Ten-year functional and oncological outcomes of a prospective randomized controlled trial comparing laparoscopic versus robot-assisted radical prostatectomy.

BACKGROUND: Among prostate cancer (PCa) treatment options, mini-invasive surgical approaches have gained a wide diffusion in the last decades. The aim of this study was to present oncological, functional, and quality of life data after 10 years of follow-up of a prospective randomized controlled trial (RCT) (ISRCTN11552140) comparing robot-assisted radical prostatectomy (RARP) versus laparoscopic radical prostatectomy (LRP) for the treatment of PCa. METHODS: Patients with localized PCa were randomized to undergo LRP or RARP between January 2010 and January 2011. Functional (continence and potency) and oncological (prostate-specific antigen, biochemical recurrence [BCR] and BCR-free survival [BCRFS]) variables were evaluated. BCRFS curves were estimated by the Kaplan-Meier method and compared using the log-rank test. Machine learning partial least square-discriminant analysis (PLS-DA) was used to identify the variables characterizing more the patients who underwent RARP or LRP. RESULTS: Seventy-five of the originally enrolled 120 patients remained on follow-up for 10 years; 40 (53%) underwent RARP and 35 (47%) LRP. Continence and potency recovery rates did not show significant differences (p = 0.068 and p = 0.56, respectively), despite a Δ12% for continence and Δ8% for potency in favor of the robotic approach. However, the quality of continence (in terms of International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF] score) and erection (in terms of International Index of Erectile Function-5 [IIEF-5] score) was significantly better after 10 years in the robotic group (p = 0.02 and p < 0.001). PLS-DA revealed that LRP was characterized by the worst functional-related outcomes analyzing the entire follow-up period. Four (10%) and six (17%) patients experienced BCR in RARP and LRP groups, respectively (p = 0.36), with an overall 10-year BCR-free survival of 88% and 78% (p = 0.16). CONCLUSIONS: Comparable continence and potency rates were observed between RARP and LRP after a 10-year follow-up. However, the RARP group exhibited superior totally dry rate and erection quality. No difference in terms of oncological outcomes was found.

Visual extended reality tools in image-guided surgery in urology: a systematic review.

PURPOSE: The aim of this systematic review is to assess the clinical implications of employing various Extended Reality (XR) tools for image guidance in urological surgery. METHODS: In June 2023, a systematic electronic literature search was conducted using the Medline database (via PubMed), Embase (via Ovid), Scopus, and Web of Science. The search strategy was designed based on the PICO (Patients, Intervention, Comparison, Outcome) criteria. Study protocol was registered on PROSPERO (registry number CRD42023449025). We incorporated retrospective and prospective comparative studies, along with single-arm studies, which provided information on the use of XR, Mixed Reality (MR), Augmented Reality (AR), and Virtual Reality (VR) in urological surgical procedures. Studies that were not written in English, non-original investigations, and those involving experimental research on animals or cadavers were excluded from our analysis. The quality assessment of comparative and cohort studies was conducted utilizing the Newcastle-Ottawa scale, whilst for randomized controlled trials (RCTs), the Jadad scale was adopted. The level of evidence for each study was determined based on the guidelines provided by the Oxford Centre for Evidence-Based Medicine. RESULTS: The initial electronic search yielded 1,803 papers after removing duplicates. Among these, 58 publications underwent a comprehensive review, leading to the inclusion of 40 studies that met the specified criteria for analysis. 11, 20 and 9 studies tested XR on prostate cancer, kidney cancer and miscellaneous, including bladder cancer and lithiasis surgeries, respectively. Focusing on the different technologies 20, 15 and 5 explored the potential of VR, AR and MR. The majority of the included studies (i.e., 22) were prospective non-randomized, whilst 7 and 11 were RCT and retrospective studies respectively. The included studies that revealed how these new tools can be useful both in preoperative and intraoperative setting for a tailored surgical approach. CONCLUSIONS: AR, VR and MR techniques have emerged as highly effective new tools for image-guided surgery, especially for urologic oncology. Nevertheless, the complete clinical advantages of these innovations are still in the process of evaluation.

Health Information Technology Usability Evaluation Scale (Health-ITUES) and User-Experience Questionnaire (UEQ) for 3D Intraoperative Cognitive Navigation (ICON3DTM) System for Urological Procedures.

Backgound and objectives: In recent years, the adoption of 3D models for surgical planning and intraoperative guidance has gained a wide diffusion. The aim of this study was to evaluate the surgeons' perception and usability of ICON3DTM platform for robotic and laparoscopic urological surgical procedures. Materials and Methods: During the 10th edition of the Techno-Urology Meeting, surgeons and attendees had the opportunity to test the new ICON3DTM platform. The capability of the user to manipulate the model with hands/mouse, the software usability, the quality of the 3D model's reproduction, and the quality of its use during the surgery were evaluated with the Health Information Technology Usability Evaluation Scale (Health-ITUES) and the User-Experience Questionnaire (UEQ). Results: Fifty-three participants responded to the questionnaires. Based on the answers to the Health-ITUES questionnaire, ICON3DTM resulted to have a positive additional value in presurgical/surgical planning with 43.4% and 39.6% of responders that rated 4 (agree) and 5 (strongly agree), respectively. Regarding the UEQ questionnaire, both mouse and infrared hand-tracking system resulted to be easy to use for 99% of the responders, while the software resulted to be easy to use for 93.4% of the responders. Conclusions: In conclusion, ICON3DTM has been widely appreciated by urologists thanks to its various applications, from preoperative planning to its support for intraoperative decision-making in both robot-assisted and laparoscopic settings.

The impact of 3D models on positive surgical margins after robot-assisted radical prostatectomy.

PURPOSE: To evaluate the role of 3D models on positive surgical margin rate (PSM) rate in patients who underwent robot-assisted radical prostatectomy (RARP) compared to a no-3D control group. Secondarily, we evaluated the postoperative functional and oncological outcomes. METHODS: Prospective study enrolling patients with localized prostate cancer (PCa) undergoing RARP with mp-MRI-based 3D model reconstruction, displayed in a cognitive or augmented-reality fashion, at our Centre from 01/2016 to 01/2020. A control no-3D group was extracted from the last two years of our Institutional RARP database. PSMr between the two groups was evaluated and multivariable linear regression (MLR) models were applied. Finally, Kaplan-Meier estimator was used to calculate biochemical recurrence at 12 months after the intervention. RESULTS: 160 patients were enrolled in the 3D Group, while 640 were selected for the Control Group. A more conservative NS approach was registered in the 3D Group (full NS 20.6% vs 12.7%; intermediate NS 38.1% vs 38.0%; standard NS 41.2% vs 49.2%; p = 0.02). 3D Group patients had lower PSM rates (25 vs. 35.1%, p = 0.01). At MLR models, the availability of 3D technology (p = 0.005) and the absence of extracapsular extension (ECE, p = 0.004) at mp-MRI were independent predictors of lower PSMr. Moreover, 3D model represented a significant protective factor for PSM in patients with ECE or pT3 disease. CONCLUSION: The availability of 3D models during the intervention allows to modulate the NS approach, limiting the occurrence of PSM, especially in patients with ECE at mp-MRI or pT3 PCa.

Implementing telemedicine for the management of benign urologic conditions: a single centre experience in Italy.

PURPOSE: To assess the use of telemedicine with phone-call visits as a practical tool to follow-up with patients affected by urological benign diseases, whose clinic visits had been cancelled during the acute phase of the COVID-19 pandemic. METHODS: Patients were contacted via phone-call and a specific questionnaire was administered to evaluate the health status of these patients and to identify those who needed an "in-person" ambulatory visit due to the worsening of their condition. Secondarily, the patients' perception of a potential shift towards a "telemedicine" approach to the management of their condition and to indirectly evaluate their desire to return to "in-person" clinic visits. RESULTS: 607 were contacted by phone-call. 87.5% (531/607) of the cases showed stability of the symptoms so no clinic in-person or emergency visits were needed. 81.5% (495/607) of patients were more concerned about the risk of contagion than their urological condition. The median score for phone visit comprehensibility and ease of communication of exams was 5/5; whilst patients' perception of phone visits' usefulness was scored 4/5. 53% (322/607) of the interviewees didn't own the basic supports required to be able to perform a real telemedicine consult according to the required standards. CONCLUSION: Telemedicine approach limits the number of unnecessary accesses to medical facilities and represents an important tool for the limitation of the risk of transmission of infectious diseases, such as COVID-19. However, infrastructures, health workers and patients should reach out to a computerization process to allow a wider diffusion of more advanced forms of telemedicine, such as televisit.

Single-port robot-assisted radical prostatectomy: a systematic review and pooled analysis of the preliminary experiences.

OBJECTIVE: To summarize the clinical experiences with single-port (SP) robot-assisted radical prostatectomy (RARP) reported in the literature and to describe the peri-operative and short-term outcomes of this procedure. MATERIAL AND METHODS: A systematic review of the literature was performed in December 2019 using Medline (via PubMed), Embase (via Ovid), Cochrane databases, Scopus and Web of Science (PROSPERO registry number 164129). All studies that reported intra- and peri-operative data on SP-RARP were included. Cadaveric series and perineal or partial prostatectomy series were excluded. RESULTS: The pooled mean operating time, estimated blood loss, length of hospital stay and catheterization time were 190.55 min, 198.4 mL, 1.86 days and 8.21 days, respectively. The pooled mean number of lymph nodes removed was 8.33, and the pooled rate of positive surgical margins was 33%. The pooled minor complication rate was 15%. Only one urinary leakage and one major complication (transient ischaemic attack) were recorded. Regarding functional outcomes, pooled continence and potency rates at 12 weeks were 55% and 42%, respectively. CONCLUSIONS: The present analysis confirms that SP-RARP is safe and feasible. This novel robotic platform resulted in similar intra-operative and peri-operative outcomes to those obtained with the standard multiport da Vinci system. The advantages of single incision can be translated into a preservation of the patient's body image and self-esteem and cosmesis, which have a great impact on a patient's quality of life.

First- and Second-Generation Temporary Implantable Nitinol Devices As Minimally Invasive Treatments for BPH-Related LUTS: Systematic Review of the Literature.

INTRODUCTION: In the last decade, there has been a growing interest in minimally invasive treatment for benign prostatic hyperplasia (BPH) associated with lower urinary tract symptoms (LUTS). In this field, one of the options currently available is the temporary implantable nitinol device (iTIND) (Medi-Tate®; Medi-Tate Ltd., Or Akiva, Israel). PURPOSE OF THE WORK: To review the recent data available in the literature regarding the role of the first-generation (TIND) and second-generation (iTIND) devices for the management of BPH with LUTS, especially focusing on follow-up of functional outcomes. EVIDENCE ACQUISITION: PubMed, Embase, and the Cochrane Central Register of Controlled Trials were screened for clinical trials on this topic. EVIDENCE SYNTHESIS: Literature evidences regarding implantation of TIND and iTIND for PBH with LUTS are limited. There are only three studies available, one with a medium-term follow-up. The results of these studies suggested that both the TIND and iTIND implantations are safe, effective, and well-tolerated procedures, allowing spare ejaculation in sexually active patients. CONCLUSIONS: Current evidences emphasize that the temporary implantable nitinol devices are promising alternatives to the standard minimally invasive surgical options for BPH-related LUTS. Further studies are needed to confirm the effectiveness over a long-term follow-up.

Robotic Vena Cava Thrombectomy with Three-dimensional Augmented Reality Guidance.

Robotic surgery has recently been used for treatment of renal cell carcinoma (RCC) and neoplastic thrombus located in the renal vein or inferior vena cava (IVC). Accurate identification of the thrombus location is crucial, and three-dimensional augmented reality (3D AR) may be valuable in achieving this. We enrolled patients with nonmetastatic RCC and level 0-I venous thrombus (Mayo Clinic classification) for robot-assisted radical nephrectomy and thrombectomy with 3D AR guidance. Five patients were prospectively enrolled; three had a level 0 thrombus and two had a level I thrombus. The mean operative time was 123 ± 15 min, mean IVC clamping time was 9.4 ± 6.8 min, and mean estimated blood loss was 750 ± 150 ml. The AR system allowed precise estimation of the thrombus location in all cases. No intraoperative complications or postoperative Clavien-Dindo grade >2 complications occurred. Use of 3D AR guidance allowed correct estimation of the limits of the thrombus and guided the surgeon in selecting an appropriate surgical strategy.

3D virtual models and augmented reality for radical prostatectomy: a narrative review.

BACKGROUND AND OBJECTIVE: The increasing popularity of three-dimensional (3D) virtual reconstructions of two-dimensional (2D) imaging in urology has led to significant technological advancements, resulting in the creation of highly accurate 3D virtual models (3DVMs) that faithfully replicate individual anatomical details. This technology enhances surgical reality, providing surgeons with hyper-accurate insights into instantaneous subjective surgical anatomy and improving preoperative surgical planning. In the uro-oncologic field, the utility of 3D virtual reconstruction has been demonstrated in nephron-sparing surgery, impacting surgical strategy and postoperative outcomes in prostate cancer (PCa). The aim of this study is to offer a thorough narrative review of the current state and application of 3D reconstructions and augmented reality (AR) in radical prostatectomy (RP). METHODS: A non-systematic literature review was conducted using Medline, PubMed, the Cochrane Database, and Embase to gather information on clinical trials, randomized controlled trials, review articles, and prospective and retrospective studies related to 3DVMs and AR in RP. The search strategy followed the PICOS (Patients, Intervention, Comparison, Outcome, Study design) criteria and was performed in January 2024. KEY CONTENT AND FINDINGS: The adoption of 3D visualization has become widespread, with applications ranging from preoperative planning to intraoperative consultations. The urological community's interest in intraoperative surgical navigation using cognitive, virtual, mixed, and AR during RP is evident in a substantial body of literature, including 16 noteworthy investigations. These studies highlight the varied experiences and benefits of incorporating 3D reconstructions and AR into RP, showcasing improvements in preoperative planning, intraoperative navigation, and real-time decision-making. CONCLUSIONS: The integration of 3DVMs and AR technologies in urological oncology, particularly in the context of RP, has shown promising advancements. These technologies provide crucial support in preoperative planning, intraoperative navigation, and real-time decision-making, significantly improving the visualization of complex anatomical structures helping in the nerve sparing (NS) approach modulation and reducing positive surgical margin (PSM) rate. Despite positive outcomes, challenges such as small patient cohorts, lack of standardized methodologies, and concerns about costs and technology adoption persist.

Automatic 3D Augmented-Reality Robot-Assisted Partial Nephrectomy Using Machine Learning: Our Pioneer Experience.

The aim of "Precision Surgery" is to reduce the impact of surgeries on patients' global health. In this context, over the last years, the use of three-dimensional virtual models (3DVMs) of organs has allowed for intraoperative guidance, showing hidden anatomical targets, thus limiting healthy-tissue dissections and subsequent damage during an operation. In order to provide an automatic 3DVM overlapping in the surgical field, we developed and tested a new software, called "ikidney", based on convolutional neural networks (CNNs). From January 2022 to April 2023, patients affected by organ-confined renal masses amenable to RAPN were enrolled. A bioengineer, a software developer, and a surgeon collaborated to create hyper-accurate 3D models for automatic 3D AR-guided RAPN, using CNNs. For each patient, demographic and clinical data were collected. A total of 13 patients were included in the present study. The average anchoring time was 11 (6-13) s. Unintended 3D-model automatic co-registration temporary failures happened in a static setting in one patient, while this happened in one patient in a dynamic setting. There was one failure; in this single case, an ultrasound drop-in probe was used to detect the neoplasm, and the surgery was performed under ultrasound guidance instead of AR guidance. No major intraoperative nor postoperative complications (i.e., Clavien Dindo > 2) were recorded. The employment of AI has unveiled several new scenarios in clinical practice, thanks to its ability to perform specific tasks autonomously. We employed CNNs for an automatic 3DVM overlapping during RAPN, thus improving the accuracy of the superimposition process.