Enhancing continence post holmium laser enucleation of the prostate: assessment of novel technique through randomized clinical trial.

BACKGROUND: Transient urinary incontinence (UI) is distressing event following holmium laser enucleation of the prostate (HoLEP). Novel technique namely, veil sparing HoLEP (VS-HoLEP), was proposed to improve early continence outcome. In this trial (NCT03494049), VS-HoLEP was compared to standard HoLEP (St-HoLEP). METHODS: VS-HoLEP entails early apical separation with sparing of ventral apical mucosal veil proximal to the verumontanum. Eligible symptomatic BPH patients were randomly allocated to St-HoLEP (91) and VS-HoLEP (89). The primary outcome was UI as depicted by one-hour pad test at one month postoperatively. Other outcome measures include all perioperative parameters, complications, and urinary outcome measures at different follow-up points. RESULTS: Median preoperative prostate size was 138 (50:282) and 128 (50:228) mL in St-HoLEP and VS-HoLEP groups respectively. At one month the number of patients with positive one-hour pad test was 21 (23.1%) and 10 (11.4%) in St-HoLEP and VS-HoLEP groups respectively (P 0.047). The difference was significantly in favor of VS-HoLEP considering the number of patients reporting UI, the number of patients with positive one-hour pad test as well as the grade of UI reported at one and 4 months. The difference was not statistically significant at 12 months. The median time to patients' reported continence was 8 (1-52) and 1.5 (1-52) weeks in St-HoLEP and VS-HoLEP groups respectively (P≤0.005). The technique independently predicted positive one-hour pad test at one and four months respectively. At twelve months presence of DM (diabetes mellitus) and more percent PSA reduction independently predicted positive one-hour pad test. CONCLUSIONS: Veil sparing HoLEP enhances significantly early postoperative urine continence both subjectively and objectively. Optimization of the surgical technique could cut short the number of leaking patients and reduce the degree as well as the duration of transient postoperative urine leak.

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.

A randomized trial of holmium laser vs thulium laser vs bipolar enucleation of large prostate glands.

OBJECTIVE: To compare the outcome and morbidity of bipolar transurethral enucleation of the prostate (B-TUEP) and thulium laser enucleation of the prostate (ThuLEP) with those of holmium laser enucleation of the prostate (HoLEP) in the treatment of large symptomatic benign prostatic obstruction (BPO) through a non-inferiority randomized controlled trial (NCT03916536). PATIENTS AND METHODS: A total of 155 patients were recruited from a single centre between February 2019 and August 2020. All had BPO, with a prostate volume ≥80 ml. Patients were randomly assigned to HoLEP, ThuLEP or B-TUEP using computer-generated random tables in a 1:1:1 ratio. Participants, investigators and surgeons were blinded to group assignment until the date of the operation. Thereafter, the patients were followed up at 1, 3, 6 and 12 months. The primary outcome was maximum urinary flow rate (Qmax ) at 6 months. Secondary outcomes included assessment of other functional urinary variables, peri-operative records, and adverse events. RESULTS: There were 138 and 120 patients available for analysis at 6 and 12 months. There was no significant difference in Qmax between the groups at 6 and 12 months (P = 0.4 and P = 0.7, respectively), and no significant difference regarding International Prostate Symptom Score (IPSS), quality of life (QoL) or postvoid residual urine volume (PVR). The median (interquartile range) prostate-specific antigen (PSA) reductions (ng/ml) were similar in the three groups at last follow-up point (4.7 [2.2-7.1]; 5.6 [2.3-9.5] and 5 [3.4-10] after HoLEP, ThuLEP and B-TUEP, respectively). Differences in enucleation time, enucleation efficiencies and auxiliary manoeuvres were statistically insignificant (P = 0.1, 0.8 and 0.07, respectively). At 1 year, patients with prostate volumes >120 ml showed significant IPSS improvement in favour of HoLEP and ThuLEP (P = 0.01). Low- and high-grade adverse effects were recorded in 31 and five cases, respectively, with no statistically significant difference between the groups. CONCLUSIONS: We conclude that ThuLEP and B-TUEP are as safe and effective as HoLEP for the treatment of large-sized BPO. Significant PSA reductions indicate that there was effective adenoma enucleation with all three approaches. The study provides objective evidence that endoscopic enucleation of the prostate is a technique rather than energy dependent procedure.

The efficacy of the new Bosniak classification v.2019 in benign lesions prediction within the higher Bosniak cysts classes.

INTRODUCTION: Identification of benign lesions among higher classes of renal Bosniak cysts who are vulnerable to active surveillance instead of surgical approach is still questionable. We aimed in this study to delineate the efficacy of the new Bosniak v2019 classification in benign lesions identification among those cases with higher Bosniak classes in comparison with the final histopathology. MATERIALS: In a retrospective review between 2010 and 2021 for patients diagnosed as higher classes Bosniak renal masses was done. Patients' demographics and radiological data i.e.,: age, gender, and final Bosniak v2019 categorization for class III: (1) Enhancing thick wall/septa >4 mm (III-WS) and (2) Enhancing irregular wall/septa or convex protrusion with obtuse margins <3 mm (III-OP) and for class IV as: (1) Enhancing nodule or convex protrusion with obtuse margins >4 mm (IV-OP) and (2) Enhancing nodule or convex protrusion with acute margins of any size (IV-AP). RESULTS: A total of 137 patients were included. Bosniak III was identified in 56 patients. Malignancy was detected in 74.5% of resected masses. Among resected Bosniak III cyst, 46.4% were benign histopathologically. Male gender and Bosniak III-OP were independent risks for malignancy among the resected Bosniak III cysts. Conversely, in resected Bosniak IV renal cysts, only 9 of resected masses were benign. In univariate analysis, male gender, absence of multilocular cyst and endophytic masses were predictors for malignancy in resected Bosniak IV cyst. None of the previous predictors was significant in multivariate analysis. CONCLUSION: The Bosniak subclassification v.2019 can define benign lesions. Bosniak III-OP was an independent risk for malignancy detection among the resected Bosniak III cysts.

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.

Is JJ Ureteral Stenting Inferior to Percutaneous Nephrostomy as a Drainage Method in Emphysematous Pyelonephritis?

INTRODUCTION: The aim of the study was to examine the efficacy of JJ stenting in comparison with percutaneous nephrostomy (PCN) as a drainage method in patients with emphysematous pyelonephritis (EPN). METHODS: We retrospectively identified patients with EPN between January 2000 and January 2021. Platelet-to-leukocytic ratio (PLR) at the time of hospital admission and discharge, time taken to clear air locules and to normalize leukocytic count, and air locule volume in mm3 were identified. Renal drainage by either PCN or JJ stent was required if symptoms persist for ≥3 days or in obstructed renal units. Failure of drainage method was defined as conversion to another method of drainage, need for intensive care unit admission, salvage nephrectomy, and mortality. RESULTS: Twenty-nine patients were managed by JJ stent. Treatment success was identified in 20 patients and 19 patients who were managed by PCN and JJ stent, respectively. Higher air locule volume ≥16.7 mm3 and lower PLR ≤18.4 increased the risk of drainage failure (p = 0.009 and 0.001, respectively). CONCLUSION: Ureteral JJ stenting is an effective method for EPN drainage with a comparable overall success to the PCN use. Higher air locule volume and lower PLR increased the risk of drainage failure.

Repurposing metformin as anticancer drug: Randomized controlled trial in advanced prostate cancer (MANSMED).

BACKGROUND: The proposal of metformin as an anticancer drug has been explored in many types of cancers. Metformin may act synergistically with standard prostate cancer therapies. However, there is still a debate about the effect of metformin on hormone sensitive prostate cancer (HSPC). PATIENTS AND METHODS: randomized controlled trial. Eligible patients were high risk locally advanced or metastatic HSPC. Patients were randomly assigned to receive either metformin plus standard of care or standard of care alone. The primary endpoint was castration-resistant prostate cancer-free survival (CRPC-FS). The secondary endpoints were overall survival, PSA level and adverse events. RESULTS: A total number of 124 patients underwent randomization where 62 patients were allocated in each arm. Over a median follow up of 22 months, the CRPC-FS was significantly improved with metformin (29 months, 95% CI 25-33 vs. 20 months 95% CI 16-24; P = 0.01). After subgroup analysis, the addition of metformin improved the CRPC-FS in patients with high risk localized disease (median not reached vs. 25 months, 95% CI 18-31; P = 0.02) and in patients with metastatic low tumor volume disease (median not reached vs. 15 months, 95% CI 5-25; P = 0.009). No significant difference in overall survival or PSA response in both treatment arms (P = 0.1 and 0.5, respectively). Metformin was not associated with significant adverse events apart from grade II diarrhea. CONCLUSION: Metformin is a safe and low-cost drug. Combining with androgen deprivation therapy improves the outcome in locally advanced or metastatic prostate cancer. Patients with low volume metastatic prostate cancer seem to drive more benefit.

Diagnostic performance and predictive capacity of early urine cytology after transurethral resection of nonmuscle invasive bladder cancer: A prospective study.

OBJECTIVES: To prospectively evaluate the value of early urine cytology (EUC) after the primary transurethral resection of bladder tumor (TURBT) of nonmuscle invasive bladder cancer (NMIBC) for the prediction of positive biopsy findings on repeat TURBT. METHODS: After approval of institutional review board, patients who underwent TURBT for NMIBC between February 2014 and July 2018 were included in the study. Patients with concomitant Carcinoma in Situ (CIS), upper tract urothelial tumors, biopsy proven muscle invasion, or low-risk NMIBC (single, primary, Ta, and G1 tumor) were excluded. Forty-eight hours after primary TURBT, EUC was retrieved and patients were scheduled for repeat TURBT 2 to 6 weeks later according to the predetermined protocol. The primary outcome was to determine the role of positive EUC to predict positive biopsy findings on repeat TURBT. RESULTS: During the study period, 198 patients fulfilled the study inclusion criteria of which 49 (25%) had recurrent NMIBC. Primary TURBT pathology results showed T1 stage in 195 (98.5%) patients and high-grade malignancy in 158 (79.8%). Intermediate- and high-risk NMIBC were defined in 49 (25%) and 149 (75%) patients, respectively. EUC was positive in 114 patients; of whom 78 (68.4%) showed positive biopsy findings on repeat TURBT (P = 0.001). The sensitivity, specificity, negative, and positive predictive values of EUC for biopsy findings at repeat TURBT were 90% (95%CI: 87-94), 75% (95%CI: 71-79), 89% (95%CI: 85-94), and 68% (95%CI: 62-74), respectively. On mean (±SD) follow-up of 42(±13) months, tumor recurrence was encountered in 101 (53%) patients. On multivariate Cox regression analysis, EUC was significantly associated with tumor recurrence (HR = 4.6, 95%CI: 2.37-8.9, P < 0.001). CONCLUSIONS: Positive EUC after primary TURBT for NMIBC is significantly associated with positive repeat TURBT for malignancy. EUC is an independent predictor of tumor recurrence. EUC might be implemented after primary TURBT to help refining indications of repeat biopsy and planning of further intervention.

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.

Efficacy of pethidine, ketorolac, and lidocaine gel as analgesics for pain control in shockwave lithotripsy: A single-blinded randomized controlled trial.

Purpose: To compare the safety and efficacy of xylocaine gel and ketorolac as opioid-sparing analgesia compared with pethidine for shock wave lithotripsy (SWL) pain. Materials and Methods: A single-blinded randomized controlled trial (RCT) was performed in 132 patients with renal and upper ureteral stones amenable to treatment with SWL. The first patient group received intravenous (IV) pethidine and placebo gel; the second group received IV ketorolac plus placebo gel; the third group received lidocaine gel locally plus normal saline IV. Stone disintegration was classified as none (no change from basal by kidney, ureter, bladder X-ray or ultrasound [US] imaging), partial (fragmented and >4-mm residual fragments), and complete (≤4-mm residual fragments). Stone disintegration was assessed by kidney-ureter-bladder X-ray and US imaging. Pain was evaluated by use of the Numeric Pain Rating Scale (NPRS). Results: The NPRS scores were highest in the xylocaine group at 10, 20, and 30 minutes (p=0.0001) with no significant difference between the ketorolac and pethidine groups, except at 10 minutes (p=0.03) and a near significant difference at 30 minutes (p=0.054) in favor of ketorolac. Results for stone disintegration (none, partial, and complete, respectively) were as follows: 25 (50.0%), 23 (46.0%), and 2 (4.0%) for pethidine; 19 (35.8%), 23 (43.4%), and 11 (20.8%) for ketorolac; and 26 (89.7%), 3 (10.3%), and 0 (0.0%) for lidocaine (p=0.008). Conclusions: Ketorolac is a safe and more effective alternative to morphine derivatives for SWL analgesia. Lidocaine gel should not be used as mono-analgesia for SWL.

Could platelet to leucocytic count ratio (PLR) predict sepsis and clinical outcomes in patients with emphysematous pyelonephritis?

OBJECTIVES: To study risk factors for sepsis and mortality evaluating the role of platelet to leucocytic count ratio (PLR) as a marker for urosepsis and clinical outcomes in cases of emphysematous pyelonephritis (EPN). MATERIALS: Patients with EPN were retrospectively reviewed. Patients' age, sex, diabetes mellitus (DM), Body Mass Index (BMI), hydronephrosis, types of EPN, air locules volume, serum creatinine, leucocytic count, and platelet count, PLR, albumin, INR and the line of treatment were analyzed as risk factors of sepsis. Correlation between PLR and other variables was done using Pearson correlation coefficient. Univariate and multivariate analyses for sepsis and mortality were performed. RESULTS: Of fifty four patients, 38 patients had SIRS ≥2 criteria on admission. Twenty patients developed sepsis requiring ICU admission. In univariate analysis, male gender, lower BMI, higher INR, higher WBCs count and lower PLR were associated with sepsis (P = 0.0001, 0.009, 0.04, 0.003 and 0.001, respectively). In multivariate analysis, PLR ≤18.4, male sex and BMI ≤24.2 were independent risk factors. Lower PLR directly correlated with serum albumin (P = 0.01) and inversely correlated with serum creatinine and random blood glucose level and Klebsiella infection (P = 0.001, 0.007 and 0.005, respectively). Also, it was correlated with a higher total score of qSOFA and SOFA (P = 0.02 and 0.04). Lower PLR was independent risk factors for death in EPN patients with (P = 0.003). CONCLUSION: EPN is associated with sepsis development. Lower PLR is an independent simple predictor for sepsis and mortality in patients with EPN.

Low-Power Vs High-Power Holmium Laser Enucleation of the Prostate: Critical Assessment through Randomized Trial.

OBJECTIVE: To assess the non-inferiority of Low-power Holmium laser enucleation of the prostate (LP-HoLEP) to high-power (HP-HoLEP) for enucleation efficiency pertaining to the advantages of lower cost and minimal postoperative dysuria, storage symptoms, and negative sexual impact. PATIENTS AND METHODS: HoLEP was performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP (61 patients) and 2J/50Hz for HP-HoLEP (60 patients). Two surgeons with different experience performed equal number of both procedures. Non-inferiority of enucleation efficiency (enucleated weight/min) was evaluated. All perioperative parameters were recorded and compared. Dysuria was assessed at 2 weeks by dysuria visual analog scale, urinary (Q.max and IPSS) and sexual (sexual health inventory for men score) outcome measures were evaluated at 1, 4, and 12 months. RESULTS: Baseline and perioperative parameters were comparable between the two groups. Mean enucleation efficiency was 1.42±0.6 vs 1.47±0.6 gm/min, P = .6 following LP-HoLEP and HP-HoLEP, respectively. Patients reported postoperative dysuria similarly in both groups as per dysuria visual analog scale. There was significant comparable improvement in IPSS (international prostate symptom score) and Q.max in both groups at different follow-up points. At one year, median IPSS and Q.max were comparable in both groups (P = .4 and .7 following LP-HoLEP and HP-HoLEP, respectively). Median postoperative reduction in prostate specific antigen was 89% (42:99) following LP-HoLEP vs 81% (62:94) after HP-HoLEP, P = .92. Both groups showed comparable perioperative and late postoperative complications. There were no statistically significant changes in the last follow-up sexual health inventory for men score in comparison to baseline score. CONCLUSION: LP-HoLEP is non-inferior to HP-HoLEP in terms of all efficiency parameters regardless level of surgeon experience.

Computed Tomography Assessment of Hepatic Metastases of Breast Cancer with Revised Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Version 1.1): Inter-Observer Agreement.

BACKGROUND: To assess inter-observer agreement of revised RECIST criteria (version 1.1) for computed tomography assessment of hepatic metastases of breast cancer. MATERIAL/METHODS: A prospective study was conducted in 28 female patients with breast cancer and with at least one measurable metastatic lesion in the liver that was treated with 3 cycles of anthracycline-based chemotherapy. All patients underwent computed tomography of the abdomen with 64-row multi- detector CT at baseline and after 3 cycles of chemotherapy for response assessment. Image analysis was performed by 2 observers, based on the RECIST criteria (version 1.1). RESULTS: Computed tomography revealed partial response of hepatic metastases in 7 patients (25%) by one observer and in 10 patients (35.7%) by the other observer, with good inter-observer agreement (k=0.75, percent agreement of 89.29%). Stable disease was detected in 19 patients (67.8%) by one observer and in 16 patients (57.1%) by the other observer, with good agreement (k=0.774, percent agreement of 89.29%). Progressive disease was detected in 2 patients (7.2%) by both observers, with perfect agreement (k=1, percent agreement of 100%). The overall inter-observer agreement in the CT-based response assessment of hepatic metastasis between the two observers was good (k=0.793, percent agreement of 89.29%). CONCLUSIONS: We concluded that computed tomography is a reliable and reproducible imaging modality for response assessment of hepatic metastases of breast cancer according to the RECIST criteria (version 1.1).