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1.
Urol Pract ; 11(3): 462-468, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38526412

RESUMO

INTRODUCTION: The Karl Storz FLEX-XC1 is a novel single-use flexible ureteroscope that uses the same videographics platform as its reusable digital counterpart. We evaluated the technical performance of the FLEX-XC1 in its initial clinical use. METHODS: We reviewed a series of consecutive ureteroscopy procedures performed by 2 endourologists using the FLEX-XC1 for indications for which we typically use a single-use device: total stone burden > 15 mm or > 10 mm in the lower pole, anticipated case duration > 60 minutes, bilateral procedure, or upper tract urothelial cancer procedures. We assessed device tip deflection, intraoperative mechanical failure, and clinical outcomes for each case. Surgeons rated visual clarity, image quality, and maneuverability on a 1 to 5 Likert scale. RESULTS: Of 29 procedures using FLEX-XC1, 27 (93%) were successfully completed. Preoperative upward deflection was < 270° in 6 (21%) cases, and downward deflection was < 270° in 9 (31%) cases. Three types of intraoperative malfunctions occurred: rotational twisting of deflectable tip (4 cases, 13%), device not advancing through distal ureter (1 case, 3%), and working channel not accommodating a 365-µm laser (1 case, 3%). Visual clarity, image quality, and maneuverability were rated as 5 "very good" or 4 "good" in 100%, 100%, and 97% of cases, respectively. No device-specific or general 30-day complications were observed. CONCLUSIONS: The FLEX-XC1 showed comparable image quality and maneuverability to reusable digital devices. We observed incomplete deflection in up to 31% of cases and mechanical failure in 2 cases. The FLEX-XC1 may be advantageous in prolonged cases where maintaining visual clarity is paramount.


Assuntos
Cálculos Renais , Ureteroscópios , Humanos , Desenho de Equipamento , Ureteroscopia , Cálculos Renais/cirurgia
2.
Curr Opin Urol ; 34(2): 110-115, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-37962372

RESUMO

PURPOSE OF REVIEW: Flexible ureteroscopy (fURS) has evolved into both diagnostic and therapeutic modalities. Our review discusses the cost-effectiveness of single use flexible ureteroscopes (su-fURS) and the use of these instruments in routine urological practice. RECENT FINDINGS: There are studies which support the use of su-fURS with an argument of both cost and clinical utility over reusable flexible ureteroscopes (ru-fURS). However, the cost may vary across countries, hence is difficult to compare the results based on the current literature. Perhaps therefore there is a role for hybrid strategy incorporating ru- and su-fURS, where su-fURS are employed in complex endourological cases with a high risk of scope damage or fracture to preserve ru-fURS, with the ability to maintain clinical activity in such an event. SUMMARY: While there seems to be some cost advantages with su-fURS with reduced sterilization and maintenance costs, the data supporting it is sparse and limited. This choice of scope would depend on the durability of ru-fURS, procedural volumes, limited availability of sterilization units in some centers and potential risk of infectious complications. It is time that cost-benefit analysis is conducted with defined outcomes for a given healthcare set-up to help with the decision making on the type of scope that best serves their needs.


Assuntos
Cálculos Renais , Ureteroscópios , Humanos , Ureteroscopia/métodos , Análise de Custo-Efetividade , Análise Custo-Benefício , Cálculos Renais/terapia
3.
World J Urol ; 41(9): 2527-2534, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37477684

RESUMO

PURPOSE: To investigate the outcome and cost-effectiveness of ultrathin 6-7.5-Fr semirigid ureteroscopy in treating proximal ureteric stones compared to flexible ureteroscopy. METHODS: Two hundred and twenty patients with a solitary proximal ureteric stone were eligible for ureteroscopy (stone size = 1-2 cm). Patients were randomly subdivided into two groups: Group I included 105 patients who underwent ultrathin semirigid ureteroscopy and group II included 115 patients who underwent flexible ureteroscopy. Both groups were compared regarding successful stone access, operation time, reoperation rates, the financial cost to stone-free, complications, and stone clearance at 4 and 8 weeks. RESULTS: Groups I and II had no significant differences regarding patient demographics, stone criteria, and hospitalization time. In contrast, the mean operative time was significantly longer in group II (p < 0.001). The overall scope-to-stone access rate was 89.5%. It was 87.6% compared to 91.3% (p = 0.32), while the stone-free rate was 81.9% versus 87.8% (p = 0.22) for groups I and II, respectively. Intraoperative and postoperative complications were statistically insignificant between the study groups. The cost/person in Egyptian pounds was 8619 ± 350 in group I, compared to 17,620 ± 280 in group II (p < 0.001); similarly, the cost to attain the stone-free rate was 8950 ± 720 in group I compared to 17,950 ± 500 in group II. CONCLUSION: Ultrathin semirigid ureteroscopy is safe, durable, and considered a cost-effective method for treating upper ureteric calculi compared to the flexible ureteroscopy and could be considered a first treatment option in developing countries.


Assuntos
Cálculos Ureterais , Ureteroscopia , Humanos , Ureteroscopia/métodos , Estudos Prospectivos , Cálculos Ureterais/cirurgia , Ureteroscópios , Duração da Cirurgia , Resultado do Tratamento
4.
J Endourol ; 37(8): 956-964, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37261994

RESUMO

Introduction: Flexible ureteroscopy (fURS) is the most common procedure for treatment of urolithiasis. We previously utilized kinematic evaluations of simulated fURS to demonstrate that certain body movements are associated with efficient ureteroscopic manipulation for complex tasks. In this study, we incorporated computer vision to create an efficiency score using the ureteroscope travel distance (DIST), task time (TIME), spectral arc length (SPARC), and percentage of purposeful wall collisions (COLL). The goal is a simulation-based system that can abstract these automated performance metrics (APMs) to differentiate between novice and expert ureteroscope handling. Methods: A ureteroscopic simulation box was used. Body kinematics, task time, and ureteroscopic movements were analyzed using a motion capture system and video camera. Optical flow computer vision was used to track the ureteroscope. DIST, TIME, and SPARC were automatically calculated. Wall collisions were automatically captured and independently judged by two authors; an algorithm was developed to automatically determine the COLL variable. A mixed-effects model was used to aggregate these variables and distinguish between surgeons' first and final task attempts. Normalized values of these metrics were added to create a composite ureteroscopic efficiency score (CUES). Results: Twelve urologists completed the simulated tasks. The COLL assessment algorithm determined beneficial wall collisions with an accuracy of 77%. Normalized values of TIME, DIST, SPARC, and COLL were combined to create a composite ureteroscopic efficiency score (CUES). Compared with the first attempt, both the second and third attempts showed statistically significant improvements in CUES. The ROC-AUC score reached 0.86, suggesting excellent discrimination between attempts. There was also a statistically significant difference in CUES when comparing resident and attending performance. Conclusions: APMs can be abstracted using computer vision and artificial intelligence; an aggregate composite score (CUES) may be a promising method for evaluation of ureteroscopic efficiency.


Assuntos
Ureteroscopia , Urolitíase , Humanos , Ureteroscopia/métodos , Inteligência Artificial , Ureteroscópios , Algoritmos
5.
Urology ; 176: 36-41, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36907468

RESUMO

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.


Assuntos
Cálculos Renais , Ureteroscopia , Humanos , Ureteroscopia/educação , Simulação por Computador , Ureteroscópios , Cálculos Renais/cirurgia , Impressão Tridimensional
6.
J Endourol ; 37(6): 628-633, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36974366

RESUMO

Introduction: To evaluate flexible ureteroscope working channels with a 1.06 mm digital borescope (Clarus Medical, Minneapolis, MN) and identify factors contributing to ureteroscope damage over time. Materials and Methods: We performed a single institutional prospective study of patients undergoing stone surgery using a nondisposable flexible ureteroscope. A 1.06 mm borescope was used to evaluate ureteroscopes before and after surgery. Borescope videos were reviewed by two independent researchers to quantify average pre- and postprocedural damage. Results: Twenty-five procedures were performed with pre- and postprocedural borescope assessment between August 2021 and February 2022. All patients received preoperative CT imaging depicting a mean axial stone size of 14.1 ± 8.4 mm and density of 923.4 ± 458.1 HU. Mean operative time was 63.8 ± 34.0 minutes. The average number an instrument passes through the working channel was 2.1 ± 1.6. Laser was used in 11 cases with mean laser time of 18.8 ± 19.7 minutes and mean total energy of 5.8 ± 4.2 KJ. On preoperative assessment, all ureteroscopes had some form of defect (24% shave, 32% pinhole, 96% dents and scratches, and 28% discolorations). During postoperative assessment, 23/25 (92%) ureteroscopes showed additional damage with an average of 3.7 ± 2.8 imperfections acquired after one use. Significant differences were seen in acquired shavings (p = 0.028) and scratches or dents (p = 0.018). Of the 355 imperfections seen on postoperative evaluation, 0.4% were shave, 3% were pinhole, 85.8% were dents and scratches, and 10.8% were discolorations. Conclusion: The Clarus borescope observed defects after the majority of flexible ureteroscopy procedures for nephrolithiasis. Although such disruptions may not immediately render ureteroscopes nonfunctional, they are more common than previously described and could increase maintenance costs. Further studies are needed to investigate the burden of unit damage per procedure to raise operator awareness and reduce preventable ureteroscope imperfections.


Assuntos
Cálculos Renais , Ureteroscópios , Humanos , Estudos Prospectivos , Ureteroscopia/métodos , Cálculos Renais/cirurgia , Custos e Análise de Custo , Desenho de Equipamento
7.
Urology ; 173: 68-74, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36400269

RESUMO

OBJECTIVE: To compare the maintenance costs of digital flexible ureteroscopes (DFU) versus fiberoptic flexible ureteroscopes (FFU) to understand the long-term financial impact associated with breakage in a flexible ureteroscopy (f-URS) program. METHODS: Data for breakage of FFU and DFU at an academic institution from 2019 to 2021 were obtained from our vendor (Karl Storz) and analyzed by month. Correlation test was used to evaluate significant differences in number of procedures, number of breakage events, breakage rates, and repair cost per month. Cumulative analyses were utilized to examine the number of procedures before failure (time to failure - TTF) and repair costs per procedure (RCpP). RESULTS: We performed a total of 2,154 f-URS, including 1,355 with FFU and 799 with DFU (P<.001). Although we found a higher number of breakage events in FFU (n=124) than DFU (n=73) (P<.001), the overall breakage rate was similar, 9.9% vs. 8.8%, respectively (P=0.86). On cumulative analysis, both modalities reached the same TTF plateau (11 cases) after 18 months. After 400 cases, the RCpP for DFU was 1.25 times higher than for FFU (P=0.04). CONCLUSION: Overall, we found no difference in overall scope breakage rates between DFU and FFU. Although there was no difference in TTF over time, at the beginning DFU displayed considerable higher durability, leading to lower RCpP. Furthermore, DFU's endurance leveled off to FFU over time, resulting in higher RCpP after 400 cases. This finding may be explained by the presence of renewed scopes after repair.


Assuntos
Ureteroscópios , Ureteroscopia , Humanos , Ureteroscopia/métodos , Tecnologia de Fibra Óptica , Desenho de Equipamento
8.
BMC Urol ; 22(1): 43, 2022 Mar 24.
Artigo em Inglês | MEDLINE | ID: mdl-35331199

RESUMO

BACKGROUND: Anti-retropulsive devices are often used to prevent stone migration in the treatment of proximal ureteral calculi. They are helpful. However, in the meantime, they also add extra expenses. This study was carried out to investigate the best criteria for treating proximal ureteral stones with anti-retropulsive devices. METHODS: Data from all patients who underwent ureteroscopic holmium: YAG laser lithotripsy for solitary upper ureteral stones in 2018 were collected. Patients who encountered stone retropulsion during the process of inserting the ureteroscope were excluded. Patients were divided into either group URS or group URS + ARD depending on whether the anti-retropulsive device was used. Then, the stone-free rate, expenses and other criteria were compared between groups according to stone location. Stone-free was defined as no stones present. RESULTS: For stones located ≤ 30 mm from the ureteropelvic junction (UPJ), the stone-free rates for the URS group were 80% and 80% at one day and one month after the operation, respectively. Those for the URS + ARD group were 71.4% and 78.6% at one day and one month, respectively. For stones located 31-90 mm from the UPJ, the stone-free rates were 84.7% and 84.7% for the URS group and 89.6% and 95.5% for the URS + ARD group at one day and one month, respectively. A statistically significant difference occurred at one month. For stones located > 90 mm from the UPJ, the two groups were both stone free. In the URS + ARD group, expenses were higher. In addition, the mean diameter of residual stones derived from stones located at 31-90 mm from the UPJ was statistically smaller, and 4 of 7 residual stones passed spontaneously within one month, which was obviously more than that in other locations and the URS group. Other outcomes, including operation time and postoperative stay, showed no significant difference between the groups. CONCLUSION: Anti-retropulsive devices are indeed helpful, but they might be cost-effective for stones located solely in the middle part of the upper ureter, not for those too close to or far from the ureteropelvic junction.


Assuntos
Análise Custo-Benefício , Litotripsia a Laser/instrumentação , Cálculos Ureterais/terapia , Ureteroscopia/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Desenho de Equipamento , Feminino , Hólmio , Humanos , Lasers de Estado Sólido , Litotripsia a Laser/economia , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Estudos Retrospectivos , Ureteroscópios
9.
Actas Urol Esp (Engl Ed) ; 46(1): 16-21, 2022.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-34844902

RESUMO

INTRODUCTION: Training in experimental models is a valid option that improves the outcomes and shortens surgical learning curves. Our objective was to develop a 3D printed plastic model for teaching, training and education in flexible ureteroscopy, analyzing costs and suitability for the practice of this surgical technique. METHODS: A 3D printed model was developed based on a CT scan from a real-life patient's upper urinary tract. Horos™ software was used for segmentation and an FDM-Ultimaker for 3D printing. Renal calyces were numbered to be identified, as in the European Association of Urology Endoscopic Stone Treatment training curriculum, Task 4. The following were used: Innovex single-use flexible ureteroscope (Palex) and nitinol baskets (Coloplast). RESULTS: Printing time was 19 h, with a total cost of €8.77. The three-dimensional model allowed the insertion of the flexible ureteroscope and the exploration of the renal calyces by urologists in training as well as in current practice of the specialty without difficulty. The model also allowed the use of baskets and the mobilization and removal of previously placed stones. CONCLUSION: We unveil a valid three-dimensional model for flexible ureteroscopy training exercises with reasonable costs, which will allow acquiring the necessary skills and confidence to initiate the procedure in a real-life scenario.


Assuntos
Ureteroscópios , Urologia , Humanos , Impressão Tridimensional , Ureteroscopia , Urologistas
10.
World J Urol ; 40(3): 823-829, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34608509

RESUMO

PURPOSE: Non-surgical skills involving hand-eye coordination and bimanual dexterity may have a transferable impact on the acquisition of ureteroscopy skills. In this study, we aim to investigate the predictors of initial flexible ureteroscopy skills among novice trainees. METHODS: This was a prospective study involving students with no prior ureteroscopy exposure. Non-surgical parameters were assessed with a detailed survey, including demographics, video game, and musical history. Musical ability was objectively evaluated with the mini-Profile of Music Perception Skills test. Ureteroscopic performance was evaluated using a Boston Scientific© flexible ureteroscope on a bench model. Each participant completed diagnostic ureteroscopy and stone extraction. Outcomes included both speed and quality of performance, based on an Objective Structured Assessment of Technical Skills rubric. RESULTS: A total of 28 pre-clerkship medical students and 10 urology residents were included. Age and musical background were not associated with ureteroscopic aptitude. Those with video game history tended to perform ureteroscopy tasks faster with a higher OSATS score, although no statistical significance was reached. Male gender was associated with faster task completion with statistically higher OSATS score independent of video game activities (p = 0.011), however, the absolute score difference was small. CONCLUSIONS: Among novice trainees, musical and video game experience was not predictive of ureteroscopy skills. Male gender was associated with slightly faster and higher ureteroscopy technique scores, however, the differences are small and unlikely to represent clinical significance. Nevertheless, the use of ureteroscopy trainer provides useful insights and should be adopted in training programs as a marker of skills progression.


Assuntos
Ureteroscopia , Urologia , Aptidão , Competência Clínica , Humanos , Masculino , Estudos Prospectivos , Ureteroscópios , Ureteroscopia/educação , Urologia/educação
11.
Urol Clin North Am ; 49(1): 153-159, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34776048

RESUMO

Ureteroscopy is the most common surgical modality for stone treatment. Reusable flexible ureteroscopes are delicate instruments that require expensive maintenance and repairs. Multiple single use ureteroscopes have been developed recently to combat the expensive and time-intensive sterilization and repair of ureteroscopes. Although multiple studies have looked at different aspects of reusable and single use ureteroscopes, there is significant heterogeneity in performance measures and cost between the 2 categories, and neither has a clear advantage. Both can be used successfully, and individual and institution level factors should be considered when deciding which ureteroscope to use.


Assuntos
Equipamentos Descartáveis , Meio Ambiente , Contaminação de Equipamentos , Ureteroscópios , Equipamentos Descartáveis/economia , Equipamentos Descartáveis/normas , Humanos , Manutenção/economia , Ureteroscópios/economia , Ureteroscópios/normas , Urolitíase/cirurgia
12.
Prog Urol ; 31(14): 937-942, 2021 Nov.
Artigo em Francês | MEDLINE | ID: mdl-34456138

RESUMO

INTRODUCTION: Sate of the art on the indications, methods of implementation and medico-economic considerations of reusable flexible ureteroscopes (URSr) vs single use (URSuu)? METHOD: Review of the literature (Pubmed) on reusable and single-use ureteroscopes, as well as on the expertise of our center. A PubMed search and narrative review of the data was performed in July 2021. Only articles in French or English were selected. RESULTS: The URSr and URSuu have similar technical characteristics and are suitable for the exploration of the upper urinary excretory tract: treatment of stones of the kidney <2cm or of the ureter. The URSr is the most common type of ureteroscope. URSuu are newer and associated with many advantages: no sterilization procedure, immediate availability of equipment in the operating room, reduced waste production at the institutional level. A hybrid use of URSr and URSuu currently seems to be the best compromise from a medico-economic point of view for high volume centers. In the case of a smaller activity or a secondary site, URSuu are more advantageous and the reduction in purchasing costs should accentuate this benefit. CONCLUSION: URSr and URSuu are technically similar and allow identical treatment of upper urinary tract pathologies. Their complementary use optimizes the care of urology patients. The barrier to the exclusive use of URSuu remains their cost.


Assuntos
Ureteroscopia , Urologia , Desenho de Equipamento , Humanos , Salas Cirúrgicas , Ureteroscópios
13.
J Endourol ; 35(10): 1454-1459, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33775101

RESUMO

Objectives: To determine which flexible ureterorenoscopy program would be most cost-efficient in our center, a cost efficiency analysis and a formula to assess cost efficiency feasibility of a hybrid model were performed. Methods: Total cost per case of reusable flexible ureterorenoscopes (rfURS) was retrospectively calculated and compared with two single-use flexible ureterorenoscopes (sufURS) marketed. A mathematical formula was developed from our data to identify the necessary increase of use of rfURS (NIU-rfURS) to be cost-efficient in a hybrid system utilizing sufURS for only high-risk-of-breakage cases. Results: In 57 months, 983 procedures were performed using 4 digital rfURS (Flex-XC; Storz), necessitating 45 repairs, with a total repair cost of €256.809. Including the capital investment of €24.000 per scope and €60 per sterilization cycle, the cost per case averaged €419 after 983 cases. Consistently using sufURS would have cost 55% to 127% more (respectively, Uscope PU3022® and Lithovue® at €650 and €950 manufacturer suggested retail price). On a per case analysis, the cost was initially extremely high, but declined to reach a plateau around €480 after ∼400 cases. After 155 or 274 procedures, a rfURS program appeared more cost-efficient than consistently using Lithovue or Uscope PU3022, respectively. Based on our data and formula, if we would hypothetically use Uscope PU3022 or Lithovue for 15% of the cases, the NIU-rfURS is, respectively, 28% or 74% (∼6 or 16 cases). The NIU-rfURS increases exponentially with an increased use of sufURS. Conclusion: Consistently using rfURS is more cost-efficient than the constant use of sufURS after 155 to 274 cases. We describe the first mathematical formula that allows a calculation and feasibility assessment of using both reusable and disposable fURS. To identify whether a hybrid system may be a feasible cost-efficient alternative to a rfURS-only program, any center can calculate the NIU-rfURS by entering center-specific data in the formula.


Assuntos
Cálculos Renais , Ureteroscópios , Desenho de Equipamento , Reutilização de Equipamento , Humanos , Estudos Retrospectivos , Ureteroscopia
14.
J Endourol ; 35(6): 755-760, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33207957

RESUMO

Introduction: Single-use flexible ureteroscopes are an increasingly popular alternative to reusable ureteroscopes. In this study, we performed a benchtop examination of the physical and optical properties of the new Dornier Axis™ (Webling, Germany) single-use ureteroscope. Methods: Ten new, never-used Dornier Axis ureteroscopes were assessed for optical performance, maximal tip deflection, and irrigation flow rate with an empty working channel and with insertion of 200 and 365 µm laser fibers, and a 1.9F nitinol basket. All ureteroscopes were then fully deflected 100 times in each direction, and maximal deflection angles were re-measured with and without instruments in the working channel. All measurements were performed in duplicate. In vitro optical testing for resolution, image distortion, and depth of field was performed and compared vs the LithoVue™ (Boston Scientific, Marlborough, MA) single-use ureteroscope. Statistical analyses using paired Wilcoxon rank-sum tests and Kruskal-Wallis multiple-group comparison tests were performed in R. Results: Median maximal deflection angles exceeded 300° in both directions before and after 100 full deflection cycles for all groups except the 365 µm laser fiber group. After 100 deflection cycles, there was no change in the majority of working instruments, except a decrease in upward flexion with an empty channel and 200 µm Moses™ laser fiber, and downward flexion with 200 µm Flexiva™ laser fiber (all <10°). After excluding the 365 µm fiber, there was no difference in multi-group comparison for upward and downward flexion pre- and post-cycling. Median flow rate through an empty channel was 48.0 mL/min, and it decreased significantly with all used instruments (p < 0.001). Compared with the LithoVue, the Axis demonstrated superior resolution at all tested distances and less distortion. Conclusions: The new Dornier Axis single-use ureteroscope demonstrates excellent tip deflection, which remains unchanged after 100 manual flexions in each direction. The Axis also demonstrates superior optical performance compared with the LithoVue in benchtop testing.


Assuntos
Ureteroscópios , Ureteroscopia , Desenho de Equipamento , Alemanha , Humanos , Técnicas In Vitro
15.
Expert Rev Med Devices ; 17(12): 1257-1264, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33307869

RESUMO

Introduction: Flexible ureteroscopy is a commonly performed urologic procedure for visualization and treatment of the upper urinary tracts. Traditionally, ureteroscopy has been performed with reusable scopes, which have large initial purchasing costs. LithoVue was the first widely adopted single-use flexible ureteroscope clinically available in 2016 and has caused reevaluation of this paradigm. Areas covered: This review is an objective assessment of the LithoVue single-use ureteroscope based on available studies at the time of publication. The authors searched major databases for papers that included the term 'LithoVue' and included relevant papers. The state of the market, technical specifications, results from clinical studies and cost analyses, and competitors are discussed. Expert opinion: The LithoVue single-use flexible ureteroscope has comparable clinical performance to existing reusable ureteroscopes based on available data. Direct clinical comparisons to competing single-use ureteroscopes, many of which are relatively new, are limited. In numerous pre-clinical studies LithoVue performed favorably compared to available competitors. Cost analyses suggest that benefit of single-use ureteroscopes is institution-specific, and will likely be favorable at a low volume of cases and with high local costs for repairs of reusable scopes.


Assuntos
Cálculos Renais/cirurgia , Ureteroscópios/efeitos adversos , Aprovação de Equipamentos , Desenho de Equipamento , Humanos , Vigilância de Produtos Comercializados/economia , Resultado do Tratamento , Ureteroscópios/economia
17.
Int J Urol ; 27(9): 742-747, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32594597

RESUMO

OBJECTIVES: To develop a novel simple quantitative scoring model for predicting stone-free status after a flexible ureteroscopy lithotripsy procedure by standardizing the complexity of ureteral stone characteristics. METHODS: We retrospectively reviewed 586 patients with renal or ureteral stones who underwent flexible ureteroscopy lithotripsy at Abiko Toho Hospital, Chiba, Japan, from 2015 to 2018. Multivariate regression was applied to examine the relationship between preoperative descriptors and stone-free status, and a nomogram was developed using significant predictors. Next, the individual components of the nomogram were assigned points to form a simple scoring system. The predictive performance of this new scoring system was compared with the STONE score at optimal cut-off values using receiver operating characteristic curve and area under the curve analyses. RESULTS: Multivariate logistic regression findings showed that factors associated with stone-free status were length, Hounsfield unit and stone location. A nomogram prediction model was developed with an area under the curve value of 0.845, then consequently used to develop a new simple score system termed the T.O.HO. score consisting of three stone characteristics: (T)allness (1-5 points), (O)ccupied lesion (1-3 points) and (HO)unsfield units evaluation (1-3 points). The T.O.HO. score was significantly higher in stone remaining (7.66) than stone-free (5.27; P < 0.001) cases. The area under the curve for the T.O.HO. score was 0.833 at an optimal cut-off value of 7, whereas that for the STONE score was 0.683 at an optimal cut-off value of 9, showing the superiority of this new scoring system. CONCLUSION: The T.O.HO. score is a useful tool for predicting stone-free status in patients who have undergone a flexible ureteroscopy lithotripsy procedure.


Assuntos
Cálculos Renais , Litotripsia , Cálculos Ureterais , Humanos , Japão , Cálculos Renais/terapia , Litotripsia/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento , Cálculos Ureterais/terapia , Ureteroscópios , Ureteroscopia
18.
Urology ; 143: 68-74, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32540300

RESUMO

OBJECTIVES: To assess the financial impact of switching to single-use ureteroscopes (sURS) in urolithiasis management for a hospital, over a 5-year period, and to identify possible solutions to contain or reduce it. METHODS: A Budget Impact (BI) model was designed for a public hospital performing around 200 ureteroscopies or extracorporeal shockwave lithotripsies per year. The BI was estimated as the difference between financial balances (between costs and revenues) of 2 environments (with and without sURS). The population was defined as adults treated for urolithiasis. The BI model was based on assumptions about the expected progression in the incidence of urolithiasis, and the expected change in clinical practices due to the availability of sURS. We considered the costs and revenues of hospital stays, the purchase price of sURS and the costs of digital or fiberoptic reusable ureteroscopes (rURS). Univariate and multivariate sensitivity analyses were performed. RESULTS: The cumulative 5-year financial impact of switching completely to sURS was €807,824 and €649,677 in comparison with fiberoptic and digital rURS respectively. This impact could be reduced by half or more if the health-care facility were to adopt different solutions, including negotiating the purchase price of sURS, developing outpatient activity and reducing production costs for ureteroscopy procedures. CONCLUSION: The BI model gives decision-makers a more accurate picture of the financial impact of switching to sURS and highlights ways to reduce the expected additional cost.


Assuntos
Redução de Custos , Equipamentos Descartáveis/economia , Ureteroscópios/economia , Urolitíase/economia , Urolitíase/cirurgia , Desenho de Equipamento , França , Humanos , Fatores de Tempo
19.
J Endourol ; 34(4): 495-501, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32059622

RESUMO

Objective: To objectively assess the performance of graduating urology residents performing flexible ureterorenoscopy (fURS) using a simulation-based model and to set an entrustability standard or benchmark for use across the educational spectrum. Methods: Chief urology residents and attending endourologists performed a standardized fURS task (ureterorenoscopy and repositioning of stones) using a Boston Scientific© Lithovue ureteroscope on a Cook Medical© URS model. All performances were video-recorded and blindly scored by both endourology experts and crowd-workers (C-SATS) using the Ureteroscopic Global Rating Scale, plus an overall entrustability score. Validity evidence supporting the scores was collected and categorized. The Borderline Group (BG) method was used to set absolute performance standards for the expert and crowdsourced ratings. Results: A total of 44 participants (40 chief residents, 4 faculties) completed testing. Eighty-three percent of participants had performed >50 fURS cases at the time of the study. Only 47.7% (mean score 12.6/20) and 61.4% (mean score 12.4/20) of participants were deemed "entrustable" by experts and crowd-workers, respectively. The BG method produced entrustability benchmarks of 11.8/20 for experts and 11.4/20 for crowd-worker ratings, resulting in pass rates of 56.9% and 61.4%. Conclusion: Using absolute standard setting methods, benchmark scores were set to identify trainees who could safely carry out fURS in the simulated setting. Only 60% of residents in our cohort were rated as entrustable. These findings support the use of benchmarks to earlier identify trainees requiring remediation.


Assuntos
Internato e Residência , Urologia , Competência Clínica , Humanos , Padrões de Referência , Ureteroscópios , Ureteroscopia , Urologia/educação
20.
Curr Opin Urol ; 30(2): 113-119, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31815748

RESUMO

PURPOSE OF REVIEW: Single-use flexible ureteroscopes (su-fURS) aim at overcoming the main limitations of conventional reusable ureteroscopes in terms of acquisition and maintenance costs, breakages, and reprocessing. However, little data exist to date regarding the superiority of su-fURS at this regard. We aimed to perform a systematic literature review on available su-fURS performance with a focus on clinical data for all articles in the last 10 years. RECENT FINDINGS: To date, more than 10 different su-fURS are available on the market, with different characteristics and performance. Some of these devices have top-level features, almost catching up with those observed in reusable flexible ureteroscopes. Clinical evidence is mainly available only for two models, LithoVue and Uscope PU3022, and to date it is not strong enough to support routine adoption and use of su-fURS, with a consequent lack of consensus of specific clinical indications. Cost-effectiveness analyses seem to indicate an economic disadvantage in the routine adoption of su-fURS. Environmental issues related to the use of su-fURS also remain to be inquired and addressed. SUMMARY: Since their introduction, su-fURS have gained widespread popularity. Despite their ability at addressing reusable ureteroscope limitations, high-cost and a substantial lack of evidence are still limiting their routine adoption.


Assuntos
Cálculos Renais/cirurgia , Ureteroscópios , Ureteroscopia/instrumentação , Análise Custo-Benefício , Equipamentos Descartáveis/normas , Desenho de Equipamento , Humanos , Cálculos Renais/economia , Ureteroscópios/economia , Ureteroscópios/normas , Ureteroscopia/economia , Ureteroscopia/métodos , Ureteroscopia/normas
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