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.

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.

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.

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.

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.

Development of a robot-assisted kidney transplantation programme from deceased donors in a referral academic centre: technical nuances and preliminary results.

OBJECTIVE: To report the development of the first robot-assisted kidney transplantation (RAKT) programme from deceased donors, examining technical feasibility and early perioperative and functional outcomes at a referral academic centre. PATIENTS AND METHODS: A RAKT programme was developed in 2016 at our institution following structured modular training. Specific inclusion/exclusion criteria for both living and deceased donors were set. Data from patients undergoing RAKT from January 2017 to April 2018 were prospectively collected in an a priori developed web-based data set. RAKT followed the principles of the Vattikuti Urology Institute-Medanta technique, with specific technical modifications based on clinical recipient characteristics, as well as surgeon's skills and preference during the learning curve. Technical feasibility of RAKT from deceased donors and evaluation of perioperative and early functional outcomes were the main study endpoints. RESULTS: In all, 17 RAKTs were performed during the study period. Of these, six were from living donors and 11 were from deceased donors. All RAKTs were successfully completed without need of conversion. The median (interquartile range [IQR]) console time was 190 (160-220) min and the median (IQR) estimated blood loss was 120 (110-140) mL. The median times to complete venous, arterial and uretero-vesical anastomoses were 21, 22 and 21 min, respectively. The median (IQR) length of stay was 8 (6-12) days. At a median (IQR) follow-up of 8 (6-11) months, five (30%) complications were recorded. Of these, four (24%) were minor (Clavien-Dindo Grade I-II) and one major (Clavien-Dindo Grade IIIb, requiring graft nephrectomy). Overall, two patients were still on dialysis at last follow-up. A significant improvement in graft function was recorded progressively at all postoperative time points. CONCLUSION: Our preliminary experience outlines that: (i) the development of a RAKT programme is feasible in centres experienced in robotic surgery and open kidney transplantation; (ii) RAKT from deceased donors is feasible from both a technical and logistical perspective; and (iii) RAKT from deceased donors appears to achieve favourable early postoperative and functional outcomes. Larger studies with longer follow-up are needed to confirm these findings and compare the outcomes of RAKT from deceased donors with those from living donors.

Performance Improvement (Pi) score: an algorithm to score Pi objectively during E-BLUS hands-on training sessions. A European Association of Urology, Section of Uro-Technology (ESUT) project.

OBJECTIVE: To evaluate the variability of subjective tutor performance improvement (Pi) assessment and to compare it with a novel measurement algorithm: the Pi score. MATERIALS AND METHODS: The Pi-score algorithm considers time measurement and number of errors from two different repetitions (first and fifth) of the same training task and compares them to the relative task goals, to produce an objective score. We collected data during eight courses on the four European Association of Urology training in Basic Laparoscopic Urological Skills (E-BLUS) tasks. The same tutor instructed on all courses. Collected data were independently analysed by 14 hands-on training experts for Pi assessment. Their subjective Pi assessments were compared for inter-rater reliability. The average per-participant subjective scores from all 14 proctors were then compared with the objective Pi-score algorithm results. Cohen's κ statistic was used for comparison analysis. RESULTS: A total of 50 participants were enrolled. Concordance found between the 14 proctors' scores was the following: Task 1, κ = 0.42 (moderate); Task 2, κ = 0.27 (fair); Task 3, κ = 0.32 (fair); and Task 4, κ = 0.55 (moderate). Concordance between Pi-score results and proctor average scores per participant was the following: Task 1, κ = 0.85 (almost perfect); Task 2, κ = 0.46 (moderate); Task 3, κ = 0.92 (almost perfect); Task 4 = 0.65 (substantial). CONCLUSION: The present study shows that evaluation of Pi is highly variable, even when formulated by a cohort of experts. Our algorithm successfully provided an objective score that was equal to the average Pi assessment of a cohort of experts, in relation to a small amount of training attempts.

Full Robot-Assisted Living Donor Nephrectomy and Kidney Transplantation in a Twin Dedicated Operating Room: Initial Experience From a High-Volume Robotic Center.

Purpose. To describe our initial experience with a full robot-assisted approach for living donor nephrectomy (RALDN) and kidney transplantation (RAKT) in a dedicated twin operating room. Methods. From January to December 2017, 5 cases of RALDN and RAKT were performed in a single high-volume robotic center. All patients underwent a standard left RALDN. The renal hilum was controlled with Hem-O-Lok clips (WECK) and the kidney extracted through a Pfannenstiel incision. RAKT was performed according to the Vattikuti Urology Institute-Medanta technique. Results. RALDN: median estimated blood loss was 182 mL (range = 80-450 mL), no postoperative blood transfusion was required. The median (range) warm ischemia time was 175 (90-220 seconds). No conversion was registered. Median console time was 143 minutes (range = 115-220 minutes). No major surgical intraoperative and postoperative early and late complications occurred. RAKT: all 5 patients successfully underwent RAKT. Median (range) console time was 230 (190-200) minutes, vascular suture time was 58.7 (48-73) minutes, cold ischemia time was 46.2 (30-88) minutes, and rewarming time was 61.2 (55-72) minutes. No conversion was required. No major surgical intraoperative and postoperative early and late complications occurred. Mean glomerular filtration rate at days 1, 3, and 7 postoperatively was 26, 42, and 57 (range = 6-90) mL/min/1.73 m2, respectively. No case of delayed graft function was observed. No anastomosis revision, urological complications, lymphocele, and surgical site infection occurred. Conclusions. In our experience, RALDN and RAKT are safe and effective. The intuitiveness of the robotic approach provided substantial benefits both for the living donor and recipient from the very beginning of our series. No intraoperative and postoperative complications occurred.

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.

European experience of robot-assisted kidney transplantation: minimum of 1-year follow-up.

OBJECTIVES: To evaluate functional results, graft survival and late complications in patients who underwent robot-assisted kidney transplantation (RAKT) and who had a minimum of 1 year of follow-up data, and to analyse the correlations between surgical data and functional results at a minimum of 1-year postoperatively and between renal function in the immediate postoperative period and after 1 year. MATERIALS AND METHODS: A common prospectively collected RAKT database was created by the European Robotic Urological Section (ERUS) RAKT working group, which included eight different European centres. In each centre RAKTs were performed with kidneys from living donors. Data on demographic variables, surgical results, graft survival, functional outcomes (creatinine and estimated glomerular filtration rate [eGFR]) on postoperative days 7 and 30 and at 1 year, and late complications were extracted from the common database. RESULTS: A total of 147 RAKTs were performed by the ERUS RAKT working group. Of the 147 patients, 83 had at least 1-year follow-up (mean [range] 21 [13-27] months). Of these 83 patients, 30 were women. The patients' median (range) age was 43 (30-75) years, body mass index was 25.3 (20-40) kg/m2 , pre-transplantation serum creatinine was 517 (198-1 414) µmol/L and estimated GFR (eGFR) was 10 (3-29) mL/min per 1.73 m2 . Of the 83 cases, 46 were pre-emptive. The median (range) overall ischaemia time was 116 (53-377) min. The median (range) rewarming time was 60 (35-110) min. At 1-year follow-up, the median (range) serum creatinine was 131 (66-244) µmol/L, with a median (range) eGFR of 57.4 (28-97) mL/min per 1.73 m2 . There was no statistically significant difference between functional data at postoperative day 30 and those at 1 year for creatinine (P = 0.78) or eGFR (P = 0.91). Regarding the correlation between the surgical data and the functional outcomes, the data showed that overall operating time and rewarming time did not affect the graft function at 1 year. Three cases of graft loss occurred as a result of massive arterial thrombosis within the first postoperative week. Late complications comprised one case of ureteric stenosis and one case of graft pyelonephritis. No late vascular complications or cases of incisional hernia were recorded. CONCLUSION: Findings at 1-year follow-up indicate RAKT from a living donor to be a safe procedure in a properly selected group of recipients. RAKT was associated with a low complication rate and there was maintenance of excellent graft survival and function. This is the first and largest study to report functional results after RAKT from a living donor with a minimum follow-up of 1 year.

Sexual Rehabilitation After Nerve-Sparing Radical Prostatectomy: Free-of-Charge Phosphodiesterase Type 5 Inhibitor Administration Improves Compliance to Treatment.

BACKGROUND: In December 2006, the region of Tuscany (Italy) authorized the free-of-charge provision of phosphodiesterase type 5 inhibitors (PDE5I) for all patients with Tuscan citizenship who undergo nerve-sparing radical prostatectomy (NSRP). OBJECTIVE: To compare sexual rehabilitation outcomes in patients with low risk of erectile dysfunction and minimal comorbidities who received PDE5Is free of charge (PDE5I-F) with those who paid for PDE5Is (PDE5I-P) after bilateral NSRP. METHODS: We reviewed prospectively recorded clinical data of 2,368 patients with Tuscan (PDE5I-F) and non-Tuscan (PDE5I-P) citizenship treated with NSRP at 3 different institutions in Tuscany from 2008 to 2013. Inclusion criteria for the final analysis were open or robot-assisted bilateral NSRP; low risk of postoperative erectile dysfunction according to the Briganti risk stratification tool; no smoking and no drug and alcohol abuse; no cardiovascular risk factors; no major surgery before and after NSRP; no neoadjuvant or adjuvant treatment; and no biochemical relapse. Dropout was defined as an interruption longer than 40 days of the treatment protocol indicated in the inclusion criteria. Treatment compliance was defined as more than 90% consumption of the prescribed PDE5I. OUTCOMES: The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and the Italian version of the University of California-Los Angeles Prostate Cancer Index sexual function (UCLA-PCI-s) questionnaires were administered to assess patients' satisfaction with PDE5I treatment and sexual function. RESULTS: Overall, 648 patients in the PDE5I-F group and 182 in the PDE5I-P group met the inclusion criteria and were eligible for the study. Patients had comparable preoperative and surgical characteristics. The PDE5I-F group had a significantly higher early rehabilitation onset (P < .001), lower treatment dropout at 12, 24, and 36 months (P < .001 for all comparisons), and higher compliance to the treatment protocol at 6 and 12 months (P = .01 and P < .001, respectively). At multivariable analysis, the PDE5I-F protocol was an independent predictor of an EDITS score higher than 50 (hazard ratio = 1.54, P = .03) and a UCLA-PCI-s score higher than 50 (hazard ratio = 3.12, P = .01) after adjusting for the effects of several clinical features. CLINICAL IMPLICATIONS: The free-of-charge protocol has a significant impact on patients' satisfaction with PDE5I treatment. STRENGTHS AND LIMITATIONS: To our knowledge, this is the first study comparing free vs paid access to a sexual rehabilitation protocol. Major limitations are the observational nature of the study and the different population sizes of the 2 groups. CONCLUSIONS: In a selected cohort of patients after NSRP, free-of-charge access to a sexual rehabilitation protocol was significantly associated with higher early rehabilitation onset, major compliance to the protocol, minor treatment dropout, and higher satisfaction rate of patients. Siena G, Mari A, Canale A, et al. Sexual Rehabilitation After Nerve-Sparing Radical Prostatectomy: Free-of-Charge Phosphodiesterase Type 5 Inhibitor Administration Improves Compliance to Treatment. J Sex Med 2018;15:120-123.

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.

Open versus laparoscopic partial nephrectomy for clinical T1a renal masses: a matched-pair comparison of 280 patients with TRIFECTA outcomes (RECORd Project).

AIM OF THE STUDY: To report a matched-pair comparative analysis between open (OPN) and laparoscopic partial nephrectomy (LPN) for clinical (c) T1a renal masses from a large prospective multicenter dataset. MATERIALS AND METHODS: The RECORd Project includes all patients who underwent OPN and LPN for kidney cancer between January 2009 and January 2011 at 19 Italian centers. Open and laparoscopic groups were compared regarding clinical, surgical, pathologic, functional results and TRIFECTA outcome. Multivariable logistic regression models were used to analyze predictors of WIT >25 min, surgical complications (SC) and the achievement of the TRIFECTA outcome. RESULTS: Overall, 301 patients had OPN and 149 LPN. Groups were matched 1:1 (140 matched pairs) for clinical diameter, tumor location and type of indication. Laparoscopic partial nephrectomy was associated with a significantly mean longer WIT (19.9 vs. 15.1 min; p < 0.001), and it was an independent predictor of a WIT >25 min (RR 6.29, p < 0.0001). The TRIFECTA was achieved in 78.6 and 74.3% after OPN and LPN (p = ns), respectively, and the surgical approach was not a predictor of a negative TRIFECTA and SC at multivariable analysis. At 6-month follow-up, no significant differences were observed between the OPN and LPN group both in estimated glomerular filtration rate (eGFR) (∆GFR 1.1 vs. 4.1 mL/min) and in new-onset stage III-V chronic kidney disease (CKD) rate (0 vs. 0.7%). CONCLUSION: No significant difference in achieving the TRIFECTA outcome was reported after OPN and LPN. LPN was associated with a significantly longer WIT. However, eGFR at 6-month follow-up did not differ significantly between the two surgical approaches.

Sutureless hemostatic control during laparoscopic NSS for the treatment of small renal masses.

BACKGROUND: This study aimed to evaluate the safety and efficacy of a sutureless hemostatic control during laparoscopic nephron sparing surgery (LNSS) for the treatment of small renal masses. METHODS: Between November 2007 and August 2010, 245 patients underwent nephron sparing surgery. Overall, 100 patients (41%) had LNSS. Hemostasis was controlled either by a knot-tying suture repair (standard-LNSS) or by a sutureless technique (s-LNSS). The s-LNSS was done using a bipolar cauterization of the resection bed, followed by Floseal apposition. Operative and warm ischemia time (WIT), intraoperative blood loss, hospital stay, blood tests, and perioperative complications were recorded. RESULTS: In 32 cases (32%) hemostasis was controlled by the sutureless technique. The s-LNSS was the treatment of choice for small tumors ≤1.5 cm, and it was also used for the treatment of tumors between 1.6 and 2.5 cm, aside from their spatial extension. Indeed, the mean (range; interquartile range) clinical dimension of the tumors in the s-LNSS group was 1.9 (1-3.5; 1.5-2.1) cm. On the contrary, the vast majority of tumors >2.5 cm were treated with standard-LNSS. Mean (range; interquartile range) WIT in the s-LNSS group was 16 (8-22; 12-16) minutes. The mean (range) intraoperative blood loss in the s-LNSS group was 107 cc (25-205). No postoperative early and late bleeding were reported in the s-LNSS group, and the mean (range) time to drainage removal and time to discharge were 3 (2-5) and 4 (3-7) days, respectively. CONCLUSIONS: The sutureless technique with bipolar cauterization of the surgical bed and Floseal apposition is safe and effective for the hemostatic control in the treatment of small cortical masses. It can be always used for tumors ≤1.5 cm and can be a valid option also for tumors between 1.6 and 2.5 cm, aside from their spatial extension.

European Initial Hands-On Experience with HEMOPATCH, a Novel Sealing Hemostatic Patch: Application in General, Gastrointestinal, Biliopancreatic, Cardiac, and Urologic Surgery.

Topical hemostatic agents that can seal tissues and assist in the coagulation cascade of patients undergoing surgery have been readily available for several decades. Using either synthetic or animal/plant-derived materials, these agents represent a powerful tool to reduce postoperative bleeding complications in cases where mechanical or energy-driven hemostasis is not possible or insufficient. Recently, a novel sealing hemostatic patch, HEMOPATCH (Baxter International, Deerfield, IL), was developed. The device is a thin and flexible patch consisting of a specifically-formulated porous collagen matrix, coated on one side with a thin protein-binding layer. This gives the patch a dual mechanism of action, in which the two components interact to achieve hemostasis by sealing off the bleeding surface and initiating the body's own clotting mechanisms. Here we present a series of case reports that outline the quick, effective hemostatic sealing of HEMOPATCH in a variety of clinical applications, including solid organ, gastrointestinal, biliopancreatic, endocrine, cardiovascular, and urologic surgeries. Essentially a feasibility study, these reports demonstrate how HEMOPATCH can be applied to seal almost any bleeding surface encountered during a range of procedures. Our results show that the device is eminently capable in both via laparotomy and laparoscopic approaches, and in patients with impaired coagulation or highly variable anatomies. In conclusion, our cases document the ease-of-use, application, and immediate hemostatic effect of the patch across a broad range of surgical settings and paves the way for future randomized clinical trials with more extensive follow-up.

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.

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.

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.

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.