Robot-assisted radical prostatectomy (RARP) is one of the treatment options for localised clinically significant prostate cancer [1]. However, postoperative urinary incontinence (UI) affects 4–31% of patients 12 months after surgery and is associated with a reduced quality of life [2]. Several surgical strategies have been described to reduce the incidence of UI, including anterior and posterior reconstruction [3], dorsal venous complex and preperitoneal space sparing (PSS) [4], but no consensus exists on the best method to achieve early return of continence. Bladder neck preservation (BNP) aims to safeguard the internal sphincter (lisso-sphincter), believed to support passive continence, which was recently supported by a systematic review [5]. This effect could be amplified by increasing the length of the spared intraprostatic urethra to achieve coaptation when intra-abdominal pressure increases [6] (Fig. 1). In fact, a urethral sparing method was described by Tongco et al. [7] in open RPs but was never widely adopted. The advantages of robotic surgery allow for improved anatomical dissection, to go beyond the standard BNP and dissect the intraprostatic urethra away from the prostatic tissue in a reproducible way. In this paper, we describe the steps and anatomical landmarks to perform the complete urethral preservation (CUP) technique. Our objective was to evaluate the rate of immediate continence recovery (ICR), and present oncological outcomes in a cohort of patients with a minimum 1-year follow-up (Video 1). We retrospectively collected data for patients with prostate cancer who underwent RARP with CUP at University College London Hospitals, from June 2021 to August 2022. Surgeries were performed by a single high-volume urological surgeon (G.S.), and by trainees under supervision, using the da Vinci X/Xi® platform (Intuitive Surgical Inc., Sunnyvale, CA, USA). A successful CUP was defined as the incision of the urethra at the proximal end of the verumontanum with direct end-to-end anastomosis to the membranous urethra. Continence outcomes were collected during clinical follow-up. ICR was defined as the absence of leakage and the use of zero pads immediately after urethral catheter removal. Biochemical recurrence (BCR) was defined as a PSA level of 0.2 ng/mL at any point after RARP. All data were collected by a dedicated database manager as part of the prospective audit within the quality assurance programme, additional data specific for this project were collected retrospectively by T.A.H., R.A., G.S., L.T. and O.A. Descriptive statistical analysis was performed using R version 4.3.2 (R Foundation for Statistical Computing, Vienna, Austria). Trocar placement is standard for anterior RARP [8]. After developing the Retzius space, removal of pre-prostatic fat to expose the puboprostatic ligaments, the bladder is retracted cranially and posteriorly using a ProGrasp® instrument (Intuitive Surgical Inc.). An incision is made in the bladder muscular fibres with monopolar scissors proximal to the edge of the puboprostatic ligaments (Fig. 2A). By changing the tension of bladder retraction posteriorly, dissection proceeds along the avascular plane of the lateral vesico-prostatic junction, where the plane resembles the 'spine of an open book' (Fig. 2B). Once the vertical fibres of the urethra are identified, perform blunt dissection along the lateral edges using the active opening of the fenestrated bipolar (FB) forceps (Fig. 2C). Correct alignment is indicated by finding the white avascular plane. The FB forceps can be used to lift the prostate away from the urethra, exposing its anterior surface at the most distal point achievable (Fig. 2D). The urethra appears thin and changes trajectory near the level of the verumontanum. The anterior urethra is incised horizontally at the most distal point. If needed, the catheter can be used for anterior retraction with the ProGrasp to expose the verumontanum. Otherwise, exert cranial retraction of the bladder and incise the lateral and posterior sides of the urethra. Then divide the posterior urethra while avoiding the tendency to cut proximally, which can create a deficient posterior urethral cuff. Careful 'hot' dissection with monopolar scissors is employed to separate the remaining attachments. Once free, the posterior lip of the urethra is grasped with the FB forceps and gentle cranial retraction is applied. Monopolar electrocautery helps separate the posterior urethra off the prostate, dividing the ejaculatory ducts. If a median lobe is present, this can be carefully dissected off of the urethral stump at this stage. To avoid tearing the urethral stump during retraction, advancement of one jaw of the FB forceps as far as possible across the posterior wall of the urethral stump is effective. The lateral fat pads between the bladder and prostate serve as helpful landmarks. The detrusor slips are then incised until the two vasa are visualised running in the midline. Occasional inadvertent buttonholing around the bladder neck or splits to the urethral cuff can be repaired with 3/0 absorbable sutures. The rest of the RARP is completed, including neurovascular bundles and anterior tissue-sparing techniques. The anastomosis of the urethral ends is performed using 3/0 barbed sutures circumferentially and crossing anteriorly with eight to 10 throws. A single knot is used to snug down the anastomosis. A RARP with CUP was performed in 97 patients. Pre- and postoperative key patient characteristics are shown in Table 1. Continence outcomes at different visits are shown in Fig. 3. Detailed numbers and percentages can be found in Table S1. All complications were classified as Clavien–Dindo Grade I–II as shown in Table S2. This cohort of patients who underwent RARP with the CUP technique have a high proportion of both ICR and complete continence at 12 months, despite using a strict continence definition. This proportion of ICR is similar to rates (45–69%) previously described with PSS prostatectomy [6]. The CUP technique involves a relatively easy technical modification rather than a major change in approach for those who favour the anterior approach. Previous descriptions of urethral preservation employed a retrograde approach starting from the membranous urethra at the apex [9]. However, the maximum length of preservable urethra is limited by the natural distal insertion of the ejaculatory ducts at the verumontanum, as shown in Fig. 1A. In our study, the rate of positive margins, particularly basal prostatic margins, and BCR are comparable to our current practice and published meta-analysis [10]. Reassuringly no urethral strictures/contractures and only one case of urinary retention was observed. The learning curve for mastering the technique seems feasible. Approximately 10 supervised cases were adequate for our trainees to perform CUP independently. While these initial results are encouraging, we recognise the need for prospective randomised comparative studies to understand the impact of CUP on continence outcomes. Additionally, it is important to formally evaluate the learning curve to achieve consistent CUP quality. This technique is not without limitations; we avoid performing CUP in salvage RARP and in patients with a history of BOO surgery, where the bladder neck is deficient. In cases with anterior basal prostate tumours, an oblique approach to the anterior urethra leaves a detrusor cuff and reduces the risk of basal PSM, as described in PSS surgery [11]. In rare cases where MRI locates peri-urethral tumours, or bladder neck invasion is suspected, we do not perform CUP. The CUP technique is a reproducible method to achieve early continence recovery. In this case series, we observed a high rate of ICR, without compromising complications or oncological safety. Future research with randomised cohorts would be essential for validating these encouraging findings. Authors declare they have no conflict of interest. Table S1 Number of UI pads reported by patients at each postoperative visit. Table S2 Description of complications reported during follow-up according to the Clavien–Dindo classification. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

Intraoperative frozen section (IFS) is used with the intention to improve functional and oncological outcomes for patients undergoing radical prostatectomy (RP). High resource requirements of IFS techniques such as NeuroSAFE may preclude widespread adoption, even if there are benefits to patients. Recent advances in fresh-tissue microscopic digital imaging technologies may offer an attractive alternative, and there is a growing body of evidence regarding these technologies. In this narrative review, we discuss some of the familiar limitations of IFS and compare these to the attractive counterpoints of modern digital imaging technologies such as the speed and ease of image generation, the locality of equipment within (or near) the operating room, the ability to maintain tissue integrity, and digital transfer of images. Confocal laser microscopy (CLM) is the modality most frequently reported in the literature for margin assessment during RP. We discuss several imitations and obstacles to widespread dissemination of digital imaging technologies. Among these, we consider how the 'en-face' margin perspective will challenge urologists and pathologists to understand afresh the meaning of positive margin significance. As a part of this, discussions on how to describe, categorize, react to, and evaluate these technologies are needed to improve patient outcomes. Limitations of this review include its narrative structure and that the evidence base in this field is relatively immature but developing at pace.

In January 2020, NHS England and NHS Improvement, in the United Kingdom, issued a permissive framework for streamlining cancer multidisciplinary (MDT) meetings. Streamlining is defined as a process whereby complex cases are prioritized for full discussion by an MDT in an MDT meeting (MDM), while the management of straightforward cases is expedited using Standards of Care (SoC). SoC are points in the pathway of patient management where there are recognized guidelines and clear clinical consensus on the options for management and should be regionally agreed and uniformly applied by regional Cancer Alliances. While this report marks the first major change in cancer MDT management since the Calman-Hine report in 1995, its implementation, nationally, has been slow with now nearly four years since its publication. It is argued however that streamlining is a necessary step in ensuring the viability of MDT processes, and therefore maintaining patient care in the current socioeconomic context of rising workload and cancer incidence, financial pressures, and workforce shortages. In this mini review, we offer a succinct summary of the recent developments around the implementation of the 2020 streamlining framework, including challenges and barriers to its implementation, and the potential future directions in this field, which we propose should increase utilisation of implementation science. We conclude that ensuring successful implementation of the framework and the SOC requires securing a buy-in from key stakeholders, including MDTs and hospital management teams, with clearly defined (a) management approaches that include triage (e.g. through a mini MDT meeting), (b) assessment of case complexity (something that directly feeds into the SOC), and (c) roles of the MDT lead and the members, while acknowledging that the SOC cannot be universally applied without the consideration of individual variations across teams and hospital Trusts.

INTRODUCTION AND OBJECTIVES:Fluorescence confocal microscopy (FCM) is a new imaging modality capable of generating digital microscopic resolution scans of fresh surgical specimens, and holds potential as an alternative to frozen section (FS) analysis for intra-operative assessment of surgical margins. Previously, we described the LaserSAFE technique as an application of FCM for margin assessment in robot-assisted radical prostatectomy (RARP) using the Histolog® scanner. This study describes the accuracy and inter-rater agreement of FCM imaging compared to corresponding paraffin-embedded analysis (PA) among four blinded pathologists for the presence of positive surgical margins (PSM). MATERIALS AND METHODS:RARP specimens from patients enrolled in the control arm of the NeuroSAFE PROOF study (NCT03317990) were analysed from April 2022 to February 2023. Prostate specimens were imaged using the Histolog® scanner before formalin fixation and PA. Four trained assessors, blinded to PA, reviewed and analysed FCM images of the posterolateral prostatic surface. RESULTS:A total of 31 prostate specimens were included in the study. PA per lateral side of the prostate identified 11 instances of positive margins. Among the four histopathologists included in our study, FCM achieved a sensitivity of 73-91 and specificity of 94-100% for the presence of PSM. Fleiss' Kappa for inter-rater agreement on PSM was 0.78 (95% confidence interval = 0.64-0.92), indicating substantial agreement. CONCLUSION:This blinded analysis of FCM versus PA among histopathologists with different experience levels demonstrated high accuracy and substantial inter-rater agreement for diagnosing PSM. This supports the role of the FCM as an alternative to FS.

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Purpose Accurate prediction of extraprostatic extension (EPE) is pivotal for surgical planning. Herein, we aimed to provide an updated model for predicting EPE among patients diagnosed with MRI-targeted biopsy. Materials and methods We analyzed a multi-institutional dataset of men with clinically localized prostate cancer diagnosed by MRI-targeted biopsy and subsequently underwent prostatectomy. To develop a side-specific predictive model, we considered the prostatic lobes separately. A multivariable logistic regression analysis was fitted to predict side-specific EPE. The decision curve analysis was used to evaluate the net clinical benefit. Finally, a regression tree was employed to identify three risk categories to assist urologists in selecting candidates for nerve-sparing, incremental nerve sparing and non-nerve-sparing surgery. Results Overall, data from 3169 hemi-prostates were considered, after the exclusion of prostatic lobes with no biopsy-documented tumor. EPE was present on final pathology in 1,094 (34%) cases. Among these, MRI was able to predict EPE correctly in 568 (52%) cases. A model including PSA, maximum diameter of the index lesion, presence of EPE on MRI, highest ISUP grade in the ipsilateral hemi-prostate, and percentage of positive cores in the ipsilateral hemi-prostate achieved an AUC of 81% after internal validation. Overall, 566, 577, and 2,026 observations fell in the low-, intermediate- and high-risk groups for EPE, as identified by the regression tree. The EPE rate across the groups was: 5.1%, 14.9%, and 48% for the low-, intermediate- and high-risk group, respectively. Conclusion In this study we present an update of the first side-specific MRI-based nomogram for the prediction of extraprostatic extension together with updated risk categories to help clinicians in deciding on the best approach to nerve-preservation.

Background Treatment decisions in prostate cancer (PCa) rely on disease stratification between localised and metastatic stages, but current imaging staging technologies are not sensitive to micro-metastatic disease. Circulating tumour cells (CTCs) status is a promising tool in this regard. The Parsortix® CTC isolation system employs an epitope-independent approach based on cell size and deformability to increase the capture rate of CTCs. Here, we present a protocol for prospective evaluation of this method to predict post radical prostatectomy (RP) PCa cancer recurrence. Methods We plan to recruit 294 patients diagnosed with unfavourable intermediate, to high and very high-risk localised PCa. Exclusion criteria include synchronous cancer diagnosis or prior PCa treatment, including hormone therapy. RP is performed according to the standard of care. Two blood samples (20 ml) are collected before and again 3-months after RP. The clinical team are blinded to CTC results and the laboratory researchers are blinded to clinical information. Treatment failure is defined as a PSA ≥ 0.2 mg/ml, start of salvage treatment or imaging-proven metastatic lesions. The CTC analysis entails enumeration and RNA analysis of gene expression in captured CTCs. The primary outcome is the accuracy of CTC status to predict post-RP treatment failure at 4.5 years. Observed sensitivity, positive and negative predictive values will be reported. Specificity will be presented over time. Discussion CTC status may reflect the true potential for PCa metastasis and may predict clinical outcomes better than the current PCa progression risk grading systems. Therefore establishing a robust biomarker for predicting treatment failure in localized high-risk PCa would significantly enhance guidance in treatment decision-making, optimizing cure rates while minimizing unnecessary harm from overtreatment. Trial registration ISRCTN17332543.

A 61-year-old male patient was referred to the urology department of the University College London Hospitals (London, UK) in June, 2022, after experiencing left testicular and hip pain. Prior to the referral, his local general practitioner had prescribed antibiotics for suspected epididymo-orchitis. His symptoms improved and the patient was reassured. 1 month later, his pain relapsed and hip osteoarthritis was suspected. X-ray examinations were unremarkable, but upon further evaluation, a pelvic MRI demonstrated a prostatic tumour with apparent rectal wall invasion (figure, A). The patient's prostate-specific antigen (PSA) level at the time was 0·32 ng/mL (normal range: PSA <0·4 ng/mL).

Fluorescence confocal microscopy (FCM) is a novel technology that enables rapid high-resolution digital imaging of non-formalin-fixed tissue specimens and offers real-time positive surgical margin identification. In this systematic review, we evaluated the accuracy metrics of ex vivo FCM for intraoperative margin assessment of different tumor types. A systematic search of MEDLINE via PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus was performed for relevant papers (PROSPERO ID: CRD42022372558). We included 14 studies evaluating four types of microscopes in six different tumor types, including breast, prostate, central nervous system, kidney, bladder, and conjunctival tumors. Using the Quality Assessment of Diagnostic Accuracy Studies tool, we identified a high risk of bias in patient selection (21%) and index test (36%) of the included studies. Overall, we found that FCM has good accuracy metrics in all tumor types, with high sensitivity and specificity (>80%) and almost perfect concordance (>90%) against final pathology results. Despite these promising findings, the quality of the available evidence and bias concerns highlight the need for adequately designed studies to further define the role of ex vivo FCM in replacing the frozen section as the tool of choice for intraoperative margin assessment.

You have accessJournal of UrologyCME1 Apr 2023PD36-12 MEASURING OBJECTIVE RECOVERY OF ACTIVITY LEVELS USING WEARABLE DEVICES FOLLOWING OPEN VS INTRACORPOREAL ROBOTIC CYSTECTOMY: SECONDARY OUTCOMES ANALYSIS OF THE IROC RANDOMIZED TRIAL Pramit Khetrapal, James Catto, Gareth Ambler, Norman Williams, Tarek Al-Hammouri, Muhammad Shamim Khan, Ramesh Thurairaja, Rajesh Nair, Senthil Nathan, Ashwin Sridhar, Imran Ahmad, Philip Charlesworth, Christopher Blick, Marcus Cumberbatch, Syed Hussain, Sanjeev Kotwal, Anthony Koupparis, John Mcgrath, Aidan Noon, Edward Rowe, Nikhil Vasdev, Parasdeep Bains, Vishwanath Hanchanale, and John Kelly Pramit KhetrapalPramit Khetrapal More articles by this author , James CattoJames Catto More articles by this author , Gareth AmblerGareth Ambler More articles by this author , Norman WilliamsNorman Williams More articles by this author , Tarek Al-HammouriTarek Al-Hammouri More articles by this author , Muhammad Shamim KhanMuhammad Shamim Khan More articles by this author , Ramesh ThurairajaRamesh Thurairaja More articles by this author , Rajesh NairRajesh Nair More articles by this author , Senthil NathanSenthil Nathan More articles by this author , Ashwin SridharAshwin Sridhar More articles by this author , Imran AhmadImran Ahmad More articles by this author , Philip CharlesworthPhilip Charlesworth More articles by this author , Christopher BlickChristopher Blick More articles by this author , Marcus CumberbatchMarcus Cumberbatch More articles by this author , Syed HussainSyed Hussain More articles by this author , Sanjeev KotwalSanjeev Kotwal More articles by this author , Anthony KoupparisAnthony Koupparis More articles by this author , John McgrathJohn Mcgrath More articles by this author , Aidan NoonAidan Noon More articles by this author , Edward RoweEdward Rowe More articles by this author , Nikhil VasdevNikhil Vasdev More articles by this author , Parasdeep BainsParasdeep Bains More articles by this author , Vishwanath HanchanaleVishwanath Hanchanale More articles by this author , and John KellyJohn Kelly More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003334.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Radical cystectomy is associated with significant morbidity and extended recovery time. No previous randomized trials have used objective measures such as fitness trackers to measure recovery in mobility. In this study, we compare recovery of mobility in open and intracorporeal robotic cystectomy in the randomised setting of the iROC trial. METHODS: The iROC randomized trial (ClinicalTrials.gov Identifier: NCT03049410) compared recovery following iRARC vs ORC for bladder cancer. Physical activity levels were measured by collecting mean and maximum number of steps taken per day over a 7-day period using Misfit Shine (Fossil Group Inc.) and number of chair-to-stands (CTS) in 30 seconds at baseline, as well as 5 days, 5 weeks and 12 weeks post-operatively. Complications in the post-operative period were measured using the Clavien-Dindo (CD) classification at 30 days (early) and 90 days (late). RESULTS: Among 260 patients who provided wearable device data, there was no difference in average (iRARC 6430 (SD 3189) vs ORC 6550 (SD 2864)) or maximum (iRARC 9659 (SD 5238) vs ORC 9525 (SD 4039)) step-counts at baseline. There was no significant difference in absolute step-counts between iRARC and ORC at any of the post-operative timepoints. However, there was a significant difference in recovery of average steps (iRARC 34.7% vs ORC 24.6%, p=0.042) but not maximum steps favoring iRARC at the 5-day timepoint when compared to baseline, no difference was noted in other timepoints. Recovery of CTS was significantly different at 5 weeks (iRARC 84.6% vs ORC 74.0%, p=0.013) favoring iRARC, but not at 5 days or 12 weeks post-operatively. Early and late major complications (CD≥3) were associated with a delayed recovery of maximum steps at 5 weeks (p=0.014) and 12 weeks (p=0.019) respectively, with no difference in average step-counts. CONCLUSIONS: Wearable devices offer a new way to measure post-operative recovery. In the randomized setting, iRARC was associated with faster recovery of mobility in the early post-operative period (5 days post-operatively), but this effect was not sustained into the 5th week post-operatively. However, recovery in CTS counts were significantly different at 5 weeks and may be more useful in capturing differences in the later peri-operative period. Major complications were associated with a delayed recovery in step-counts. Source of Funding: The Urology Foundation and the Champniss Foundation © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e985 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Pramit Khetrapal More articles by this author James Catto More articles by this author Gareth Ambler More articles by this author Norman Williams More articles by this author Tarek Al-Hammouri More articles by this author Muhammad Shamim Khan More articles by this author Ramesh Thurairaja More articles by this author Rajesh Nair More articles by this author Senthil Nathan More articles by this author Ashwin Sridhar More articles by this author Imran Ahmad More articles by this author Philip Charlesworth More articles by this author Christopher Blick More articles by this author Marcus Cumberbatch More articles by this author Syed Hussain More articles by this author Sanjeev Kotwal More articles by this author Anthony Koupparis More articles by this author John Mcgrath More articles by this author Aidan Noon More articles by this author Edward Rowe More articles by this author Nikhil Vasdev More articles by this author Parasdeep Bains More articles by this author Vishwanath Hanchanale More articles by this author John Kelly More articles by this author Expand All Advertisement PDF downloadLoading ...

Background:The COVID-19 pandemic has posed daunting challenges for the conduction of clinical research. Adopting new technologies such as remote electronic consent (e-Consent) can help overcome them. However, guidelines for e-Consent implementation in ongoing clinical trials are currently lacking. The NeuroSAFE PROOF trial is a randomised clinical trial evaluating the role of frozen section analysis during RARP for prostate cancer. In response to the COVID-19 crisis, recruitment was halted, and a remote e-Consent solution was designed. The aim of this paper is to describe the process of implementation, impact on recruitment rate and patients’ experience using e-Consent.Methods:A substantial amendment of the protocol granted the creation of a remote e-Consent framework based on the REDCap environment, following the structure and content of the already approved paper consent form. A new pathway was developed which offered continuous support to patients through remote consultations. The whole process was judged to be compliant with regulatory requirements before implementation.Results:Before the first recruitment suspension, NeuroSAFE PROOF was recruiting an average of 9 patients per month. After e-Consent implementation, 63 new patients (4/month) have been enrolled despite a second lockdown, none of whom would have been recruited using the old methods given restrictions on face-to-face consultations. Patients have given positive feedback on the use of the platform. Limited troubleshooting has been required after implementation.Conclusion:Remote e-Consent based recruitment was critical for the continuation of the NeuroSAFE PROOF trial during the COVID-19 pandemic. The described pathway complies with ethical and regulatory guidelines for informed consent, while minimizing face-to-face interactions that increase the risk of COVID-19 transmission. This guide will help researchers integrate e-Consent to ongoing or planned clinical trials while uncertainty about the course of the pandemic continues.Trial registration: The NeuroSAFE PROOF trial has the registration number NCT03317990 (23 October 2017). Regional Ethics Committee; reference 17/LO/1978