Precise Prediction of Long-Term Urinary Incontinence after Robot-Assisted Laparoscopic Radical Prostatectomy by Readily Accessible "Everyday" Diagnostics during Post-Surgical Hospitalization.

Aim and Objectives: We aimed to test the predictive value of readily accessible and easily performed post-surgical "bedside tests" on their validity of long-term urinary incontinence (UI) (≥12 months) in patients following robot-assisted laparoscopic radical prostatectomy (RALP). Material and Methods: Patients undergoing RALP between July 2020 and March 2021 were prospectively included and subdivided into two groups based on their pad usage after 12 months (0 vs. ≥1 pad). After catheter removal, patients performed a 1 h pad test, documented the need for pad change in a micturition protocol and received post-voiding residual urine volume ultrasound. Univariate and multivariable analyses were used to demonstrate the predictive value of easily accessible tests applied after catheter removal for UI following RALP. Results: Of 109 patients, 47 (43%) had to use at least one pad (vs. 62 (57%) zero pads) after 12 months. Univariate testing showed a significant difference in urine loss between both groups evaluated by the 1 h pad test performed within 24 h after catheter removal (70% < 10 mL, vs. 30% ≥ 10 mL, p = 0.004) and in the need for pad change within the first 24 h after catheter removal (14% dry pads vs. 86% wet pads, p = 0.003). In multivariable analyses, the combination of both tests (synoptical incontinence score) could be confirmed as an independent predictor for UI after 12 months (p = 0.011). Conclusions: Readily accessible "everyday" diagnostics (pad test/change of pads after catheter removal) following RALP seem to be associated with a higher rate of long-term UI. This finding is crucial since patients with a potentially higher need for patient education and counselling can be identified using these readily accessible tests. This could lead to a higher patient satisfaction and improved outcomes.

Radiomics and machine learning for renal tumor subtype assessment using multiphase computed tomography in a multicenter setting.

OBJECTIVES: To distinguish histological subtypes of renal tumors using radiomic features and machine learning (ML) based on multiphase computed tomography (CT). MATERIAL AND METHODS: Patients who underwent surgical treatment for renal tumors at two tertiary centers from 2012 to 2022 were included retrospectively. Preoperative arterial (corticomedullary) and venous (nephrogenic) phase CT scans from these centers, as well as from external imaging facilities, were manually segmented, and standardized radiomic features were extracted. Following preprocessing and addressing the class imbalance, a ML algorithm based on extreme gradient boosting trees (XGB) was employed to predict renal tumor subtypes using 10-fold cross-validation. The evaluation was conducted using the multiclass area under the receiver operating characteristic curve (AUC). Algorithms were trained on data from one center and independently tested on data from the other center. RESULTS: The training cohort comprised n = 297 patients (64.3% clear cell renal cell cancer [RCC], 13.5% papillary renal cell carcinoma (pRCC), 7.4% chromophobe RCC, 9.4% oncocytomas, and 5.4% angiomyolipomas (AML)), and the testing cohort n = 121 patients (56.2%/16.5%/3.3%/21.5%/2.5%). The XGB algorithm demonstrated a diagnostic performance of AUC = 0.81/0.64/0.8 for venous/arterial/combined contrast phase CT in the training cohort, and AUC = 0.75/0.67/0.75 in the independent testing cohort. In pairwise comparisons, the lowest diagnostic accuracy was evident for the identification of oncocytomas (AUC = 0.57-0.69), and the highest for the identification of AMLs (AUC = 0.9-0.94) CONCLUSION: Radiomic feature analyses can distinguish renal tumor subtypes on routinely acquired CTs, with oncocytomas being the hardest subtype to identify. CLINICAL RELEVANCE STATEMENT: Radiomic feature analyses yield robust results for renal tumor assessment on routine CTs. Although radiologists routinely rely on arterial phase CT for renal tumor assessment and operative planning, radiomic features derived from arterial phase did not improve the accuracy of renal tumor subtype identification in our cohort.

Surgical approach affecting long-term urinary continence status after robot-assisted laparoscopic prostatectomy prospectively evaluated using self-reported functional status (Expanded Prostate Cancer Index Composite, EPIC-26).

Purpose: The aim of the study was to examine the influence of the surgical approach for robot-assisted laparoscopic prostatectomy (RALP) on long-term urinary continence status in the era of self-reported functional status measures using the Expanded Prostate Cancer Index Composite 26. Materials and methods: This is a prospective evaluation of 232 patients undergoing RALP between September, 2019 and September, 2020. Urinary continence status and postoperative incontinence (pad usage) were evaluated 12 months after RALP using Expanded Prostate Cancer Index Composite 26 questionnaires. Patients were categorized according to their surgical approach and outcome into the following groups: successful nerve sparing (NS), primarily without nerve sparing (prim. NNS), and no nerve sparing by secondary resection (NNS by SR). The median levels of their questionnaire outcomes were evaluated and compared using the Wilcoxon rank sum test with continuity correction. Results: Urinary continence status 12 months after RALP differed significantly between the NS and prim. NNS (p = 0.0071) and the NS and NNS by SR (p = 0.0076) groups. There was no significant difference between the prim. NNS and NNS by SR (p = 0.53) groups. Pad usage 12 months after RALP had no significant difference with regard to SR of the neurovascular bundle (p = 0.14). Conclusions: Patient-reported outcomes of long-term urinary continence status seem to show no difference in postoperative continence, regardless of whether a non-nerve-sparing result was planned or reached through SR. Instead, preservation of neurovascular bundle seems to lead to better long-term continence rates.

Personalized Treatment Strategy in "Low-Risk Prostate Cancer Active Surveillance Candidates" Using Irreversible Electroporation: Prospective Evaluation of Feasibility, Morbidity, Functional and Oncological Outcomes.

PURPOSE: To evaluate the morbidity, functional and oncological outcome of irreversible electroporation (IRE) as a focal therapy for prostate cancer (PCa) when used in "active surveillance (AS)" candidates refusing standard treatment options. MATERIALS AND METHODS: IRE was performed under general anaesthesia, and the transurethral catheter was removed one day after intervention in all patients. Pre- and post-interventional voiding parameters (measured by International Prostate Symptom Score Questionnaire [IPSS], uroflowmetry and post-void residue) were compared. Follow-up (FU) was observed over a minimum of six months, including oncological outcome (controlled by multiparametric magnetic resonance imaging, rebiopsy, prostate-specific antigen dynamic as well as the need and type of secondary treatment) and general functional outcome (International Index of Erectile Function Questionnaire, satisfaction of the procedure). RESULTS: Twenty-four patients refusing AS or standard treatment with a median FU of 18.7 months were included. IPSS showed nine patients with mild, 12 with moderate and two with severe obstructive voiding symptoms pre-intervention (focal IRE). Median IPSS pre-IRE was 9 points, 8.5 (p=0.341) at six months and 10 (p=0.392) after 12 months, respectively. Pre-IRE maximum urinary flow (Qmax) (median: 16.1±8.0 mL/sec) and Qmax after catheter removal (16.2±7.6 mL/sec) did not differ significantly (p=0.904). Thirteen PCa recurrences occurred (54.2%). Out-of-lesion-PCa was found in 12/13 patients (92.3%), while 4/13 patients showed in-lesion-PCa recurrence simultaneously (30.8%). In one patient, there was an in-lesion-PCa recurrence only (7.7%). Six out of 24 patients (25.0%) received a secondary treatment. All patients were satisfied with the IRE procedure. CONCLUSIONS: Focal IRE underperforms regarding the overall oncological outcome and should not be offered as an equivalent therapy to established curative treatment strategies. Nevertheless, under a strict FU regimen, its lack of significant additional morbidity compared to an active surveillance strategy makes IRE a feasible alternative for low-risk PCa in highly selected patients as a personalised approach.

Sunitinib for Metastatic Renal Cell Carcinoma: Real-World Data from the STAR-TOR Registry and Detailed Literature Review.

INTRODUCTION: We evaluated the effectiveness and safety profile of the tyrosine kinase inhibitor sunitinib in patients with advanced or metastatic renal cell carcinoma (a/mRCC) in a real-world setting. METHODS: We analyzed data of adult a/mRCC patients treated with sunitinib. Data were derived from the German non-interventional post-approval multicenter STAR-TOR registry (NCT00700258). Progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated using descriptive statistics and survival analyses for the entire cohort and patient subgroups. RESULTS: A total of 116 study sites recruited 702 patients treated with sunitinib (73.1% male; median age 68.0 years; median Karnofsky index 90%) between November 2010 and May 2020. The most frequent histological subtype was clear cell RCC (81.6%). Sunitinib was administered as first-line treatment in 83.5%, as second line in 11.7%, and as third line or beyond in 4.8% of the patients. Drug-related AEs and serious AEs were reported in 66.3% and 13.9% of the patients, respectively (most common AE: gastrointestinal disorders; 39.7% of all patients). CONCLUSIONS: This study adds further real-world evidence of the persisting relevance of sunitinib for patients with a/mRCC who cannot receive or tolerate immune checkpoint inhibitors. The study population includes a high proportion of patients with unfavorable MSKCC poor-risk score, but shows still good PFS and OS results, while the drug demonstrates a favorable safety profile. The STAR-TOR registry is also registered in the database of US library of medicine (NCT00700258).

[Closure of a prostatocutaneous urinary fistula while preserving sexual function using a perineal approach with Gracilis flap interposition]. / Funktionsprotektiver Verschluss einer urethrokutanen Fistel der prostatischen Harnröhre über einen perinealen Zugang mit Gracilis-Flap.

We present the case of a 36-year-old man suffering from perianal loss of urine through a cutaneous pore while urinating. Appropriate diagnostic investigation showed a urethrocutaneous fistula of the prostatic urethra of unclear aetiology. Because of the patient's young age and sexual activity, surgical treatment was challenging. The fistula was isolated via a perineal access and ligated close to the prostate without endangering the neurovascular bundles. In order to achieve a secure closure of the fistula, a Gracilis flap was placed as an interposition between the dorsal prostate and the percutaneous fistula outlet. To date, no case has been described of a successful, function-preserving surgical treatment of a prostatocutaneous urinary fistula.

Impact of multiparametric magnetic resonance imaging targeted biopsy on functional outcomes in patients following robot-assisted laparoscopic radical prostatectomy.

Introduction: Multiparametric magnetic resonance imaging guided prostate biopsy (mpMRI PBx) leads to a higher rate of successful nerve-sparing in robot-assisted laparoscopic prostatectomy (ns-RALP) for prostate cancer (PCa). This study aimed to evaluate the impact of mpMRI PBx compared to standard ultrasound-guided PBx on functional outcomes focusing on erectile function in patients following ns-RALP. Material and methods: All RALPs performed between 01/2016 and 06/2021 were retrospectively stratified according to (attempted) ns vs. non ns RALPs and were then categorized based on the PBx technique (mpMRI PBx vs. standard PBx). We compared RALP outcomes such as pathological tumor stage, rates of secondary nerve resection (SNR) and positive surgical margin status (PSM). Furthermore, we explored the association between PBx-technique and patient-reported outcomes assessed 12 months after RALP using the prospectively collected 26-item Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. Chi-square tests and logistic regression analysis were conducted. Results: A total of 849 RALPs included 517 (61%) procedures with (attempted) ns. Among these, 37.5% were diagnosed via preoperative mpMRI PBx. Patients with a preoperative standard PBx had a 57% higher association of PSM (p = 0.030) compared to patients with mpMRI PBx and a 24% higher risk of erectile dysfunction (ED) 12 months post RALP (p = 0.025). When ns was attempted, we observed a significantly higher rate of SNR in patients who underwent a standard PBx compared to those who received a mpMRI PBx (50.8% vs. 26.7%, p < 0.001) prior RALP. In comparison, upgrading occurred more often in the standard PBx group (50% vs. 40% mpMRI PBx, p = 0.008). Conclusion: The combination of mpMRI PBx for PCa diagnosis followed by ns-RALP resulted in significantly fewer cases of SNR, better oncological outcomes and reduced incidence of ED 1 year after surgery. This included fewer PSM and a lower rate of postoperative tumor upgrading.

Development, validation, and prognostic evaluation of a risk score for long-term liver-related outcomes in the general population: a multicohort study.

BACKGROUND: Liver cirrhosis is a major cause of death worldwide. Cirrhosis develops after a long asymptomatic period of fibrosis progression, with the diagnosis frequently occurring late, when major complications or cancer develop. Few reliable tools exist for timely identification of individuals at risk of cirrhosis to allow for early intervention. We aimed to develop a novel score to identify individuals at risk for future liver-related outcomes. METHODS: We derived the LiverRisk score from an international prospective cohort of individuals from six countries without known liver disease from the general population, who underwent liver fibrosis assessment by transient elastography. The score included age, sex, and six standard laboratory variables. We created four groups: minimal risk, low risk, medium risk, and high risk according to selected cutoff values of the LiverRisk score (6, 10, and 15). The model's discriminatory accuracy and calibration were externally validated in two prospective cohorts from the general population. Moreover, we ascertained the prognostic value of the score in the prediction of liver-related outcomes in participants without known liver disease with median follow-up of 12 years (UK Biobank cohort). FINDINGS: We included 14 726 participants: 6357 (43·2%) in the derivation cohort, 4370 (29·7%) in the first external validation cohort, and 3999 (27·2%) in the second external validation cohort. The score accurately predicted liver stiffness in the development and external validation cohorts, and was superior to conventional serum biomarkers of fibrosis, as measured by area under the receiver-operating characteristics curve (AUC; 0·83 [95% CI [0·78-0·89]) versus the fibrosis-4 index (FIB-4; 0·68 [0·61-0·75] at 10 kPa). The score was effective in identifying individuals at risk of liver-related mortality, liver-related hospitalisation, and liver cancer, thereby allowing stratification to different risk groups for liver-related outcomes. The hazard ratio for liver-related mortality in the high-risk group was 471 (95% CI 347-641) compared with the minimal risk group, and the overall AUC of the score in predicting 10-year liver-related mortality was 0·90 (0·88-0·91) versus 0.84 (0·82-0·86) for FIB-4. INTERPRETATION: The LiverRisk score, based on simple parameters, predicted liver fibrosis and future development of liver-related outcomes in the general population. The score might allow for stratification of individuals according to liver risk and thus guide preventive care. FUNDING: European Commission under the H20/20 programme; Fondo de Investigación Sanitaria de Salud; Instituto de Salud Carlos III; Spanish Ministry of Economy, Industry, and Competitiveness; the European Regional Development Fund; and the German Ministry of Education and Research (BMBF).

The influence of secondary resection using NeuroSAFE-technique on sexual function in unilateral nerve-sparing robot-assisted laparoscopic prostatectomies.

OBJECTIVE: To demonstrate the surgical influence of secondary resection on sexual function in finally unilateral nerve-sparing robot- assisted laparoscopic prostatectomies (RALPs) performed with the 'neurovascular structure-adjacent frozen-section examination' (NeuroSAFE) technique by prospectively collecting EPIC-26-questionnaires. MATERIAL & METHODS: Sexual function status measured by the sexual-symptom-score (SexSS) in the EPIC-26-questionnaires was collected preoperatively and 12 months after RALP from 378 patients between 09/2019 and 04/2021. Cohorts of interest were defined as those patients undergoing unilateral nerve-sparing by secondary resection of the other neurovascular bundle (NVB), and as those patients undergoing primarily planned and successful unilateral nerve-sparing (unilateral nerve-sparing without secondary resection) in ≤cT2 prostate cancer. NeuroSAFE frozen section technique was performed in all nerve-sparing RALPs, and in case of cancer-positive surgical margins, the complete NVB was resected. RESULTS: In 109 RALPs with unilateral nerve-sparing (48 primarily vs. 61 by secondary resection), analyses showed a significant difference in postoperative SexSS for 'unilateral nerve-sparing by secondary resection' compared with 'unilateral nerve-sparing without secondary resection' (43 [interquartile range (IQR): 14;50] vs. 26 [IQR: 22;62], P = 0.04). In multivariable analyses, the preoperative SexSS was predictive for postoperative erectile dysfunction (OR = 0.96, 95% confidence interval: 0.93-0.98, P < 0.001). Oncological safety was not compromised by secondary resection (prostate-specific antigen after 12 months 0.01 ng/mL vs. 0.01 ng/mL [P = 0.3] for unilateral nerve-sparing by secondary resection vs. unilateral nerve-sparing without secondary resection). CONCLUSION: The results of this study suggest that nerve-sparing attempts applying the NeuroSAFEtechnique should be generously performed since a unilateral complete secondary resection leading to a unilateral nerve-sparing RALP did not seem to have a negative influence on sexual function and did not seem to compromise oncological safety compared with primarily performed and successful unilateral nerve-sparing RALP.

Prospective evaluation of an intraoperative urodynamic stress test predicting urinary incontinence after robot-assisted laparoscopic radical prostatectomy.

Introduction: Multiple factors influence postprostatectomy incontinence (PPI). This study evaluates the association between an intraoperative urodynamic stress test (IST) with PPI. Materials and Methods: This is an observational, single-center, prospective evaluation of 109 robot-assisted laparoscopic radical prostatectomies (RALPs) performed between July 2020 and March 2021. All patients underwent an intraoperative urodynamic stress test (IST) in which the bladder is filled up to an intravesical pressure of 40 cm H2O to evaluate whether the rhabdomyosphincter is capable of withstanding the pressure and ensure continence. Early PPI was evaluated using a standardized 1-h pad test performed the day after removal of the urinary catheter. The association of IST and PPI was evaluated using univariate and multivariable logistic regression models. Results: Nearly 76.6% of the patients showed no urine loss during the IST ("sufficient" population group). There was no significant correlation between this group and PPI after catheter removal (P = 0.5). Subgroup analyses of the "sufficient" patient population showed a 3.1 higher risk of PPI when no nerve sparing was performed (95% confidence interval: 1.05-9.70, P = 0.045). Conclusion: A sufficient IST, as a surrogate variable for a fully obtained rhabdomyosphincter, has no significant predictive value on its own but seems to be the optimal prerequisite for continence, since the data shows that the lack of neurovascular supply required for a functioning sphincter leads up to a 3.1 times higher risk for PPI.

[A noteworthy case: An atypically located urachal cyst after continent urinary diversion using a MAINZ pouch with an appendix stoma]. / Ein bemerkenswerter Fall: Eine atypisch gelegene Urachuszyste nach kontinenter Harnableitung mittels MAINZ-Pouch mit Appendixstoma.

This case presents a 29-year-old man, with a urinary diversion via MAINZ Pouch I after cystectomy due to trauma in early childhood with a history of multiple previous surgeries. The reason for the presentation was a non-specific paraumbilical swelling on the right, which was disturbing for him. Despite further diagnostics by means of magnetic resonance imaging, a clear diagnosis of the subcutaneous tissue could not be made. After surgical removal of the complete cyst and after histological work-up, the diagnosis of an urachus-cyst could be made.

[Use of men's support underwear after elective scrotal surgery-a prospective, randomized assessment of postoperative complication rates and health-related quality of life : A prospective, randomized assessment of postoperative complication rates and health-related quality of life]. / Einsatz einer stützenden Herrenunterhose bei elektiven skrotalen Eingriffen : Eine prospektive, randomisierte Bewertung hinsichtlich postoperativer Komplikationsraten und gesundheitsbezogener Lebensqualität.

BACKGROUND: Elective scrotal surgery is associated with a high rate of postoperative complications. There is no specific recommendation for postoperative care. AIM: We investigated whether support underwear has an impact on postoperative complications and quality of life. MATERIALS AND METHODS: From July 2020 to November 2021, patients with prior elective scrotal surgery were randomized into the intervention group "support underwear" or the control group. In addition to patient characteristics, intraoperative and postoperative findings were documented. The primary endpoint comprised postoperative complications. Secondary endpoints were prolonged length of hospital stay, emergency visits, unplanned readmissions, increased use of analgesics, and quality of life, which was recorded using the EQ5D (European Quality of Life 5 Dimensions) questionnaire preoperatively, on day 1 and 4 weeks postoperatively. RESULTS: Data from 50 patients were analyzed. The mean age was 46.7 years (standard deviation [SD] 18.6). Inguinal surgery with/without orchiectomy (52%), hydrocele resection (22%), or ligation of varicocele (14%) were performed most frequently. The mean operating time was 62.8 min (SD 35.2); length hospital stay was 2.6 days (SD 1.2). In all, 20% of the patients suffered a postoperative complication. Type of surgery was significantly associated with postoperative complications (p = 0.01) and unplanned readmission (p = 0.04). Regarding biometric and perioperative data, there were no significant differences between the interventional group (n = 27) and control group (n = 23). CONCLUSION: A nonnegligible number of complications occurs after elective scrotal surgery. Complications affects quality of life up to 4 weeks after the surgery. Postoperative care with support underwear does not appear to affect the postoperative complication rate, but it positively influences the quality of life in patients with scrotal access.

Understanding long-term continence rates after robot-assisted laparoscopic prostatectomy - one-year follow-up on "Cognitive ability as a non-modifiable risk factor for post-prostatectomy urinary incontinence".

Purpose: To evaluate long-term continence rates (12 months) in patients after robot-assisted laparoscopic prostatectomy (RALP) in relation to their cognitive ability (CoAb), which proved to be a predictor for early post-prostatectomy incontinence. Material & Methods: This is the 12-month follow-up evaluation of our previously published observational single-center, prospective evaluation of 84 patients who underwent RALP as treatment of their localized prostate cancer between 07/2020 and 03/2021. Post-prostatectomy incontinence (PPI) was measured by asking patients about their 24 h pad usage, whereby 0 pads were considered continent and ≥1 pad was considered incontinent. CoAb was evaluated by performing the Mini-Mental State Examination prior to surgery. Possible predictors for PPI were evaluated using univariate and multivariable logistic regression models. Results: Multivariable logistic regression analyses identified early incontinence status and nerve sparing (NS) as independent predictors for PPI after 12 months, resulting in a 5.69 times higher risk for PPI when the loss of urine was between 10 and 50 ml during the early performed pad test (one day after catheter removal) compared to 0-1 ml loss of urine [95% confidence interval (CI): 1.33-28.30, p = 0.024] and a 6.77 times higher risk for PPI, respectively, when only unilateral NS was performed compared to bilateral NS (95% CI: 1.79-30.89, p = 0.007). CoAb lost its predictive value for long-term PPI (p = 0.44). Conclusion: The results of this study suggest that PPI is a dynamic, rather than a static condition with a dynamically changing pathophysiology within the first 12 months after RALP. Coping methods and therapies should adapt to this circumstance.

Mesh Graft Urethroplasty-Still a Safe and Promising Technique in Mostly Unpromising Complex Urethral Strictures.

Long urethral strictures or even recurrent urethral strictures, mostly with scar tissue showing insufficient healing tendencies, are defined as complex and represent a big challenge in modern reconstructive urology. Initially, the treatment of complicated urethral strictures was associated with a high failure rate (20-40%) due to the growth of hair in the neourethra and a lack of sufficient suitable epithelium when scrotal skin was used. Although much effort was put into tissue engineering recently, harvesting and transplanting autologous tissue represent the standard of care for urethral substitution or augmentation. Since 1977, two-staged urethroplasty with the usage of free foreskin or 0.1 mm thick meshed skin from the upper leg was performed in complicated cases and was initially described in 1984 and 1989 by Schreiter and Schreiter and Noll, respectively. In stage 1, the graft is harvested by cutting the skin thinly above the hair follicles and transplanted as a plate around the opened urethra. In stage 2, after 8-12 weeks, the neourethra is formed. Success rates of up to 84% are described. Considering the complexity of the strictures in which mesh graft urethroplasty is usually performed, the reachable success rates are outstanding, especially considering that this surgery is most likely the last opportunity to prevent perineostomy or even urinary diversion. This article describes the surgical technique and embeds the mesh graft urethroplasty in today's literature to underline its importance in the surgical management of complex urethral strictures.

LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries.

BACKGROUND: The development of liver cirrhosis is usually an asymptomatic process until late stages when complications occur. The potential reversibility of the disease is dependent on early diagnosis of liver fibrosis and timely targeted treatment. Recently, the use of non-invasive tools has been suggested for screening of liver fibrosis, especially in subjects with risk factors for chronic liver disease. Nevertheless, large population-based studies with cost-effectiveness analyses are still lacking to support the widespread use of such tools. The aim of this study is to investigate whether non-invasive liver stiffness measurement in the general population is useful to identify subjects with asymptomatic, advanced chronic liver disease. METHODS: This study aims to include 30,000 subjects from eight European countries. Subjects from the general population aged ≥ 40 years without known liver disease will be invited to participate in the study either through phone calls/letters or through their primary care center. In the first study visit, subjects will undergo bloodwork as well as hepatic fat quantification and liver stiffness measurement (LSM) by vibration-controlled transient elastography. If LSM is ≥ 8 kPa and/or if ALT levels are ≥1.5 x upper limit of normal, subjects will be referred to hospital for further evaluation and consideration of liver biopsy. The primary outcome is the percentage of subjects with LSM ≥ 8kPa. In addition, a health economic evaluation will be performed to assess the cost-effectiveness and budget impact of such an intervention. The project is funded by the European Commission H2020 program. DISCUSSION: This study comes at an especially important time, as the burden of chronic liver diseases is expected to increase in the coming years. There is consequently an urgent need to change our current approach, from diagnosing the disease late when the impact of interventions may be limited to diagnosing the disease earlier, when the patient is asymptomatic and free of complications, and the disease potentially reversible. Ultimately, the LiverScreen study will serve as a basis from which diagnostic pathways can be developed and adapted to the specific socio-economic and healthcare conditions in each country. TRIAL REGISTRATION: This study is registered on Clinicaltrials.gov ( NCT03789825 ).

Impact of mpMRI targeted biopsy on intraoperative nerve-sparing (NeuroSAFE) during robot-assisted laparoscopic radical prostatectomy.

BACKGROUND: The aim of our study was to evaluate the impact of prostate biopsy technique (transrectal ultrasound (US)-prostate biopsy (PBx) versus multiparametric magnetic resonance imaging (mpMRI) targeted prostate biopsy (MRI-PBx) on intraoperative nerve-sparing and the rate of secondary neurovascular-bundle resection (SNR) in patients undergoing robot-assisted laparoscopic radical prostatectomy (RARP). A real-time investigation with a frozen-section examination (NeuroSAFE) microscopically excluded or confirmed prostate cancer invasion of the nerve structures resulting in preservation of the neurovascular bundle or SNR. Additionally, we analyzed risk factors related to SNR, such as longer operation time and postoperative complications. METHODS: The total study cohort was stratified according to non-nerve-sparing versus nerve-sparing RARP. Patients with nerve-sparing approach were then stratified according to biopsy technique (PBx vs. MRI-PBx). Further, we compared PBx versus MRI-PBx according to SNR rate. RESULTS: We included a total of 470 consecutive patients, who underwent RARP for PCa at our institution between January 2016 and December 2019. Patients with a preoperative MRI-PBx had a 2.12-fold higher chance of successful nerve-sparing (without SNR) compared to patients with PBx (p < 0.01). Patients with preoperative MRI-PBx required 73% less intraoperative SNR compared to patients with PBx (p < 0.0001). Prior MRI-PBx is thus a predictor for successful nerve-sparing RARP approach. CONCLUSION: Preoperative MRI-PBx led to better oncological outcomes and less SNR. Young patients with good erectile function could benefit from a preoperative MRI-PBx before nerve-sparing RARP.

Cognitive Ability as a Non-modifiable Risk Factor for Post-prostatectomy Urinary Incontinence: A Double-Blinded, Prospective, Single-Center Trial.

Introduction: Urinary incontinence (UI) is a wide-spread and feared side-effect of conventional or even robot-assisted laparoscopic prostatectomy (RALP) due to its high impact on patients' quality of life (QoL). Non-modifiable risk factors for UI have already been identified - on surgical and patient side. Yet, to our knowledge, focus thus far has not been placed on functional aspects regarding general cognitive ability. Materials and Methods: This is an observational single-center, prospective, double-blinded evaluation of 109 RALPs performed between 07/2020 and 03/2021. All patients underwent a Mini Mental State Examination (MMSE) prior to surgery to evaluate their cognitive ability. Early post-prostatectomy incontinence (PPI) was evaluated using a standardized 1 h pad test performed 24 h after removal of the urinary catheter. The association between MMSE results and PPI were evaluated using univariate and multivariate logistic regression models. Results: Multivariate logistic regression analyses identified MMSE results and nerve sparing (NS) as independent predictors for PPI in patients with an intermediate MMSE result (25-27 points) having a 3.17 times higher risk of PPI when compared to patients with a good MMSE result (≥28) (95% Confidence Interval (CI): 1.22-9.06, p = 0.023), while patients without NS had a 3.53 times higher risk of PPI when compared to patients with NS (95% CI: 1.54-11.09, p = 0.006). Conclusion: A lower cognitive ability should be treated as a non-modifiable risk-factor for early PPI. In the future it could find its place as a clinical screening tool to identify patients who require more attention especially in the pre-, but also in the postoperative phase.

The presence of prostate cancer on saturation biopsy can be accurately predicted.

OBJECTIVE: To improve the ability of our previously reported saturation biopsy nomogram quantifying the risk of prostate cancer, as the use of office-based saturation biopsy has increased. PATIENTS AND METHODS: Saturation biopsies of 540 men with one or more previously negative 6-12 core biopsies were used to develop a multivariable logistic regression model-based nomogram, predicting the probability of prostate cancer. Candidate predictors were used in their original or stratified format, and consisted of age, total prostate-specific antigen (PSA) level, percentage free PSA (%fPSA), gland volume, findings on a digital rectal examination, cumulative number of previous biopsy sessions, presence of high-grade prostatic intraepithelial neoplasia on any previous biopsy, and presence of atypical small acinar proliferation (ASAP) on any previous biopsy. Two hundred bootstraps re-samples were used to adjust for overfit bias. RESULTS: Prostate cancer was diagnosed in 39.4% of saturation biopsies. Age, total PSA, %fPSA, gland volume, number of previous biopsies, and presence of ASAP at any previous biopsy were independent predictors for prostate cancer (all P < 0.05). The nomogram was 77.2% accurate and had a virtually perfect correlation between predicted and observed rates of prostate cancer. CONCLUSIONS: We improved the accuracy of the saturation biopsy nomogram from 72% to 77%; it relies on three previously included variables, i.e. age, %fPSA and prostate volume, and on three previously excluded variables, i.e. PSA, the number of previous biopsy sessions, and evidence of ASAP on previous biopsy. Our study represents the largest series of saturation biopsies to date.