Prognostic significance of residual tumor at restaging transurethral bladder resection in high-risk non-muscle-invasive bladder cancer.

PURPOSE: To assess prognostic significance of residual tumor at repeat transurethral resection (reTUR) in contemporary non-muscle-invasive bladder cancer (NMIBC) patients. METHODS: Patients were identified retrospectively from eight referral centers in France, Italy and Spain. The cohort included consecutive patients with high or very-high risk NMIBC who underwent reTUR and subsequent adjuvant BCG therapy. RESULTS: A total of 440 high-risk NMIBC patients were screened, 29 (6%) were upstaged ≥ T2 at reTUR and 411 were analyzed (T1 stage: n = 275, 67%). Residual tumor was found in 191 cases (46%). In patients with T1 tumor on initial TURBT, persistent T1 tumor was found in 18% of reTUR (n = 49/275). In patients with high-grade Ta tumor on initial TURBT, T1 tumor was found in 6% of reTUR (n = 9/136). In multivariable logistic regression analysis, we found no statistical association between the use of photodynamic diagnosis (PDD, p = 0.4) or type of resection (conventional vs. en bloc, p = 0.6) and the risk of residual tumor. The estimated 5-yr recurrence and progression-free survival were 56% and 94%, respectively. Residual tumor was significantly associated with a higher risk of recurrence (p < 0.001) but not progression (p = 0.11). Only residual T1 tumor was associated with a higher risk of progression (p < 0.001) with an estimated 5-yr progression-free survival rate of 76%. CONCLUSIONS: ReTUR should remain a standard for T1 tumors, irrespective of the use of en bloc resection or PDD and could be safely omitted in high-grade Ta tumors. Persistent T1 tumor at reTUR should not exclude these patients from conservative management, and further studies are needed to explore the benefit of a third resection in this subgroup.

Modified holmium laser enucleation for benign prostatic obstruction to preserve sexual and ejaculatory function.

INTRODUCTION: To report ejaculatory and urinary results in patients who underwent holmium laser enucleation of the prostate (HoLEP) with selective laser enucleation of the median lobe (MLHoLEP). METHODS: Patients with lower urinary tract symptoms (LUTS)/benign prostatic obstruction (BPO) who underwent MLHoLEP to preserve ejaculatory function in a single center were retrospectively identified. Urinary function was assessed using International Prostate Score Symptom (IPSS), IPSS-Quality of Life index (IPSS-QoL), peak urinary flow (Qmax) and postvoid residual (PVR). Erectile function was assessed using International Index of Erectile Function (IIEF-5). In patients with preoperative antegrade ejaculation, retrograde ejaculation was routinely screened at each follow-up visit. Sexual and urinary functions at 3 and 12 months were compared with baseline values. RESULTS: A total of 55 patients met our inclusion criteria. A significant improvement in the IPSS, IPSS-QoL, PVR and Qmax was found at 3 and 12 months, compared with baseline (all P<0.05). Eight patients (14.5%) required surgical reintervention due to persistant LUTS/BPO. No significant changes in the erectile function were found at 3 (P=0.3) and 12 months (P>0.9). In patients with preoperative antegrade ejaculation (n=32), only four cases of de novo retrograde ejaculation were recorded postoperatively. CONCLUSION: MLHoLEP represents a new alternative for men with LUTS/BPO who wish to preserve their ejaculatory function. Patients should be aware that improvement in urinary function may be inferior to the traditional technique, with a higher reintervention rate due to persistent LUTS. LEVEL OF EVIDENCE: Grade 4.

Salvage high-intensity focused ultrasound (S-HIFU) for recurrence after primary radiotherapy of prostate cancer.

OBJECTIVES: To evaluate functional and oncological outcomes of salvage high-intensity focal ultrasound (S-HIFU) after external beam radiotherapy (EBRT) failure in prostate cancer (PCa) patients. METHODS: This single-center study included patients who underwent S-HIFU for local recurrence after EBRT between 2006 and 2023. Cancer-specific survival, metastasis-free survival and progression-free survival were illustrated using Kaplan-Meier curves. Disease progression was defined by one of the following criteria: increase of 2ng/mL or more above the PSA nadir, positive post-S-HIFU biopsy or initiation of androgen deprivation therapy (ADT). Multivariable Cox proportional hazards model was used to identify predictors of disease progression after S-HIFU. RESULTS: A total of 52 S-HIFU sessions for 48 patients were performed. Median time between EBRT and S-HIFU was 6.5 years. Median PSA before S-HIFU was 3.2ng/mL and median PSA nadir after S-HIFU was 0.58ng/mL. A total of 39 (81.3%) complications was recorded, including 3 (6.3%) high grade complications according to the Clavien-Dindo classification. After a median follow-up period of 6 years, 14 (29.2%) patients developed metastatic disease. Eighteen (37.5%) patients had no recurrence, whereas 30 (62.5%) patients received ADT for disease progression. The estimated 5-yr cancer-specific survival (CSS), metastasis-free survival (MFS) and progression-free survival rates (PFSR) were 100%, 79.9% (95% CI 67-92) and 41.2% (95% CI 74-96), respectively. The estimated 10-yr CSS, MFS and PFSR were 80% (95% CI 45-100), 50.7% (95% CI 19.4-82.1) and 14% (95% CI 10.8-45), respectively. The hazard of progression increased with the intermediate (HR 3.8; 95% CI 0.99 to 15; p=0.049) and high pre-EBRT d'Amico-s risk group (HR 4.1; 95% CI 0.98 to 16.2; p=0.050). Also, the time between EBRT and S-HIFU was significantly associated with risk of progression (HR 0.61; 95% CI 0.43 to 0.86; p=0.004). No significant difference linked to the disease progression (DP) risk was found between focal vs whole-gland treatment (p=0.70). CONCLUSION: Physicians should consider HIFU as a local salvage treatment after failed EBRT, thus avoiding or delaying palliative androgen deprivation therapy. Further studies are needed to improve patient selection for this therapy.

Expanding inclusion criteria for active surveillance in intermediate-risk prostate cancer: a machine learning approach.

PURPOSE: To develop new selection criteria for active surveillance (AS) in intermediate-risk (IR) prostate cancer (PCa) patients. METHODS: Retrospective study including patients from 14 referral centers who underwent pre-biopsy mpMRI, image-guided biopsies and radical prostatectomy. The cohort included biopsy-naive IR PCa patients who met the following inclusion criteria: Gleason Grade Group (GGG) 1-2, PSA < 20 ng/mL, and cT1-cT2 tumors. We relied on a recursive machine learning partitioning algorithm developed to predict adverse pathological features (i.e., ≥ pT3a and/or pN + and/or GGG ≥ 3). RESULTS: A total of 594 patients with IR PCa were included, of whom 220 (37%) had adverse features. PI-RADS score (weight:0.726), PSA density (weight:0.158), and clinical T stage (weight:0.116) were selected as the most informative risk factors to classify patients according to their risk of adverse features, leading to the creation of five risk clusters. The adverse feature rates for cluster #1 (PI-RADS ≤ 3 and PSA density < 0.15), cluster #2 (PI-RADS 4 and PSA density < 0.15), cluster #3 (PI-RADS 1-4 and PSA density ≥ 0.15), cluster #4 (normal DRE and PI-RADS 5), and cluster #5 (abnormal DRE and PI-RADS 5) were 11.8, 27.9, 37.3, 42.7, and 65.1%, respectively. Compared with the current inclusion criteria, extending the AS criteria to clusters #1 + #2 or #1 + #2 + #3 would increase the number of eligible patients (+ 60 and + 253%, respectively) without increasing the risk of adverse pathological features. CONCLUSIONS: The newly developed model has the potential to expand the number of patients eligible for AS without compromising oncologic outcomes. Prospective validation is warranted.

Patient Blood Management in Transurethral Resection Surgery: Overview and Strategy Analysis from a French Tertiary Hospital.

INTRODUCTION: Since Patient blood management (PBM) suggests a bundle of measures aiming to reduce perioperative blood transfusion because preoperative anemia and blood transfusion are associated with poor postoperative outcomes. There is a lack of data on the effect of PBM in patients undergoing transurethral resection of prostate (TURP) or bladder tumor (TURBT). We aimed to assess the bleeding risk in TURP and TURBT procedures and the effect of preoperative anemia on postoperative morbimortality. METHODS: A single-center retrospective observational cohort study was conducted in a tertiary hospital in Marseille, France. All patients undergoing TURP or TURBT were included in 2020 and divided into two groups: preoperative anemia (n = 19) and no preoperative anemia (n = 59). We recorded demographic characteristics, preoperative hemoglobin concentration, iron deficiency markers, preoperative initiation of a treatment for anemia, perioperative bleeding, and postoperative outcomes up to 30 days including blood transfusion, hospital readmission, reintervention, infection, and mortality. RESULTS: Baseline characteristics were comparable between groups. No patient had iron deficiency markers and no prescription of iron was initiated before surgery. No major bleeding was reported during surgery. Postoperative anemia was found in 21 patients, including 16 (76%) in the preoperative anemia group and 5 (24%) in the non-preoperative anemia group. One patient of each group received a blood transfusion after surgery. No significant differences in 30-day outcomes were reported. CONCLUSION: Our study suggests that TURP and TURBT are not associated with a high-risk of postoperative bleeding. In such procedures, adherence PBM strategies do not seem beneficial. Since recent guidelines recommend restricting preoperative testing, our results may help to improve preoperative risk stratification.

Life Cycle Assessment of Reusable and Disposable Cystoscopes: A Path to Greener Urological Procedures.

BACKGROUND: The environmental impact of reusable and disposable devices is unclear; reuse is expected to reduce the carbon footprint, but the environmental impact of reprocessing of reusable devices is increasingly being questioned. OBJECTIVE: The aim was to provide the first rigorous life cycle assessment of reusable and disposable flexible cystoscopes. DESIGN, SETTING, AND PARTICIPANTS: We performed a life cycle assessment of reusable flexible cystoscopes and the aS4C single-use cystoscope (aScope; Ambu, Ballerup, Denmark). For the aScope, the complete lifespan of the scope was evaluated, including raw material extraction, material formulation, component production, product assembly, distribution, transportation after use, and final disposal. For reusable cystoscopes, we limited our analysis to their reprocessing, using a model consisting of standard high-level disinfection with peracetic acid. The environmental impact was evaluated by an independent third-party consulting company APESA (Technopole Hélioparc, Pau, France) dedicated to such risk assessments. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The environmental footprint of both cystoscopes was assessed using five environmental impact categories, namely, climate change, mineral resource depletion, ecotoxicity, acidification, and eutrophication. To perform the life cycle assessment, Simapro v9.3.3 software was used and the Ecoinvent v3.5 database was employed as the primary life cycle inventory database. A Monte Carlo analysis was used to account for the inherent uncertainty in life cycle inventory data and the variability in material and energy consumption for each type of flexible cystoscope. RESULTS AND LIMITATIONS: By only comparing the disinfection reprocessing of reusable cystoscopes with the complete lifespan of the single-use cystoscope, the use of the aScope would allow a reduction of at least 33% in the climate change category, 50% in the mineral resources' depletion category, 51% in the ecotoxicity category, 71% in the acidification category, and 49% in the eutrophication category. Our results cannot be generalized to all health care facilities as we studied only one type of reprocessing method and one disposable flexible cystoscope. CONCLUSIONS: Disinfection reprocessing of reusable cystoscopes was found to have a significantly larger environmental footprint and impact than the whole lifespan of the single-use cystoscope aScope. PATIENT SUMMARY: Using a cradle-to-grave life cycle analysis, we showed that the environmental footprint of a flexible cystoscopy procedure can be reduced by using a disposable cystoscope instead of a reusable cystoscope.

Radioisotope-guided Lymphadenectomy for Pelvic Lymph Node Staging in Patients With Intermediate- and High-risk Prostate Cancer (The Prospective SENTINELLE Study).

PURPOSE: Our aim was to prospectively evaluate the diagnostic accuracy of sentinel lymph node biopsy-guided lymph node dissection compared to extended pelvic lymph node dissection in patients with intermediate- or high-risk prostate cancer. MATERIALS AND METHODS: We conducted a prospective, single-arm, multicenter study at 3 tertiary centers in France between February 2012 and May 2019. Eligible patients had clinically localized intermediate- or high-risk prostate cancer. After intraprostatic injection of (99m)Tc-nanocolloid, the locations of the sentinel lymph nodes were defined by preoperative lymphoscintigraphy. Surgical excision of the sentinel lymph nodes was performed using intraoperative gamma probe guidance. After resection of the sentinel lymph nodes, extended pelvic lymph node dissection was performed in all patients. We assessed the diagnostic accuracy of the sentinel lymph node biopsy method using extended pelvic lymph node dissection as the reference standard. This trial was registered in ClinicalTrials.gov (NCT02732392). RESULTS: A total of 162 men cN0M0 (CT scan and bone scan) were enrolled: 106 (65.4%) and 56 (34.6%) patients had intermediate- and high-risk prostate cancer, respectively. The median number of nodes retrieved was 14 (mean 16, IQR 10-21) per patient. At final pathological analysis, 22 patients (13.6%) were pN+. Sensitivity, specificity, negative predictive value, and positive predictive value of sentinel lymph node biopsy method in detecting patients with at least 1 lymph node metastasis were 95.4% (95% CI, 75.1-99.7), 100% (95% CI, 96.6-100), 99.2% (95% CI, 95.5-99.9), and 100% (95% CI, 80.7-100), respectively. CONCLUSIONS: Our multicenter prospective study supports that sentinel lymph node biopsy is a very effective and sensitive method for pelvic lymph node staging in patients with intermediate- or high-risk localized prostate cancer.

DDX5 mRNA-targeting antisense oligonucleotide as a new promising therapeutic in combating castration-resistant prostate cancer.

The heat shock protein 27 (Hsp27) has emerged as a principal factor of the castration-resistant prostate cancer (CRPC) progression. Also, an antisense oligonucleotide (ASO) against Hsp27 (OGX-427 or apatorsen) has been assessed in different clinical trials. Here, we illustrate that Hsp27 highly regulates the expression of the human DEAD-box protein 5 (DDX5), and we define DDX5 as a novel therapeutic target for CRPC treatment. DDX5 overexpression is strongly correlated with aggressive tumor features, notably with CRPC. DDX5 downregulation using a specific ASO-based inhibitor that acts on DDX5 mRNAs inhibits cell proliferation in preclinical models, and it particularly restores the treatment sensitivity of CRPC. Interestingly, through the identification and analysis of DDX5 protein interaction networks, we have identified some specific functions of DDX5 in CRPC that could contribute actively to tumor progression and therapeutic resistance. We first present the interactions of DDX5 and the Ku70/80 heterodimer and the transcription factor IIH, thereby uncovering DDX5 roles in different DNA repair pathways. Collectively, our study highlights critical functions of DDX5 contributing to CRPC progression and provides preclinical proof of concept that a combination of ASO-directed DDX5 inhibition with a DNA damage-inducing therapy can serve as a highly potential novel strategy to treat CRPC.

Active Surveillance for Intermediate-risk Prostate Cancer: A Systematic Review, Meta-analysis, and Metaregression.

CONTEXT: Active surveillance (AS) is increasingly selected among patients with localized, intermediate-risk (IR) prostate cancer (PCa). However, the safety and optimal candidate selection for those with IR PCa remain uncertain. OBJECTIVE: To evaluate treatment-free survival and oncologic outcomes in patients with IR PCa managed with AS and to compare with AS outcomes in low-risk (LR) PCa patients. EVIDENCE ACQUISITION: A literature search was conducted through February 2022 using PubMed/Medline, Embase, and Web of Science databases. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed to identify eligible studies. The coprimary outcomes were treatment-free, metastasis-free, cancer-specific, and overall survival. A subgroup analysis was planned a priori to explore AS outcomes when limiting inclusion to IR patients with a Gleason grade (GG) of ≤2. EVIDENCE SYNTHESIS: A total of 25 studies including 29 673 unselected IR patients met our inclusion criteria. The 10-yr treatment-free, metastasis-free, cancer-specific, and overall survival ranged from 19.4% to 69%, 80.8% to 99%, 88.2% to 99%, and 59.4% to 83.9%, respectively. IR patients had similar treatment-free survival to LR patients (risk ratio [RR] 1.16, 95% confidence interval (CI), 0.99-1.36, p = 0.07), but significantly higher risks of metastasis (RR 5.79, 95% CI, 4.61-7.29, p < 0.001), death from PCa (RR 3.93, 95% CI, 2.93-5.27, p < 0.001), and all-cause death (RR 1.44, 95% CI, 1.11-1.86, p = 0.005). In a subgroup analysis of studies including patients with GG ≤2 only (n = 4), treatment-free survival (RR 1.03, 95% CI, 0.62-1.71, p = 0.91) and metastasis-free survival (RR 2.09, 95% CI, 0.75-5.82, p = 0.16) were similar between LR and IR patients. Treatment-free survival was significantly reduced in subgroups of patients with unfavorable IR disease and increased cancer length on biopsy. CONCLUSIONS: The present systematic review and meta-analysis highlight the need to optimize patient selection for those with IR features. Our findings support limiting the inclusion of IR patients in AS to those with low-volume GG 2 tumor. PATIENT SUMMARY: Active surveillance is increasingly used in patients with localized, intermediate-risk (IR) prostate cancer. In this population, we have reported higher risks of metastasis and cancer mortality in unselected patients than in patients with low-risk features, underscoring the need to optimize the selection of patients with IR features.

Cost and Environmental Impact of Disposable Flexible Cystoscopes Compared to Reusable Devices.

Objectives: To quantify the environmental impact and costs associated with flexible cystoscopy procedures from an institutional perspective, with particular attention for the comparison between disposable and reusable cystoscopes. Materials and Methods: This is a single-center retrospective study, including all flexible cystoscopies performed between 2020 and 2021 using reusable or single-use devices. The Ambu aS4C single-use cystoscope (Ballerup, Denmark) gradually replaced the reusable device in our center, with exclusive use from October 2021. Reprocessing costs for reusable cystoscopes were evaluated using a micro-costing approach. The environmental impact of reusable and disposable cystoscopes was assessed by the amount of waste and water consumed for each procedure. Results: A total of 1578 flexible cystoscopies using reusable cystoscopes were performed in 2020, and 550 cystoscopies were performed using the Ambu aS4C cystoscope from October 2021 to February 2022. The cost of flexible cystoscopy with a reusable and a disposable endoscope was €196 and €192, respectively. The amount of waste generated by reprocessing reusable and disposable cystoscopes was 800 and 200 g per procedure, respectively. Water consumption for sterilization of the reusable cystoscope was 60 L per procedure, whereas no water consumption was required with the Ambu aS4C cystoscope. A 100% Ambu aS4C cystoscope use would reduce waste generation and water consumption by 946.8 kg and 94.68 m3 per year. Conclusion: In this study, implementing a strategy of using 100% disposable cystoscopes was associated with similar costs and reduced waste generation and water consumption compared to reusable devices. Future studies are needed to compare the carbon footprint of these devices, through a comprehensive and rigorous life cycle assessment from manufacturing to recycling.

Benefit and Harm of Active Surveillance for Biopsy-proven Renal Oncocytoma: A Systematic Review and Pooled Analysis.

Context: Active surveillance (AS) of biopsy-proven renal oncocytomas may reduce overtreatment. However, on biopsy, the risk of misdiagnosis owing principally to entities with peculiar hybrids and overlap morphology, and phenotypes argues for early intervention. Objective: To assess the benefit and harm of AS in biopsy-proven renal oncocytoma. Evidence acquisition: A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). We systematically searched PubMed, Scopus, and Web of Science databases from September 26 up to October 2021, for studies that analyzed the outcomes of AS in patients with biopsy-proven renal oncocytoma. Evidence synthesis: A total of ten studies with 633 patients met our inclusion criteria and were included for analysis. After a median follow-up of 34.5 mo (95% confidence interval [CI] 30.6-38.4), the overall definitive treatment rate from AS to definitive treatment was 17.3% (n = 75/433, six studies). The pooled pathological agreement between the initial renal mass biopsy and the surgical pathology report was 91.1%. The main indications for surgery during follow-up were rapid tumor growth and patient request. The pooled median growth rate was 1.55 mm/yr (95% CI 0.9-2.2). No metastasis or death related to renal oncocytoma was reported. Conclusions: Annual tumor growth of biopsy-proven renal oncocytoma is low. AS is oncologically safe, with favorable compliance of patients. Crossover to definitive treatment revealed a strong concordance between biopsy and final pathology. Further studies on the long-term outcomes of AS are needed. Patient summary: In this study, we examined the benefit and harm of active surveillance (AS) in biopsy-proven oncocytoma. Based on the available data, AS appears oncologically safe and may represent a promising alternative to immediate treatment. Patients should be included in AS decision discussions.

Long-term outcomes of whole gland high-intensity focused ultrasound for localized prostate cancer.

OBJECTIVES: To report the 10-year oncologic and functional outcomes of whole-gland HIFU as first-line treatment for localized prostate cancer (PCa). PATIENTS AND METHODS: Patients were retrospectively included between January 2005 and July 2018 from a prospectively maintained database at a single academic institution. No patient underwent androgen deprivation therapy prior to HIFU. Primary endpoint was biochemical recurrence-free survival (BRFS). Secondary oncological endpoints included salvage treatment-free survival (STFS), cancer-specific survival (CSS) and overall survival (OS). RESULTS: A total of 97 patients met our inclusion criteria and were included in the final analysis. According to D'Amico classification, the numbers of patients with low-, intermediate-, and high-risk disease were 38 (39.2%), 52 (53.6%), and 7 (7.2%). A total of 21 (21.6%) patients received salvage treatment at a mean of 4.1 years (± 2.8) after HIFU. The 10-year OS, CSS and BRFS rates were 91.8%, 100% and 40.3% in the overall cohort, respectively. In multivariate analysis, predictive factors for biochemical recurrence were intermediate-risk group (RR = 2.065; 95% CI 1.008-4.230; p = 0.047) and PSA nadir > 0.5 ng/mL (RR = 4.963; 95% CI 2.251-10.947; p < 0.001). Symptoms related to bladder outlet obstruction were the most frequently recorded adverse events. In multivariate analysis, positive biopsy on the prostatic apex was predictor of obstructive complications (RR = 3.2, 95% CI 1.092-9.476, p = 0.034). Only four patients developed severe urinary incontinence (> 1 pad/day). CONCLUSIONS: HIFU showed low PCa-specific mortality, but biochemical recurrence rates were highly variable among patients. Future studies are needed to improve patient selection.

HoSAGE: sarcopenia in older patient with intermediate / high-risk prostate cancer, prevalence and incidence after androgen deprivation therapy: study protocol for a cohort trial.

BACKGROUND: Sarcopenia is defined by a loss of muscle strength associated to a decrease in skeletal muscle mass. Ageing greatly contributes to sarcopenia as may many other factors such as cancer or androgen deprivation therapies (ADT). This cohort study aims to evaluate (1) the prevalence of muscle disorders and sarcopenia in older patients before initiation of intermediate to high risk prostate cancer treatment with ADT and radiotherapy, and (2) the occurrence and/or aggravation of muscle disorders and sarcopenia at the end of cancer treatment. METHODS: This cohort study is monocentric and prospective. The primary objectives are to determine the risk factor of sarcopenia prevalence and to study the relationship between ADT and sarcopenia incidence, in patients 70 years and older with histologically proven localized or locally advanced prostate cancer, addressed to a geriatrician (G8 score ≤14) for comprehensive geriatric assessment (CGA) in Marseille University Hospital. Secondary objectives encompass, measurement of sarcopenia clinical criteria along prostate oncological treatment; evaluation of the quality of life of patients with sarcopenia; evaluation of the impact of socio-behavioral and anthropological factors on sarcopenia evolution and incidence; finally the evaluation of the impact of ADT exposure on sarcopenia. Sarcopenia prevalence was estimated to be between 20 and 30%, therefore the study will enroll 200 patients. DISCUSSION: The current guidelines for older patients with prostate cancer recommend a pelvic radiotherapy treatment associated to variable duration (6 to 36 months) of ADT. However ADT impacts muscle mass and could exacerbate the risks of sarcopenia. Our study intends to assess the specific effect of ADT on sarcopenia incidence and/or worsening as well as to estimate sarcopenia prevalence in this population. The results of this cohort trial will lead to a better understanding of sarcopenia prevalence and incidence necessary to further elaborate a prevention plan. TRIAL REGISTRATION: The protocol was registered to the French drug and device regulation agency under the number 2019-A02319-48, before beginning the study (11/12/2019). The ClinicalTrials.gov identifier is NCT04484246, registration on the ClinicalTrials.gov ( https://clinicaltrials.gov/ct2/show/NCT04484246 ).

Long-term results of endoscopic treatment in vesicoureteral reflux after kidney transplantation.

OBJECTIVES: To assess the long-term clinical outcomes and identify factors predicting success of endoscopic treatment for symptomatic vesicoureteral reflux (VUR) after kidney transplantation. PATIENTS AND METHODS: A retrospective chart review of all patients who had a symptomatic VUR after renal transplantation at our centre between January 2000 and December 2020 was performed. VUR was documented by retrograde cystography and was determined by at least one episode of acute graft pyelonephritis (AGPN). Endoscopic injections of polydimethylsiloxane (MacroPlastique™) or dextranomer/hyaluronic acid copolymer (Deflux™) were performed by expert urologists via rigid cystoscopy with a bevelled needle system. The results of endoscopic treatment were evaluated by cystography at three months. The primary endpoint was clinical efficacy as defined by the absence of AGPN during follow-up. Radiological success was defined by the absence of VUR at the three months follow-up cystography. RESULTS: Out of 2135 kidney transplantations, a total of 117 (5.5%) patients had symptomatic VUR: 100 (85.5%) underwent Deflux™ and 17 (14.5%) MacroPlastique™. Preoperative high-grade VUR was recorded in 71% of patients. One postoperative complication was observed, Clavien > II. After a median follow-up of 11.2 years (IQR 6.5-14.4), clinical success was achieved in 73 patients (62.4%). Radiological success was obtained in 42 patients (36%). Multivariable analysis failed to identify predictors of endoscopic treatment success, which was independent of the preoperative grade of VUR and the type of bulking agent used. CONCLUSION: Endoscopic treatment of VUR is a simple and well-tolerated procedure with long-term clinical efficacy.

Active Surveillance for Biopsy Proven Renal Oncocytomas: Outcomes and Feasibility.

OBJECTIVES: To report the outcomes and feasibility of active surveillance (AS) of biopsy-proven renal oncocytomas. METHODS: Multicentric retrospective study (2010-2016) in 6 academic centers that included patients with biopsy-proven renal oncocytomas who were allocated to AS (imperative or elective indication) with a follow-up ≥1 year. Imaging was performed at least once a year, by CT-scan or ultrasound or MRI. Conversion to active treatment (surgical excision or ablative treatment) was at the discretion of the urologist. The primary endpoint was renal tumor growth (cm/year). Secondary outcomes included accuracy of biopsy, incidence, and reason to change AS to active treatment. RESULTS: Eighty-nine patients were included: Median age 67 years (26-89) and median tumor size 26 mm [15-90] on diagnosis. During a mean follow-up of 43 months'' (median 36 [12-180]), mean tumor growth was 0.24 cm/year. No predictive factors (demographical, radiological or histologic) of tumor growth could be identified. Conversion from AS to active treatment occurred in 24 patients (27%) (13 surgical excisions, 11 ablative procedures), in a median time of 45 (12-76) months'' after diagnosis. Tumor growth was the main indication to convert AS to active treatment (58%) with 8% of the patients opting to discontinue AS. No patient had metastatic progression nor disease-specific death. The correlation between biopsy and surgical specimen was 92%. CONCLUSION: Active surveillance for biopsy-proven renal oncocytomas was oncologically safe and patient adherence was high. No predictive factor for tumor growth could be identified but the tumor growth rate was low, and biopsy efficacy was high.

Efficacy and Safety of Surgery for Benign Prostatic Obstruction in Patients with Preoperative Urinary Catheter.

Purpose: To evaluate the efficacy and safety of benign prostatic obstruction (BPO) surgery in patients with preoperative urinary catheterization. Patients and Methods: We conducted a multi-institutional retrospective study including all patients who failed a trial without catheter (TWOC) after acute urinary retention (AUR) between January 2017 and January 2019. Patients with neurogenic bladder, prostate cancer, or urethral stricture were excluded from the analysis. Patients underwent either monopolar/bipolar transurethral resection of the prostate (TURP), photoselective vaporization of the prostate (PVP), prostate artery embolization (PAE), open prostatectomy (OP), or endoscopic enucleation. The primary endpoint was 12-month urinary catheter-free survival without using benign prostatic hyperplasia medications. Results: One hundred seventy-one consecutive men (median age: 71 years; median prostate volume: 75 cm3) underwent BPO surgery, including 48 (28%) TURP, 62 (36.3%) PVP, 21 (12.3%) endoscopic enucleation, 15 (8.8%) PAE, and 25 (14.6%) OP. The median duration of preoperative urinary catheterization was 69 days (interquartile range 46-125). The 12-month urinary catheter-free survival rate was 84.8% (145/171). Satisfactory voiding returned to 121 patients (70.8%). On backward stepwise multivariable analysis, PVP (odds ratio [OR] 0.27 [0.10-0.69]; p = 0.008), PAE (OR 5.27 [1.28-27.75]; p = 0.03), endoscopic enucleation (OR 0.08 [0-0.49]; p = 0.023), OP (OR 0.10 [0.01-0.57]; p = 0.034), Charlson score (OR 1.36 [1.14-1.66]; p = 0.001), and number of preoperative TWOC failure (OR 2.53 [1.23-5.51]; p = 0.014) were significantly associated with catheter-free survival. Conclusions: In this multi-institutional retrospective study, including patients with preoperative catheterization, the overall success rate of BPO surgery was 70.8% after 1-year follow-up. Compared with TURP, enucleation methods and PVP were associated with better catheter-free survival, whereas PAE was associated with higher risk of AUR recurrence.

Selective Trans-arterial Embolization of Iatrogenic Vascular Lesions Did Not Influence the Global Renal Function After Partial Nephrectomy.

OBJECTIVE: To evaluate the renal function outcomes after selective trans-arterial embolization (SAE) of iatrogenic vascular lesions (IVL), including pseudoaneurysm and arteriovenous fistula, following partial nephrectomy (PN). MATERIALS AND METHODS: A multi-institutional study was conducted including consecutive patients who underwent PN between January 2009 and March 2019. Two surgical approaches were used: open and robot-assisted PN. Patients with SAE were identified and matched (1:2) with patients without IVL. The matching criteria were age, gender, Charlson score, creatinine clearance, RENAL score, and tumor size. The primary outcome was the evolution of global renal function at 6-months postoperatively. RESULTS: A total of 493 consecutive PN (360 open PN and 133 robot-assisted PN) were included. IVL occurred in 17 cases (3.4%) without statistical difference according to the surgical approach (P = .78). Patients from embolization group were matched to 34 cases without postoperative IVL. Groups were comparable concerning clinical, tumor and surgical characteristics. The clinical success of SAE, defined as the absence of recourse to a second embolization or a total nephrectomy, was obtained in 16 (94.1%) cases. No minor or major complications were reported after SAE. The preoperative estimated glomerular filtration rate (eGFR) was similar between control group (93 [85-102] ml/min) and embolization group (95 [83-102] ml/min) (P = .99). Median (IQR) eGFR between control group (87 [72-95] ml/min) and embolization group (83 [76-93] ml/min) at a follow-up of 6 months showed no significant difference (P = .73). CONCLUSION: IVL are rare complications of PN. SAE is an effective and minimally invasive management tool, with no deleterious effect on global renal function.

Impact of Androgen Deprivation Therapy Associated to Conformal Radiotherapy in the Treatment of D'Amico Intermediate-/High-Risk Prostate Cancer in Older Patients.

PURPOSE/OBJECTIVE: The association of 3D Conformal External Beam Radiotherapy (3D-CEBRT) with adjuvant Androgen Deprivation Therapy (ADT) proved to treat patients with intermediate- and high-risk localized prostate cancer (IR and HR). However, older patients were underrepresented in literature. We aimed to report the oncological results and morbidity 3D-CEBRT +ADT in ≥80 years patients. MATERIAL AND METHODS: From June 1998 to July 2017, 101 patients ≥80 years were included in a tertiary center. The median age was 82 years. ADT was initiated 3 months prior 3D-CEBRT in all patients, with a total duration of 6 months for IR prostate cancer (group A; n = 41) and 15 months for HR prostate cancer (group B; n = 60). Endpoints included overall survival (OS), metastasis-free survival (DMFS), biochemical recurrence-free survival (BRFS) and toxicity. RESULTS: Five years-OS was 95% and 86.7% in groups A and B, respectively. Cardiovascular events occurred in 22.8% of ≥80 years patients with no impact on OS. In the multivariate analysis, age <82 years, Karnofsky index and normalization of testosterone levels were significantly associated with better OS. CONCLUSION: Age ≥80 years should not be a limitation for the treatment of IR and HR prostate cancer patients with 3D-CEBRT and ADT, but cardiovascular monitoring and prevention are mandatory.

Diagnostic ureteroscopy prior to nephroureterectomy for urothelial carcinoma is associated with a high risk of bladder recurrence despite technical precautions to avoid tumor spillage.

PURPOSE: There have recent reports in the literature of increased rates of bladder recurrence (BR) after radical nephroureterectomy (RNU) when diagnostic flexible ureteroscopy (DFU) was performed before RNU. The technical heterogeneity of DFU was a major bias in these studies. Our purpose was to evaluate the impact of a standardized DFU technique before RNU on the risk of BR. METHODS: A retrospective monocenter study including patients who underwent RNU for upper tract urothelial carcinoma (UTUC) between 2005 and 2017. 171 patients were identified. 78 patients were excluded owing to a history of bladder cancer before RNU or neo-adjuvant/adjuvant chemotherapy. 93 included patients were stratified according to pre-RNU ureteroscopy (DFU + 70 patients) or no pre-RNU ureteroscopy (DFU-23 patients). The standardized DFU technique consisted of systematic ureteral sheath (ch9-10), flexible ureteroscopy, biopsy, and drainage with a mono-J/bladder catheter to avoid contact of contaminated urine of the upper tract with the bladder. RESULTS: Epidemiological, initial staging, and postoperative tumoral characteristics were similar in both groups. Mean follow-up was 35 months [2-166], 47(50%) BR occurred with 41(87%) in the DFU + group, and pre-RNU-DFU was an independent predictive factor of BR (OR = 4[1.4-11.9], P = 0.01) (Cox regression model). The characteristics of BR were similar in both groups, although BR occurred earlier in DFU + (427 days vs. 226 days (P = 0.07)). CONCLUSION: Bladder recurrence after diagnostic ureteroscopy + nephroureterectomy was high despite technical precautions to avoid contact of bladder mucosa with contaminated urine from the upper urinary tract. Post-DFU endovesical instillation should be investigated.