Three Dimensional Printing Technology Used to Create a High-Fidelity Ureteroscopy Simulator: Development and Validity Assessment (Rein-3D-Print-UroCCR-39).

OBJECTIVE: To create and assess the validity of a high-fidelity, three dimensional (3D) printed, flexible ureteroscopy simulator resulting from a real case. METHODS: A patient's CT scan was segmented to obtain a 3D model in .stl format, including the urinary bladder, ureter and renal cavities. The file was printed and a kidney stone was introduced into the cavities. The simulated surgery consisted of monobloc stone extraction. Nineteen participants split into 3 groups according to their level (6 medical students, 7 residents and 6 urology fellows) performed the procedure twice at a 1-month interval. They were rated according to a global score and a task-specific score, based on an anonymized, timed video recording. RESULTS: Participants demonstrated a significant improvement between the 2 assessments, both on the global score (29.4 vs 21.9 points out of 35; P < .001) and the task-specific score (17.7 vs 14.7 points out of 20; P < .001) as well as procedure time (498.5 vs 700 seconds; P = .001). Medical students showed the greatest progress for the global score (+15.5 points (mean), P = .001) and the task-specific score (+6.5 points (mean), P < .001). 69.2% of participants considered the model as visually quite realistic or highly realistic and all of them judged it quite or extremely interesting for intern training purposes. CONCLUSION: Our 3D printed ureteroscopy simulator was able to enhance the progress of medical students who are new to endoscopy, whilst being valid and reasonably priced. It could become part of a training program in urology, in line with the latest recommendations for surgical education.

Machine-learning approach for prediction of pT3a upstaging and outcomes of localized renal cell carcinoma (UroCCR-15).

OBJECTIVES: To assess the impact of pathological upstaging from clinically localized to locally advanced pT3a on survival in patients with renal cell carcinoma (RCC), as well as the oncological safety of various surgical approaches in this setting, and to develop a machine-learning-based, contemporary, clinically relevant model for individual preoperative prediction of pT3a upstaging. MATERIALS AND METHODS: Clinical data from patients treated with either partial nephrectomy (PN) or radical nephrectomy (RN) for cT1/cT2a RCC from 2000 to 2019, included in the French multi-institutional kidney cancer database UroCCR, were retrospectively analysed. Seven machine-learning algorithms were applied to the cohort after a training/testing split to develop a predictive model for upstaging to pT3a. Survival curves for disease-free survival (DFS) and overall survival (OS) rates were compared between PN and RN after G-computation for pT3a tumours. RESULTS: A total of 4395 patients were included, among whom 667 patients (15%, 337 PN and 330 RN) had a pT3a-upstaged RCC. The UroCCR-15 predictive model presented an area under the receiver-operating characteristic curve of 0.77. Survival analysis after adjustment for confounders showed no difference in DFS or OS for PN vs RN in pT3a tumours (DFS: hazard ratio [HR] 1.08, P = 0.7; OS: HR 1.03, P > 0.9). CONCLUSIONS: Our study shows that machine-learning technology can play a useful role in the evaluation and prognosis of upstaged RCC. In the context of incidental upstaging, PN does not compromise oncological outcomes, even for large tumour sizes.

Adjustable Continence Therapy (ACT®) balloons to treat female stress urinary incontinence: effectiveness, safety and risk factors of failure and complication.

INTRODUCTION AND HYPOTHESIS: To assess the effectiveness, safety and risk factors of failure and complications associated with Adjustable Continence Therapy (ACT®) balloons as a treatment for female stress urinary incontinence (SUI). METHODS: In the present multicentric retrospective study, all women implanted with ACT® balloons between 2000 and 2018 were considered eligible. Effectiveness and safety were assessed at 1 year, and risk factors for failure and complications were sought. The effectiveness was categorized into three distinct groups: Success = maximum 1 pad/day and patient's impression of improvement using a numerical rating scale (NRS) ≥ 8/10; Improvement = decrease of daily pad use and NRS ≥ 5/10; Failure = increase or stability of daily pad use or NRS < 5/10. The intra- and postoperative surgical complications were collected. RESULTS: Over the study period, 281 women were included. Among them, 104 (37.0%), 94 (33.5%) and 83 (29.5%) were categorized as success, improvement, and failure, respectively. Intra-, early and late postoperative complications occurred in 13 (4.6%), 35 (12.5%) and 75 (26.7%) women, respectively. Most early surgical complications were minor according to the Dindo-Clavien classification. Of women that presented a late postoperative surgical complication, 64 (22.8%) underwent an explantation performed under local or general anesthesia without associated sequalae. CONCLUSIONS: The short-term effectiveness associated with ACT® balloons, their minimally invasive implantation and the frequent but easily manageable and sequelae-free complications suggest that they should be part of the therapeutic arsenal for female SUI.

3D-Image guided robotic-assisted partial nephrectomy: a multi-institutional propensity score-matched analysis (UroCCR study 51).

PURPOSE: Robot-assisted partial nephrectomy (RAPN) is a difficult procedure with risk of significant perioperative complications. The objective was to evaluate the impact of preoperative planning and intraoperative guidance with 3D model reconstructions on perioperative outcomes of RAPN. METHODS: We conducted a retrospective analysis of all patients who underwent RAPN for kidney tumor by three high-volume expert surgeons from academic centers. Clinical data were collected prospectively after written consent into the French kidney cancer network database UroCCR (CNIL-DR 2013-206; NCT03293563). Our cohort was divided into two groups: 3D-Image guided RAPN group (3D-IGRAPN) and control group. A propensity score according to age, pre-operative renal function and RENAL tumor complexity score was used. Both surgical techniques were compared in terms of perioperative outcomes. RESULTS: The initial study cohort included 230 3D-IGRAPN and 415 control RAPN. Before propensity-score matching, patients in the 3D-IGRAPN group had a larger tumor (4.3 cm vs. 3.5 cm, P < 0.001) and higher RENAL complexity score (9 vs. 8, P < 0.001). Following propensity-score matching, there were 157 patients in both groups. The rate of major complications was lower for patients in the 3D-IGRAPN group (3.8% vs. 9.5%, P = 0.04). The median percentage of eGFR variation recorded at first follow-up was lower in the 3D-IGRAPN group (- 5.6% vs. - 10.5%, P = 0.002). The trifecta achievement rate was higher in the 3D-IGRAPN group (55.7% vs. 45.1%; P = 0.005). CONCLUSION: Three-dimensional kidney reconstructions use for pre-operative planning and intraoperative surgical guidance lowers the risk of complications and improve perioperative clinical outcomes of RAPN.

Adjustable continence therapy (ACT®) balloons to treat neurogenic and non-neurogenic female urinary incontinence.

AIMS: To compare efficacy and safety between neurogenic and non-neurogenic women after adjustable continence therapy (ACT®) balloons implantation to treat stress urinary incontinence (SUI) due to intrinsic sphincter deficiency. METHODS: In the present retrospective multicentric study, all neurogenic and non-neurogenic women implanted with ACT® balloons between 2000 and 2018 were considered for inclusion. Efficacy was compared 1 year after implantation, and women were allocated in three different groups as follows. Success: maximum 1 pad per day and patient's impression of improvement assessed using a numeral rating scale (NRS) ≥8/10. Improvement: decrease of daily pad use and/or NRS ≥5/10. Failure: increase or stability of daily pad use or NRS <5/10. Overall surgical complications and explantations were compared 1 year after implantation. RESULTS: Among the 277 included women, 51 presented with a neurologic underlying disease. Mean age at implantation was 68.5 years. There was no significant difference in efficacy between neurogenic and non-neurogenic women with a success rate of 39.2% and 36.3%, respectively (p = 0.69). Similarly, improvement rate was reported to be 31.4% and 33.6%, in neurogenic and non-neurogenic women, respectively (p = 0.92). The overall surgical complications rate (24% vs. 34.5%, p = 0.15) and the explantation rate (19.6% vs. 28.8%, p = 0.18) were not significantly different. CONCLUSION: ACT balloons may be proposed to treat mixed or SUI in females with ISD. Efficacy and safety profiles appear to be similar in both neurogenic and non-neurogenic patients.

High-Dose Methylprednisolone to Prevent Platelet Decline in Preeclampsia: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether early administration of high-dose methylprednisolone limits the fall of platelets in preeclampsia. METHODS: A randomized trial of 180 mg methylprednisolone or placebo administered in divided doses over 36 hours was conducted in women admitted for preeclampsia and platelet counts below 150×10/L in four French academic centers. Patients were not included when platelet counts were below 50×10/L or when immediate delivery was required. The primary study outcome was the proportion of patients with platelet counts above 100×10/L 36 hours after the first dose of study medication. The total sample size needed to detect a 23% difference in the rate of this outcome between groups with a one-tailed α of 0.05 and 90% power was 94 patients. RESULTS: Thirty-six patients were randomly assigned to receive methylprednisolone and 34 placebo between October 2007 and May 2011. Platelet counts above 100×10/L at 36 hours after the first dose of study medication were recorded in 30 (83%) in the active group and 29 (85%) in the placebo group (relative risk 0.98, 95% confidence interval 0.80-1.20; P=.82). The only adverse potentially study-related event was hyperglycemia in one woman allocated to methylprednisolone. CONCLUSION: In women with preeclampsia and platelet counts under 150×10/L, methylprednisolone was not effective in maintaining platelet counts above 100×10/L. CLINICAL TRIAL REGISTRATION: EU Clinical Trials Register, http://clinicaltrialsregister.eu, EudraCT 2006-004881-15-FR.

Dynamic Changes in Renal Function Are Associated With Major Cardiovascular Events in Patients With Type 2 Diabetes.

OBJECTIVE: The pattern of renal function decline prior to cardiovascular (CV) events in type 2 diabetes is not well known. Our aim was to describe the association between renal function trajectories and the occurrence of a CV event. RESEARCH DESIGN AND METHODS: We considered patients with type 2 diabetes from the SURDIAGENE (Survie, Diabete de type 2 et Genetique) study (discovery cohort) and the DIABHYCAR (Non-Insulin-Dependent Diabetes, Hypertension, Microalbuminuria or Proteinuria, Cardiovascular Events, and Ramipril) study (replication cohort). Global patterns of estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) and serum creatinine (SCr) prior to a major CV event (MACE) or last update were determined using a linear mixed-effects model and annual individual slopes computed by simple linear regression. RESULTS: In the 1,040 participants of the discovery cohort, establishment of global patterns including 22,227 SCr over 6.3 years of follow-up showed an annual eGFR decline and an annual SCr increase that were significantly greater in patients with MACE compared with patients without (-3.0 and -1.7 mL/min/1.73 m(2)/year and +10.7 and +4.0 µmol/L/year, respectively; P < 0.0001 for both). Median annual individual slopes were also significantly steeper in patients with MACE, and adjusted risk of MACE was 4.11 times higher (3.09-5.45) in patients with rapid decline in eGFR (change less than -5 mL/min/1.73 m(2)/year). Consideration of renal function trajectories provided significant additive information helping to explain the occurrence of MACE for both SCr and eGFR (PIDI < 0.0001 and P = 0.0005, respectively). These results were confirmed in the replication cohort. CONCLUSIONS: Renal function decline was associated with a higher risk of MACE. The pattern of renal function decline, beyond baseline kidney function, is an independent factor of CV risk.