no or single calix; II = more than one calix; and III = more than 2 calices or complete staghorn stones). CSRF was defined as any residuals >4 mm in postoperative CT. A logistic regression model to predict the CSRF was fitted, and coefficients were used to develop the SSS. The SSS was validated by discrimination, calibration, and decision curve analysis (DCA). RESULTS: Patients' data were split into training (936, 80%) and validating (234, 20%) datasets. In the training partition, independent predictors of CSRF were CSD-grade II (OR: 4.2; 95%CI: 2.5-7; P<0.001), grade III (OR: 7.8; 95%CI: 4.2-14.4; P<0.001) and largest stone diameter (LSD) (OR:1.3; 95%CI: 1.1-1.6; P<0.001). Score points 0, 1, 2, and 0, 3, 9 were given to LSD<30, 30-40, >40 mm, and CSD grades I, II, III, respectively. Discrimination of the SSS was 0.79 and after 10-fold cross-validation and internal validation was 0.86. The calibration plot and DCA highlighted the validity and clinical significance of the SSS. CONCLUSIONS: The novel SSS could be used to describe the risk of CSRF prior to PNL. Further studies are invited for external validation.

A Randomized Trial to Examine the Utility of Mebeverine on the Early Return of Continence Following Orthotopic Bladder Substitution.

PURPOSE: We assessed the effect of mebeverine in the enhancement of the orthotopic bladder substitute continence. MATERIALS AND METHODS: A randomized trial was carried out for incontinent adult male patients during the first year post-orthotopic bladder substitute surgery. Patients were allocated to receive mebeverine 135 mg or placebo 3 times a day for only 3 months. The primary outcome was to compare the continence improvement between groups, assessed by the urinary domain of the Bladder Cancer Index and sanitary pad use. The secondary outcomes were to assess the safety of the drugs used. RESULTS: In placebo group 47 and in mebeverine group 52 patients completed followup. The median (range) interval time between orthotopic bladder substitute surgery and starting treatment was 7 (3-10) months and 6.5 (3-10) months in the placebo and mebeverine group, respectively (p=0.3). Compared to the baseline evaluation, the 3-month urinary domain of Bladder Cancer Index scores improved in both groups with significant improvement in the mebeverine group. The mean±SD 3-month urinary domain of Bladder Cancer Index was 67.79±13.05 and 83.27±12.21 in the placebo and mebeverine group, respectively (p <0.001). Also, the 3-month patient pad use decreased to 30 (63.8%) and 19 (36.5%) patients in the placebo and mebeverine group, respectively (p=0.007). Constipation occurred in 1 (2.1%) and 3 (5.8%) patients in the placebo and mebeverine group, respectively; abdominal distention occurred in 2 (3.8%) in the mebeverine group (p=0.25). CONCLUSIONS: Mebeverine accelerated continence development in male patients with ileal orthotopic bladder substitute during the first year post-orthotopic bladder substitute construction.

Preoperative risk factors for complications of percutaneous nephrolithotomy.

This study was conducted to evaluate preoperative risk factors for development of complications of percutaneous nephrolithotomy (PCNL). All consecutive patients aged ≥ 16 years who underwent PCNL during 2015 were retrospectively reviewed. Non-contrast CT (NCCT) was performed for all patients to evaluate stone complexity. The technique of PCNL was the same for all patients. Intra-operative and postoperative complications were recorded and classified based on modified Clavien system. The differences in preoperative data (patients, renal and stone characteristics including Guy's and STONE scores) between complicated and uncomplicated cases were compared using univariate and multivariate statistical analyses for detection of independent risk factors. The study included 1178 patients (61% were males). Mean age was 50 ± 12 years, and mean BMI was 30.7 ± 5.7 kg/m2. Complicated group included 166 patients (14.1%). Independent risk factors on multivariate analysis were infected preoperative urine culture (RR: 2.098, P 0.001, 95%CI: 1.380-3.189), largest stones diameter 30 mm or more (RR: 2.481, P > 0.001, 95%CI: 1.697-3.627) and number of calyces affected by the stones (RR: 2.431, P 0.002, 95%CI: 1.400-4.222 for affection of two calyces and RR: 2.778, P 0.005, 95%CI: 1.357-5.684 for affection of three calyces). While two scoring systems (Guy's and STONE) were not predictive of complications after PCNL, preoperative risk factors were infected preoperative urine culture, distribution of the stones or stone branches in two or three calyceal groups and stone size 30 mm or more.

Randomised trial of bipolar resection vs holmium laser enucleation vs Greenlight laser vapo-enucleation of the prostate for treatment of large benign prostate obstruction: 3-years outcomes.

OBJECTIVE: To compare transurethral resection in saline (TURIS), Greenlight laser vapo-enucleation of the prostate (GL.PVEP), and holmium laser enucleation of the prostate (HoLEP), for controlling lower urinary tract symptoms secondary to large benign prostatic hyperplasia (BPH) and to assess non-inferiority of 3-year re-treatment rates. PATIENTS AND METHODS: Eligible patients with BPH (prostate size 80-150 mL) were randomly assigned to one of the intervention groups. Non-inferiority of re-treatment rate was evaluated using a one-sided test at 5% level of significance. RESULTS: At the time of analysis, 60 GL.PVEP, 60 HoLEP and 62 TURIS procedures were included. Perioperative parameters were comparable between groups; however, the operative time was longer in GL.PVEP vs HoLEP and TURIS, at a mean (SD) of 92 (32) vs 73 (30) and 83 (28) min (P = 0.005); and was less effective with a mean (SD) removal of 1.2 (0.4) vs 1.7 (0.7) and 1.4 (0.6) g/min (P < 0.001), respectively. Perioperative complications and need for auxiliary procedures were similar in the three groups; however, there was a significantly higher rate of capsular perforation in TURIS group (five, 8%) compared to one (1.6%) in the GL.PVEP group and none in the HoLEP group (P = 0.01). There was a significantly longer hospital stay, catheter-time and higher rate of blood transfusion in the TURIS group. There was significant but comparable improvements in the International Prostate Symptom Score in three groups at different follow-up points. At 3 years, re-treatment for recurrent bladder outlet obstruction was required more after GL.PVEP and TURIS. More re-do surgeries for recurrent obstructing prostate adenoma was reported after GL.PVEP (four, 6.7%) and TURIS (six, 9.7%) than for HoLEP (none) (P = 0.04). CONCLUSION: The perioperative outcomes of GL.PVEP and HoLEP surpassed that of TURIS for the treatment of large prostates, but with a significantly prolonged operative time with GL.PVEP. The three techniques achieve good functional outcomes; however, 3-year re-treatment rates following TURIS and GL.PVEP were inferior to HoLEP.

A randomized trial comparing bipolar transurethral vaporization of the prostate with GreenLight laser (xps-180watt) photoselective vaporization of the prostate for treatment of small to moderate benign prostatic obstruction: outcomes after 2 years.

OBJECTIVE: To test the non-inferiority of bipolar transurethral vaporization of the prostate (TUVP) compared to GreenLight laser (GL) photoselective vaporization of the prostate (PVP) for reduction of benign prostatic hyperplasia-related lower urinary tract symptoms in a randomized trial. METHODS: Eligible patients with prostate volumes of 30-80 mL were randomly allocated to GL-PVP (n = 58) or bipolar TUVP (n = 61). Non-inferiority of symptom score (International Prostate Symptom Score [IPSS]) at 24 months was evaluated. All peri-operative variables were recorded and compared. Urinary (IPSS, maximum urinary flow rate and post-void residual urine volume) and sexual (International Index of Erectile Function-15) outcome measures were evaluated at 1, 4, 12 and 24 months. Need for retreatment and complications, change in PSA level and health resources-related costs of both procedures were recorded and compared. RESULTS: Baseline and peri-operative variables were similar in the two groups. At 1, 4, 12 and 24 months, 117, 116, 99 and 96 patients, respectively, were evaluable. Regarding urinary outcome measures, there was no significant difference between the groups. The mean ± sd IPSS at 1 and 2 years was 7.1 ± 3 and 7.9 ± 2.9 (P = 0.8), respectively, after GL-PVP and 6.3 ± 3.1 and 7.2 ± 2.8, respectively, after bipolar TUVP (P = 0.31). At 24 months, the mean difference in IPSS was 0.7 (95% confidence interval -0.6 to 2.3; P = 0.6). The median (range) postoperative PSA reduction was 64.7 (25-99)% and 65.9 (50-99)% (P = 0.006) after GL-PVP, and 32.1 (28.6-89.7)% and 39.3 (68.8-90.5)% (P = 0.005) after bipolar TUVP, at 1 and 2 years, respectively. After 2 years, retreatment for recurrent bladder outlet obstruction was reported in eight (13.8%) and 10 (16.4%) patients in the GL-PVP and bipolar TUVP groups, respectively (P = 0.8). The mean estimated cost per bipolar TUVP procedure was significantly lower than per GL-PVP procedure after 24 months (P = 0.01). CONCLUSIONS: In terms of symptom control, bipolar TUVP was not inferior to GL-PVP at 2 years. Durability of the outcome needs to be tracked. The greater cost of GL-PVP compared with bipolar TUVP is an important concern.