An in vitro Comparative Assessment of Single-Use Flexible Ureteroscopes Using a Standardized Ureteroscopy Training Model.

INTRODUCTION: Perceived benefits like decreased contamination rates and reduced postoperative incidence of complications after urolithiasis surgery have led to increased adoption of single-use flexible ureteroscopes (su-fURS). Using a validated, standardized simulator model with enhanced "fluoroscopic" capabilities, we performed an in vitro comparative assessment of four commercially available models of su-fURS. Both objective and subjective parameters were assessed in this study. METHODS: Two standardized tasks, (1) exploration of the model's kidney collecting system and (2) repositioning of a stone fragment from the upper renal to lower renal pole were assigned to participants, who performed these tasks on all four scopes. Four models of su-fURS (Boston LithoVue, PUSEN PU3033A, REDPINE, INNOVEX EU-ScopeTM) were assessed, with task timings as end-points for objective analysis. Cumulative "fluoroscopic" time was also recorded as a novel feature of our enhanced model. Post-task questionnaires evaluating specific components of the scopes were distributed to document subjective ratings. RESULTS: Both subjective and objective performances (except stone repositioning time) across all four su-fURS demonstrated significant differences. However, objective performance (task timings) did not reflect subjective scope ratings by the participants (Rs < 0.6). Upon Kruskal-Wallis H test with post hoc analyses, REDPINE and INNOVEX EU-ScopeTM were the preferred su-fURS as rated by the participants, with overall scope scores of 9.00/10 and 9.57/10. CONCLUSIONS: Using a standardized in vitro simulation model with enhanced fluoroscopic capabilities, we demonstrated both objective and subjective differences between models of su-fURS. However, variations in perception of scope features (visibility, image quality, deflection, maneuverability, ease of stone retrieval) did not translate into actual technical performance. Eventually, the optimal choice of su-fURS fundamentally lies in individual surgeon preference, as well as cost-related factors.

Comparing outcomes of single-use vs reusable ureteroscopes: a systematic review and meta analysis.

Flexible ureterolithotripsy is a frequent urological procedure, usually used to remove stones from the kidney and upper ureter. Reusable uretero-scopes were the standard tool for that procedure, but recent concerns related to sterility and maintenance and repair costs created the opportunity to develop new technologies. In 2016, the first single-use digital flexible ureteroscope was introduced. Since then, other single-use ureteroscopes were developed, and studies compared them with the reusable ureteroscopes with conflicting results. The purpose of this study is to describe the literature that compares the performance of single-use and reusable flexible ureteroscopes in retrograde intrarenal surgery for urinary stones. A Systematic Review was performed in October 2022 in accordance with the Cochrane Handbook and the Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA). A search in MEDLINE, EMBASE, Web of Science, Google Scholar and LILACS retrieved 10,039 articles. After screening, 12 articles were selected for the Meta-Analysis. No differences were found in stone-free rate (OR 1.31, CI 95% [0.88, 1.97]), operative time (MD 0.12, CI 95% [-5.52, 5.76]), incidence of post-operative fever (OR 0.64, CI 95% [0.22, 1.89]), or incidence of post-operative urinary tract infection (OR 0.63 CI 95% [0.30, 1.32]). No differences were observed in the studied variables. Hence, the device choice should rely on the availability, cost analysis and surgeons' preference.

Stone removing efficiency and safety comparison between single use ureteroscope and reusable ureteroscope: a systematic review and meta-analysis.

BACKGROUND: Urologists are gradually beginning to use single-use ureteroscopes (sufURSs), despite a lack of high-level evidence as to their efficacy and safety. This systematic review was registered on PROSPERO (no. CRD42020181808). METHODS: The PubMed, Embase, Web of Science, and Cochrane Library databases were searched for studies published before October 1, 2020. Jadad score tools were used to evaluate the quality of the included randomized controlled trials (RCTs) and the Newcastle-Ottawa Scale (NOS) was used to evaluate the quality of the included nonrandomized studies. Two researchers independently extracted data according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) principles. A data synthesis was performed using Stata 15.0. Heterogeneity was mainly evaluated with I2 tests. In addition to funnel plots, Egger's and Begg's tests were used to detect publication bias. A sensitivity analysis was also performed. Stone-free rates and postoperative complications were the 2 primary outcomes; operation-time data were also extracted. RESULTS: Six studies (comprising 887 patients) containing the efficacy data and 5 studies (comprising 952 patients) containing the safety data that were finally included in the quantitative analysis. In relation to stone removal, no significant difference was found in terms of efficacy [Mantel-Haenszel statistic (M-H), relative risk (RR): 1.01, 95% confidence interval (CI): 0.96-1.07, P=0.658) or safety (M-H, RR: 1.30, 95% CI: 0.96-1.75, P=0.093) between the sufURS and the reusable flexible ureteroscope (rfURS), and no significant heterogeneity was found. A publication bias was detected in the efficacy comparison; however, the trim-and-fill analysis indicated that the original synthesis results remained stable. CONCLUSIONS: In relation to stone removal, sufURSs were found to be comparable to rfURS, and no compromising complications were found. However, the results should be treated with caution due to limitations related to the small number of studies included in the analysis.

Disposable versus Reusable Ureteroscopes: A Prospective Multicenter Randomized Comparison.

PURPOSE: To compare reusable and disposable flexible ureteroscopes in terms of efficacy and safety for patients undergoing Retrograde Intrarenal Surgery (RIRS). PATIENTS AND METHODS: Patients with a renal stone eligible for RIRS were enrolled in this multicenter, randomized, clinical trial study. Patients were randomized into two groups: group A (90 patients) underwent RIRS with a reusable flexible ureteroscope and group B (90 patients) were treated with a disposable one. RESULTS: The patients' demographics, stone features and pre-operative urine cultures were comparable between the groups. The Stone Free Rates (SFRs) were not significantly different (86.6% and 90.0% for group A and group B, respectively, p=0.11) and the mean cost for each procedure was comparable (2321 € in group A vs 2543 € in group B, p=0.09). However, the days of hospitalization and of antibiotic therapy were higher in group A (p ≤ 0.05). The overall complication rate in group A was 8.8% whilst in group B it was 3.3% (p ≤ 0.05); in particular, group A exhibited a greater number of major complications (Clavien score IIIa-V). The overall postoperative infection rate was 16.6% in group A and 3.3% in group B (p ≤ 0.05). Furthermore, none of the patients in group B developed urosepsis or had a positive blood culture, while 3 patients in group A did (p<0.05). CONCLUSION: The use of disposable ureteroscopes is characterized by significantly lower post-operative complications and infection rates, while having comparable costs and SFRs vis à vis reusable ureteroscopes. Clinical Trial Registration Number: ISRCTN92289221.