Prostatic urethral lift for subjects in urinary retention (PULSAR): 12-Month results of a prospective controlled trial compared with real-world outcomes.

Objective: To examine the safety and efficacy of prostatic urethral lift (PUL) in acute urinary retention (AUR) patients within a controlled (PULSAR) and real-world setting (Real-World Retrospective study). Materials and methods: PULSAR was a 12-month prospective study of PUL in AUR patients (n = 51) performed at six centres in the United Kingdom; enrolled BPH patients aged ≥50 years, with prostate volume of ≤100 cc. AUR was defined as being catheter dependent with at least one prior failed trial without catheter (TWOC) while on an alpha-blocker. RWR consisted of 3226 consecutive PUL patients across 22 international sites treated between July 2017 and March 2020; 469 of whom were in urinary retention (RWRr), that is, catheter-dependent at the time of their procedure. Symptom response, uroflow and catheter independence rates were compared between PULSAR and RWRr subjects. A logistical regression model was constructed to evaluate patient baseline and dynamic factors predicting success after the procedure. Results: Seventy-three percent of PULSAR subjects were catheter independent and free from surgical reintervention at 12 months post-PUL. Success was associated with higher voiding efficiency during the perioperative period. Slightly higher catheter-independent rates (80%) were seen in RWRr patients; variables that influenced success included age <70 years, lower baseline prostate-specific antigen (PSA), lower baseline post-void residual (PVR) and shorter pre-procedural catheter duration. Logistic regression of the combined PULSAR and RWRr retention groups revealed that procedural age <70 years and higher bladder voiding efficiency (BVE) were associated with success. Conclusions: Lower baseline PSA and PVR, younger age and shorter pre-procedure catheter durations drove successful outcomes in AUR patients undergoing PUL. Post-PUL voiding efficiencies may help ascertain long-term response to treatment.

Aquablation versus TURP: 5-year outcomes of the WATER randomized clinical trial for prostate volumes 50-80 mL.

INTRODUCTION: To report the 5-year efficacy and safety of Aquablation compared with transurethral resection of the prostate for the management of lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with prostate volumes 50-80 mL. MATERIALS AND METHODS: In a large double-blinded, multicenter, and prospective randomized controlled trial, 96 randomized men with 50-80 mL prostates who underwent Aquablation or transurethral prostate resection were prospectively identified for subgroup analysis. Follow up was performed for up to 5 years. The primary efficacy endpoint was the reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo (CD) postoperative complications grade 1 persistent and grade 2 or higher at 3 months. RESULTS: Both groups had comparable baseline characteristics. Reduction in IPSS score was significantly higher in the Aquablation group across 5 years of follow up (-14.1 vs. -10.8, p = 0.02). The Aquablation group achieved a significantly lower rate of CD1P and CD2 or higher events at 3 months follow up (risk difference of -23.1%). Among recorded adverse events, de novo postoperative ejaculatory dysfunction was notably lower in Aquablation (risk difference of -21.9%), while the risk of bleeding remained similar after 6 months. The surgical and medical retreatment rate at 6 months was also lower in Aquablation (risk difference of -14.4%). CONCLUSIONS: In the 50-80 mL prostate volume subgroup, Aquablation yields superior long-term symptom relief and lower complication rates than standard transurethral resection, with notably lower rates of ejaculatory dysfunction. This further supports the adoption of Aquablation for men with medium-sized prostates.

Aquablation in Patients on Antithrombotics: Assessment of Safety, Postoperative Bleeding Rates and Clinical Outcomes.

OBJECTIVE: To analyze the impact of perioperative antithrombotic use on the bleeding outcomes following Aquablation. METHODS: One hundred sixteen men with who underwent Aquablation as part of the WATER prospective trial (NCT02505919) were assigned to 2 groups based on perioperative antithrombotic status. Antithrombotic cessation and restart timing were based on the surgeon's discretion. Methods of achieving intraoperative hemostasis consisted of no-cautery balloon tamponade or cautery. Primary endpoints included immediate postoperative hematuria rates and changes in hemoglobin. Secondary endpoints included 90-day bleeding complications and nonbleeding postoperative adverse events. RESULTS: Forty-one men took antithrombotic medications in the perioperative period while 75 men had no antithrombotic medication. Preoperative hemoglobin levels were comparable between both groups. Postoperative hemoglobin change from baseline (drop of 1.8 ± 1.5 g/dL among the antithrombotic group vs 1.8 ± 1.7 g/dL among the antithrombotic-naïve group) did not differ between both groups (P = .896). In total, 4 (9.8%) men in the antithrombotic group and 4 (5.3%) patients in the antithrombotic-naïve group experienced a Clavien-Dindo grade 1 complication (P = .451) in the 3-month postoperative period. Eight (19.5%) patients in the antithrombotic group and 11 (14.7%) patients in the antithrombotic-naïve group experienced a Clavien-Dindo grade 2 complication (P = .601), none of which is associated with bleeding in both groups. No men in either group demonstrated de novo erectile dysfunction. One patient (2.4%) in the antithrombotic group and none in the antithrombotic-naïve group required blood products (P = .353). CONCLUSION: Aquablation demonstrates comparable postoperative bleeding outcomes and other adverse effects for men with benign prostatic hypertrophy who are on antithrombotic therapy.

External validation of yonsei nomogram predicting chronic kidney disease development after partial nephrectomy: An international, multicenter study.

OBJECTIVE: To externally validate Yonsei nomogram. METHODS: From 2000 through 2018, 3526 consecutive patients underwent on-clamp PN for cT1 renal masses at 23 centers were included. All patients had two kidneys, preoperative eGFR ≥60 ml/min/1.73 m2, and a minimum follow-up of 12 months. New-onset CKD was defined as upgrading from CKD stage I or II into CKD stage ≥III. We obtained the CKD-free progression probabilities at 1, 3, 5, and 10 years for all patients by applying the nomogram found at https://eservices.ksmc.med.sa/ckd/. Thereafter, external validation of Yonsei nomogram for estimating new-onset CKD stage ≥III was assessed by calibration and discrimination analysis. RESULTS AND LIMITATION: Median values of patients' age, tumor size, eGFR and follow-up period were 47 years (IQR: 47-62), 3.3 cm (IQR: 2.5-4.2), 90.5 ml/min/1.73 m2 (IQR: 82.8-98), and 47 months (IQR: 27-65), respectively. A total of 683 patients (19.4%) developed new-onset CKD. The 5-year CKD-free progression rate was 77.9%. Yonsei nomogram demonstrated an AUC of 0.69, 0.72, 0.77, and 0.78 for the prediction of CKD stage ≥III at 1, 3, 5, and 10 years, respectively. The calibration plots at 1, 3, 5, and 10 years showed that the model was well calibrated with calibration slope values of 0.77, 0.83, 0.76, and 0.75, respectively. Retrospective database collection is a limitation of our study. CONCLUSIONS: The largest external validation of Yonsei nomogram showed good calibration properties. The nomogram can provide an accurate estimate of the individual risk of CKD-free progression on long-term follow-up.

Aquablation Treatment for Benign Prostate Hyperplasia: Current Standardized Procedure.

The following video Atlas summary reviews all technical elements of the standardized setup, robotic execution, aquablation procedure, and hemostasis for efficient rapid benign prostate hyperplasia treatment.

Functional and surgical outcomes of Aquablation in elderly men.

PURPOSE: As benign prostatic hyperplasia (BPH) is an age-related process, growing interest in surgical management for elderly men has emerged. Recently, Aquablation was approved for treatment of BPH associated lower urinary tract symptoms (LUTS) and utilizes robotic ultrasound guided surgeon-controlled waterjet ablation. We assessed the differences in functional and surgical outcomes between elderly and young men undergoing Aquablation for BPH/LUTS. MATERIALS AND METHODS: We retrospectively assessed prospectively collected data from the WATER I (NCT02505919) and WATER II (NCT03123250) clinical trials reporting safety and efficacy of Aquablation in the treatment of LUTS/BPH in men 45-80 years with a prostate between 30 and 80 cc, and 80 cc and 150 cc, respectively. Men ≥ 65 years were defined as elderly and men < 65 years as young. RESULTS: Of 217 patients included, 83 (38.2%) were young and 134 (61.8%) were elderly. Mean age (SD) was 59.3 (± 3.4) years and 71.2 (± 4.2) years for young and elderly men, respectively. At 3 years of follow-up compared to baseline, elderly men showed similar reductions in total IPSS (7.68 points vs 7.12 points, p > 0.05) and similar increases in Qmax (20.6 mL/s vs 19.3 mL/s, p > 0.05) compared to young men. The ejaculatory dysfunction rate was similar for both cohorts (12.0% vs 9.7%, p > 0.05). Elderly men experienced similar annual retreatment rates compared to young men (1.5% vs 0.8% p > 0.05). CONCLUSIONS: Elderly men undergoing Aquablation have similar functional and surgical outcomes as young men. Elderly patient BPH surgical counseling should, therefore, consider Aquablation as a treatment option for LUTS/BPH.

Aquablation Outcomes in Men With LUTS Due to BPH Following Single Versus Multi-pass Treatments.

OBJECTIVE: To determine whether existing data support the use of multiple passes in Aquablation for LUTS due to BPH. METHODS: Data were obtained from 2sources. The WATER trial (NCT02505919) is a prospective, multicenter, double-blind, randomized controlled trial of Aquablation vs TURP in prostate volumes of 30 - 80 ml. The WATER II trial (NCT03123250) is a prospective single-arm multicenter trial of Aquablation in prostate volumes of 80-150ml. The number of passes was determined by the procedural data collected and the video recordings of all study cases. RESULTS: In total, 127 Aquablation subjects underwent a single pass, 90 underwent multiple passes (80 had 2passes and 10 underwent 3passes), and 65 underwent TURP (in WATER only). Men undergoing 2or more passes with Aquablation had larger prostates but few differences in other baseline parameters, including prostate size range. Compared to a single pass, the use of 2or more passes during Aquablation resulted in lower IPSS scores (by ∼4 points, P = .0002) and lower IPSS QoL scores (by ∼0.7 points, P = .0096) at the later timepoints of 24 and 36 months. Similarly, 36-month Qmax values were higher (by ∼5 ml/sec, P = .0220) in those with 2or more passes than in those with 1pass. There was no statistically significant difference in ejaculatory dysfunction between groups. CONCLUSION: Independent of prostate volume, a multiple treatment pass protocol led to improved voiding outcomes and IPSS improvement.

WATER vs WATER II 3-Year Update: Comparing Aquablation Therapy for Benign Prostatic Hyperplasia in 30-80 cc and 80-150 cc Prostates.

OBJECTIVE: To compare the outcomes of Aquablation for small-to-moderate (30-80cc) prostates with the outcomes for large (80-150 cc) prostates at 3-year follow up. METHODS: WATER is a prospective, double-blind, multicenter, international clinical trial comparing the safety and efficacy of Aquablation and TURP in the treatment of LUTS/BPH in men 45-80 year with a prostate of 30cc-80cc. WATER II is a prospective, multicenter, single-arm international clinical trial of Aquablation in men with a prostate of 80cc-150cc. We compare 36-mo outcomes amongst 116 WATER and 101 WATER II study subjects undergoing Aquablation. RESULTS: International Prostate Symptom Score (IPSS) scores improved from 22.9 and 23.2 at baseline in WATER and WATER II, respectively, to 8.0 and 6.5 at 36-month, with 36-mo reductions of 14.4 and 16.3 points, respectively (P = .247). At baseline, urinary flow rate (Qmax) was 9.4 and 8.7 cc/sec in WATER and WATER II, improving to 20.6 and 18.5 cc/sec, respectively (P = .552) at 36-mo. Improvements in both IPSS and Qmax were immediate and sustained throughout follow-up. At 3 year, 98% and 94% of treated patients were BPH medication-free in WATER and WATER II, respectively (P = .038). At 3yr, 96% and 97% of treated patients were free from surgical retreatment in WATER and WATER II, respectively (P = .613). CONCLUSIONS: Three-year follow-up demonstrates that Aquablation therapy leads to sustained outcomes, few irreversible complications, and low retreatment rates for the treatment of LUTS/BPH independently of prostate volume.

Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH.

INTRODUCTION: To determine if Aquablation therapy can maintain long term effectiveness in treating men with moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with a baseline prostate volume between 30 and 80 mL at 5 years compared to TURP. MATERIALS AND METHODS: In a double-blinded, multicenter prospective randomized controlled trial, 181 patients with moderate to severe LUTS secondary to BPH underwent TURP or Aquablation. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo persistent Grade 1 or Grade 2 or higher operative complications at 3 months. The assessments included IPSS, Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function (IIEF) and uroflow (Qmax). The patients were followed for 5 years. RESULTS: The primary safety endpoint was successfully achieved at 3 months where the Aquablation group had a lower event rate than TURP (26% vs. 42%, p = .0149 for superiority). Procedure-related ejaculatory dysfunction was lower for Aquablation (7% vs. 25%, p = .0004). The primary efficacy endpoint was successfully achieved at 6 months, where the mean IPSS decreased from baseline by 16.9 points for Aquablation and 15.1 points for TURP; the mean difference in change score at 6 months was 1.8 points larger for Aquablation (p < .0001 for non-inferiority, p = .1346 for superiority). At 5 years, IPSS scores improved by 15.1 points in the Aquablation group and 13.2 points in TURP (p = .2764). However, for men with larger prostates (≥ 50 mL), IPSS reduction was 3.5 points greater across all follow up visits in the Aquablation group compared to the TURP group (p = .0123). Improvement in peak urinary flow rate was 125% and 89% compared to baseline for Aquablation and TURP, respectively. The risk of patients needing a secondary BPH therapy, defined as needing BPH medication or surgical intervention, up to 5 years due to recurrent LUTS was 51% less in the Aquablation arm compared to the TURP arm. CONCLUSIONS: The improvement in net health outcomes from Aquablation therapy outweigh those offered by a TURP when considering the efficacy benefit along with the lower risk of needing a secondary BPH therapy and avoiding retrograde ejaculation. Following Aquablation therapy, symptom reduction and uroflow improvement at 5 years have shown to be durable and consistent across all years of follow up compared to TURP. Larger prostates (≥ 50 mL) demonstrated a larger safety and efficacy benefit for Aquablation over TURP.

Experiences of a "COVID protected" robotic surgical centre for colorectal and urological cancer in the COVID-19 pandemic.

The recent COVID-19 pandemic led to the cancellation of elective surgery across the United Kingdom. Re-establishing elective surgery in a manner that ensures patient and staff safety has been a priority. We report our experience and patient outcomes from setting up a "COVID protected" robotic unit for colorectal and renal surgery that housed both the da Vinci Si (Intuitive, Sunnyvale, CA, USA) and the Versius (CMR Surgical, Cambridge, UK) robotic systems. "COVID protected" robotic surgery was undertaken in a day-surgical unit attached to the main hospital. A standard operating procedure was developed in collaboration with the trust COVID-19 leadership team and adapted to national recommendations. 60 patients underwent elective robotic surgery in the initial 10-weeks of the study. This included 10 colorectal procedures and 50 urology procedures. Median length of stay was 4 days for rectal cancer procedures, 2 days less than prior to the COVID period, and 1 day for renal procedures. There were no instances of in-patient coronavirus transmission. Six rectal cancer patients waited more than 62 days for their surgery because of the initial COVID peak but none had an increase T-stage between pre-operative staging and post-operative histology. Robotic surgery can be undertaken in "COVID protected" units within acute hospitals in a safe way that mitigates the increased risk of undergoing major surgery in the current pandemic. Some benefits were seen such as reduced length of stay for colorectal patients that may be associated with having a dedicated unit for elective robotic surgical services.

Warm ischemia time length during on-clamp partial nephrectomy: does it really matter?

BACKGROUND: The impact of warm ischemia time (WIT) on renal functional recovery remains controversial. We examined the length of WIT>30 min on the long-term renal function following on-clamp partial nephrectomy (PN). METHODS: Data from 23 centers for patients undergoing on-clamp PN between 2000 and 2018 were analyzed. We included patients with two kidneys, single tumor, cT1, minimum 1-year follow-up, and preoperative eGFR≥60 mL/min/1.73m2. Patients were divided into two groups according to WIT length: group I "WIT≤30 min" and group II "WIT>30 min." A propensity-score matched analysis (1:1 match) was performed to eliminate potential confounding factors between groups. We compared eGFR values, eGFR (%) preservation, eGFR decline, events of chronic kidney disease (CKD) upgrading, and CKD-free progression rates between both groups. Cox regression analysis evaluated WIT impact on upgrading of CKD stages. RESULTS: The primary cohort consisted of 3526 patients: group I (N.=2868) and group II (N.=658). After matching the final cohort consisted of 344 patients in each group. At last follow-up, there were no significant differences in median eGFR values at 1, 3, 5, and 10 years (P>0.05) between the matched groups. In addition, the median eGFR (%) preservation and absolute eGFR change were similar (89% in group I vs. 87% in group II, P=0.638) and (-10 in group I vs. -11 in group II, P=0.577), respectively. The 5 years new-onset CKD-free progression rates were comparable in the non-matched groups (79% in group I vs. 81% in group II, log-rank, P=0.763) and the matched groups (78.8% in group I vs. 76.3% in group II, log-rank, P=0.905). Univariable Cox regression analysis showed that WIT>30 min was not a predictor of overall CKD upgrading (HR:0.953, 95%CI 0.829-1.094, P=0.764) nor upgrading into CKD stage ≥III (HR:0.972, 95%CI 0.805-1.173, P=0.764). Retrospective design is a limitation of our study. CONCLUSIONS: Our analysis based on a large multicenter international cohort study suggests that WIT length during PN has no effect on the long-term renal function outcomes in patients having two kidneys and preoperative eGFR≥60 mL/min/1.73m2.

Retroperitoneal Robotic-Assisted Laparoscopic Pyeloplasty: A 10 Year Experience in a Single Institution.

Introduction: Pelvi-ureteric junction (PUJ) obstruction was traditionally treated with open pyeloplasty. In recent decades, the development of minimally invasive techniques, including laparoscopic and later robotic surgery, has transformed treatment. The transperitoneal approach has most commonly been undertaken, with a few institutions reporting outcomes of the retroperitoneal approach. We report our 10-year experience of retroperitoneal robotic-assisted laparoscopic pyeloplasty (R-RALP). Methods: A prospective database of 160 patients undergoing RALP between February 2010 and November 2019 was analyzed. Data were recorded on demographics, operative details, complications, and success rate. Success was determined as symptomatic improvement and/or an unobstructed renogram. Results: One hundred fifty-two cases (95.0%) were performed by using a retroperitoneal approach, and 8 (5.0%) were performed by using a transperitoneal approach. Mean age was 45.3 ± 17.4 years. Mean operating time was 139.4 ± 45.6 minutes. A surgical drain was placed in 57 (71.3%) of the first 80 cases and 15 (18.8%) of the second 80 cases. Median hospital stay was one night (range 1-27). One case was converted to open pyeloplasty due to dense inflammatory tissue and one to robotic-assisted nephrectomy due to severe adhesions around the PUJ. There were no blood transfusions. There were six major (>grade 2 Clavien-Dindo) postoperative complications in four patients (2.5%). Two (1.3%) grade 3a complications, urine leak and pain after stent removal, required nephrostomy. There were three (1.9%) grade 3b complications: migrated stent requiring ureteroscopy, perirenal hematoma requiring open evacuation, and stent re-insertion. One (0.6%) grade 4 complication required ventilatory support on intensive care. Eighteen patients received follow-up at an alternative hospital, and 13 were lost to follow-up. Of the remaining cases, 94.5% were successful. Conclusions: R-RALP is a safe and effective treatment for PUJ obstruction allowing predictably rapid discharge from hospital without the need for a routine surgical drain. To our knowledge, our study represents the largest single institution experience on RALP using a retroperitoneal approach.

WATER versus WATER II 2-Year Update: Comparing Aquablation Therapy for Benign Prostatic Hyperplasia in 30-80-cm3 and 80-150-cm3 Prostates.

BACKGROUND: Surgical options are limited when treating large (>80 cm3) prostates for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Open simple prostatectomy remains the most common procedure performed for large prostates. There is a need for novel surgical approaches with shorter learning curves and effective treatment. Aquablation could be this novel tool. OBJECTIVE: To compare the outcome of Aquablation for 30-80-cm3 prostates with the outcome for 80-150-cm3 prostates at 2-yr follow-up. DESIGN SETTING AND PARTICIPANTS: We used data from two trials. WATER is a prospective, double-blind, multicenter, international clinical trial comparing the safety and efficacy of Aquablation and transurethral resection of the prostate in the treatment of LUTS/BPH in men aged 45-80 yr with a prostate of 30-80 cm3. WATER II is a prospective, multicenter, single-arm international clinical trial of Aquablation in men with a prostate of 80-150 cm3. INTERVENTION: Aquablation, an ultrasound-guided, robotically executed waterjet ablative procedure. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We compared 24-mo outcomes between 116 WATER and 101 WATER II study subjects. Student's t test or a Wilcoxon test was used to compare continuous variables and Fisher's test for categorical variables. RESULTS AND LIMITATIONS: The International Prostate Symptom Score (IPSS) reductions at 24 mo was 14.5 points for WATER and 17.4 points for WATER II (p = 0.31). At baseline, the maximum urinary flow rate (Qmax) was 9.4 and 8.7 cm3/s in WATER and WATER II, improving to 20.5 and 18.2 cm3/s, respectively (p = 0.60) at 24 mo. Improvements in both IPSS and Qmax were immediate and sustained throughout follow-up. At 2 yr, the surgical retreatment rate was 4% in WATER and 2% in WATER II. CONCLUSIONS: Aquablation is effective in patients with a prostate of 30-80 cm3 and patients with a prostate of 80-150 cm3 treated for LUTS/BPH, with comparable outcomes in both groups. It has low complication and retreatment rates at 2 yr of follow-up, with durable improvements in functional outcome. PATIENT SUMMARY: Outcomes of Aquablation for both small-to-moderately-sized and large prostates are similar and sustainable at 2 yr of follow-up.

Initial single centre experience of Aquablation of the prostate using the AquaBeam system with athermal haemostasis for the treatment of benign prostatic hyperplasia: 1-year outcomes.

PURPOSE: Aquablation using the AquaBeam system combines real-time image guidance and robotics to enable precise and heat-free removal of prostatic tissue with a high velocity water jet. The aim of this study is to report the outcomes of Aquablation up to 1 year in a single centre within the UK employing an athermal approach to haemostasis. METHODS: Fifty-five consecutive men underwent Aquablation between September 2017 and December 2018 (as part of OPEN WATER trial). Standard Aquablation was performed with the AquaBeam system (PROCEPT® BioRobotics) with 2 passes of Aquablation followed by bladder washout with application of continuous bladder irrigation via a catheter on a continuous traction device. Patients were followed up at 3 and 12 months. The data were prospectively collected on patient demographics, uroflowmetry, prostate volume, International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) and International Index of Erectile Function (IIEF-15). RESULTS: The mean age was 64.1 ± 7.9 years. Operating time was 26.9 ± 9.2 min. Mean prostate volume decreased from 58.2 ± 23.9 cc to 33.2 ± 12.9 cc (p < 0.0001). There were significant improvements at the 12 month follow-up in maximum urinary flow rate (9.9 ± 5.1 ml/s vs. 23.9 ± 11.6 ml/s), IPSS (21.7 ± 7.4 vs. 6.1 ± 4.2) and quality of life score (4.8 ± 1.1 vs. 1.4 ± 1.4) (p < 0.0001). There was no significant change in IIEF-15 and MSHQ-EjD scores. There were 8 (14.5%) Clavien grade 2 or higher complications. CONCLUSION: Our single centre experience suggests Aquablation using an entirely athermal approach is a safe cavitating procedure resulting in significant LUTS improvement comparable to standard cavitating procedures with greater preservation of sexual function.

Preclinical Evaluation of the Versius Surgical System, a New Robot-assisted Surgical Device for Use in Minimal Access Renal and Prostate Surgery.

BACKGROUND: Minimal access surgery (MAS) is well-established in urological surgery. However, MAS is technically demanding and associated with a prolonged learning curve. Robot-assisted laparoscopy has made progress in overcoming these challenges. OBJECTIVE: The aim of this study was to evaluate the feasibility of a new robot-assisted surgical system (the Versius Surgical System; CMR Surgical, Cambridge, UK) for renal and prostate procedures in a preclinical setting, at the IDEAL-D phase 0. DESIGN, SETTING, AND PARTICIPANTS: Cadaveric sessions were conducted to evaluate the ability of the system to complete all surgical steps required for a radical nephrectomy, prostatectomy, and pelvic lymph node dissection. A live animal (porcine) model was also used to assess the surgical device in performing radical nephrectomy safely and effectively. Procedures were performed by experienced renal and prostate surgeons, supported by a full operating room team. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Surgical access and reach were evaluated by the lead surgeon using a visual analogue scale. The precise surgical steps conducted to make the assessment that the procedures could be completed fully were recorded, as well as instruments used (including manual laparoscopic instruments) and endoscope angle. RESULTS AND LIMITATIONS: In total, all 24 procedures were completed successfully in cadavers by eight different lead surgeons. Positioning of the ports and bedside units reflected the lead surgeon's preferred laparoscopic set-up and enabled good surgical access and reach, as quantified by a median visual analogue score of ≥6.5. Radical nephrectomies performed in pigs were all completed successfully, with no device- or non-device-related intraoperative complications recorded. Testing in human cadavers and pig models balances the bias introduced by each model; however, it is impossible to completely replicate the experience and performance of the robot for surgery in live humans. CONCLUSIONS: This is the first preclinical assessment of the Versius Surgical System for renal and prostate procedures. The safety and effectiveness of the system have been demonstrated and warrant progressive assessment in a clinical setting utilising the IDEAL-D framework. PATIENT SUMMARY: In this report, we looked at the usability of a new robot-assisted surgical device for renal and prostate surgery by testing the system in cadavers and pigs. We found that a number of different surgeons and operating team personnel were able to use the system to successfully complete the procedures under evaluation. We conclude that the system is ready to be tested in live human studies.

Meta-analysis with individual data of functional outcomes following Aquablation for lower urinary tract symptoms due to BPH in various prostate anatomies.

OBJECTIVES: To evaluate functional outcomes following Aquablation in various prostate volume and anatomical subgroups. DESIGN: A meta-analysis with individual patient data undergoing Aquablation therapy from four prospective, global, clinical studies that have been conducted with Aquablation; WATER, WATER II, FRANCAIS WATER and OPEN WATER. SETTING: Australia, Canada, Lebanon, Germany, New Zealand, UK and the USA. PARTICIPANTS: 425 men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with 1-year follow-up. INTERVENTIONS: Aquablation therapy is an ultrasound guided, robotically executed waterjet ablative procedure for the prostate. MAIN OUTCOME MEASURES: The analyses focus International Prostate Symptom Score (IPSS), uroflowmetry, postoperative Incontinence Severity Index (ISI) and surgical retreatment. RESULTS: 425 men with prostates ranging in size from 20 to 150 mL underwent Aquablation therapy. The outcomes from the seven questions in the IPSS questionnaire were grouped by the following; prostates <100 mL, prostates ≥100 mL, prostate anatomy with an obstructive median lobe identifed by imaging, and prostate anatomy without an obstructive median lobe. Regardless of subgroup, all outcomes are consistent and demonstrate a significant improvement from baseline. Specifically, improvements in frequency, urgency and nocturia demonstrated bladder function improvement. Patients entering treatment with severe incontinence, ISI score >4, and regardless of prostate size, showed a reduction in incontinence during patient follow-up. Surgical retreatment due to BPH symptoms occurred in 0.7% (95% CI 0.1%-2.0%). CONCLUSIONS: Across a variety of prostate anatomies, Aquablation therapy showed remarkable functional improvements following the index procedure. Additionally, men with moderate to severe LUTS/BPH and overactive bladder resulting in urge incontinence showed a reduction in incontinence symptoms postprocedure.

Nephrometry scores: a validation of three systems for peri-operative outcomes in retroperitoneal robot-assisted partial nephrectomy.

OBJECTIVE: To externally validate the RENAL, PADUA and SPARE nephrometry scoring systems for use in retroperitoneal robot-assisted partial nephrectomy (RAPN). MATERIALS AND METHODS: Nephrometry scores were calculated for 322 consecutive patients receiving retroperitoneal RAPN at a tertiary referral centre from 2017. Patients with multiple tumours were excluded. Scores were correlated with peri-operative outcomes, including the trifecta (warm ischaemia time <25 min, no peri-operative complications and a negative surgical margin), both as continuous and categorical variables. Comparisons were performed using Spearman correlation and ability to predict the trifecta was assessed using binomial logistical regression. RESULTS: All three scoring systems correlated significantly with the main variables (operating time, warm ischaemia time and estimated blood loss), both as continuous and categorical variables. Only PADUA and SPARE were able to predict achievement of the trifecta (PADUA area under the curve [AUC] 0.623, 95% confidence interval [CI] 0.559-0.668; SPARE AUC 0.612, 95% CI 0.548-0.677). CONCLUSION: This study validates the RENAL, PADUA and SPARE scoring systems to predict key intra-operative outcomes in retroperitoneal RAPN. Only PADUA and SPARE were able to predict achievement of the trifecta. As a simplified version of the PADUA scoring system with comparable outcomes, we recommend using the SPARE system.

A Simple Clinical Tool for Stratifying Risk of Clinically Significant CKD after Nephrectomy: Development and Multinational Validation.

BACKGROUND: Clinically significant CKD following surgery for kidney cancer is associated with increased morbidity and mortality, but identifying patients at increased CKD risk remains difficult. Simple methods to stratify risk of clinically significant CKD after nephrectomy are needed. METHODS: To develop a tool for stratifying patients' risk of CKD arising after surgery for kidney cancer, we tested models in a population-based cohort of 699 patients with kidney cancer in Queensland, Australia (2012-2013). We validated these models in a population-based cohort of 423 patients from Victoria, Australia, and in patient cohorts from single centers in Queensland, Scotland, and England. Eligible patients had two functioning kidneys and a preoperative eGFR ≥60 ml/min per 1.73 m2. The main outcome was incident eGFR <45 ml/min per 1.73 m2 at 12 months postnephrectomy. We used prespecified predictors-age ≥65 years old, diabetes mellitus, preoperative eGFR, and nephrectomy type (partial/radical)-to fit logistic regression models and grouped patients according to degree of risk of clinically significant CKD (negligible, low, moderate, or high risk). RESULTS: Absolute risks of stage 3b or higher CKD were <2%, 3% to 14%, 21% to 26%, and 46% to 69% across the four strata of negligible, low, moderate, and high risk, respectively. The negative predictive value of the negligible risk category was 98.9% for clinically significant CKD. The c statistic for this score ranged from 0.84 to 0.88 across derivation and validation cohorts. CONCLUSIONS: Our simple scoring system can reproducibly stratify postnephrectomy CKD risk on the basis of readily available parameters. This clinical tool's quantitative assessment of CKD risk may be weighed against other considerations when planning management of kidney tumors and help inform shared decision making between clinicians and patients.