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.