Holmium and Thulium Fiber Laser Enucleation of the Prostate: A Prospective Randomized Multicenter Study

Abstract

Abstract Background: Benign Prostatic Hyperplasia (BPH) is a common condition causing lower urinary tract symptoms (LUTS) in men. Holmium (HoLEP) and thulium (ThuLEP) laser enucleation are established minimally invasive techniques to treat BPH. Recently, thulium fiber laser (TFL) has been proposed for prostate enucleation (ThuFLEP) with promising outcomes. Methods: We designed a prospective randomized multicenter study to compare the efficacy and safety of HoLEP and ThuFLEP. Patients with BPH-related lower urinary tract symptoms and failure of BPH medical therapy were enrolled. Preoperative, surgical, perioperative and postoperative data were recorded. Follow-up visits were scheduled at 3 and 6 months. Efficacy in terms of improvement of functional outcomes was chosen as the primary outcome, whereas safety in terms of intraoperative and postoperative complications was selected as the secondary outcome. Results: A total of 200 patients were included (HoLEP 100, ThuFLEP 100). No significant difference in baseline characteristics was found between the two groups. At 3 and 6 months we found statistically significant improvements from baseline for both HoLEP and ThuFLEP in IPSS, IPSS-QoL, Qmax, and PVR (p<0.05). At 6 months, mean±SD IPSS, IPSS-QoL, Qmax, and PVR for HoLEP vs. ThuFLEP were 5.8±4.9 vs. 4.8±5.0 points (p=0.57), 1.6±1.4 vs. 0.7±1.1 points (p=0.09), 29.9±12.5 vs. 29.6±8.0 mL/s (p=0.8), and 16.3±17.7 vs. 15.5±13.4 mL (p=0.92), respectively. No intraoperative complication was recorded. No Clavien-Dindo ≥ III complication occurred during hospitalization. After 6 months 8 (8%) and 6 (6%) patients reported mild stress urinary incontinence in HoLEP and ThuFLEP group, respectively (p=0.24). Urethral stenosis was observed in 3 men (3%) in the HoLEP group and 1 subject (1%) in the ThuFLEP group (p=0.72). Conclusions: Both HoLEP and ThuFLEP are effective and safe for benign prostatic hyperplasia treatment, with comparable functional outcomes and complications at 6 months. Further studies are needed to confirm our preliminary findings.