Paul Anderson

Objective: To develop and evaluate a 4‐week robotic surgery curriculum for penultimate‐year medical students. Design: A prospective mixed‐methods evaluation was conducted during the first year of implementation (2024). The curriculum, designed using Kern's six‐step framework, integrated asynchronous learning, simulator training, technical workshops and human factors simulation. Students were assessed using structured rubrics, including the Global Evaluative Assessment of Robotic Skills (GEARS) performed on the ImraSurgical Roboset Hydroskin™, a checklist for open access (Hasson technique) performed on the ImraSurgical Hydrogel Abdominal Wall Model™ and a structured assessment tool for non‐technical skills evaluating communication, leadership and situational awareness. Pre‐ and post‐course surveys evaluated learner perceptions and self‐reported knowledge (Kirkpatrick Levels 1–2). Setting: This study was conducted at the International Medical Robotics Academy (IMRA), a dedicated surgical simulation and robotics training centre in Melbourne, Australia, in collaboration with the University of Melbourne Medical School. The curriculum was delivered as an elective Discovery subject within the Doctor of Medicine programme. Thirty‐five penultimate‐year medical students enrolled in the subject during the 2024 academic year. Results: At baseline, all respondents reported limited or no prior knowledge of robotic surgery and felt unprepared to care for patients undergoing robotic procedures. The programme was delivered with high fidelity. Mean GEARS score was 21.9 (SD 3.4). Mean non‐technical skills score was 3.83/5 (SD 0.7) and mean open access score was 3.85/5. Group presentations achieved a pooled mean of 4.83/5. Post‐course, all respondents reported increased knowledge and 80% felt better prepared for future clinical roles. Hands‐on simulation was rated the most valuable component. Conclusions: A structured, competency‐aligned robotic surgery curriculum for medical students is feasible and associated with positive educational outcomes. Early integration of robotic literacy, simulation and human factors training may better prepare future clinicians for technology‐enabled surgical practice. Further study should examine long‐term impact and clinical transfer.

Benign Prostatic Hyperplasia (BPH) affects more than half of men over age 50, yet current treatment options are limited to medications that cause bothersome side effects or surgical procedures, including minimally invasive surgical therapies (MIST) that involve piercing, cutting, or burning tissue, often leading to discomfort and recovery concerns. The Zenflow Spring System® provides a tissue-preserving alternative that offers symptom relief with quicker recovery and less procedural discomfort. Three single-arm, multicenter, prospective pilot studies with similar trial designs were conducted from 2018-2021 across four countries and data were combined to evaluate the feasibility, safety, and effectiveness of the Spring System in relieving symptoms of obstructive BPH. Men ≥ 45 years with moderate-to-severe symptoms (International Prostate Symptom Score (IPSS ) >13), peak urinary flow rate (QMax) between 5 and 15 mL/s, prostate volume between 25 and 80 cc, prostatic urethral length between 25 and 45 mm, and voided volume of at least ≥ 125 mL were enrolled. The primary endpoint was symptom improvement 3 months post-procedure, measured by change in IPSS. Secondary endpoints included IPSS-QoL, and functional improvement measured by Qmax. Follow-up visits occurred through 24 months. Successful implantation of the Spring Implant was achieved in all 72 study participants, with no perioperative serious adverse events. At 3 months, mean change from baseline was -10.71 (95% CI: -12.90, -8.51, p < 0.001) for IPSS, -2.1 (95% CI: -2.61, -1.58, p < 0.001) for IPSS-QoL, and 2.86 (95% CI: 1.68, 4.04, p < 0.001) for Qmax, corresponding to 49%, 47%, and 27% improvements, respectively. These improvements were sustained through 24 months, with 48%, 55%, and 32% improvement relative to baseline in IPSS, IPSS-QoL, and Qmax, respectively. At 24-months, treatment with the Spring System resulted in immediate, significant, and durable improvements compared with baseline, supporting its role as a minimally invasive, tissue-preserving treatment option for men with lower urinary tract symptoms secondary to BPH. NCT03595735, NCT03577236, NCT04309695.

Objective: This study aims to compare the long‐term outcomes of Aquablation for small‐to‐moderate (30–80 cm³) prostates with the outcomes for large (80–150 cm³) prostates at 5‐year follow up.Methods: The Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER; NCT02505919) is a prospective, double‐blind, international clinical trial encompassing 116 patients, examining Aquablation versus transurethral resection of the prostate (TURP) for LUTS/BPH in prostates sized between 30 and 80 cm³. In parallel, WATER II (W‐II; NCT03123250), a prospective, multicentre, single‐arm international clinical trial, explores Aquablation outcomes in prostates ranging from 80 to 150 cm³. Baseline parameters and 60‐month outcomes were scrutinized using statistical analyses, including Students' t test, Wilcoxon tests for continuous variables, and Fisher's test for binary variables.Results: There is a significant improvement in International Prostate Symptom Score (IPSS) from baseline to 60 months in both WATER (22.9 to 7.0) and WATER II (23.2 to 6.8) (P = 0.852). Urinary flow rate (Qmax) increased in both groups from baseline to 60 months (WATER: 9.4 to 17.3 cc/s; WATER II: 8.7 to 17.1 cc/s) (P = 0.933). Immediate and sustained enhancements were observed in IPSS and Qmax. At 5 years, a notable percentage of patients in both groups were BPH medication‐free (WATER: 99%; WATER II: 94%) (P = 0.0517) and free from surgical retreatment (WATER: 95%; WATER II: 97%) (P = 0.508).Conclusions: The 5‐year follow‐up affirms that Aquablation therapy exhibits sustained outcomes, minimal irreversible complications, and low retreatment rates for treating LUTS/BPH, irrespective of prostate volume ranging from 30 to 150 cm³.

IntroductionCG0070 is a serotype 5 adenovirus engineered to express GM-CSF and replicate in cells with mutated or deficient RB, with response rates (RR) of approximately 45% observed in patients with recurrent NMIBC after BCG (J Urol. 2012;188:2391-7; Urol Oncol. 2018;36(10):440-7). This single arm phase 3 study (NCT04452591) was launched to confirm the clinical activity of CG0070 in patients with BCG Unresponsive NMIBC.Methods110 patients with BCG-unresponsive CIS with or without concurrent Ta or T1 disease will be treated with intravesical (IVe) CG0070 at a dose of 1x10¹² vp. CG0070 will be administered as follows: induction weekly x 6 followed by weekly x 3 maintenance instillations at months 3, 6, 9, 12, and 18. Patients with persistent CIS or HG Ta at 3 months (m) may receive re-induction with weekly x 6 CG0070. Assessment of response will include q 3 m cystoscopy with biopsy of areas suspicious for disease, urine cytology, CTU/MRU, and mandatory bladder mapping at 12 m. Detection of high grade disease within the bladder will be enumerated as recurrence or non-response.ResultsThe primary endpoint of the study is CR at any time on study as assessed by biopsy (directed to cystoscopic abnormalities and mandatory mapping at 12 m), urine cytology, and radiography, as above. Secondary endpoints include CR at 12 m, duration of response, progression free survival, cystectomy free survival and safety. Correlative assessments include changes in the tumor immune microenvironment, systemic immune induction as reflected in the peripheral blood and urine, as well as viral replication and transgene expression. Baseline expression of coxsackie adenovirus receptor, E2F transcription factor as well as anti-adenovirus antibody titer will be correlated with tumor response.ConclusionThe study an ongoing trial, currently enrolling in the United States, Japan, South Korea, Australia, and Taiwan.Refs. Burke JM, Lamm DL, Meng MV, Nemunaitis JJ, Stephenson JJ, Arseneau JC, Aimi J, Lerner S, Yeung AW, Kazarian T, Maslyar DJ, McKiernan JM. A first in human phase 1 study of CG0070, a GM-CSF expressing oncolytic adenovirus, for the treatment of nonmuscle invasive bladder cancer. Citation Format: Ed Uchio, Donald Lamm, Neil Shore, Trinity Bivalacqua, Ashish Kamat, Mark Tyson, Paul Anderson, Paola Grandi, James Burke. A phase 3, single-arm study of CG0070 in subjects with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr CT233.

Transperineal biopsy is becoming more commonly used, driven by improved detection rates, better complication profile and increasing application of prostate MRI leading to guided biopsy. However, it can still lead to complications such as urinary retention, postoperative pain and erectile dysfunction. There is also a potential for adverse events such as severe infection, abscess and fistula. This article describes a case of an intrascrotal abscess post-transperineal biopsy, which required an orchidectomy.

Background Sexual dysfunction following stroke is common but often is poorly managed. As awareness of sexual dysfunction following stroke increases as an important issue, a clearer evidence base for interventions for sexual dysfunction is needed to optimise management. Objectives To evaluate the effectiveness of interventions to reduce sexual dysfunction following stroke, and to assess adverse events associated with interventions for sexual dysfunction following stroke. Search methods We conducted the search on 27 November 2019. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; from June 2014), in the Cochrane Library; MEDLINE (from 1950); Embase (from 1980); the Cumulative Index to Nursing and Allied Health Literature (CINAHL; from 1982); the Allied and Complementary Medicine Database (AMED; from 1985); PsycINFO (from 1806); the Physiotherapy Evidence Database (PEDro; from 1999); and 10 additional bibliographic databases and ongoing trial registers. Selection criteria We included randomised controlled trials (RCTs) that compared pharmacological treatments, mechanical devices, or complementary medicine interventions versus placebo. We also included other non‐pharmacological interventions (such as education or therapy), which were compared against usual care or different forms of intervention (such as different intensities) for treating sexual dysfunction in stroke survivors. Data collection and analysis Two review authors independently selected eligible studies, extracted data, and assessed study quality. We determined the risk of bias for each study and performed a 'best evidence' synthesis using the GRADE approach. Main results We identified three RCTs with a total of 212 participants. We noted significant heterogeneity in interventions (one pharmacological, one physiotherapy‐based, and one psycho‐educational), and all RCTs were small and of 'low' or 'very low' quality. Based on these RCTs, data are insufficient to provide any reliable indication of benefit or risk to guide clinical practice in terms of the use of sertraline, specific pelvic floor muscle training, or individualised sexual rehabilitation. Authors' conclusions Use of sertraline to treat premature ejaculation needs to be tested in further RCTs. The lack of benefit with structured sexual rehabilitation and pelvic floor physiotherapy should not be interpreted as proof of ineffectiveness. Well‐designed, randomised, double‐blinded, placebo‐controlled trials of long‐term duration are needed to determine the effectiveness of various types of interventions for sexual dysfunction. It should be noted, however, that it may not be possible to double‐blind trials of complex interventions.

Waterjet-based prostate resection (Aquablation procedure) is an increasingly recognized treatment for symptomatic benign prostatic hyperplasia (BPH). We confirmed the safety and effectiveness of the Aquablation procedure in the commercial setting in 178 men at five sites. The mean prostate volume was 59 cc. The procedure time averaged 24 min and total anesthesia duration was 50 min. The International Prostate Symptom Score (IPSS) decreased from 21.6 at the baseline to 6.5 at the 12-month follow-up, a 15.3-point improvement (p < 0.0001). The maximum urinary flow rate increased from 10 cc/s at the baseline to 20.8 cc/s at month 12 (increase of 11.8 cc, p < 0.0001). Ejaculatory function was relatively preserved. Prostate volume assessed with transrectal ultrasound decreased 36% by month three. Five patients (2.7%) underwent a transfusion in the first week after the procedure. Real-world evidence shows that Aquablation is safe and effective for the treatment of BPH.

Objective: To determine if athermal methods are as effective in preventing blood transfusions as the use of cautery across various prostate volumes following prostate tissue resection for benign prostatic hyperplasia using Aquablation. Patients and methods: The current commercial AQUABEAM robot that performs Aquablation therapy was first used in 2014. Since then numerous clinical studies have been conducted in various countries; Australia, Canada, Germany, India, Lebanon, Spain, New Zealand, United Kingdom, and the United States. All of the clinical trial data since 2014 were pooled with the early commercial procedures from France, Germany, and Spain to determine the effectiveness of haemostatic techniques in reducing the transfusion rate in patients after Aquablation. Results: In all, 801 patients were treated with Aquablation therapy from 2014 to early 2019. The mean (SD, range) prostate volume was 67 (33, 20–280) mL and 31 (3.9%) transfusions were reported. The largest contributing factor to transfusion risk was prostate size and method of traction. There was an increasing risk of transfusions in larger prostates when robust traction using a catheter‐tensioning device (CTD) without cautery was used, ranging from 0.8% to 7.8% in prostates ranging from 20 to 280 mL. However, when standard traction (taping the catheter to the leg, gauze knot synched up to the meatus, or no traction at all) was used and where the surgeon performed bladder neck cautery only when necessary, the risk of transfusion was 1.4–2.5% in prostates ranging from 20 to 280 mL. Conclusions: While the athermal subgroup with robust traction with a CTD had comparable transfusion rates for smaller prostates, the risk increased significantly as prostate volume increased. With standard traction methods and selective bladder neck cautery, the risk of transfusion was reduced to 1.9% across all prostate sizes.