Three-dimensional virtual model for robot-assisted partial nephrectomy: a propensity-score matching analysis with a contemporary control group.

PURPOSE: To compare two cohorts of patients submitted to robot-assisted partial nephrectomy (RAPN) with vs without the use of three-dimensional virtual models (3DVMs). METHODS: We screened a prospective consecutive cohort of 152 patients submitted to RAPN with 3DVM and 1264 patients submitted to RAPN without 3DVM between 2019 and 2022. Propensity score matching analysis (PSMA) was applied. Primary endpoint was to evaluate whereas RAPNs with 3DVM were superior in terms of functional outcomes at 12-month. Secondary endopoints were to compare perioperative and oncological outcomes. Multivariable logistic regression analyses (MVA) tested the associations of clinically significant eGFR drop and 3DVMs. Subgroups analysis was performed for PAUDA-risk categories. RESULTS: 100 patients for each group were analyzed after PSMA. RAPN with 3DVM presented a higher rate of selective/no clamping procedure (32% vs 16%, p = 0.03) and a higher enucleation rate (40% vs 29%, p = 0.04). As concern to primary endopoint, 12-month functional preservation performed better within 3DVM group in terms of creatinine serum level (median 1.2 [IQR 1.1-1.4] vs 1.6 [IQR 1.1-1.8], p = 0.03) and eGFR (median 64.6 [IQR 56.2-74.1] vs 52.3 [IQR 49.2-74.1], p = 0.03). However, this result was confirmed only in the PADUA ≥ 10 renal masses. Regarding secondary endpoints, no significative difference emerged between the two cohorts. MVA confirmed 3DVM as a protective factor for clinically significant eGFR drop only in high-risk (PADUA ≥ 10) masses. CONCLUSIONS: RAPN performed with the use of 3DVM assistance resulted in lower incidence of global ischemia and higher rate of enucleations. The positive impact of such technology was found at 12-month only in high-risk renal masses.

Computer-aided diagnosis in prostate cancer: a retrospective evaluation of the Watson Elementary® system for preoperative tumor characterization in patients treated with robot-assisted radical prostatectomy.

PURPOSE: Computer-aided diagnosis (CAD) may improve prostate cancer (PCa) detection and support multiparametric magnetic resonance imaging (mpMRI) readers for better characterization. We evaluated Watson Elementary® (WE®) CAD system results referring to definitive pathological examination in patients treated with robot-assisted radical prostatectomy (RARP) in a tertiary referral center. METHODS: Patients treated with RARP between 2020 and 2021 were selected. WE® calculates the Malignancy Attention Index (MAI), starting from the information contained in the mpMRI images. Outcome measures were the capability to predict the presence of PCa, to correctly locate the dominant lesion, to delimit the largest diameter of the dominant lesion, and to predict the extraprostatic extension (EPE). RESULTS: Overall, tumor presence was confirmed in 46 (92%) WE® highly suspicious areas, while it was confirmed in 43 (86%) mpMRI PI-RADS ≥ 4 lesions. The WE® showed a positive agreement with mpMRI of 92%. In 98% of cases, visible tumor at WE® showed that the highly suspicious areas were within the same prostate sector of the dominant tumor nodule at pathology. WE® showed a 2.5 mm median difference of diameter with pathology, compared with a 3.8 mm of mpMRI versus pathology (p = 0.019). In prediction of EPE, WE® and mpMRI showed sensitivity, specificity, positive and negative predictive value of 0.81 vs 0.71, 0.56 vs 0.60, 0.88 vs 0.85 and 0.42 vs 0.40, respectively. CONCLUSION: The WE® system resulted accurate in the PCa dominant lesion detection, localization and delimitation providing additional information concerning EPE prediction.

Florence robotic intracorporeal neobladder (FloRIN): a new reconfiguration strategy developed following the IDEAL guidelines.

OBJECTIVE: To describe our step-by-step technique for robotic intracorporeal neobladder configuration, including the stages of conception, development and exploration of this surgical innovation, according to the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) Collaboration guidelines. PATIENTS AND METHODS: The Florence robotic intracorporeal neobladder (FloRIN) was performed employing the following main surgical steps: isolation of 50 cm of ileum; bowel anastomosis; urethro-ileal anastomosis creating an asymmetrical 'U'-shape (30 cm distally and 20 cm proximally to anastomosis), ileum detubularisation; posterior wall reconfiguration as an 'L'; bladder neck reconstruction; anterior folding of the posterior plate to reach the 12 o'clock position; uretero-enteral 'orthotopic' bilateral anastomosis. The conception and development of the FloRIN followed the IDEAL guidelines recommended stages: Phase 1 (simulation) involved the neobladder robotic configuration using silicone models. Phase 2a (development) aimed to reproduce the configuration in an open fashion in one patient, and then in the first three robotic procedures. Phase 2b (exploration) consisted of the technique standardisation in 15 consecutive robotic approaches. Phase 2a and 2b included urodynamics and imaging assessment of the patients treated. RESULTS: From February 2016 to September 2017 FloRIN was performed in 18 patients. Comparing the first three (Phase 2a) with the subsequent 15 patients (Phase 2b), the median (interquartile range [IQR]) reconstruction operating time was 260 (220-340) vs 160 (150-210) min, respectively. Postoperative surgical complications occurred in four of the 18 patients (22.1%), including one surgical Clavien-Dindo Grade III and three Grade I, postoperative medical Clavien-Dindo Grade II complications occurred in three (16.7%) patients. On urodynamic examination (available in nine [50%] patients) the median (IQR) reservoir cystometric capacity, compliance, and post-void residual were 240 (220-267) mL, 18 (12.5-19.8) mL/cmH2 O, and 0 (0-50) mL, respectively. Ultrasonography showed no Grade ≥2 vesico-ureteric reflux. CONCLUSION: We describe the FloRIN configuration, showing its technical feasibility with acceptable time efficiency. The first cases studied had good reservoir capacity, low pressure with no reflux, and complete voiding.

Hemidiaphragm Paralysis after Robotic Prostatectomy: Medical Malpractice or Unforeseeable Event?

The authors present a case of suspected malpractice linked to the onset of hemidiaphragm paralysis after robot-assisted radical prostatectomy (RARP). The approach to the case is shown from a medico-legal point of view. It is demonstrated how, after a thorough review of the literature, this was not a case of medical malpractice but an unforeseeable event. This paper aims at contributing to the very few reports dealing with the onset of hemidiaphragm paralysis after RARP, thus fostering clinical knowledge of these rare events and meanwhile providing useful data for the medico-legal handling in case of alleged negligence of surgeons.

Endoscopic robot-assisted simple enucleation (ERASE) for clinical T1 renal masses: description of the technique and early postoperative results.

BACKGROUND: Simple enucleation (SE) has proven to be oncologically safe. We describe the surgical steps and report the results of the Endoscopic Robotic-Assisted Simple Enucleation (ERASE) technique. METHODS: Data were gathered prospectively from 130 consecutive patients undergone ERASE for intracapsular kidney cancer, between 2010 and 2013. ERASE was performed using the 4S Da Vinci surgical system, (Intuitive Surgical, Sunnyvale, CA, USA) in a three-arm configuration. Patients' characteristics and surgical outcomes of ERASE in cT1 were analyzed and the results in cT1a tumors were compared to those of pure laparoscopic SE performed in the same institution in the same time period. RESULTS: The mean (range) preoperative tumor size was 3.2 cm (0.8-10.0 cm), and clinical stage was T1a for 101 patients, T1b for 28, and T2a for 1. Median PADUA score was 8 (IQR 7-9). In 33.9% of patients, ERASE was done without pedicle clamping. Mean (±SD) warm ischemia time (WIT) was 18 ± 6 min. According to Clavien system, 1 grade 1 (0.8%), 5 grade 2 (3.1%), 4 grade 3 (3.8%), and 1 grade 4 (0.8%) surgical complications occurred. Positive surgical margin (PSM) rate was 2.8%. ERASE in cT1a tumors was associated with a significantly lower need for pedicle clamping, shorter WIT, and lower estimated blood loss (EBL) along with similar operative time and intra and postoperative complication rates but with a significantly lower incidence of urinary fistulas requiring stent insertion compared to laparoscopic SE. Also mean time to drainage removal and length of hospital stay (LOS) were significantly lower in for ERASE. The two groups had comparable PSM rate. CONCLUSIONS: ERASE has proven to be a feasible technique for the minimal invasive treatment of clinical stage T1 renal masses. The robotic approach can achieve surgical results superior to those of pure laparoscopy by reducing the need for clamping, WIT, EBL, and LOS.

A multicentre matched-pair analysis comparing robot-assisted versus open partial nephrectomy.

OBJECTIVE: To compare the perioperative, pathological and functional outcomes in two contemporary, large series of patients in different institutions and who underwent open partial nephrectomy (OPN) or robot-assisted PN (RAPN) for suspected renal tumours. PATIENTS AND METHODS: This was a retrospective, multicentre, international, matched-pair analysis comparing patients who underwent RAPN or OPN for suspected renal cell carcinoma. Data on patients who underwent OPN were extracted by an Italian observational registry collecting data from 19 different centres. Data on patients who received RAPN were extracted from a multicentre, international database collecting cases treated in four high-volume referral centres of robotic surgery. The matching was in a 1:1 ratio for the surgical approach and included 200 patients in each arm. RESULTS: The mean warm ischaemia time was shorter in the OPN group than in the RAPN group, at a mean (SD) of 15.4 (5.9) vs 19.2 (7.3) min (P < 0.001). Conversely, the median (interquartile range) estimated blood loss was 150 (100-300) mL in the OPN group and 100 (50-150) mL in the RAPN group (P < 0.001). There were no differences in operating time (P = 0.18) and the intraoperative complication rate (P = 0.31) between the approaches. Postoperative complications were recorded in 43 (21.5%) patients who underwent OPN and in 28 (14%) who received RAPN (P = 0.02). Moreover, major complications (grade 3-4) were reported in nine (4.5%) patients after OPN and in nine (4.5%) after RAPN. Positive margins were detected in nine (5.5%) patients after OPN and in nine (5.7%) after RAPN (P = 0.98). The mean (SD) 3-month estimated glomerular filtration rate declined by 16.6 (18.1) mL/min from the preoperative value in the OPN group and by 16.4 (22.9) mL/min in the RAPN group (P = 0.28). CONCLUSION: RAPN can achieve equivalent perioperative, early oncological and functional outcomes as OPN. Moreover, RAPN is a less invasive approach, offering a lower risk of bleeding and postoperative complications than OPN.

Open versus robotic-assisted partial nephrectomy: a multicenter comparison study of perioperative results and complications.

PURPOSE: To compare surgical results, morbidity and positive surgical margins rate of patients undergoing robotic partial nephrectomy (RPN) versus open partial nephrectomy (OPN). METHODS: This is an observational multicenter study promoted by the "Associazione GIovani Laparoscopisti Endoscopisti" (AGILE) no-Profit Foundation, which involved six Italian urologic centers. All clinical, surgical, and pathological variables of patients treated with OPN or RPN for renal tumors were gathered in a prospectively maintained database. Tumor nephrometry was measured with PADUA score, and complications were stratified with modified Clavien system. Differences between RPN and OPN group were assessed with univariate analysis. Perioperative variables independently associated with complications were assessed with multivariate analysis. RESULTS: A total of 198 and 105 patients were enrolled in OPN and RPN group, respectively. Both had similar demographics, indications to surgery, tumor nephrometry, renal function, WIT (18.7 vs. 18.2 min; p = NS), positive margin rate (5.6 vs. 5.7%; p = NS), intraoperative complications, and postoperative medical complications. Compared to OPN, RPN group was significantly more morbid (p = 0.04), included tumors with smaller size (p = 0.002), had longer operative time (p < 0.001), lower blood loss, surgical postoperative complications (5.7 vs. 21.2%, p < 0.001), Clavien 3-4 surgical complications (1 vs. 9.1%, p = 0.001), and shorter hospitalization. The surgical approach resulted independently correlated with surgical complications on multivariate analysis. CONCLUSION: In the present series, RPN was associated with a significant reduction of blood loss, surgical complications, including the reintervention rate for urinary fistula and postoperative bleeding, and with a shorter hospitalization.

3D virtual model for robot-assisted partial nephrectomy in highly-complex cases (PADUA ⩾ 10).

PURPOSE: To compare two cohorts of patients submitted to robot-assisted partial nephrectomy (RAPN) for highly-complex renal masses (PADUA ⩾ 10) with versus without the use of 3DVMs. MATERIALS AND METHODS: We screened a prospective consecutive cohort of 152 patients submitted to RAPN with 3DVM and 1264 patients submitted to RAPN without 3DVM between 2019 and 2022. Only PADUA ⩾ 10 cases were considered eligible for analysis. Propensity score matching (PSM) analysis was applied. Primary endpoint was to evaluate whereas RAPNs with 3DVM were superior in terms of functional outcomes at 12-month. Secondary outcomes were to compare perioperative and oncological outcomes. Multivariable logistic regression analyses (MVA) tested the associations of clinically significant eGFR drop and 3DVMs. Subgroups analysis was performed for PAUDA-risk categories. RESULTS: Thirty seven patients for each group were analyzed after PSM. RAPN with 3DVM presented a higher rate of selective/no clamping procedure (32.5% vs 16.2%, p = 0.03) and a higher enucleation rate (43.2% vs 29.8%, p = 0.04). Twelve-month functional preservation performed better within 3DVM group in terms of creatinine serum level (median 1.2 [IQR 1.1-1.4] vs 1.6 [IQR 1.1-1.8], p = 0.03) and eGFR (median 64.6 [IQR 56.2-74.1] vs 52.3 [IQR 49.2-74.1], p = 0.03). MVA confirmed 3DVM as a protective factor for clinically significant eGFR drop in this subgroup of patients. CONCLUSIONS: RAPN performed with the use of 3DVM assistance for PADUA ⩾ 10 cases resulted in lower incidence of global ischemia and higher rate of enucleations. The positive impact of such technology was found at 12-month follow-up.

Stentless florence robotic intracorporeal neobladder (FloRIN), a feasibility prospective randomized clinical trial.

INTRODUCTION: Aim of the study was to evaluate perioperative, postoperative and mid-term functional outcomes of Florence intracorporeal neobladder (FloRIN) configuration technique performed with stentless procedure. MATERIALS AND METHODS: This single institution randomized 1:1 prospective series included consecutive patients treated with Robot-Assisted Radical Cystectomy (RARC) and FloRIN reconfiguration from January 2021 to February 2022. Postoperative complications were graded according to Clavien Dindo classification and divided in early (<30 days from discharge) and delayed (>30 days). RESULTS: Overall, 63 patients were included in the analysis. Among these 32 (50.8 %) were treated with RARC + stentless FloRIN while 31 (49.2 %) underwent stent placement procedure. No differences were found in terms of baseline characteristics between the two groups. Stentless procedure was associated with significant shorter console time 328 vs 374 min (p = 0.04) and lower estimated blood loss (EBL) 330 vs 350 ml (p = 0.04) comparing to stent group. As regards perioperative features, no significant differences were recorded in terms of canalization (p = 0.58) and time to drainage removal (p = 0.11) while a shorter length of hospital stay was found in case of stentless procedure (p = 0.04). Early postoperative complications Clavien ≥ 3a occurred in 9.3 % and 12.9 % of patients while delayed major complications were recorded in the 3.1 % and 9.6 % of patients treated with stentless and stent FloRIN, respectively (p = 0.09). As regards the mid-term functional outcomes, no differences were found in terms of kidney function loss in both 3rd and 6th month assessment (p = 0.13 and p = 0.14, respectively). CONCLUSIONS: In conclusion, Stentless FloRIN is a feasible and safe IntraCorporeal Neobladder technique, as confirmed by the worthy functional and perioperative outcomes achieved in comparison with the standard FloRIN ureteral management strategy.

Is it safe to defer prostate cancer treatment? Assessing the impact of surgical delay on the risk of pathological upstaging after robot-assisted radical prostatectomy.

INTRODUCTION: We sought to investigate whether surgical delay may be associated with pathological upstaging in patients treated with robot assisted radical prostatectomy (RARP) for localized and locally advanced prostate cancer (PCa). MATERIALS AND METHODS: Consecutive firstly-diagnosed PCa patients starting from March 2020 have been enrolled. All the patients were categorized according to EAU risk categories for PCa risk. Uni- and multivariate analysis were fitted to explore clinical and surgical predictors of pathological upstaging to locally advanced disease (pT3/pT4 - pN1 disease). RESULTS: Overall 2017 patients entered the study. Median age at surgery was 68 (IQR 63-73) years. Overall low risk, intermediate risk, localized high risk and locally advanced disease were recorded in 368 (18.2 %), 1071 (53.1 %), 388 (19.2 %) and 190 (9.4 %), respectively. Median time from to diagnosis to treatment was 51 (IQR 29-70) days. Time to surgery was 56 (IQR 32-75), 52 (IQR 30-70), 45 (IQR 24-60) and 41 (IQR 22-57) days for localized low, intermediate and high risk and locally advanced disease, respectively. Considering 1827 patients with localized PCa, at multivariate analysis ISUP grade group ≥4 on prostate biopsy (HR: 1.30; 95 % CI 1.07-1.86; p = 0.02) and surgical delay only in localized high-risk disease (HR: 1.02; 95 % CI 1.01-1.54; p = 0.02) were confirmed as independent predictors of pathological upstaging to pT3-T4/pN1 disease at final histopathological examination. CONCLUSIONS: In localized high-risk disease surgical delay could be associated with a higher risk of adverse pathologic findings.

Complication rate across the minimally invasive surgical treatments (MISTs): where do we stand? A systematic review of the literature.

BACKGROUND: Over the past decade, the range of surgical options to benign prostatic obstruction (BPO) has expanded significantly with the advent of minimally invasive surgical therapies (MISTs). Nevertheless, the available evidence in the field is heterogeneous. Efficacy and safety thresholds are yet to be determined. OBJECTIVE: To evaluate perioperative and long-term complications after MISTs - including Aquablation, steam injection (Rezum), Transperineal laser ablation of the prostate (TPLA), implantation of a prostatic urethral lift (PUL) and temporary implantable nitinol device (iTIND) - in patients with lower urinary tract symptoms due to BPO. EVIDENCE ACQUISITION: A systematic literature search was conducted in January 2024 using Medline (via PubMed), Embase (via Ovid), Scopus, and Web of Science. The search strategy used PICO criteria (Patients, Interventions, Comparisons, Outcomes) [1], focusing specifically on patients with BPH-associated LUTS who underwent MIST or other comparative treatments, aiming to assess both perioperative and long-term safety outcomes. Article selection was conducted in accordance with the PRISMA guidelines. The risk of bias and the quality of the articles included were assessed. A dedicated data extraction form was used to collect the data of interest. EVIDENCE SYNTHESIS: The initial electronic search identified 3660 records, of which 24 ultimately met the inclusion criteria and were included in the analysis. Overall, Aquablation was associated with a higher major complications rate of 14% (IQR 6-22), particularly in the case of patients with prostates <70 ml. PUL showed a higher early postoperative acute urinary retention rate (10.9%, IQR 9.2-12.3%), while 1.4% of patients treated with iTIND experienced major perioperative complications. Urinary tract infections were mostly reported in series assessing TPLA and Rezum. CONCLUSIONS: The adoption of MISTs for LUTS due to BPH is associated with a varied spectrum of perioperative and long-term complications. Our findings showed an acceptable safety profile with specific complications dependent on the type of MIST performed, highlighting the importance of individualized patient selection and procedure-specific considerations.

Analysis of surgical complications of renal tumor enucleation with standardized instruments and external validation of PADUA classification.

PURPOSE: To assess surgical results and morbidity of tumor enucleation (TE), and to evaluate their correlation with PADUA nephrometric score. METHODS: We prospectively gathered data, including accurate analysis of tumor nephrometry, from 244 consecutive patients treated with TE for clinically localized renal cell carcinoma. All surgical results were collected, and perioperative complications were stratified for severity according to Clavien system. Correlation between preoperative variables and surgical results/complications was assessed with uni- and multivariate analysis. RESULTS: Mean (range) tumor size was 3.6 (0.8-10.0) cm, and mean (range) warm ischemia time was 16.8 (5-35) min. Overall, perioperative complications occurred in 45 patients (18.4 %), and of those 8 were medical and 37 were surgical (4 Clavien grade 1, 25 grade 2, and 8 grade 3) complications. Urine leakage rate was 2.0 %. No grade 4/5 complications occurred in this series. At univariate analysis PADUA score, endophytic tumor growth, tumor diameter, involvement of UCS and renal sinus resulted associated with warm ischemia time (p < 0.0001 each) and surgical complications (p = 0.0007, p = 0.049, p = 0.021, p = 0.036, and p = 0.029, respectively). At logistic regression, nephrometry score resulted independently associated with overall complications (related risk for each increased point 1.54; p = 0.017), surgical complications (related risk 1.58; p = 0.016), and Clavien grade 3 surgical complications (related risk 2.99; p = 0.008). CONCLUSIONS: The TE technique was associated with a 15.2 % surgical complication rate with a 3.3 % reintervention rate (including ureteral stenting and superselective renal artery embolization). Tumor nephrometry and surgical indication resulted independent predictors of Clavien grade 3 complications. The PADUA score is a reliable tool to predict surgical results and morbidity of TE.

Simple enucleation versus radical nephrectomy in the treatment of pT1a and pT1b renal cell carcinoma.

BACKGROUND: Simple tumor enucleation (TE) showed excellent oncologic results in large retrospective series. No study has compared oncologic outcomes after TE and radical nephrectomy (RN) for the treatment of pT1 renal cell carcinoma (RCC). The aim of the present study is to compare the oncologic outcomes after TE and RN in pT1 RCCs. METHODS: We retrospectively analyzed 475 patients who underwent TE or RN for pT1 RCC, N0, M0, between 1995 and 2007. TE was performed in 332 patients and RN in 143. Local recurrence, progression-free survival (PFS), and cancer-specific survival (CSS) were the main outcomes of this study. The Kaplan-Meier method was used to calculate survival functions, and differences were assessed with the log rank statistic. Univariate and multivariate Cox regression models were also used. RESULTS: The 5- and 10-year PFS estimates were 91.3 and 88.7% after RN and 95.3 and 92.8% after TE (P = NS), respectively. The 5- and 10-year CSS estimates were 92.1 and 89.4% after RN and 94.4% (5- and 10-year CSS) after TE (P = NS), respectively. No statistically significant differences between RN and TE were found after adjusting CSS probabilities according to age at surgery, grade, stage, or clear cell subtype. Surgical treatment was not a predictor of PFS or CSS by both univariate and multivariate analyses. The potential limitation of this study is that the data originate from a retrospective review. CONCLUSIONS: TE can achieve oncologic results similar to those of RN for the treatment of pT1 RCCs, provided tumors are carefully selected on the basis of their safe and complete removal.

Morbidity of tumour enucleation for renal cell carcinoma (RCC): results of a single-centre prospective study.

OBJECTIVE: To evaluate the incidence and risk factors of adverse events (AEs) after tumour enucleation (TE). PATIENTS AND METHODS: Between 2006 and 2009, clinical, surgical and functional data were prospectively gathered from 200 consecutive patients who had open TE. TE was done by blunt dissection using the natural cleavage plane between the tumour capsule and normal parenchyma. All the AEs were stratified for severity according to the National Cancer Institute Common Toxicity Criteria version 2.0 grading system. Risk factors for AEs were determined by univariate analysis. RESULTS: The mean (range) tumour size was 3.2 (0.8-10.0) cm, and mean (range) warm ischaemia time (WIT) was 16.5 (5-31) min. Overall, 32 AEs (six grade I, 20 grade II, and six grade III) occurred after TE in 30 patients and of those 27 were surgical (13.5%) and five were medical AEs (2.5%). On univariate analysis, imperative/relative surgical indication was the only predictive factor for the development of medical AEs. Statistically significant predictors of overall surgical AEs and urinary fistula were clinical tumour dimension, completely endorenal tumour growth and a positive tumour relationship with the urinary collecting system (UCS). A completely endorenal tumour growth and a positive tumour relationship with the UCS also correlated with bleeding requiring transfusions. Completely endorenal tumour growth was significantly associated with major (grade III) AEs. CONCLUSIONS: The TE technique was associated with a 16% AE rate and of those only 3% required re-intervention (grade III). Urinary fistula occurred in six patients (3%) and ureteric stenting was required in 0.5% of cases.

A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.

INTRODUCTION: Safety and efficacy of tamsulosin and vardenafil are well established: however, there is no report regarding combined therapy with these drugs for lower urinary tract symptoms (LUTSs) secondary to benign prostatic hyperplasia (BPH). AIM: To compare the safety and efficacy of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus vardenafil 10 mg/day in patients with LUTS/BPH in a randomized trial with 12-week follow-up. METHODS: We conducted a randomized, double-blind, placebo-controlled study on 60 men with persistent storage LUTS after 2-week run-in with tamsulosin. MAIN OUTCOME MEASURES: International Prostate Symptom Score (IPSS), IPSS-bother, International Index of Erectile Function, Version 5 (IIEF-5) and Over Active Bladder questionnaire (OAB-q) scores, uroflowmetry data (Qmax, Qave), and postvoiding residual urine were recorded after run-in (baseline), and 2 and 12 weeks after treatment. Differences between vardenafil and placebo at different times were calculated with unpaired samples t-test. Between-group differences in change from baseline to 2 and 12 weeks were evaluated with analysis of variance. RESULTS: We found a between-group significant difference from baseline to 12 weeks in the following: (i) Qmax (placebo: +0.07, vardenafil: +2.56, P = 0.034); (ii) Qave (placebo: -0.15, vardenafil: +1.02, P = 0.031); (iii) irritative-IPSS subscores (placebo: -1.67, vardenafil: -3.11, P = 0.039); and (iv) IIEF (placebo: +0.06, vardenafil: +2.61, P = 0.030). No patient reported any serious (grade ≥ 2) adverse event (AE). There were no differences in the incidence of common, treatment-related AEs between men undergoing combined therapy or tamsulosin alone. CONCLUSIONS: The combination of tamsulosin and vardenafil for 12 weeks was well tolerated and more effective to improve both LUTS and erectile function, as compared with tamsulosin alone. Further studies are needed to assess the role of combined therapy of phosphodiesterase type 5 inhibitors and alpha blockers in treating LUTS/BPH.

A comparison of hexaminolevulinate (Hexvix(®)) fluorescence cystoscopy and white-light cystoscopy for detection of bladder cancer: results of the HeRo observational study.

BACKGROUND: To date, no study has presented results of photodynamic diagnosis (PDD) cystoscopy compared with white-light cystoscopy (WLC) in daily practice. The aim of the present study is to evaluate the diagnostic accuracy of hexylaminolevulinate hydrochloride (Hexvix(®)) PDD cystoscopy compared with standard WLC used in daily practice. METHODS: An observational, open-label, comparative, controlled (within patient), multicenter study was carried out on 96 consecutive patients with suspected or confirmed bladder cancer. All patients had standard WLC followed by blue-light cystoscopy (BLC). Positive lesions detected using WLC and BLC were recorded. Biopsies/resection of each positive lesion were taken after the bladder was inspected. Sensitivity, specificity, positive predictive value, and negative predictive value with each method were calculated. RESULTS: Overall, 234 suspicious lesions were detected; 108 (46.2%) were histologically confirmed to be bladder tumors/carcinoma in situ (CIS). The sensitivity of BLC biopsies was significantly higher than for WLC technique (99.1 vs 76.8%; p < 0.00001). The relative sensitivity of BLC versus WLC was 1.289, showing superiority of BLC of 28.9%. The specificity of BLC biopsies was not significantly different compared with WLC (36.5 vs 30.2%). Positive predictive value for BLC- and WLC-guided biopsies was 54.9 and 50.9%, respectively. Negative predictive value per biopsy for BLC- and WLC-guided biopsies was 97.4 and 64.8%, respectively. BLC and WLC reached the correct diagnosis in 97.9 and 88.5% of patients, respectively. This difference was statistically significant (p = 0.0265). The lack of a random biopsy protocol was the major limitation of the study. CONCLUSIONS: Hexvix(®) PDD cystoscopy used in daily practice enhances the diagnostic accuracy of standard cystoscopy with higher negative predictive value, potentially permitting an improvement in patient prognosis.

Nephron-sparing surgery for giant angiomyolipomas of kidney.

AIMS: To investigate the potential role of tumor enucleation (TE) for the treatment of giant angiomyolipomas (AML). METHODS: We retrospectively analyzed a prospectively derived database of 707 patients with kidney tumor, who were treated with conservative surgery, between January 1995 and September 2009. Overall, 31 patients had a histopathologic diagnosis of renal AML and of those, 3 patients had a diagnosis of unilateral or bilateral renal mass, with at least one clinically suggestive of giant AML (maximal tumor diameter > or = 9 cm), either central or perihilar. These patients were the subjects of the analysis. Nephron sparing surgery (NSS) was performed as tumor enucleation (TE), carried out by a blunt dissection, using the natural cleavage plane between the tumor and the normal parenchyma. RESULTS: Preoperative tumor size ranged between 9.0 and 15.0 centimetres. At surgery, after kidney capsule incision, TE was done in all cases. In critical surgical steps, in case of difficult visualization of the correct enucleation plane, a sharp dissection a few millimetres away from the tumor was adopted. Warm ischemia time (WIT) was always below 20 minutes. Intraoperative blood loss was negligible. Unsignificant postoperative creatinine variation was recorded in all cases. No intra- and post-operative complications occurred. At last follow up visit, no tumor recurrence at the enucleation site was reported. CONCLUSIONS: TE technique can be considered a viable and effective treatment option for this very rare pathologic condition, since it provides a maximal glomerular preservation and minimizes WIT and intra- and postoperative complications.

Robot assisted radical cystectomy with Florence Robotic Intracorporeal Neobladder (FloRIN): Functional and urodynamic features compared with a contemporary series of open Vescica Ileale Padovana (VIP).

INTRODUCTION: FloRIN reconfiguration technique was introduced in 2016 according to the IDEAL-Collaboration Guidelines, with the attempt to conjugate the advantages of both intracorporeal neobladder and robotic assistance. Herein we report functional outcomes of FloRIN reservoir, specifically focusing on urodynamic features. MATERIALS AND METHODS: Consecutive patients treated with RARC and FloRIN reconstruction were prospectively collected from February 2016 to June 2020. Only patients with a minimum 6-month follow up were analyzed to obtain a stable grade of neobladder maturation before performing the urodynamic study (UDS). The FACT-BL and the QLQ-C30 EORTC questionnaires were used to evaluate urinary function and health-related QoL. Results were compared with a contemporary series of patients treated at the same Institution with open radical cystectomy (ORC) and Vescica Ileale Padovana (VIP). RESULTS: One hundred patients entered the study and 69 patients had complete functional data. Overall, 52 (75.4%) patients reached the daytime continence. Among these, 28 (40.6%) were dry (no pads during daytime), while 24 (34.8%) used one pad/12 h. Night-time continence was achieved by 45 (65.2%) patients. Complete UDS findings were available for 28 patients. No statistically significant differences were found with the VIP-ORC group except for neobladder compliance, being higher in the FloRIN group (p = 0.03). When evaluating QoL scores, RARC with FloRIN reconfiguration showed a better continence recovery, as well as a higher improvement in urgency domain (p = 0.01), psychological status (0.02) and physical self-acceptance (p = 0.02), compared to the VIP-ORC group. CONCLUSIONS: The FloRIN technique showed excellent functional outcomes when compared to the referral VIP-ORC procedure.

Robot-assisted sacro(hystero)colpopexy with anterior and posterior mesh placement: impact on lower bowel tract function and clinical outcomes at mid-term follow-up.

Background: Robotic sacrocolpopexy (RSCP) is an established option for the treatment of apical, anterior, and proximal posterior compartment pelvic organ prolapses (POP). However, there is lack of evidence investigating how lower bowel tract symptoms (LBTS) may change after RSCP. Methods: Data from consecutive patients treated with RSCP for stage 3 or higher POP from 2012 to 2019 at a single tertiary referral center with at least 1 year of follow-up were prospectively collected and retrospectively analyzed. RSCP was performed following a standardized technique which always employed both anterior and posterior hand-shaped meshes. Outcomes were collected at follow-up and analyzed. LBTS were evaluated through the Wexner questionnaire. Results: Overall, 114 women underwent RSCP. Eleven were excluded for missing data, whereas 12 had insufficient follow-up. Thus, 91 (79.8%) patients were included in this cohort. Median follow-up was 42 [interquartile range (IQR), 19-62] months. Mean age was 65 ± 10 years. In our series, RSCP was mainly performed for anterior and apical/medium stage 3 POP (in 95.6% of patients). Anatomic success rate of RSCP was 97.8%, with 89 patients with POP stage 0-1 at 12-month follow-up. Two patients (2.2%) experienced POP recurrence and were treated with redo-SCP. No patient experienced clinically significant posterior vaginal wall prolapse after RSCP. When analyzing LBTS, there was no significant change in postoperative total Wexner's score as compared to the preoperative value (p > 0.05). However, the manual assistance subscore was statistically significantly lower within the first-year follow-up (p = 0.04), but it spontaneously improved during the follow-up (p = 0.12). Conclusion: RSCP with simultaneous placement of both anterior and posterior mesh is safe and successful to treat high-stage POP in carefully selected patients. Of note, LBTS appear unaffected by posterior mesh placement, supporting its routine use to prevent posterior POP recurrence. Larger prospective studies are needed to confirm our results.