A prospective, randomized controlled trial is currently evaluating the superpulse thulium fiber laser (SPTL) against the holmium laser for ureteroscopic lithotripsy (URS) in treating upper urinary tract stones. The study, designed to assess both clinical efficacy and safety, is being conducted by researchers aiming to refine stone management techniques.
Trial Design and Objectives
The trial is designed to compare the stone-free rate, operative time, and complication rates between patients undergoing URS with SPTL versus those treated with the holmium laser. The primary outcome is the stone-free rate at a 3-month follow-up, assessed through imaging techniques. Secondary outcomes include operative time, energy consumption, and the incidence of adverse events.
Laser Technology
The superpulse thulium fiber laser is a relatively new technology in urology, offering potential advantages over traditional holmium lasers. SPTL emits laser energy at a wavelength of 1.94 μm, which is highly absorbed by water, leading to efficient stone ablation with potentially less thermal damage to surrounding tissues. The holmium laser, a well-established tool in lithotripsy, operates at a wavelength of 2.12 μm.
Patient Population and Methodology
The study includes patients with upper urinary tract stones who are suitable candidates for URS. Exclusion criteria include bleeding disorders, pregnancy, and active urinary tract infections. Participants are randomized to either the SPTL or holmium laser group. All procedures are performed by experienced urologists, and a standardized URS technique is employed.
Data Monitoring and Safety
The trial incorporates a data monitoring committee that provides regular oversight through monthly meetings and bimonthly site visits. This committee ensures the trial's smooth and ethical conduct. Adverse events (AEs) are meticulously recorded and graded according to the NCI-CTCAE, version 5.0, with all AEs occurring within 30 days after the procedure being documented. Common complications of URS, such as ureteral perforation and hematuria, are closely monitored.
Statistical Analysis
Data analysis will be performed using SPSS 26.0 statistical software. Count data will be analyzed using chi-square or Fisher’s exact tests, while normally distributed measurement data will be compared using independent sample t-tests. Non-normally distributed data will be analyzed using the Wilcoxon rank sum test. A p-value < 0.05 will be considered statistically significant. Multiple imputation will be used to manage missing values.
Ethical Considerations and Dissemination
The study protocol has been approved by the Institutional Medical Ethics Committee. Any protocol modifications will be submitted to the committee for approval, and investigators will be notified in writing. The main findings will be published in a peer-reviewed journal.
