Disposable versus Reusable Ureteroscopes: A Prospective Multicenter Randomized Comparison
Giorgio Bozzini, B. Filippi, Sulieman Alriyalat, Alberto Calori, Umberto Besana, Alexander Mueller, D. Pushkar, Javier Otero, Antonio Luigi Pastore, Maria Chiara Sighinolfi, Salvatore Micali, Carlo Buizza, Bernardo Rocco
Abstract
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.