Randomized Study Comparing Moses 2.0 Holmium Laser and Thulium Fiber Laser for Endoscopic Prostate Surgery in Men with Medium to Large Prostates

What this Trial Is About

Researchers are evaluating two laser technologies, Holmium laser with Moses 2.0 technology MoLEP and Thulium Fiber laser ThuFLEP, for endoscopic anatomical enucleation of the prostate EEAP in men with enlarged prostates exceeding 80cc. This prospective, randomized, non-blind, multicenter clinical trial aims to compare the efficiency and clinical outcomes of these two laser methods for treating benign prostatic hyperplasia BPH. The study seeks to demonstrate the superiority of MoLEP in surgical time and to assess non-inferiority in bleeding, hospital stay, complications, and urinary symptom improvement. Participants will be randomly assigned to receive prostate enucleation surgery using either MoLEP or ThuFLEP, performed by experienced surgeons who have completed their learning curve with both laser types. Surgeries are scheduled between September 2024 and September 2025. Follow-up visits will occur at 1 month, 3 months, 6 months, and annually up to 3 years, allowing comprehensive monitoring of outcomes. The study plans to enroll 120 patients, balanced evenly between the two groups. During the study, participants will undergo assessments including uroflowmetry, blood tests, and symptom evaluations using the International Prostate Symptom Score IPSS. Researchers will measure total surgical time as the primary outcome, along with secondary outcomes such as perioperative bleeding, hospital stay duration, postoperative complications, and improvements in urinary symptoms and flow parameters. Statistical analyses will evaluate differences between the two surgical methods, and safety will be monitored throughout the follow-up period until March 2026 and beyond.

EEAP Using Moses 2.0 Technology vs the Thulium Fiber Laser in Medium-Large Prostates