Trends and incidence of reported events associated with ureteral stents: an analysis of the food and drug administration's manufacturer and user facility device experience (MAUDE) database.

PURPOSE: Aim of this study is to summarize medical device reports (MDRs) between 2012 and 2022 relating to ureteral stents within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). METHODS: MAUDE was analyzed for all MDRs relating to each FDA-approved ureteral stent. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific ureteral stent and reported events as detailed by the MDRs. Data is presented as number of specific event/total events. Pooled Relative risk was used to compare data. RESULTS: 2652 reports were retrieved in 10 years and a progressive rise in reported events was recorded. 831/2652 (31%) were reported as injury while 1810/2652 (68%) as malfunction of the ureteral stent and 4 events of death. The most frequently reported adverse events (AEs) were stent break (627/2652: 23%); material problems (384/2652: 14%); calcification (222/2652: 8%); difficulty to insert, advance or remove the device (155/2652: 6%). Bard stents were associated with most material problems (19%), Resonance stents were associated with most difficulty to insert, advance or remove the device (9%) and calcification (15%) while filiform double pigtail stent set were associated with most breakage reports (56%) when compared to the other stents (PRR > 1, p < 0,05). CONCLUSIONS: According to MAUDE database the most frequent complications related to ureteral stents are breakage, material problems, calcification and difficulty to insert/advance/remove the device. As well Resonance ureteral stents seem to be associated with a higher risk of device problems.

Open versus Minimally Invasive Partial Nephrectomy: Trends and Outcomes from a Wide National Population-Based Database.

Objectives: To investigate temporal trends and overall complication rates among open partial nephrectomy (OPN) and minimally invasive partial nephrectomy (MIPN), including the impact of social determinants of health (SDOH) on postoperative outcomes. Methods: Patients who underwent OPN or MIPN between 2011 and 2021 were retrospectively analyzed by using PearlDiver-Mariner, an all-payer insurance claims database. The International Classification of Diseases diagnosis and procedure codes were used to identify the type of surgical operation, patient's characteristics (age, sex, region, insurance plan), postoperative complications and SDOH, categorized in education, healthcare, environmental, social, and economic domains. Outcomes were compared using multivariable regression models. Results: Overall, 65,325 patients underwent OPN (n = 23,377) or MIPN (n = 41,948). OPN adoption declined over the study period, whereas that of MIPN increased from 24% to 34% (p = 0.001). The 60-day postoperative complication rate was 15% for the open and 9% for the minimally invasive approach. Approximately 16% and 11% of patients reported at least one SDOH at baseline for OPN and MIPN, respectively. SDOH were associated with higher odds of postoperative complications (OPN = OR: 1.11, 95% CI: 1.01-1.25; MIPN = OR: 1.31, 95% CI: 1.18-1.46). The open approach showed a significantly higher risk of postoperative complications (OR: 1.62, 95% CI: 1.54-1.70) compared to the minimally invasive one. Conclusions: Our findings confirm that MIPN is gradually replacing OPN, which carries a higher risk of complications. SDOH are significant predictors of postoperative complications following PN, regardless of the approach.

Postoperative urinary incontinence following BPH surgery: insights from a comprehensive national database analysis.

BACKGROUND: Postoperative urinary incontinence (UI) is a feared complication of BPH surgery. Our study aims to investigate the incidence of UI among patients undergoing different procedures for BPH. METHODS: A retrospective analysis was conducted using a large national database, containing patient records between 2011 and 2022. The most employed surgical procedures for BPH were considered, including TURP, Transurethral Incision of the Prostate (TUIP), Holmium/Thulium Laser Enucleation of the Prostate (HoLEP/ThuLEP), Open Simple Prostatectomy (OSP), minimally invasive simple prostatectomy (Lap/Rob SP), Photoselective Vaporization of the Prostate (PVP), Prostatic Urethral Lift (PUL), Robotic Waterjet Treatment (RWT - Aquablation®), Water Vapor Thermal Therapy (WVTT - Rezum®) and Prostatic Artery Embolization (PAE). Rates of any type of UI, including stress UI (SUI), urge UI (UUI) and mixed UI (MUI) were assessed. Multivariate regression analysis was used to identify predictors of "persistent" postoperative UI, defined as the presence of an active UI diagnosis at 12 months post-surgery. RESULTS: Among 274,808 patients who underwent BPH surgery, 11,017 (4.01%) experienced persistent UI. UUI rates varied between 0.62% (PAE) and 2.71% (PVP), SUI ranged from 0.04% (PAE) and 2.75% (Lap/Rob SP), while MUI between 0.11% (PAE) and 1.17% (HoLEP/ThuLEP). On multivariable analysis, HoLEP/ThuLEP (OR 1.612; 95% CI: 1.508-1.721; P<0.001), PVP (OR 1.164; 95% CI:1.122-1.208; P<0.001), Open SP (OR 1.424; 95% CI:1.241- 1.624; P<0.001), and Lap/Rob SP (OR 1.667; 95% CI:1.119-2.384; P<0.01) showed significant higher likelihood of UI compared to TURP. PUL (OR 0.604; 95% CI:0.566-0.644; P<0.001), WVTT (OR 0.661; 95% CI:0.579-0.752; P<0.001), RWT (OR 0.434; 95% CI:0.216-0.767; P<0.01), and PAE (OR 0.178; 95% CI:0.111-0.269; P<0.001) were associated with lower likelihood of UI. CONCLUSIONS: UI remains a concerning complication following BPH surgery, but it is an uncommon event affecting <5% of patients. Some differences in UI rates and risk might exist among various BPH procedures. These findings underscore the need for thorough patient selection and counseling.

Organized prostate cancer screening program: a proposal from the Italian Society of Urology (SIU).

To contrast opportunistic PCa screening, the European Union Council suggested extending screening programs to PCa by recommending the implementation of a stepwise approach in the EU Countries to evaluate the feasibility and effectiveness of an organized program based on PSA testing in combination with additional MRI as a follow-up test. The objective of this expert-based document is to propose an organized PCa screening program according to the EU Council recommendations. The Italian Society of Urology (SIU) developed a team of experts with the aim to report 1) the most recent epidemiologic data about incidence, prevalence, and mortality of PCa; 2) the most important risk factors to identify categories of men with an increased risk to eventually develop the disease; 3) the most relevant studies presenting data on population-based screening; and 4) the current recommendations of the leading International Guidelines. According to previous evidence, the Panel proposed some indications to develop a new organized PCa screening program for asymptomatic men with a life-expectancy of at least fifteen years. The SIU Panel strongly supports the implementation of a pilot, organized PCa screening program inviting asymptomatic men in the age range of 50-55 years. Invited men who are already performing opportunistic screening will be randomized to continue opportunistic screening or to cross into the organized protocol. Men with PSA level ≤3 ng/mL and familiarity for PCa received a DRE as well as all those with PSA levels >3 ng/mL. All other men with PSA levels greater than 3 ng/mL proceed to secondary testing represented by mpMRI. Men with Prostate Imaging-Reporting and Data System (PI-RADS) lesions 3 and PSAD 0.15 ng/mL/cc or higher as well as those with PI-RADS 4-5 lesions proceed to targeted plus systematic prostate biopsy. The primary outcome of the proposed pilot PCa screening program will be the detection rate of clinically significant PCa defined as a tumor with a ISUP Grade Group ≥2. Main secondary outcomes will be the detection rate of aggressive PCa (ISUP Grade Group ≥4); the detection rate of insignificant PCa (ISUP Grade Group 1); the number of unnecessary prostate biopsy avoided, the metastasis-free survival, and the overall survival. Men will be invited over a one-year period. Preliminary analyses will be planned 2 and 5 years after the baseline enrollment. According to the recent EU Council recommendations on cancer screening, pilot studies evaluating the feasibility and effectiveness of PCa screening programs using PSA as the primary and mpMRI as the secondary screening test in selected cohorts of patients must be strongly promoted by scientific societies and supported by national governments.

Prostate cancer diagnostic pathway in men with lower urinary tract symptoms or performing opportunistic screening: The Italian Society of Urology (SIU) position paper.

BACKGROUND: Voluntary PCa screening frequently results in excessive use of unnecessary diagnostic tests and an increasing risk of detection of indolent PCa and unaffordable costs for the various national health systems. In this scenario, the Italian Society of Urology (Società Italiana di Urologia, SIU) proposes an organized flow chart guiding physicians to improve early diagnosis of significant PCa avoiding unnecessary diagnostic tests and prostate biopsy. METHODS: According to available evidence and international guidelines [i.e., European Association of Urology (EAU), American Association of Urology (AUA) and National Comprehensive Cancer Network (NCCN)] on PCa, a Panel of expert urologists selected by Italian Society of Urology (SIU, Società Italiana di Urologia) proposed some indications to develop a stepwise diagnostic pathway based on the diagnostic tests mainly used in the clinical practice. The final document was submitted to six expert urologists for external revision and approval. Moreover, the final document was shared with patient advocacy groups. RESULTS: In voluntary men and symptomatic patients with elevated PSA value (>3 ng/mL), the Panel strongly discourage the use of antibiotic agents in absence of urinary tract infection confirmed by urine culture. DRE remains a key part of the urologic physical examination helping urologists to correctly interpret PSA elevation and prioritizing the execution of multiparametric Magnetic Resonance Imaging (mpMRI) in presence of suspicious PCa. Men with negative mpMRI and low clinical suspicion of PSA (PSA density < 0.20 ng/mL/cc, negative DRE findings, no family history) can be further monitored. Men with negative mpMRI and a higher risk of PCa (familial history, suspicious DRE, PSAD>0.20 ng/mL/cc or PSA>20 ng/mL) should be considered for systematic prostate biopsy. While PI-RADS 4-5 lesions represent a strong indication for prostate biopsy, PI-RADS 3 lesions should be further stratified according to PSAD values and prostate biopsy performed when PSAD is higher than 0.20. Accreditation, certification, and quality audits of radiologists and centers performing prostatic mpMRI should be strongly considered. The accessibility and/or the waiting list for MRI examinations should be also evaluated in the diagnostic pathway. The panel suggests performing transperineal or transrectal targeted plus systematic biopsies as standard of care. CONCLUSIONS: Scientific societies must support the use of shared diagnostic pathway with the aim to increase the early detection of significant PCa reducing a delayed diagnosis of advanced PCa. Moreover, a shared diagnostic pathway can reduce the incorrect use of antibiotic, the number of unnecessary laboratory and radiologic examinations as well as of prostate biopsies.

Biopsy strategies in the era of mpMRI: a comprehensive review.

BACKGROUND: Since its initial description the prostate biopsy technique for detection of prostate cancer (PCA) has constantly evolved. Multiparametric magnetic resonance imaging (mpMRI) has been proven to have a sensitivity exceeding 90% to detect the index lesion. This narrative review discusses the evidence around several biopsy strategies, especially in the context of patients that might be eligible for focal therapy. METHOD: A non-systematic literature research was performed on February 15th 2024 using the Medical Literature Analysis and Retrieval System Online (Medline), Web of Science and Google Scholar. RESULTS: The transrectal (TR) route is associated with an increased postoperative sepsis rate, even with adequate antibiotic prophylaxis. The transperineal (TP) route is now recommended by international guidelines, firstly for its decreased rate of urosepsis. Recent evidence shows a non-inferiority of TP compared to TR route, and even a higher detection rate of clinically significant PCA (csPCA) in the anterior and apical region, that are usually difficult to target using the TR route. Several targeting techniques (cognitive, software-fusion or in-bore) enhance our ability to provide an accurate risk assessment of prostate cancer aggressiveness and burden, while reducing the number of cores and reducing the number of clinically insignificant prostate cancer (ciPCA). While MRI-TB have proven their role, the role of systematic biopsies (SB) is still important because it detects 5-16% of csPCA that would have been missed by MRI-TB alone. The strategies of SB depend mainly on the route used (TR vs. TP) and the number of cores to be collected (10-12 cores vs. saturation biopsies vs. trans-perineal template mapping-biopsies or Ginsburg Protocol vs. regional biopsies). CONCLUSION: Several biopsy strategies have been described and should be known when assessing patients for focal therapy. Because MRI systematically under evaluates the lesion size, systematic biopsies, and especially perilesional biopsies, can help to increase sensitivity at the cost of an increased number of cores.

Neurovascular structure-adjacent frozen-section examination (NeuroSAFE) during robot-assisted radical prostatectomy: a systematic review and meta-analysis of comparative studies.

BACKGROUND: To compare surgical, pathological, and functional outcomes of patients undergoing NeuroSAFE-guided RARP vs. RARP alone. METHODS: In February 2024, a literature search and assessment was conducted through PubMed®, Scopus®, and Web of Science™, to retrieve data of men with PCa (P) undergoing RARP with NeuroSAFE (I) versus RARP without NeuroSAFE (C) to evaluate surgical, pathological, oncological, and functional outcomes (O), across retrospective and/or prospective comparative studies (Studies). Surgical (operative time [OT], number of nerve-sparing [NS] RARP, number of secondary resections after NeuroSAFE), pathological (PSM), oncological (biochemical recurrence [BCR]), and functional (postoperative continence and sexual function recovery) outcomes were analyzed, using weighted mean difference (WMD) for continuous variables and odd ratio (OR) for dichotomous variables. RESULTS: Overall, seven studies met the inclusion criteria (one randomized clinical trial, one prospective non-randomized trial and five retrospective studies) and were eligible for SR and MA. A total of 4,207 patients were included in the MA, with 2247 patients (53%) undergoing RARP with the addition of NeuroSAFE, and 1 960 (47%) receiving RARP alone. The addition of NeuroSAFE enhanced the likelihood of receiving a nerve-sparing (NS) RARP (OR 5.49, 95% CI 2.48-12.12, I2 = 72%). In the NeuroSAFE cohort, a statistically significant reduction in the likelihood of PSM at final pathology (OR 0.55, 95% CI 0.39-0.79, I2 = 73%) was observed. Similarly, a reduced likelihood of BCR favoring the NeuroSAFE was obtained (OR 0.47, 95% CI 0.35-0.62, I2 = 0%). At 12-month postoperatively, NeuroSAFE led to a significantly higher likelihood of being pad-free (OR 2.01, 95% CI 1.25-3.25, I2 = 0%), and of erectile function recovery (OR 3.50, 95% CI 2.34-5.23, I2 = 0%). CONCLUSION: Available evidence suggests that NeuroSAFE might represent a histologically based approach to NVB preservation, broadening the indications of NS RARP, reducing the likelihood of PSM and subsequent BCR. In addition, it might translate into better functional postoperative outcomes. However, the current body of evidence is mostly derived from non-randomized studies with a high risk of bias.

Renal Function Preservation in Purely Off-Clamp Sutureless Robotic Partial Nephrectomy: Initial Experience and Technique.

The aim of our study is to evaluate the effectiveness and safety of a sutureless off-clamp robot-assisted partial nephrectomy (sl-oc RAPN), particularly its impact on renal function. A multicenter study was conducted from April 2021 to June 2022. Patients diagnosed with a renal mass of >2 cm and a PADUA score of ≤6 consecutively underwent an sl-oc RAPN procedure. Tumor features, patients characteristics, and intraoperative outcomes were assessed. An evaluation of renal function was performed preoperatively, and again at 1 and 3 months after surgery by measuring the creatinine and blood urea nitrogen levels. The renal function of the two separate kidneys was assessed by a sequential renal scintigraphy performed before and at least 30 days after surgery. A total of 21 patients underwent an sl-oc RAPN. The median age was 64 years (IQR 52/70), the median tumor diameter was 40 mm (IQR 29/45), and the median PADUA score was 4 (3.5/5). The intraoperative outcomes included operative time (OT), 90 (IQR 74/100) min; estimated blood loss (EBL), 150 (IQR 50/300) mL; and perioperative complications, CD > 3 1(5%); only two patients presented positive surgical margins in their final histology (2/21, 10%). Compared to the preoperative value, a decrease in renal function was highlighted with a statistically significant median decrease of 10 mL/min (p < 0.01). The renal scintigraphy showed an overall decrease in renal function compared to the preoperative value, with a range in the operated kidney that varied from 0 to 15 mL/s and from 0% to 40%, with a median value of 4 mL/s and 12%. sl-oc RAPN is a safe procedure, with a minimal impact on kidney function alteration. This technique has proven effective in preserving renal function and maintaining optimal oncological outcomes with limited complications.

ASO Visual Abstract: Open Versus Minimally Invasive Nephroureterectomy: Contemporary Analysis from a Wide National Population-Based Database.

Contemporary trend analysis of a large national data set confirms the occurrence of a significant shift toward minimally invasive nephroureterectomy (MINU), which is gradually replacing open nephroureterectomy (ONU). A minimally invasive approach is associated with a lower risk of complications. Social determinants of health (SDOH) are non-clinical factors that ultimately may have an impact on the outcomes of the nephroureterectomy (NU) procedure ( https://doi.org/10.1245/s10434-024-15565-6 ).

Multiparametric Prostate MRI Accuracy of Prostate Imaging Reporting and Data System (v2.1) Scores 4 and 5: The Influence of Image Quality According to the Prostate Imaging Quality Score.

Purpose: The accuracy of multiparametric magnetic resonance imaging (mpMRI) heavily relies on image quality, as evidenced by the evolution of the prostate imaging quality (PI-QUAL) scoring system for the evaluation of clinically significant prostate cancer (csPC). This study aims to evaluate the impact of PI-QUAL scores in detecting csPC within PI-RADS 4 and 5 lesions. Methods: We retrospectively selected from our database all mpMRI performed from January 2019 to March 2022. Inclusion criteria were as follows: (1) mpMRI acquired in our institution according to the technical requirements from the PI-RADS (v2.1) guidelines; (2) single lesion scored as PI-RADS (v2.1) 4 or 5; (3) MRI-TBx performed in our institution; (4) complete histology report; and (5) complete clinical record. Results: A total of 257 male patients, mean age 70.42 ± 7.6 years, with a single PI-RADS 4 or 5 lesion undergoing MRI-targeted biopsy, were retrospectively studied. Of these, 61.5% were PI-RADS 4, and 38.5% were PI-RADS 5, with 84% confirming neoplastic cells. In high-quality image lesions (PI-QUAL ≥ 4), all PI-RADS 5 lesions were accurately identified as positive at the final histological examination (100% of CDR). For PI-RADS 4 lesions, 37 (23%) were negative, resulting in a cancer detection rate of 77% (95% CI: 67.51-84.83). Conclusions: The accuracy of mpMRI, independently of the PI-RADS score, progressively decreased according to the decreasing PI-QUAL score. These findings emphasize the crucial role of the PI-QUAL scoring system in evaluating PI-RADS 4 and 5 lesions, influencing mpMRI accuracy.

Development and validation of a clinical nomogram to predict prostatic inflammation in men with lower urinary tract symptoms.

BACKGROUND: Prostatic inflammation is an important etiological component of benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS). The Prostatic Inflammation Nomogram Study (PINS) aimed to develop and validate a nomogram for predicting the presence of prostatic inflammation in men with LUTS. METHODS: This non-interventional, cross-sectional, prospective study was conducted in six secondary/tertiary centers across Cyprus, Greece, Italy, Portugal, and Spain. Men (≥40 years) with BPH/LUTS scheduled to undergo prostatic surgery or transrectal ultrasound-guided (TRUS) prostate biopsy were included. Fifteen demographic and clinical participant characteristics were selected as possible predictors of prostatic inflammation. The presence of inflammation (according to Irani score) in the prostatic tissue samples obtained from surgery/TRUS biopsy was determined. The effect of each characteristic on the likelihood a prostate specimen demonstrated inflammation (classified by Irani score into two categories, 0-2 [no/minimal inflammation] or 3-6 [moderate/severe inflammation]) was assessed using multiple logistic regression. A nomogram was developed and its discriminatory ability and validity were assessed. RESULTS: In total, 423 patients (mean age 68.9 years) were recruited. Prostate volume ultrasound (PVUS) > 50 mL, history of urinary tract infection (UTI) treatment, presence of diabetes, and International Prostate Symptom Score (IPPS) Storage score were statistically significant predictors of Irani classification. Logistic regression demonstrated a statistically significant effect for leucocytes detected via urine dipstick, presence of diabetes, PVUS > 50 mL, history of UTIs, and higher IPSS Storage score for the odds of an inflammatory score category of 3-6 versus 0-2. The nomogram had a concordance index of 0.71, and good internal validity. CONCLUSIONS: The nomogram developed from PINS had good predictive ability and identified various characteristics to be predictors of prostatic inflammation. Use of the nomogram may aid in individualizing treatment for LUTS, by identifying individuals who are candidates for therapies targeting prostatic inflammation.

Transperineal laser ablation (TPLA) of the prostate for benign prostatic obstruction: the first 100 patients cohort of a prospective, single-center study.

PURPOSE: Transperineal laser ablation (TPLA) is a new minimally-invasive surgical treatment for patients with benign prostatic obstruction (BPO). We report the perioperative and mid-term functional results of the first 100 consecutively patients undergoing TPLA at our institution. METHODS: Clinical data from consecutive patients undergoing TPLA at our institution from April 2021 to July 2023 were prospectively collected. Primary endpoints were the postoperative changes in IPSS, QoL and MSHQ 3-item questionnaires and in Qmax and post-void residual volume (PVR). RESULTS: Overall, 100 consecutive patients underwent the procedure. Median age and prostate volume were 66 (IQR 60-75) years and 50 (IQR 40-70) ml, respectively. In the cohort, 14 (14%) patients had an indwelling catheter and 81 (81%) were under oral BPO therapy at the time of TPLA. Baseline median Qmax (ml/s) and PVR (ml) were 9.1 (IQR 6.9-12) and 90 (IQR 50-150), respectively, while median IPSS and QoL were 18 (IQR 15-23) and 4 (IQR 3-4). At all the follow-up timepoints, the evaluated outcomes on both symptoms and functional parameters showed a statistically significant improvement (p < 0.001). Antegrade ejaculation was preserved in all sexually active patients. No postoperative Clavien-Dindo > 2 complications were recorded. CONCLUSIONS: TPLA represents a safe option for selected well-informed patients swith LUTS due to BPO. Our prospective study confirms the feasibility and favorable perioperative and functional outcomes in a real-world cohort with heterogenous prostate volumes and patient characteristics.

Open versus Minimally Invasive Nephroureterectomy: Contemporary Analysis from a Wide National Population-Based Database.

BACKGROUND: It is generally perceived that minimally invasive nephroureterectomy (MINU), especially in the form of robotic-assisted laparoscopy, is gaining an increasing role in many institutions. OBJECTIVE: The aim of our study was to investigate contemporary trends in the adoption of MINU in the United States compared with open nephroureterectomy (ONU). METHODS: Patients who underwent ONU or MINU between 2011 and 2021 were retrospectively analyzed using PearlDiver Mariner, an all-payer insurance claims database. International Classification of Diseases diagnosis and procedure codes were used to identify the type of surgical procedure, patients' characteristics, social determinants of health (SDOH), and perioperative complications. The primary objective assessed different trends and costs in NU adoption, while secondary objectives analyzed factors influencing the postoperative complications, including SDOH. Outcomes were compared using multivariable regression models. RESULTS: Overall, 15,240 patients underwent ONU (n = 7675) and MINU (n = 7565). Utilization of ONU declined over the study period, whereas that of MINU increased from 29 to 72% (p = 0.01). The 60-day postoperative complication rate was 23% for ONU and 19% for MINU (p < 0.001). At multivariable analysis, ONU showed a significantly higher risk of postoperative complications (odds ratio 1.33, 95% CI 1.20-1.48). Approximately 5% and 9% of patients reported at least one SDOH at baseline for both ONU and MINU (p < 0.001). CONCLUSIONS: Contemporary trend analysis of a large national dataset confirms that there has been a significant shift towards MINU, which is gradually replacing ONU. A minimally invasive approach is associated with lower risk of complications. SDOH are non-clinical factors that currently do not have an impact on the outcomes of nephroureterectomy.

Assessing risk of lymph node invasion in complete responders to neoadjuvant chemotherapy for muscle-invasive bladder cancer.

OBJECTIVES: To investigate the lymph node invasion (LNI) rate in patients exhibiting complete pathological response (CR) to neoadjuvant chemotherapy (NAC) and to test the association of CR status with lower LNI and better survival outcomes. MATERIALS AND METHODS: We included patients with bladder cancer (BCa; cT2-4a; cN0; cM0) treated with NAC and radical cystectomy (RC) + pelvic lymph node dissection (PLND) at our institution between 2012 and 2022 (N = 157). CR (ypT0) and LNI (ypN+) were defined at final pathology. Univariable and multivariable logistic regression analysis was performed to test the association between CR and LNI after adjusting for number of lymph nodes removed (NLR). Kaplan-Meier and Cox regression analyses were used to assess overall survival (OS), metastasis-free survival (MFS) and disease free-survival (DFS) according to CR status. RESULTS: Overall CR and LNI rates were 40.1% and 19%, respectively. The median (interquartile range [IQR]) NLR was 26 (19-36). The LNI rate was lower in patients with CR vs those without CR (2 [3.2%] vs 61 [29.8%]; P < 0.001). After adjusting for NLR, CR reduced the LNI risk by 93% (odds ratio 0.07, 95% confidence interval [CI] 0.01-0.25; P < 0.001). Kaplan-Meier plots depicted better 5-year OS (69.7 vs 52.2%), MFS (68.3 vs 45.5%) and DFS (66.6 vs 43.5%) in patients with CR vs those without CR. After multivariable adjustments, CR independently reduced the risk of death (hazard ratio [HR] 0.44, 95% CI 0.24-0.81; P = 0.008), metastatic progression (HR 0.41, 95% CI 0.23-0.71; P = 0.002) and disease progression (HR 0.41, 95% CI 0.24-0.70; P = 0.001). CONCLUSION: Based on these findings, we postulate that PLND could potentially be omitted in patients exhibiting CR after NAC, due to negligible risk of LNI. Prospective Phase II trials are needed to explore this challenging hypothesis.

Robot-assisted inguinal lymphadenectomy to treat penile and vulvar cancers: a scoping review.

INTRODUCTION: Inguinal lymph nodes dissection (ILND) is recommended in patients presenting with high-risk penile (PC) or vulvar cancers (VC). Though, this surgical procedure is underused because of its anticipated morbidity. Minimally invasive approaches were proposed to minimize complications associated with open surgery. In this review, we analyze current available data exploring intra and perioperative outcomes of robot-assisted ILND (RAIL). EVIDENCE ACQUISITION: On April 9th, 2023, a literature search was conducted using the PubMed and Scopus databases. The search employed the combination of the following terms: ("robotic assisted" OR "robot-assisted" OR "robotic") AND ("inguinal lymph node dissection" OR "lymphadenectomy") AND ("penile cancer" OR "vulvar cancer"). Out of the 404 identified articles, 18 were used for the present scoping review and their results were reported according to the PRISMA statement. EVIDENCE SYNTHESIS: Data on 171 patients, ranging in age from 32 to 85 years, were obtained. Most of them (90.6%) harbored a penile squamous cell carcinoma and presented with no palpable nodes (85%). Operation time (OT) ranged between 45 and 300 min. Estimated blood loss varied from 10 to 300 mL. One single intra-operative complication was reported and one conversion to open was recorded. The lymph nodes (LNs) count spanned from 3 to 26 per groin, with 17 studies reporting a median yield >7 nodes. Hospital stay was 1-7 days, while the duration of drainage ranged from 4 to 72 days. Post-operative complications included lymphocele (22.2%; 0-100%), lymphedema (13.4%; 0-40%), cellulitis (11.1%; 0-25%), skin necrosis (8.7%; 0-15.4%). seroma (3.5%; 0-20%) and wound breakdown/wound infection (2.9%; 0-10%). Out of the included studies, 7 provided at least a 12-month follow-up, with recurrence-free rates ranging from 50% to 100% in patients affected by penile cancer and from 92% to 100% in vulvar cancer patients. CONCLUSIONS: The available evidence on RAIL for the treatment of PC and VC is limited. The approach appears to be safe and effective, as it provides an adequate lymph node yield while ensuring a minimally morbid postoperative course and a short hospital stay.

No clinical benefit from sequential combination of mitomycin C plus bacillus Calmette-Guérin (BCG) than BCG alone in the adjuvant treatment of high risk non muscle invasive bladder cancer: result of a planned interim analysis of a prospective randomized trial.

BACKGROUND: The aim of this study was to evaluate whether the sequential use of Mitomycin C (MMC) and Bacillus Calmette-Guérin (BCG) is superior to BCG alone in reducing the risk of disease recurrence in patients with non-muscle invasive bladder cancer (NMIBC) with high risk of progression. METHODS: Prospective randomized trial was conducted from March 2021 to March 2023 and included 72 patients with high risk NMIBC. Trial registration number: NCT03790384; EUDRACT Number: 2017-004540-37. Thirty-one patients underwent to BCG alone and forty-one to MMC plus BCG during the induction course. The BCG schedule comprised six weekly instillation of 81 mg Connaught strain BCG as the induction course, followed by a further three-monthly instillation at three, six and twelve months, as the maintenance course. Forty mg of MMC were administered the day prior to each weekly BCG instillation in BCG plus MMC arm. A planned interim analysis was carried out in June 2023, at the end of the 12mo follow-up period. RESULTS: Six out of thirteen 6/31(19.3%) and 10/41 (24.4%) patients experienced recurrence in BCG and BCG plus MMC group (P=0.611), respectively. BCG plus MMC did not improve Disease Free Interval (HR: 1.23 95% CI:0.46-3.50; P=0.640). Patients receiving sequential treatment experienced similar AEs (P>0.05) and more urinary symptoms (P<0.05). CONCLUSIONS: This interim pre-planned analysis suggested absence of clinical advantages in terms of disease recurrence rate when MMC is administered one day prior to BCG during induction course.

Can ChatGPT provide high-quality patient information on male lower urinary tract symptoms suggestive of benign prostate enlargement?

BACKGROUND: ChatGPT has recently emerged as a novel resource for patients' disease-specific inquiries. There is, however, limited evidence assessing the quality of the information. We evaluated the accuracy and quality of the ChatGPT's responses on male lower urinary tract symptoms (LUTS) suggestive of benign prostate enlargement (BPE) when compared to two reference resources. METHODS: Using patient information websites from the European Association of Urology and the American Urological Association as reference material, we formulated 88 BPE-centric questions for ChatGPT 4.0+. Independently and in duplicate, we compared the ChatGPT's responses and the reference material, calculating accuracy through F1 score, precision, and recall metrics. We used a 5-point Likert scale for quality rating. We evaluated examiner agreement using the interclass correlation coefficient and assessed the difference in the quality scores with the Wilcoxon signed-rank test. RESULTS: ChatGPT addressed all (88/88) LUTS/BPE-related questions. For the 88 questions, the recorded F1 score was 0.79 (range: 0-1), precision 0.66 (range: 0-1), recall 0.97 (range: 0-1), and the quality score had a median of 4 (range = 1-5). Examiners had a good level of agreement (ICC = 0.86). We found no statistically significant difference between the scores given by the examiners and the overall quality of the responses (p = 0.72). DISCUSSION: ChatGPT demostrated a potential utility in educating patients about BPE/LUTS, its prognosis, and treatment that helps in the decision-making process. One must exercise prudence when recommending this as the sole information outlet. Additional studies are needed to completely understand the full extent of AI's efficacy in delivering patient education in urology.