Transperineal laser ablation (TPLA) of the prostate for benign prostatic obstruction: the first 100 patients cohort of a prospective, single-center study.

PURPOSE: Transperineal laser ablation (TPLA) is a new minimally-invasive surgical treatment for patients with benign prostatic obstruction (BPO). We report the perioperative and mid-term functional results of the first 100 consecutively patients undergoing TPLA at our institution. METHODS: Clinical data from consecutive patients undergoing TPLA at our institution from April 2021 to July 2023 were prospectively collected. Primary endpoints were the postoperative changes in IPSS, QoL and MSHQ 3-item questionnaires and in Qmax and post-void residual volume (PVR). RESULTS: Overall, 100 consecutive patients underwent the procedure. Median age and prostate volume were 66 (IQR 60-75) years and 50 (IQR 40-70) ml, respectively. In the cohort, 14 (14%) patients had an indwelling catheter and 81 (81%) were under oral BPO therapy at the time of TPLA. Baseline median Qmax (ml/s) and PVR (ml) were 9.1 (IQR 6.9-12) and 90 (IQR 50-150), respectively, while median IPSS and QoL were 18 (IQR 15-23) and 4 (IQR 3-4). At all the follow-up timepoints, the evaluated outcomes on both symptoms and functional parameters showed a statistically significant improvement (p < 0.001). Antegrade ejaculation was preserved in all sexually active patients. No postoperative Clavien-Dindo > 2 complications were recorded. CONCLUSIONS: TPLA represents a safe option for selected well-informed patients swith LUTS due to BPO. Our prospective study confirms the feasibility and favorable perioperative and functional outcomes in a real-world cohort with heterogenous prostate volumes and patient characteristics.

Use of the Schelin Catheter for transurethral intraprostatic anesthesia prior to Rezum treatment.

Minimally invasive surgery techniques (MIST) have become newly adopted in urological care.  Given this, new analgesic techniques are important in optimizing patient outcomes and resource management. Rezum treatment (RT) for BPH has emerged as a new MIST with excellent patient outcomes, including improving quality of life (QoL) and International Prostate Symptom Scores (IPSSs), while also preserving sexual function.  Currently, the standard analgesic approach for RT involves a peri-prostatic nerve block (PNB) using a transrectal ultrasound (TRUS) or systemic sedation anesthesia.  The TRUS approach is invasive, uncomfortable, and holds a risk of infection.  Additionally, alternative methods such as, inhaled methoxyflurane (Penthrox), nitric oxide, general anesthesia, as well as intravenous (IV) sedation pose safety risks or mandate the presence of an anesthesiology team.  Transurethral intraprostatic anesthesia (TUIA) using the Schelin Catheter (ProstaLund, Lund, Sweden) (SC) provides a new, non-invasive, and efficient technique for out-patient, office based Rezum procedures.  Through local administration of an analgesic around the prostate base, the SC has been shown to reduce pain, procedure times, and bleeding during MISTs.  Herein, we evaluated the analgesic efficacy of TUIA via the SC in a cohort of 10 patients undergoing in-patient RT for BPH.

Is water vapor thermal therapy safe and feasible in elderly and frail men? The Italian experience.

PURPOSE: In recent years, water vapor thermal therapy (WVTT) has spread as minimally invasive technique in lower urinary tract symptoms due to benign prostatic hyperplasia treatment. Even if its safety and feasibility have been largely proved in young men, nobody has proved the same feasibility and safety in the elderly (men older than 75 years old). Our aim is to compare WVTT safety outcomes in men older than 75 with younger men. METHODS: We prospectively collected data on men who underwent water vapor thermal therapy from 2019. We compared data on operative time, number of injections, intra-operative and post-operative complications, reinterventions rate. RESULTS: We enrolled 426 patients; among these, 60 were older than 75 years old, 366 were younger. Our cohorts of patients had similar results in terms of intra-operative and post-operative complications. Operative time accounts about 11 min for both groups (p = 0.535), total number of injections was seven for young men and eight for elderly (p = 0.314). We found no intra-operative complications in elderly men group and only one in the younger group (p = 0.678), while five younger men underwent clot retention, and two elderly men experienced this complication (p = 0.239). Only one transfusion occurred in the elderly group. No differences between groups occurred in terms of length of stay, post-operative urinary retention and reintervention rate, while catheterization time was longer in the elderly men. CONCLUSION: WVTT is a safe procedure in elderly patients with comparable intra-operative and post-operative complication rate in comparison with younger patients.

Use of a Schelin Catheter for analgesia during Rezum treatment of the prostate.

To further enhance the minimal invasiveness of Rezum treatment (RT), we sought to evaluate the advantages and feasibility of transurethral intraprostatic anesthesia (TUIA) via Schelin Catheter™ (SC). We enrolled 20 men with LUTS due to BPH, who underwent RT using TUIA via SC. Prior to the procedure, patients were asked to rate their pain on a numeric rating scale (NRS) numbered 0-10: with 0 being "No pain" and 10 being "Worst pain". Median NRS score ranged from 0 to 3. No perioperative procedure-related complications were reported.

Could transperineal interstitial laser ablation of the prostate be the right option for highly-comorbid patients with lower urinary tract symptoms due to benign prostatic obstruction? A preliminary single-center experience focusing on functional and safety outcomes.

In this paper, we aimed to highlight functional and safety outcomes of highly-comorbid patients undergoing transperineal laser ablation (TPLA) of prostate at a referral academic center. Patients undergoing TPLA from April 2021 and February 2023 with moderate to severe lower urinary tract symptoms (LUTS), prostate volume ranging from 30 to 100 mL, and an American Society of Anesthesiologists (ASA) Score ≥3 were included. All patients were evaluated as unfit for standard surgery. Procedures were performed in an outpatient setting using local anesthesia. Failure after the procedure was defined as the shift to other ultra-minimally invasive surgical treatment or the need for long-term indwelling catheter replacement. Overall, 23 patients were enrolled with a median age of 76 years. Median ASA Score and Charlson Comorbidity Index were 3 and 5, respectively. Of these, 11 (48%) were under antiplatelets, 4 (17%) under new oral anticoagulants (NOACs) and 3 (13%) under warfarin. Six (26%) patients had an indwelling catheter preoperatively. Median prostate volume was 42 mL. Median follow-up was 12 months. No Clavien-Dindo Grade ≥2 complications were recorded. Four/six (66%) patients with an indwelling catheter before TPLA achieved spontaneous micturition. Treatment failure occurred in 2 (8.5%) patients. Of the remaining 21 patients, 12/21 (57%) patients reported an improvement in International Prostate Symptoms Score (IPSS) symptoms class (i.e., severe to moderate, moderate to mild, etc.); all patients whose IPSS symptoms class remained stable (N.=8 [38%]) had a significant improvement of the IPSS score as compared to the preoperative period, while 1 (4.5%) patient reported worsening of LUTS. In conclusion, TPLA appears to be a safe and feasible ultra-minimally-invasive option for LUTS due to benign prostatic obstruction (BPO) in patients with significant comorbidities at high-risk for standard surgical options.

Transperineal Laser Ablation of the Prostate (TPLA) for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction.

We aimed to review the current evidence on surgical and functional outcomes of Transperineal Laser Ablation for LUTS due to BPH. A comprehensive review of the English-language literature was performed using the MEDLINE and Web of Science databases until 1 August 2022, aiming to select studies evaluating TPLA for the treatment of LUTS due to BPH. Additional records were found from Google Scholar. Data were extracted and summarized in Tables. An appropriate form was used for qualitative data synthesis. Seven studies were included in the review, with all being single arm, non-comparative studies. In all studies, functional outcomes were evaluated with uroflowmetry parameters and validated questionnaires, showing a promising effectiveness at short- and mid-term follow-up. There is a lack of standardized pathways for preoperative assessment of patients suitable for TPLA, and even the technique itself has been reported with a few nuances. A good safety profile has been reported by all the authors. Although promising results have been reported by different groups, selection criteria for TPLA and few technical nuances regarding the procedure were found to be heterogeneous across the published series that should be standardized in the future. Further research is needed to confirm these findings.

One-year outcomes after water vapor thermal therapy for symptomatic benign prostatic hyperplasia in an unselected Italian multicenter cohort.

BACKGROUND: Water vapor therapy (Rezum®; Boston Scientific, Marlborough, MA, USA) for bladder outflow obstruction (BOO) due to benign prostatic enlargement (BPE) is a minimally invasive and innovative surgical technique. The aim of this study was to evaluate its mid-term results in a large multicentric cohort of Italian patients. METHODS: Patients with BPO and moderate to severe LUTS who underwent Rezum® (Boston Scientific) treatment from May 2019 to July 2021 were included in this study. Pre- and postoperative evaluation comprised full urological evaluation with urine culture, digital rectal examination, serum PSA, transrectal prostate ultrasound, uroflowmetry, post-void residual and IPSS, OAB-q SF, ICIQ-UI SF and IIEF-5, ejaculatory anterograde rate. Minimum follow-up was 12 months. Patients' subjective satisfaction was recorded with Patient Global Impression of Improvement (PGI-I) Scale together with any early or late reported complications, classified according to Clavien-Dindo Scale. Statistical analysis was conducted as appropriate. RESULTS: Overall, 352 patients were eligible for the analysis. Procedures were routinely done on an outpatient basis. Mean operative was 12 minutes. The catheter was left in place for a median of 7 days. After treatment, Qmax, IPSS and IPSS-QoL, OAB-q SF, ICIQ-UI SF and IIEF-5 from baseline to last control follow-up (median 16, IQR 13-20 months) were improved (P<0.05). The postoperative anterograde ejaculation rate was recorded in 74.1% vs. preoperative 43.8% (P<0.001). Early (≤30 days) postoperative complications occurred in 176 patients (50%), all Clavien-Dindo Grade ≤2. One patient experienced clot retention and hematuria requiring hospitalization and blood transfusion. No late AEs were recorded. Surgical retreatment rate was 2.5% (9/352), all cases occurred within the first year. Median PGI-I was 2 (1-2). CONCLUSIONS: We confirmed the safety and efficacy of water vapor therapy for the treatment of symptomatic benign prostatic obstruction (BPO) on a large cohort of patients. Anterograde ejaculation was preserved in the majority of patients, with good subjective improvement. Further studies may rule out possible role of Rezum® (Boston Scientific) in new patients' setting.

Do Patients Treated with Water Vapor Therapy and Meeting Randomized Clinical Trial Criteria Have Better Urinary and Sexual Outcomes Than an Unselected Cohort?

Introduction: Water vapor intraprostatic injection (Rezum procedure) for benign prostatic hyperplasia (BPH) is one of the most promising minimally invasive surgical treatments. Five-year outcomes from the multicenter randomized controlled trial (RCT) demonstrated significant and durable urinary and sexual function results in selected patients. We compared the sexual and urinary outcomes of this procedure in patients satisfying inclusion criteria of the RCT with unselected patients. Materials and Methods: We prospectively followed all patients with symptomatic BPH who underwent Rezum therapy at eight institutions and analyzed the functional results. Patients were divided into two groups: patients who matched the 5-year RCT inclusion criteria (Group A) and patients who did not (Group B). The pre- and postoperative data, complications, presence of antegrade ejaculation, and urinary and sexual outcomes were periodically recorded. Results: A total of 426 patients were eligible for the study (232 in Group A and 194 in Group B). Patients in Group B had a higher American Society of Anesthesiologists score, prostate volume, and postvoid residual measurement. No difference was found in terms of preoperative International Prostate Symptom Score, International Index of Erectile Function, maximum urinary flow, and prostate-specific antigen. Longer operative time and higher number of vapor injections were required in Group B, with no differences in hospital stay, injection density, and complication rates. All the urinary and sexual outcomes improved with no differences between the two groups. The reintervention rate at the latest follow-up visit was 2.6% in Group A and 3.1% in Group B. Conclusions: In our large multicenter series, water vapor intraprostatic injections showed a safe and effective profile regardless of the prostate size, presence of indwelling catheter, antiplatelet/anticoagulant medications, and patients' comorbidities.

Transurethral water vapor ablation of the prostate with the Rezum system: Urodynamic findings.

AIMS: The efficacy of the transurethral convective interstitial radiofrequency water vapor thermal ablation of the prostate with the Rezum system for the treatment of male lower urinary tract symptom due to benign prostatic hyperplasia is well proven. The improvement of urodynamic parameters obtained from a simple uroflowmetry cannot measure the effect of water vapor injection on the bladder outlet obstruction. METHODS: This monocentric retrospective pilot study analyzes the data of pressure-flow studies performed before and after 17 Rezum procedures to answer the question whether thus obtained ablation of prostate tissue has a disobstructive effect on the bladder outlet. RESULTS: All the functional outcomes were consistently improved after the procedure, with a median flowrate increase of 5.1 ml/s (p = 0.0022) and a median postvoid residual urine (PVR) reduction of 100 ml (p = 0.0042). The prostate volume was reduced by 40% (p < 0.0001) and the median Bladder Outlet Obstruction Index (BOOI) reduction was 53.8 (p < 0.0001). CONCLUSIONS: These data show that the possibility to significantly reduce the obstruction grade with even a single Rezum procedure is concrete and seems to be independent from the degree of the obstruction grade.

Composite urinary and sexual outcomes after Rezum: an analysis of predictive factors from an Italian multi-centric study.

BACKGROUND: The Rezum system is one of the latest minimally invasive surgical treatments for benign prostatic hyperplasia. METHODS: We retrospectively reviewed all patients who underwent the Rezum treatment in seven different Italian institutions. A successful urinary outcome was defined as: ≥50% improvement in the IPSS <7, improvement in peak flow ≥50% and/or more than 15 ml/s, ≥1-point improvement in the QoL questionnaire and in the absence of perioperative major complications (AUR, transfusion) or postoperative incontinence. A successful sexual outcome was defined as postoperative (latest follow up consultation) antegrade ejaculation or no variation in ejaculatory function and an increase, or stability or max 1 class reduction, in IIEF-5. RESULTS: 262 patients were enrolled with a follow-up period of 11 months (IQR 5-15). No early or late serious adverse events (Clavien III-IV) occurred. Early complications occurred in 39.3% of cases, with 4 cases of clot retention and one case of blood transfusion. Urge incontinence was reported by 6 patients (2.2%). A treatment failure requiring re-intervention occurred in 4 cases (1.5%). The preoperative antegrade ejaculation rate was 56.5%, and after the procedure it increased to 78.2%. The increase of ≥1-point in the QoL was achieved in 92.7% of the cases. Optimal urinary and sexual outcomes were achieved in 52.9% and 87.8%, respectively. CONCLUSIONS: In our series, water vapor intraprostatic injections seem to be an effective and safe procedure.

Surgical Management of Synchronous, Bilateral Renal Masses: A 1-decade Referral Center Experience.

BACKGROUND: Management and decision-making in patients with bilateral renal masses are controversial. OBJECTIVE: To report our experience of surgical management in patients with bilateral renal masses undergoing surgery at a high-volume center. DESIGN, SETTING, AND PARTICIPANTS: We retrospectively collected data from patients treated with partial nephrectomy (PN) or radical nephrectomy for bilateral renal masses at a single referral institution between June 2008 and June 2019. Patient- and tumor-related features, timing (one vs two stage), and surgical approach (open vs robotic) were analyzed. SURGICAL PROCEDURE: A one- versus two-stage strategy was adopted according to the opportunity to perform at least one PN using a clampless or selective-clamping approach, in order to avoid acute kidney injury. MEASUREMENTS: Operative time, warm ischemia time, and intra- and postoperative complications were recorded. Histopathological results and tumor histology were assessed. RESULTS AND LIMITATIONS: Overall, 41 patients were included. The median age was 67 yr and the median preoperative estimated glomerular filtration rate (eGFR) was 84 ml/min/1.73 m2. The median Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) score was 8 (interquartile range [IQR] 7-8) for both sides. In 17 (42%) patients, a simultaneous approach was chosen, with a pure robotic approach in 11/17 cases, while among the 24 (58.6%) patients treated with a two-stage strategy, 15 (62.5%) were treated with a robotic approach on both sides. Intraoperative complications and postoperative major (CDC ≥3) complications were recorded in 7.3% and 4.9% of cases, respectively. The overall positive surgical margins rate was 2.4%. At a median follow-up of 42 (IQR 18-59) mo, the median eGFR was 73 (IQR 64-80) ml/min/1.73 m2, while disease-free survival and cancer-specific mortality were 90.2% and 7.3%, respectively. CONCLUSIONS: Our experience underlines that both simultaneous and staged surgical treatment of patients with bilateral renal masses are feasible and safe if grounded on proper patient selection. PATIENT SUMMARY: Management of patients with bilateral renal masses is challenging, given the heterogeneity of clinical scenarios and the need to optimize the timing of treatment to achieve maximal functional preservation while ensuring oncological efficacy.

Emerging Data on the Safety and Efficacy of Transurethral Water Vapour Therapy for Benign Prostatic Hyperplasia.

Benign prostate disease is a disease of prevalence and over 25% of men affected by bothersome lower urinary tract symptoms (LUTS) as a result of it will require surgical intervention during their lifetime. While transurethral resection of the prostate (TURP) has served as the cornerstone treatment for many years, there now exist a multitude of minimally invasive alternatives including the Rezum system. The latter is a novel form of transurethral water vapour therapy, which is attracting increasing attention. It utilizes convective water vapour energy (WAVE) and thereby radiofrequency (RF) in order to generate heat energy. Early studies have demonstrated promising results. To date there have been 12 studies published on Rezum, however only one randomized trial. This review offers an overview and evaluation of this emerging evidence.

Robot assisted radical cystectomy with Florence robotic intracorporeal neobladder (FloRIN): Analysis of survival and functional outcomes after first 100 consecutive patients upon accomplishment of phase 3 IDEAL framework.

INTRODUCTION: Aim of the study was to evaluate the Florence intracorporeal neobladder (FloRIN) oncological and functional outcomes at the end of assessment phase (phase 3) IDEAL-Guidelines. MATERIALS AND METHODS: This single-institution prospective series included consecutive patients treated with robot-assisted radical cystectomy (RARC) and FloRIN reconfiguration technique from February 2016 to June 2020. Functional features were evaluated six months after surgery. Patients were grouped into four quartiles according to time of radical cystectomy and impact of learning curve improvement was evaluated. RESULTS: One-hundred FloRIN were completed with a median console time of 373 (IQR: 312-415) minutes. Two cases were converted to open surgery. No intraoperative complications occurred. At pathological examination, 30% of patients were staged as pT ≤ 1 and 47% as pT ≥ 3. Transitional cell carcinoma was present in 87% of cases. Carcinoma in situ (CIS) and nodal involvement were observed in 38% and 29% of patients, respectively. At a median follow-up time of 17 (IQR: 7-28) months, 20 clinically relevant events (Clavien-Dindo≥3) occurred. Operative time significantly decreased throughout the series (median minutes 435; 395; 365 and 330 in the four quartiles, respectively; p < 0.001). Similarly, early Clavien-Dindo≥3 postoperative complications rate significantly decreased across the series (number of events: 1; 4; 0; 0; p = 0.03). Overall, 75% and 65% of patients achieved day-time and nigh-time continence, respectively. Twenty-seven patients experienced disease recurrence. Cancer-specific and overall survival were equal to 80%. CONCLUSIONS: RARC with FloRIN reconfiguration showed worthy functional and survival outcomes, with learning curve improvement significantly influencing operative time and early complications rate across series.

Water vapor therapy (Rezum) for lower urinary tract symptoms related to benign prostatic hyperplasia: early results from the first Italian multicentric study.

PURPOSE: Rezum is the latest developed minimally invasive treatment for benign prostatic hyperplasia (BPH). We aimed to carefully assess the functional outcomes of patients treated with Rezum for BPH. METHODS: We prospectively followed 135 consecutive patients treated by Rezum at 5 institutions from June 2019 to August 2020. The International Prostate Symptom Score (IPSS), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI SF), the Overactive Bladder Questionnaire-Short Form (OAB-q SF) score, the International Index of Erectile Function (IIEF-5) and questions 9 and 10 to assess ejaculatory dysfunction were recorded. Election criteria were age > 18, no prior prostate interventions, IPSS ≥ 13, post-void residual ≤ 250 mL, prostate volume between 30 and 120 cc. RESULTS: The median operative time was 10.5 (IQR 8.7-15) min. All patients were dismissed few hours after surgery with indwelling urinary catheter that was removed after a median of 7 (IQR 7-10) days. A significantly decrease of IPSS from baseline at first (p = 0.001) and third (p < 0.0001) month after surgery was reported. No difference was reported in terms of ICIQ-UI SF score postoperatively. A mild reduction of the OAB-q SF score was reported at 1 month from surgery (p = 0.06) that turned significant at 3 months postoperatively (p < 0.0001). A slight but statistically significant increase of the IIEF-5 score was reported from baseline at 6 months (p = 0.04). Postoperatively, patients reported a significantly decrease of ejaculatory dysfunction after alpha-blocker interruption. CONCLUSION: Rezum treatment is a feasible minimally invasive option for patients with BPH symptoms and showed optimal early functional outcomes.

Role of Rezum in the treatment of benign prostate hyperplasia: A review of the literature.

The aim of this study was to review the available literature on the efficacy and safety of the Rezum system for the treatment of symptomatic benign prostatic hyperplasia (BPH). A revision of literature up to January 2021 was carried out. Medline, Scopus, Web of Science, and PubMed archives were screened to identify all the relevant studies investigating the role of Rezum in the treatment of BPH. Randomized controlled trial (RCT), retrospective, prospective, observational, and comparative studies were included. Finally, 17 studies were included, five of which reporting data of a double blind Rezum RCT. Overall, 1,451 patients underwent Rezum procedure. All the studies performed a minimum of 3 months follow-up. Preoperatively, the mean International Prostate Symptom Score (IPSS) score was 19.8, mean Qmax was 9.2mL s1, and mean PVR was 142 cc. At 3 months after surgery, the mean IPSS score was 1.5, mean Qmax was 13.7mL s1, and mean PVR was 74 cc. Six studies investigated sexual function, most of them using the International Index of Erectile Function (IIEF)-5 questionnaire and a few also the Male Sexual Health Questionnaire (MSHQ). Preoperative mean IIEF-5 score was 18.5, and the mean MSHQ score was 7.4. At the 3 months follow-up, the mean IIEF-5 score was 16.4, and the mean MSHQ score was 9.62. None of the studies reported intraoperative complications. Rezum system is a novel minimally invasive treatment for symptomatic BPH using transurethral water vapor thermal energy. It represents a cost-effective and safe procedure with durable relief of lower urinary tract symptom, preservation of sexual function, low complications rate, and short recovery time.

A Prospective, Open-Label Comparison of Tamsulosin plus Serenoa repens and Bovine Colostrum versus Tamsulosin Alone in the Treatment of Benign Prostatic Hyperplasia.

OBJECTIVE: To compare the efficacy and safety of oral supplementation with Serenoa repens (SR) and bovine colostrum (BC) plus tamsulosin (TAM) versus TAM alone over 12 months in men suffering from lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). METHODS: Between February 2018 and February 2019, men with symptomatic BPH (IPSS ≥10) were prospectively recruited. This prospective, open-label, 12-month study included two different protocols: (1) group A, SR 320 mg/day + BC 30 mg/day + TAM 0.4 mg/day, and (2) group B, TAM 0.4 mg/day only. RESULTS: Overall, 148 patients entered the study, 76 in group A and 72 in group B. At 12 months, the total IPSS had decreased by 5.5 with TAM + SR + BC and by 5.1 with TAM only (p = 0.21). However, when the total IPSS was divided into storage and voiding subscores, at 6 months the storage symptoms had improved significantly more with TAM + SR + BC (-1.6 vs. -0.9 with TAM only, p = 0.02), with the benefit persisting also at the 1-year evaluation (-1.8 vs. -0.8, p = 0.02). Moreover, the improvement in LUTS-related quality of life (QoL) was significantly different between the groups, with a mean decrease in IPSS QoL subscore of -2.5 ± 0.2 for TAM + SR + BC versus -1.8 ± 0.3 for TAM at 6 months (p = 0.04), and of -2.9 ± 0.4 for TAM + SR + BC versus -2.1 ± 0.4 for TAM at 12 months (p = 0.04). Conversely, no significant differences were found in maximal urinary flow rate (p = 0.38), postvoid residual volume (p = 0.12), prostate-specific antigen (p = 0.41), and prostate volume (p = 0.16). CONCLUSION: Combination treatment with SR and BC plus TAM was shown to be more effective than treatment with TAM only in improving IPSS storage and QoL subscores in BPH patients after 6 months and up to 12 months of treatment.

Predictors of early postoperative and mid-term functional outcomes in patients treated with Endoscopic Robot-Assisted Simple Enucleation (ERASE): results from a tertiary referral center.

BACKGROUND: The aim of this study was to assess the early and mid-term functional outcomes of Endoscopic Robot Assisted Simple Enucleation (ERASE) verified through a standardized tumor-resection reporting system (Surface Intermediate Base [SIB] score) and to investigate for predictors of renal function (RF) loss in patients with T1 renal tumors treated in a tertiary referral institution. METHODS: Data of 553 patients treated with ERASE were analyzed. Only patients with SIB score of 0-1 and negative oncological follow-up were included. A ≥25% drop from baseline of estimated glomerular filtration rate (eGFR) was considered as a clinically meaningful functional loss. Multivariable regression models tested the relation between clinical features and RF loss at postoperative day (POD) 3 and at last follow-up. RESULTS: Overall, 347 patients with SIB 0-1 entered the study. A RF drop ≥25% was observed in 178 (37%) patients in POD 3 and in 91 (18.9%) patients at a median follow-up of 36 months, respectively. At multivariable analysis, age at surgery and PADUA score were significant predictive factors of clinically significant RF loss at POD 3, while age at surgery, female gender, higher BMI, Charlson Comorbidity Index (CCI) and preoperative eGFR were significant predictors of RF loss at last follow-up. CONCLUSIONS: Age at surgery and higher PADUA score are significant predictors of early postoperative RF loss after ERASE for T1 renal tumors, while age at surgery, female gender, higher BMI, CCI and baseline RF significantly affect mid-term RF. Larger studies and a longer follow-up are needed to confirm these results.

Outcomes of European Basic Laparoscopic Urological Skills (EBLUS) Examinations: Results from European School of Urology (ESU) and EAU Section of Uro-Technology (ESUT) over 6 Years (2013-2018).

BACKGROUND: The European School of Urology (ESU) and EAU Section of Uro-Technology (ESUT) started hands-on-training (HOT) sessions in 2007 along with structured European Basic Laparoscopic Urological Skills (EBLUS) examinations in 2013. EBLUS includes an online theoretical course, HOT by expert tutors on a set of dry-lab exercises, and finally a standardised examination for skill assessment and certification. OBJECTIVE: To analyse the results and predictors of success from the EBLUS examinations that were conducted during the European Urology Residents Education Programme (EUREP) and other international and national dedicated ESU events. DESIGN, SETTING, AND PARTICIPANTS: ESU has been delivering EBLUS courses and examinations over the past 6 yr (2013-2018) in more than 40 countries worldwide. Trainees were asked about their laparoscopic background (procedures assisted/performed) and about the availability of HOT or simulator/box trainer in their facility. Apart from the online theoretical course, 4 HOT tasks [(1) peg transfer, (2) pattern cutting, (3) single knot tying, and (4) clip and cut] with its quality assessment of depth perception, bimanual dexterity, and efficiency were a part of the assessment and were considered critical to pass the EBLUS examination. RESULTS AND LIMITATIONS: A total of 875 EBLUS examinations were delivered (EUREP, n=385; other ESU events, n=490), with complete data available for 533 (61%) participants among which 295 (55%) passed the examinations. Pass rate increased on a yearly basis from 35% to 70% (p<0.001) and was similar between EUREP (56%) and other ESU/ESUT events (55%). The significant predictors of success were passing tasks 1 [odds ratio (OR): 869.9, 95% confidence interval (CI): 89.6-8449.0, p<0.001] and 2 (OR: 3045.0, 95% CI: 99.2-93 516.2, p<0.001) of the examinations. A limitation of EBLUS was its inability to provide more advanced training such as wet-lab or cadaveric training. CONCLUSIONS: Over the past few years more trainees have passed the European Basic Laparoscopic Urological Skills (EBLUS) examinations. Trainees who spend more time on laparoscopic procedures demonstrated a better performance and pass rate. We found almost no difference between the EBLUS results collected from EUREP and other ESU/ESUT events, which confirms the robustness of the training and examinations conducted worldwide. PATIENT SUMMARY: Training in laparoscopy helps trainees pass the European Basic Laparoscopic Urological Skills (EBLUS) examinations, reflected by an increase in the pass rate over the past 6 yr. Our results also confirm the robustness of EBLUS training and examinations worldwide.