A Prospective Randomized Trial of Neoadjuvant Chemohormonal Therapy vs Hormonal Therapy in Locally Advanced Prostate Cancer Treated by Radical Prostatectomy.

PURPOSE: Benefits of docetaxel-based neoadjuvant chemohormonal therapy (NCHT) before radical prostatectomy (RP) remain largely unknown. We explored whether docetaxel-based NCHT would bring pathological benefits and improve biochemical progression-free survival (bPFS) over neoadjuvant hormonal therapy (NHT) in locally advanced prostate cancer. MATERIALS AND METHODS: A randomized trial was designed recruiting 141 locally advanced, high-risk prostate cancer patients who were randomly assigned at the ratio of 2:1 to the NCHT group (75 mg/m2 body surface area every 3 weeks plus androgen deprivation therapy for 6 cycles) and the NHT group (androgen deprivation therapy for 24 weeks). The primary end point was 3-year bPFS. Secondary end points were pathological response including pathological downstaging and minimal residual disease rates. RESULTS: The NCHT group showed significant benefits in 3-year bPFS compared to the NHT group (29% vs 9.5%, P = .002). At a median follow-up of 53 months, the NCHT group achieved a significantly longer median bPFS time than the NHT group (17 months vs 14 months). No significant differences were found between the 2 groups in pathological downstaging and minimal residual disease rates. CONCLUSIONS: NCHT plus RP achieved significant bPFS benefits when compared with NHT plus RP in high-risk, locally advanced prostate cancer. A larger cohort with longer follow-up duration is essential in further investigation.

Asymptomatic Bacteriuria and Urological Surgery: Risk Factor or Not? Results From the National and Multicenter TOCUS Database.

PURPOSE: Current guidelines recommend screening and treatment of asymptomatic bacteriuria prior to all urological surgeries breaching the mucosa. But little evidence supports this recommendation. At the least, risk stratification for postoperative UTI to support this strategy is lacking. The aim of this study was to define the associated factors for postoperative febrile infectious complications (UTI or surgical site infection) in urological surgery. MATERIALS AND METHODS: We conducted a retrospective, multicentric study including all consecutive patients undergoing any urological surgery with preoperative urine culture. The primary outcome was the occurrence of a UTI or surgical site infection occurring within 30 days after surgery. RESULTS: From 2016 to 2023, in 10 centers, 2389 patients were included with 838 (35%) positive urine cultures (mono-/bi-/polymicrobial). Postoperative infections occurred in 106 cases (4.4%), of which 44 had negative urine cultures (41%), 42 had positive mono-/bimicrobial urine cultures (40%), and 20 had polymicrobial urine cultures (19%). In multivariable analysis, UTI during the previous 12 months of surgery (odds ratio [OR] 3.43; 95% CI 2.07-5.66; P < .001), monomicrobial/bimicrobial preoperative urine culture (OR 3.68; 95% CI 1.57-8.42; P = .02), polymicrobial preoperative urine culture (OR 2.85; 95% CI 1.52-5.14; P < .001), and operative time (OR 1.09; 95% CI 1.04-1.15; P < .001) were independent associated factors for postoperative febrile infections. CONCLUSIONS: Positive urine culture, including preoperative polymicrobial urine culture, prior to urological surgery was associated with postoperative infection. Additionally, patients experiencing infectious complications also had a higher incidence of other complications. The effectiveness of systematic preventive antibiotic therapy for a positive urine culture has not been conclusively established.

Retroperitoneoscopic Clampless, Sutureless Hybrid Therapy in the Management of Renal Hilar Tumors.

OBJECTIVE: We aimed to investigate the outcomes and feasibility of a retroperitoneoscopic clampless, sutureless hybrid technique in the management of renal hilar tumors. METHODS: A retrospective cohort of consecutive patients with renal hilar tumors who received retroperitoneoscopic clampless, sutureless hybrid therapy between January 2017 and April 2021 was included. The hybrid surgical technique involved microwave ablation (MWA), followed by clampless tumor enucleation and sutureless hemostasis. Surgical, pathological, and oncological outcomes were recorded and analyzed. RESULTS: Sixty patients were included in this study. The median tumor size was 3.5 cm (2-5), the median RENAL score was 7 (range 6-10), the median operative time was 110 min (70-130), and the median estimated blood loss was 80 mL (30-130). The median length of postoperative hospital stay was 3 days (2-4), and no warm ischemia time was observed, except in one patient who required conversion to conventional on-clamp laparoscopic partial nephrectomy (LPN) with a 10 min warm ischemia time. Three minor complications (Clavien-Dindo grade I) and one major complication (Clavien-Dindo grade III) were recorded postoperatively. Thus far, no blood transfusions have been required. Renal dysfunction or tumor recurrence did not occur within a median follow-up of 45 months. CONCLUSION: The retroperitoneoscopic hybrid technique involving MWA, clampless tumor enucleation, and sutureless hemostasis is a feasible and safe option for the management of selective renal hilar tumors. Complete tumor removal with maximal renal function preservation can be achieved, with a low complication rate.

Asymptomatic bacteriuria prior to partial and radical nephrectomy: To screen or not to screen? Results from the national and multicenter TOCUS database.

INTRODUCTION: In the era of increased bacterial resistance, the main strategy is to reduce the prescription of antibiotics when possible. Nowadays, it is highly recommended to screen for asymptomatic bacteriuria (ABU), prior to urological surgery with potential mucosal breach or urine exposure. Screening and treating urinary colonization is a strategy widely adopted before radical and partial nephrectomy but without any evidence. Our main end point in this study is to analyze the relationship between preoperative urine culture and the risk of postoperative febrile urinary tract infection (UTI) or surgical-site infection (SSI) in partial or radical nephrectomy patients. METHODS: We conducted a multicenter retrospective cohort study between January 2016 and January 2023 in 11 French tertiary referral hospitals (TOCUS database). We collected the data for 269 patients including several pre-, intra-, and post-operative variables that could potentially increase the risk of postoperative UTI and SSI including preoperative urinary culture results. RESULTS: The incidence rate of postoperative UTI and SSI was 8.9% in our study. After conducting a logistic multivariate analysis, a propensity score matching analysis, and a subgroup analysis, we found no significant correlation between the urine culture and the postoperative UTI risk [OR = 1.2 (0.5-2.7) (p = 0.7)]. Only the postoperative non-infectious complications were related to a higher risk of postoperative UTI [OR = 12 (4-37), p < 0.001)]. CONCLUSION: Our research shows that screening and treating for ABU prior to radical or partial nephrectomy seems to be unnecessary to prevent postoperative UTI and SSI.

Outcomes of holmium laser enucleation of the prostate (HoLEP) for very large-sized benign prostatic hyperplasia (over 150 mL): open simple prostatectomy is dead.

INTRODUCTION: Our study aimed to describe the outcomes of transurethral enucleation of the prostate (HoLEP) for large-sized benign prostatic hyperplasia over 150 mL (bBPH). METHODS: We conducted a retrospective, descriptive, and analytical study of patients undergoing HoLEP for bBPH. The primary endpoint was the success of the procedure, defined by a mixed criteria: complete endoscopic enucleation of the prostate, absence of blood transfusion or reoperation for bleeding, post-operative improvement of quality of life (assessed by a ≥ 2 points increase at in the 8th question of the IPSS test) and post-operative continence (no pads use) at 3 months. RESULTS: Eighty-one patients were included with a mean age of 73.9 ± 7.3 and a mean measured prostate volume of 183.3 ± 34.5 cc. The mean operative time was 57.5 ± 29.7 min and the average wet weight of resected tissue removed was 151.8 ± 44.7 g. Mean hospitalization stay was 1.3 ± 0.7 days with a mean post-operative catheterization period of 1.9 ± 0.9 days. The success of the surgery was achieved in 77 patients (95%). Functional improvements were found at 1 and 6 months for Qmax, post-void residual, IPSS and QoL-IPSS. The 30-day complication rate was 9.9%. The average PSA level dropped from 14.8 ± 11.6 ng/mL at baseline to 0.8 ± 0.5 ng/mL at 6 months. CONCLUSION: HoLEP for bBPH is both safe and efficient. Regarding the benefit/risk balance, it should be highlighted as the gold standard for the management of big BPH.

Adjustable continence therapy (proACT) for the treatment of male stress urinary incontinence post-prostatectomy: a systematic review and meta-analysis (2023 update).

PURPOSE: Stress urinary incontinence (SUI) is a key factor for post-prostatectomy (RP) quality of life. Current international guidelines struggle to find the adequate place for each kind of surgeries. The aim of this systematic review and meta-analysis considering updated evidence is to assess the efficacy and safety of proACT in treating male patients with post-RP SUI. METHODS: A review of the literature was performed by searching the PubMed database. We narrowed included studies with adult male patients with SUI; outcomes included pads or pad weight per day and quality of life (QOL) questionnaires, as well as safety outcomes. RESULTS: 18 studies involving 1570 patients mean age of 68.8 (EC 2.1) were included. The mean follow-up reported was 34.7 months (EC 17.7; median 38.5; range 1-128 months). An average of 60.7% (EC 27) and 40.4% of patients suffered from mild-to-moderate and severe incontinence, respectively. The overall dryness rate was 55.1% (EC 19.3) while respecting the definition of 0-1 pads per day, and the mean dryness rate was 53% (EC 0.2). The mean overall complication rate was 31.2% (EC 18.3%), including an explantation rate of 26.5% (EC 15.3) and a reoperation rate of 22.7% (EC 8.7). The methodological quality of the 18 studies was very heterogeneous. CONCLUSION: Implantation of proACT adjustable balloons is a minimally invasive technique that provides medium outcomes (53%) with a strict definition of dryness (0-1 PPD) and important complication rate (31.2%). Past of irradiation is a negative predictive factor for incontinence.

Nephrometry scores to predict oncological outcomes following partial nephrectomy (UroCCR Study 70).

PURPOSE: Partial nephrectomy (PN) for large or complex renal tumors can be difficult and associated with a higher risk of recurrence than radical nephrectomy. We aim to evaluate the clinical useful of nephrometry scores for predicting oncological outcomes in a large cohort of patients who underwent PN for renal cell carcinomas. METHODS: Our analysis included patients who underwent PN for renal cell carcinoma in 21 French academic centers (2010-2020). RENAL, PADUA, and SPARE scores were calculated based on preoperative imaging. Uni- and multivariate cox models were performed to identify predictors of recurrence-free survival and overall survival. The area under the curve (AUC) was used to identify models with the highest discrimination. Decision curve analyses (DCAs) determined the net benefit associated with their use. RESULTS: A total of 1927 patients were analyzed with a median follow-up of 32 months (14-45). RENAL score (p = 0.01), age (p = 0.002), histological type (p = 0.001), high nuclear grade (p = 0.001), necrotic component (p < 0.001), and positive margins (p = 0.005) were significantly related to recurrence in multivariate analyses. The discriminative performance of the 3 radiological scores was modest (65, 63, and 63%, respectively). All 3 scores showed good calibration, which, however, deteriorated with time. Decision curve analysis of the three models for the prediction of overall and recurrence-free survival was similar for all three scores and of limited clinical relevance. CONCLUSION: The association between nephrometry scores and oncological outcomes after NP is very weak. The use of these scores for predicting oncological outcomes in routine practice is therefore of limited clinical value.

Development of a predictive tool for sacral nerve modulation implantation in the treatment of non-obstructive urinary retention and/or slow urinary stream: a study from the Neuro-Urology Committee of the French Association of Urology.

PURPOSE: This study aimed to seek predictive factors and develop a predictive tool for sacral nerve modulation (SNM) implantation in patients with non-obstructive urinary retention and/or slow urinary stream (NOUR/SS). METHODS: This study was designed as a retrospective study including all patients who have undergone a two-stage SNM for NOUR/SS between 2000 and 2021 in 11 academic hospitals. The primary outcome was defined as the implantation rate. Secondary outcomes included changes in bladder emptying parameters. Univariate and multivariable logistic regression analysis were performed and determined odds ratio for IPG implantation to build a predictive tool. The performance of the multivariable model discrimination was evaluated using the c-statistics and an internal validation was performed using bootstrap resampling. RESULTS: Of the 357 patients included, 210 (58.8%) were finally implanted. After multivariable logistic regression, 4 predictive factors were found, including age (≤ 52 yo; OR = 3.31 CI95% [1.79; 6.14]), gender (female; OR = 2.62 CI95% [1.39; 4.92]), maximal urethral closure pressure (≥ 70 cmH2O; OR: 2.36 CI95% [1.17; 4.74]), and the absence of an underlying neurological disease affecting the lower motor neuron (OR = 2.25 CI95% [1.07; 4.76]). Combining these factors, we established 16 response profiles with distinct IPG implantation rates, ranging from 8.7 to 81.5%. Internal validation found a good discrimination value (c-statistic, 0.724; 95% CI 0.660-0.789) with a low optimism bias (0.013). This allowed us to develop a predictive tool ( https://predictivetool.wixsite.com/void ). CONCLUSION: The present study identified 4 predictive factors, allowing to develop a predictive tool for SNM implantation in NOUR/SS patients, that may help in guiding therapeutic decision-making. External validation of the tool is warranted.

Which revision strategy is the best for non-mechanical failure of male artificial urinary sphincter?

PURPOSE: Persistence or recurrence of stress urinary incontinence (prSUI) after artificial urinary sphincter (AUS) implantation may be secondary to non-mechanical failure (NOMECA). It have for long been assumed to result from urethral atrophy. Its existence is now debated. As the pathophysiology of NOMECA is not elucidated, the most appropriate management remains unclear. We aimed to compare the several revision techniques for NOMECA of AUS in men. METHODS: NOMECA was defined as prSUI, with normally functioning device, no erosion, infection or fluid loss. Exclusion criteria were neurogenic SUI, revision or explantation for other causes. From 1991 to 2022, 143 AUS revisions for NOMECA, including 99 cuff DOWNSIZING, 10 cuff repositioning (RELOC), 13 TANDEM-CUFF placement, 18 cuff changing (CHANGE), three increasing balloon pressure (BALLOON-UP), were performed in 10 centers. BALLOON-UP patients weren't included in comparative analysis due to small sample size. All components could be changed during the revision. Patients were also categorized in COMPLETE-CHANGE vs. PARTIAL-CHANGE of the device. RESULTS: The three-months complete continence rate was 70.8% with a significant difference between RELOC and DOWNSIZING groups (p = 0.04). COMPLETE CHANGE was significantly associated with complete continence status at three months in multivariate analysis (83.3% vs. 63.3%, OR = 2.7; CI 95% [1.1-7.1], p = 0.03). Estimated five-year reoperation-free and explantation-free survival were respectively 63.4% and 75.9% (p = 0.16; p = 0.30). Those were significantly longer in COMPLETE-CHANGE vs PARTIAL-CHANGE (82.2% vs. 69.6%, p = 0.03); (71.2% vs. 58.2%, p = 0.047). CONCLUSIONS: AUS revision for prSUI due to NOMECA yields satisfactory outcomes regardless of the technique used. We observed better functional outcomes when repositioning the new cuff. COMPLETE-CHANGE may improve functional outcomes, explantation-free and reoperation-free survivals.

Minimally invasive nephron-sparing treatments for T1 renal cell cancer in patients over 75 years: a comparison of outcomes after robot-assisted partial nephrectomy and percutaneous ablation.

PURPOSE: To compare the oncological and perioperative outcomes of robot-assisted partial nephrectomy (RPN) and percutaneous thermal ablation (PTA) for treatment of T1 renal cell cancer (RCC) in patients older than 75 years. MATERIALS AND METHODS: Retrospective national multicenter study included all patients older than 75 years treated for a T1 RCC by RPN or PTA between January 2010 and January 2021. Patients' characteristics, tumor data, and perioperative and oncological outcomes were compared. RESULTS: A total of 205 patients for 209 procedures (143 RPN and 66 PTA) were included. In the PTA group, patients were older (80.4 ± 3.7 vs. 79 ± 3.7 years (p = 0.01)); frailer (ASA score (2.43 ± 0.6 vs. 2.17 ± 0.6 (p < 0.01)); and more frequently had a history of kidney surgery (16.7% [11/66] vs. 5.6% [8/143] (p = 0.01)) than in the RPN group. Tumors were larger in the RPN group (2.7 ± 0.7 vs. 3.2 ± 0.9 cm (p < 0.01)). Operation time, length of hospital stay, and increase of creatinine serum level were higher in RPN (respectively 92.1 ± 42.7 vs. 150.7 ± 61.3 min (p < 0.01); 1.7 ± 1.4 vs. 4.2 ± 3.4 days (p < 0.01); 1.9 ± 19.3% vs. 10.1 ± 23.7 (p = 0.03)). Disease-free survival and time to progression were similar (respectively, HR 2.2; 95% CI 0.88-5.5; p = 0.09; HR 2.1; 95% CI 0.86-5.2; p = 0.1). Overall survival was shorter for PTA that disappeared after Cox adjusting model (HR 3.3; 95% CI 0.87-12.72; p = 0.08). CONCLUSION: Similar oncological outcomes are observed after PTA and RPN for T1 RCC in elderly patients. CLINICAL RELEVANCE STATEMENT: Robot-assisted partial nephrectomy and percutaneous thermal ablation have similar oncological outcomes for T1a kidney cancer in patients over 75 years; however, operative time, decrease in renal function, and length of hospital stay were lower with ablation. KEY POINTS: • After adjusting model for age and ASA score, similar oncological outcomes are observed after percutaneous thermal ablation and robot-assisted partial nephrectomy for T1 renal cell cancer in elderly patients. • Operation time, length of hospital stay, and increase of creatinine serum level were higher in the robot-assisted partial nephrectomy group.

Robot-assisted vesicovaginal fistula repair: comparison of the extravesical and transvesical techniques.

INTRODUCTION AND OBJECTIVES: Almost two decades after the description of robotic vesicovaginal fistula repair (R-VVF), the literature remains limited. The aims of this study are to report the outcomes of R-VVF and to compare the transvesical versus extravesical techniques. METHODS: We performed an observational, retrospective, multicenter study, including all patients who underwent R-VVF from March 2017 to September 2021 at four academic institutions. All abdominal VVF repair over the study period were performed using a robotic approach. The success of R-VVF was defined as the absence of clinical recurrence. The outcomes of the extravesical versus transvesical techniques were compared. RESULTS: Twenty-two patients were included. The median age was 43 years old (IQR 38-50). Fistulas were supratrigonal and trigonal in 18 and 4 cases respectively. Five patients had undergone previous attempts of fistula repair (22.7%). The fistulous tract was systematically excised, and an interposition flap was used in all but two cases (90.9%). The transvesical and extravesical techniques were used in 13 and 9 cases respectively. There were four postoperative complications, three minor and one major. None of the patients had vesicovaginal fistula recurrence after a median follow-up of 15 months. CONCLUSIONS: The present series, one of the largest R-VVF reported to date, is consistent with the few series already published with a 100% cure rate. Systematic excision of the fistulous tract and the high rate of flap interposition may explain the high success rate. The transvesical and extravesical approaches yielded similar outcomes.

Nivolumab, nivolumab-ipilimumab, and VEGFR-tyrosine kinase inhibitors as first-line treatment for metastatic clear-cell renal cell carcinoma (BIONIKK): a biomarker-driven, open-label, non-comparative, randomised, phase 2 trial.

BACKGROUND: We previously reported a 35-gene expression classifier identifying four clear-cell renal cell carcinoma groups (ccrcc1 to ccrcc4) with different tumour microenvironments and sensitivities to sunitinib in metastatic clear-cell renal cell carcinoma. Efficacy profiles might differ with nivolumab and nivolumab-ipilimumab. We therefore aimed to evaluate treatment efficacy and tolerability of nivolumab, nivolumab-ipilimumab, and VEGFR-tyrosine kinase inhibitors (VEGFR-TKIs) in patients according to tumour molecular groups. METHODS: This biomarker-driven, open-label, non-comparative, randomised, phase 2 trial included patients from 15 university hospitals or expert cancer centres in France. Eligible patients were aged 18 years or older, had an Eastern Cooperative Oncology Group performance status of 0-2, and had previously untreated metastatic clear-cell renal cell carcinoma. Patients were randomly assigned (1:1) using permuted blocks of varying sizes to receive either nivolumab or nivolumab-ipilimumab (ccrcc1 and ccrcc4 groups), or either a VEGFR-TKI or nivolumab-ipilimumab (ccrcc2 and ccrcc3 groups). Patients assigned to nivolumab-ipilimumab received intravenous nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four doses followed by intravenous nivolumab 240 mg every 2 weeks. Patients assigned to nivolumab received intravenous nivolumab 240 mg every 2 weeks. Patients assigned to VEGFR-TKIs received oral sunitinib (50 mg/day for 4 weeks every 6 weeks) or oral pazopanib (800 mg daily continuously). The primary endpoint was the objective response rate by investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1. The primary endpoint and safety were assessed in the population who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT02960906, and with the EU Clinical Trials Register, EudraCT 2016-003099-28, and is closed to enrolment. FINDINGS: Between June 28, 2017, and July 18, 2019, 303 patients were screened for eligibility, 202 of whom were randomly assigned to treatment (61 to nivolumab, 101 to nivolumab-ipilimumab, 40 to a VEGFR-TKI). In the nivolumab group, two patients were excluded due to a serious adverse event before the first study dose and one patient was excluded from analyses due to incorrect diagnosis. Median follow-up was 18·0 months (IQR 17·6-18·4). In the ccrcc1 group, objective responses were seen in 12 (29%; 95% CI 16-45) of 42 patients with nivolumab and 16 (39%; 24-55) of 41 patients with nivolumab-ipilimumab (odds ratio [OR] 0·63 [95% CI 0·25-1·56]). In the ccrcc4 group, objective responses were seen in seven (44%; 95% CI 20-70) of 16 patients with nivolumab and nine (50% 26-74) of 18 patients with nivolumab-ipilimumab (OR 0·78 [95% CI 0·20-3·01]). In the ccrcc2 group, objective responses were seen in 18 (50%; 95% CI 33-67) of 36 patients with a VEGFR-TKI and 19 (51%; 34-68) of 37 patients with nivolumab-ipilimumab (OR 0·95 [95% CI 0·38-2·37]). In the ccrcc3 group, no objective responses were seen in the four patients who received a VEGFR-TKI, and in one (20%; 95% CI 1-72) of five patients who received nivolumab-ipilimumab. The most common treatment-related grade 3-4 adverse events were hepatic failure and lipase increase (two [3%] of 58 for both) with nivolumab, lipase increase and hepatobiliary disorders (six [6%] of 101 for both) with nivolumab-ipilimumab, and hypertension (six [15%] of 40) with a VEGFR-TKI. Serious treatment-related adverse events occurred in two (3%) patients in the nivolumab group, 38 (38%) in the nivolumab-ipilimumab group, and ten (25%) patients in the VEGFR-TKI group. Three deaths were treatment-related: one due to fulminant hepatitis with nivolumab-ipilimumab, one death from heart failure with sunitinib, and one due to thrombotic microangiopathy with sunitinib. INTERPRETATION: We demonstrate the feasibility and positive effect of a prospective patient selection based on tumour molecular phenotype to choose the most efficacious treatment between nivolumab with or without ipilimumab and a VEGFR-TKI in the first-line treatment of metastatic clear-cell renal cell carcinoma. FUNDING: Bristol Myers Squibb, ARTIC.

Impact of radiation therapy on artificial urinary sphincter implantation in male patients: A multicenter study.

AIMS: To evaluate the impact of an history of radiation therapy on the outcomes of artificial urinary sphincter (AUS) implantation in male patients. METHODS: The charts of all patients who underwent AUS implantation for stress urinary incontinence (SUI) after prostate surgery in thirteen centers between 2004 and 2020 were retrospectively reviewed. We excluded patients with neurogenic SUI. Continence rates and incidence of complications, revision and cuff erosion were evaluated. The outcomes in irradiated men were compared to those of non irradiated men. RESULTS: A total of 1277 patients who had an AUS met the inclusion criteria with a median age of 70 years, of which 437 had an history of prior radiotherapy. There was no difference in comorbidities. In irradiated patients, postoperative social continence, urethral atrophy and infection rates were respectively 75.6%, 2.4% and 9.5% and 76.8%, 5.4%, and 5.8% in nonirradiated men (respectively, p = 0.799, p = 0.128, p = 0.148). There were more urethral erosion in irradiated male patients. After a mean follow up of 36.8 months, the explantation free survival was poorer in irradiated patients (p = 0.001). CONCLUSION: These data suggest that pelvic radiotherapy before AUS adversely affect device survival with and increased greater occurrence of infection-erosion and therefore of explantation.

Primary care-based follow-up for prostate and kidney cancer survivors: a retrospective monocentric study.

PURPOSE: New follow-up models of care are needed to ensure long-term comprehensive care for cancer survivors. We investigated the impact of a general practitioner (GP)-led follow-up program for prostate cancer (PCa) and renal cell cancer (RCC) survivors. METHODS: This retrospective monocentric study compared standard urologist-led follow-up to experimental GP-led follow-up within a nurse-led network for PCa and RCC survivors. To assess the safe continuity of follow-up, the number of patients lost to follow-up (LFU) was collected. A microcosting analysis from the French national health system perspective was conducted to describe incremental costs associated with experimental follow-up. A satisfaction survey was conducted to determine participating patient's and GP's satisfaction scores, ranging from 0 to 4 and 0 to 5, respectively. RESULTS: Among the 1274 patients included, 92/753 (12.2%) were LFU during standard follow-up vs 0/521 (0%) during experimental follow-up (p < 0.001). In the latter, the median management delay of suspected recurrence for PCa and RCC survivors was 20 [12-27] and 16 [10.5-31.25] days, and the mean incremental cost on a per-patient basis was 34.68 ± 105.87€ and 64.24 ± 93.55€, respectively. Patient and GP mean satisfaction scores were 3.6/4 and 3.9/5, respectively. CONCLUSION: The GP-led follow-up of PCa and RCC survivors within a nurse-led network seems to provide safe continuity of follow-up and seems not to be associated with major incremental costs. The surveys indicated high level of patient's satisfaction and encouraging results regarding GP's satisfaction. Randomized clinical trials are needed to confirm these findings and promote larger implementation of this type of follow-up care.

Impact of the app-based and nurse-led supportive care program AKO@dom on dose intensity of oral-targeted therapies in patients with metastatic renal cell cancer: a multicentric observational retrospective study.

BACKGROUND: Tyrosine kinase inhibitors (TKIs) remain a cornerstone of metastatic kidney cancer (mRCC). Adverse events (AEs) may lead to dose downregulation, and optimal management of AEs is needed to maintain an efficient dose intensity (DI). The aim of our study was to evaluate the impact of an app-based and nurse-led supportive-care program on DI in mRCC patients. METHOD: This multicenter (n = 3), retrospective study evaluated all consecutive mRCC patients who participated in the AKO@dom program, which consisted of an app-based and nurse-led weekly patient evaluation at home during the first 3 months of TKI intake. Treatment patterns and modifications were described, and the mean DI (mDI) was calculated at the end of AKO@dom. RESULTS: Eighty-nine patients were included: 12 had sunitinib, 18 pazopanib, 12 axitinib, and 47 cabozantinib. Median age was 69 years (60-76). TKIs were mainly initiated at standard doses except for cabozantinib (53% started at 40 mg/day); 71% had prior systemic treatment. Nine patients discontinued permanent treatment during the program. Thirty-two patients required ≥ 1 dose interruption, and 29% experienced ≥ 1 grade 3 AE of any type. The mDI (in mg/day) at 3 months was 34.4 ± 17.7 for sunitinib, 672.8 ± 144 for pazopanib, 8.6 ± 2.6 for axitinib, and 40 (36-48) for cabozantinib. Fifty-five patients [68.75% (95% CI: 57-78%)] had a mDI ≥ than reported in the literature. Overall survival at 12 months was 64.2% (CI 95%: 55-75%). CONCLUSION: The AKO@dom program allowed 68.75% of patients to maintain a high dose intensity after 3 months of TKI treatment. The impact on survival outcomes needs to be evaluated in randomized clinical trials.

Prevalence and Risk Factors of Artificial Urinary Sphincter Revision in Nonneurological Male Patients.

PURPOSE: The main objective of this study was to assess the prevalence and risk factors of male artificial urinary sphincter (AUS) mechanical failures and nonmechanical failures. MATERIALS AND METHODS: The charts of all male patients who underwent AUS implantation between 2004 and 2020 in 16 centers were retrospectively reviewed. Patients with neurogenic stress urinary incontinence (SUI) were excluded as well as revisions/explantations due to infections and/or erosions. The causes of revision were divided into mechanical failures (fluid loss or malfunction from any components of the AUS), nonmechanical failures (urethral atrophy, recurrence/persistence of SUI despite normally functioning device) and other (pump malposition, balloon herniation, hematoma, pain). Failure-free survival analysis was performed both for general and specific causes of revision. Predictors of mechanical and nonmechanical failures were determined by Cox proportional hazards model. RESULTS: A total of 1,020 patients met the inclusion criteria. After a median followup of 20 months, the estimated 5-year and 10-year overall revision-free survival was 60% and 40%, respectively. There were 214 AUS revisions: 59 (27.6%) for mechanical failures, 121 (56.5%) for nonmechanical failures and 34 (15.9%) other causes of revision. In multivariable Cox regression analysis, larger cuff size was the only predictor of overall revisions (HR=1.04 [1.01-1.07]; p=0.01) and revision for nonmechanical failure (HR=1.05 [1.02-1.09]; p=0.004). CONCLUSIONS: Half of the male AUS patients underwent device revision within the first 10 years after implantation. Nonmechanical failures are the primary cause of AUS revision in nonneurological men. Larger cuff size appears to be the main determinant of AUS revision risk.

Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial).

INTRODUCTION: Cisplatin-based neoadjuvant chemotherapy (NAC) followed by surgery is the standard treatment for patients with non-metastatic muscle invasive bladder cancer (MIBC). Unfortunately, many patients are not candidates to receive cisplatin due to renal impairment. Additionally, no predictive biomarkers for pathological complete response (pCR) are currently validated in clinical practice. Studies evaluating immune checkpoint inhibitors in the peri-operative setting are emerging with promising results. Clinical trials are clearly required in the neoadjuvant setting in order to improve therapeutic strategies. METHODS AND ANALYSIS: Oncodistinct 004 - AURA is an ongoing multicenter phase II randomized trial assessing the efficacy and safety of avelumab single-agent or combined to different NAC regimens in patients with non-metastatic MIBC. Patients are enrolled in two distinct cohorts according to their eligibility to receive cisplatin-based NAC. In the cisplatin eligible cohort, patients are randomized in a 1:1 fashion to receive avelumab combined with cisplatin-gemcitabine or with dose-dense methotrexate-vinblastine-doxorubicin-cisplatin. In the cisplatin ineligible cohort, patients are randomized at a 1:1 ratio to paclitaxel-gemcitabine associated to avelumab or avelumab alone. Primary endpoint is pCR. Secondary endpoints are pathological response and safety. ETHICS AND DISSEMINATION: The study is approved by ethics committee from all participating centers. All participants provide informed consent prior inclusion to the study. Once completed, results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT03674424).

Outcomes of laparoscopic artificial urinary sphincter in women with stress urinary incontinence: mid-term evaluation.

PURPOSE: Although artificial urinary sphincter (AUS) has become an established treatment for moderate to severe stress urinary incontinence (SUI), implantation can be challenging. This study aimed to review the outcomes of laparoscopic AUS (LAUS) implantation and revision in women presenting with SUI. METHODS: We reviewed the files of female patients presenting with moderate to severe SUI treated with LAUS implantation from October 2007 to July 2017. Surgeries were performed by one surgeon experienced in open AUS implantation and starting LAUS implantation. The primary endpoint was postoperative urinary continence, which was divided into three categories: complete continence, improved continence, and unchanged incontinence. The secondary outcomes were complications, explantation-free and revision-free time. RESULTS: A total of 49 women (mean age 64 years, range 40-80) had LAUS implantation. Among the 42 patients (85.7%) with an AUS in place at the last follow-up, 25 (59.5%) were fully continent, 16 (38.1%) had improved continence, and 1 (2.4%) had unchanged incontinence. At the last follow-up, 29 (59.2%) patients had their initial AUS and 13 (26.5%) had at least one reintervention. There were 9 (18.4%) intraoperative complications and 25 (51%) postoperative complications, of which 9 (18.4%) were Clavien⩾3. After a median follow-up of 4 years, 9 (18.4%) explantations and 11 (22.5%) revisions occurred. The average period without explantation or revision was 3.7 and 3.1 years, respectively. CONCLUSION: Our study shows that the laparoscopic approach for AUS implantation is an efficient treatment option for women with moderate to severe SUI.

Outcomes of artificial urinary sphincter in female with neurological stress urinary incontinence: a long-term follow-up.

PURPOSE: To report the outcomes of AUS in women with neurological SUI resulting from intrinsic sphincter deficiency after a follow-up from 3 to 20 years. METHODS: The charts of female with moderate to severe neurological SUI who underwent open or laparoscopic AUS implantation between November 1994 and July 2014 were reviewed retrospectively. All patients were operated by a single experienced surgeon. Primary endpoint was a postoperative continence categorized as complete continence (no pads used), improved incontinence or unchanged incontinence. RESULTS: Twenty-three women (mean age 54 years, range 19-77) underwent open or laparoscopic AUS implantation. At the last follow-up, 7 (30.4%) initial artificial urinary sphincters remained in situ and 9 (39.1%) patients had at least one revision or reimplantation. Sixteen patients were fully continent (69.6%), four (17.4%) had improved incontinence and three (13.0%) had unchanged incontinence. After a median follow-up of 11.6 years (3-22), 8 (34.8%) explanations in 7 patients and 16 (69.6%) revisions in 11 patients occurred. The average time without explanation or revision was 10.9 and 8.5 years, respectively. Survival rates without AUS explanation were 94.4%, 76.5%, 72.8%, 50% and without revision were 83.3%, 64.7%, 45.5% and 16.7% at 5, 10, 15 and 20 years, respectively. CONCLUSION: Although all methods are imperfect at best, AUS remain toward our experience a good way to achieve long-term continence in female patients suffering from neurological SUI with preserved manual dexterity.

Real-life outcomes after artificial urinary sphincter explantation in women suffering from severe stress incontinence.

PURPOSE: Artificial urinary sphincter (AUS) implantation in female patients results in high satisfaction rates and high functional outcomes, but implantation can be challenging and explantation of the device is fairly common. The objective of this study was to review outcomes after AUS explantation in women. METHODS: This is a retrospective, monocentric study of all women who underwent open or laparoscopic AUS implantation between November 1994 and July 2019, and patients with AUS explantation were included. Management after AUS explantation using descriptive analysis was assessed. RESULTS: Over a span of 26 years, 111 women had an AUS implanted by a single surgeon. Of these surgeries, 35 explantations in 29 patients were later required: 20 initial AUSs, nine revised AUSs and six reimplanted AUS (rAUSs). The median time to explantation was 15.5 month (± 0.55). After explantation, 13 rAUSs in 10 patients were successful and two attempts failed. The median time between explantation and rAUS was 8 months (± 0.95). At the last follow-up, five patients still had their rAUS and six rAUSs had required explantation after a median time of 6.5 months (± 0.65). Surgery was still possible for 12 patients who did not have a rAUS: three cystectomies, one bladder neck closure with continent urinary diversion, and six mid-urethral slings or adjustable continence therapy balloon implantations. Among the 23 patients who did not need a cystectomy or a bladder neck closure with continent urinary diversion, four were completely dry (17.4%), 11 were improved (47.8%), and eight (34.8%) experienced unchanged incontinence with the post-explantation management. Limitations include retrospective design, heterogeneous management over time and a relatively small population of patients in our cohort. CONCLUSION: Reimplantation of an AUS after an explantation seems feasible after at least 6 months. However, the surgery will be more difficult and satisfaction is not guaranteed. Multicenter databases should be created to help surgeons and patients decide on appropriate management strategies after explantation of an AUS.