OBJECTIVE:To evaluate the feasibility of randomising patients with newly diagnosed metastatic prostate cancer (mPCa) to cytoreductive radical prostatectomy (cRP) plus systemic standard of care (SOC) vs SOC alone in Belgian centres. PATIENTS AND METHODS:This is a phase II, multicentre, prospective, randomised, open-label feasibility trial. Patients with newly diagnosed mPCa were screened across six centres from August 2018 to August 2024. The aim was to randomise 86 patients to either cRP with pelvic lymphadenectomy plus systemic SOC or SOC alone (including radiotherapy in low-volume disease). Eligible patients had an Eastern Cooperative Oncology Group Performance Status of 0-1 and were considered suitable candidates for local treatment. The primary endpoint was the feasibility of randomisation, assessed by the randomisation rate (randomised/eligible). RESULTS:A total of 325 patients with newly diagnosed mPCa were screened, of whom 170 (52%) were eligible. The main reasons for ineligibility included unresectable tumours (42% [65/155]) and inadequate surgical fitness (37% [58/155]). Among eligible patients, 75% were excluded (127/170), mostly due to patient refusal (68% [86/127]) and inclusion in competing studies (21% [27/127]). A total of 43 patients were randomised: 21 to cRP and 22 to SOC, yielding a randomisation rate of 25% (43/170). Randomisation rates were lower than anticipated, limiting feasibility in the present trial setting. CONCLUSION:Randomising men with newly diagnosed mPCa to RP plus SOC vs SOC alone proved challenging in this Belgian trial. Major barriers to recruitment included limited surgical eligibility and patient refusal. Targeted recruitment strategies or alternative trial designs should be considered.
PURPOSE:Androgen deprivation therapy (ADT) is a cornerstone treatment for advanced and metastatic prostate cancer. Real-world and patient-reported insights into ADT's impact on health-related quality of life (HRQoL) and communication experiences in healthcare settings remain underexplored. This patient organisation-initiated online survey aimed to assess these aspects. METHODS:Between December 2022 and August 2023, the patient organisation Think Blue Vlaanderen and the AZ Sint-Jan Hospital (Bruges, Belgium) invited ADT-treated patients to participate in a prospective, online, cross-sectional, patient-reported outcome survey. Demographic, clinical, HRQoL (FACT and EPIC-26), communication sources and information modality data were collected. Descriptive statistics and comparative analyses were applied. RESULTS:A total of 276/312 (88.5%) participating patients were on ADT at time of survey administration and completion, with the majority receiving a 3-monthly regimen. Sexual HRQoL was low and narrowly distributed (median (IQR): 16.7 (16.7-16.7)), with 84% of patients having erectile dysfunction (ED). Patients finding their ED problematic were more likely to seek pharmaceutical treatment. Hormonal HRQoL was widely distributed (median (IQR): 65 (45-85)), which improved with prolonged ADT duration. Physically active patients reported less lack of energy, but increased hot flashes. Within consistent FACT-G summary scores (median (IQR): 64.50 (54.75-77.00)), improved emotional wellbeing with prolonged ADT was noted. Multidisciplinary communication and multimodal information provision improved patient satisfaction. CONCLUSION:Patient organisation-initiated surveys offer real-world and patient-reported insights. Patient-tailored HRQoL assessments and longitudinal follow-up, physical activity, and multidisciplinary and multimodal communication approaches are warranted to improve patient-centred care in patients receiving ADT.
Objective:. To compare binary metrics and Global Evaluative Assessment of Robotic Skills (GEARS) evaluations of training outcome assessments for reliability, sensitivity, and specificity. Background:. GEARS–Likert-scale skills assessment are a widely accepted tool for robotic surgical training outcome evaluations. Proficiency-based progression (PBP) training is another methodology but uses binary performance metrics for evaluations. Methods:. In a prospective, randomized, and blinded study, we compared conventional with PBP training for a robotic suturing, knot-tying anastomosis task. Thirty-six surgical residents from 16 Belgium residency programs were randomized. In the skills laboratory, the PBP group trained until they demonstrated a quantitatively defined proficiency benchmark. The conventional group were yoked to the same training time but without the proficiency requirement. The final trial was video recorded and assessed with binary metrics and GEARS by robotic surgeons blinded to individual, group, and residency program. Sensitivity and specificity of the two assessment methods were evaluated with area under the curve (AUC) and receiver operating characteristics (ROC) curves. Results:. The PBP group made 42% fewer objectively assessed performance errors than the conventional group (P < 0.001) and scored 15% better on the GEARS assessment (P = 0.033). The mean interrater reliability for binary metrics and GEARS was 0.87 and 0.38, respectively. Binary total error metrics AUC was 97% and for GEARS 85%. With a sensitivity threshold of 0.8, false positives rates were 3% and 25% for, respectively, the binary and GEARS assessments. Conclusions:. Binary metrics for scoring a robotic VUA task demonstrated better psychometric properties than the GEARS assessment.
Every day, left-handed individuals experience difficulties with tools designed for the right-handed persons. With a growing rate of left-handedness, there is a need to adapt and expand our surgical training and practice. The goal of this chapter is to provide tips and tricks to left-handed surgeons. As it rethinks the different possibilities in instrument usage within upper tract robotic surgery, it could be of interest to every upper tract surgeon. To our knowledge, no similar chapter has been written before. This chapter fills a gap that exists in current literature and is therefore based on experience and expert opinions.
Introduction: Burnout syndrome has increased dramatically in urology within recent years. A healthy lifestyle has been described as a protective factor. However, data on lifestyle is lacking among residents and urologists and remains to be elucidated. We aim to assess lifestyle among urology residents and young urologists across Europe. Materials and methods: Members of the European Society of Residents in Urology (ESRU) designed a 34-item online survey via surveymonkey.com . The survey was designed in accordance with Checklist for Reporting Results of Internet E-Surveys (CHERRIES) guidelines and was distributed via e-mail and social media in 23 European countries to urology residents and young urologists. The primary endpoint was reported as self-perceived health status. Secondary endpoints included questions on sleeping disorders, exercise and dietary habits. Data was analyzed SPSS software. Results: A total of 412 residents and young urologists responded to the survey. The mean age of the respondents was 31.4 +/- 3.9 yr. The data on dietary intake demonstrate a mean of 2 or more cups/day of coffee and alcohol consumption 2-3 times/week. The intake of fruits and vegetables is very low, almost 60% of responders consume < 1 portions of fruit/day and more than half (52%) eat < 1 portion of vegetable/day. Overall, the majority of respondents reported to have a moderate to low satisfaction with lifestyle (59.65%) and low to moderate self-perceived health status (45.94%). Moreover, 46% of respondents reported to have some kind of steep disturbance and 60% only slept 6 hours/night or less with 53% reporting a moderate to very low quality of Sleep. Regular exercise of at least 30 min twice weekly was only performed by 33% of the respondents. Conclusions: Residents and young urologists have unbalanced diet, tend to exercise too little and often suffer from sleep disturbances all of which increases the risk of burnout. Physicians, organizations and institutions should strive to promote healthy lifestyle, resiliency and support programs. (C) 2019 AEU. Published by Elsevier Espana, S.L.U. All rights reserved.
Background: Evidence on the learning curve for robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) is limited. Objective: To assess the effect of surgical experience (SE) on perioperative and intermediate-term oncological outcomes in a large contemporary cohort of RARC patients after accounting for the impact of intersurgeon variability. Design, setting, and participants: The study cohort included 164 patients treated with RARC and ICUD by two surgeons between 2004 and 2017 at a single European referral centre. Outcome measurements and statistical analysis: For each patient, SE was defined as the total number of RARCs performed by each surgeon before the patient's operation. The relationship between SE and operative time (OT), lymph node yield (LNY), positive surgical margins (PSMs), Clavien-Dindo grade >= 2 30-d postoperative complication (CD >= 2), and oncological outcomes (18-mo recurrence rate) was evaluated in multivariable linear and logistic regression models, clustering at a single-surgeon level. Results and limitations: After adjusting for case mix, SE was associated with shorter OT (p = 0.003), lower probability of postoperative CD >= 2 rates (p = 0.01), and lower 18-mo recurrence rates (p = 0.002). Conversely, SE did not predict lower PSM rates (p = 0.3) and higher LNY (p = 0.4). The relationship between SE and OT was nonlinear, with a plateau observed after 50 cases. Conversely, the relationship between SE and CD >= 2 and 18-mo recurrence was linear without reaching a plateau after 88 procedures. Conclusions: SE affects perioperative and oncological outcomes after RARC with ICUD in a linear fashion, and its beneficial effect does not reach a plateau. Conversely, after 50 cases, no further improvement was observed for OT. Patient summary: Robot-assisted radical cystectomy with intracorporeal urinary diversion is a complex surgical procedure with a relatively long learning curve. (C) 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Apalutamide, a competent inhibitor of the androgen receptor, has shown promising clinical efficacy results for patients with advanced prostate cancer. Here, we describe the rationale and design for the SAVE trial, a multi-center, Phase II study, wherein 202 men with biochemical progression after radical prostatectomy are randomly assigned 1:1 to apalutamide plus salvage radiotherapy (SRT) or androgen-deprivation therapy with an luteinizing hormone-releasing hormone agonist or antagonist plus SRT. The primary objective is to compare sexual function between the two treatment arms based on the expanded prostate cancer index-26 sexual domain score at nine months after start of hormonal treatment. The key secondary objectives are to assess quality of life, to evaluate the safety profile and the short-term efficacy of apalutamide in combination with SRT. ClinicalTrials.gov identifier: NCT03899077.
Urinary tract infections (UTI) affect a large proportion of the population, causing among other symptoms, more frequent and urgent micturition. Previous studies reported that the gram-negative bacterial wall component lipopolysaccharides (LPS) trigger acute epithelial and bladder voiding responses, but the underlying mechanisms remain unknown. The cation channel TRPV4 is implicated in the regulation of the bladder voiding. Since TRPV4 is activated by LPS in airway epithelial cells, we sought to determine whether this channel plays a role in LPS-induced responses in urothelial cells (UCs). We found that human-derived UCs display a fast increase in intracellular Ca2+ concentration upon acute application of Escherichia coli LPS. Such responses were detected also in freshly isolated mouse UCs, and found to be dependent on TRPV4, but not to require the canonical TLR4 signaling pathway of LPS detection. Confocal microscopy experiments revealed that TRPV4 is dispensable for LPS-induced nuclear translocation of NF-κB in mouse UCs. On the other hand, quantitative RT PCR determinations showed an enhanced LPS-induced production of proinflammatory cytokines in TRPV4-deficient UCs. Cystometry experiments in anesthetized wild type mice revealed that acute intravesical instillation of LPS rapidly increases voiding frequency. This effect was not observed in TRPV4-deficient animals, but was largely preserved in Tlr4 KO and Trpa1 KO mice. Our results suggest that activation of TRPV4 by LPS in UCs regulates the proinflammatory response and contributes to LPS-induced increase in voiding frequency. These findings further support the concept that TRP channels are sensors of LPS, mediating fast innate immunity mechanisms against gram-negative bacteria.
Regardless of career intentions, junior doctors will meet patients with urological problems. There are no studies on the status of undergraduate education for urology in Europe. We designed an 18-item online survey using the platform www. surveymonkey.com to assess the current status of undergraduate education in urology. A total of 347 medical students, trainees, and urologists responded to the survey. Medical students' exposure to urology during their undergraduate career was heterogeneous. Although the quality of urology education was valued from moderate to high, urology as a speciality did not influence their future training decision making. Decision making in relation to residency training correlated with the number of hours spent on practical training, duration of urology rotation, and year of medical school in which urological exposure was introduced. The current European exposure to urology at undergraduate level is heterogeneous, with various factors influencing future decisions regarding training and specialisation. A uniform undergraduate curriculum would eliminate such heterogeneous exposure and facilitate a workforce fit for the future urological needs. Patient summary: Junior doctors will meet patients with urological problems in the wards, emergency departments, and primary care. Institutions should work together for a urological curriculum that fits the future clinical requirements. (C) 2020 Published by Elsevier B.V. on behalf of European Association of Urology.
Background Salvage radiotherapy (SRT) is a potentially curative option for patients with rising PSA (biochemical recurrence) after radical prostatectomy. Recently, success rates of SRT were significantly improved through the use of concomitant anti-androgen (AAT) or androgen-deprivation (ADT) therapy. In RTOG 96-01, 2 years of bicalutamide 150 mg resulted in a 5% OS benefit at 12-years. In GETUG-AFU 16, 5-year progression-free survival was significantly improved when SRT was combined with 6 months of an LHRH agonist. Based on GETUG-AFU 16, most European urologists and (radiation) oncologists now combine SRT with at least 6 months of ADT. However, ADT comes with several serious side-effects, both physical (cardiovascular, metabolic, musculoskeletal) and psychological (sexual, emotional and cognitive). Considering RTOG 96-01, and in view of new AAT options, it appears worthwhile to look for alternatives. In that respect, apalutamide (ERLEADA®), a next-generation anti-androgen, is an interesting candidate. Trial design This is a phase II randomized, open-label study comparing SRT in combination with 6 months of LHRH (ant)agonist (arm A) versus 6 cycles of apalutamide 240 mg daily (each cycle is 28 +/- 2 days) (arm B) in hormone-naive patients with biochemical recurrence (PSA > 0.1 µg/L at least 8 weeks after radical prostatectomy). Patients with severe erectile dysfunction are excluded. All subjects will receive SRT as standard of care and will be randomly assigned in a 1:1 ratio to arm A or B. Primary objective is to compare sexual function, based on the EPIC-26 sexual domain score, at 9 months (i.e. 3 months after the end of hormonal treatment). Secondary endpoints include general quality of life (EPIC-26, EORTC QLQ C30 and PR25, FACT-P), acute as well as late toxicity (CTCAE version 5.0), and PSA (complete) response rates (i.e. decline from baseline in PSA level of 80% (90%) or greater). The trial was approved by the local ethics committee on April 2nd 2019 and started recruiting immediately thereafter. Clinical trial identification NCT03899077; 2018-004365-13. Legal entity responsible for the study GZA Hospitals. Funding Janssen. Disclosure All authors have declared no conflicts of interest.
The Charlson comorbidity index is an outdated comorbidity assessment tool which is not disease specific and is not applicable to contemporary BCa patients.
IntroducciónEl síndrome de burnout ha aumentado espectacularmente en el ámbito de la urología en los últimos años. Un estilo de vida saludable se ha descrito como un factor protector. Sin embargo, aún no han sido evaluados los datos relacionados con el estilo de vida de residentes y urólogos. Nuestro objetivo es evaluar el estilo de vida entre los residentes y urólogos jóvenes de toda Europa.Materiales y métodosLos miembros de la Sociedad Europea de Residentes de Urología (ESRU, por sus siglas en inglés) diseñaron una encuesta online de 34 ítems, a través de surveyymonkey.com. La encuesta fue diseñada de acuerdo con la lista de verificación para reportar resultados de encuestas online (Checklist for Reporting Results of Internet E-Surveys [CHERRIES]), y se distribuyó por correo electrónico y redes sociales en 23 países europeos, a residentes de urología y urólogos jóvenes. La variable principal del estudio ha sido la autovaloración del estado de salud. Para las variables secundarias había preguntas sobre los trastornos del sueño, el deporte y los hábitos alimentarios. Se analizaron los datos con el software SPSS.ResultadosUn total de 412 residentes y urólogos jóvenes respondieron la encuesta. La media de edad de los encuestados fue de 31,4±3,9 años. Los datos sobre la ingesta alimentaria delatan una media de consumo de 2 o más tazas/día de café y 2-3 veces/ semana de alcohol. La ingesta de fruta y verdura es muy baja, casi el 60% de los encuestados consumen<1 ración de fruta al día y más de la mitad (52%) toman<1 ración de verdura por día. En general, la mayoría de los encuestados reportaron estar baja/medianamente satisfechos con su estilo de vida (59,65%) y en la autovaloración del estado de salud los resultados están entre bajo y moderado (45,94%). Además, el 46% de los encuestados informó tener algún tipo de trastorno del sueño: el 60% solo duerme 6h/noche o menos, y el 53% afirmó tener una calidad del sueño de moderada a muy baja. Solo un 30% de los encuestados practica al menos 30min de deporte, 2 veces por semana.ConclusionesLos residentes y urólogos jóvenes tienen una dieta desequilibrada, tienden a hacer poco ejercicio y, a menudo, sufren trastornos del sueño, lo que aumenta el riesgo de desgaste y agotamiento. Los médicos, las organizaciones y las instituciones deben esforzarse por promover programas de estilo de vida saludable, resiliencia y apoyo.