Prospective randomized multicenter study to evaluate holmium vs. new thulium fiber laser for prostate enucleation

BACKGROUND: Benign prostatic hyperplasia (BPH) commonly causes lower urinary tract symptoms (LUTS) in men. Holmium (HoLEP) and thulium (ThuLEP) laser enucleation are established techniques for BPH treatment. Thulium fiber laser (TFL) for prostate enucleation (ThuFLEP) shows promising outcomes. METHODS: A prospective randomized multicenter study was conducted. Patients with BPH and LUTS unresponsive to medical therapy were enrolled. Preoperative, surgical, perioperative and postoperative data were recorded with follow-up at 3 and 6 months. The primary outcome was functional improvement, and the secondary outcome was safety in terms of complications. RESULTS: Two hundred patients were included (HoLEP 100, ThuFLEP 100). No significant baseline difference was found between groups. At 3 and 6 months we found statistically significant improvements from baseline for both HoLEP and ThuFLEP in efficacy: International Prostatic Symptoms Score (IPSS), IPSS-Quality of Life (QoL), maximum urinary flow rate (Qmax), and post-void residual volume (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 complications occurred during hospitalization. After 6 months, 8 (8%) and 6 (6%) patients reported mild stress urinary incontinence in HoLEP and ThuFLEP groups, 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: HoLEP and ThuFLEP are effective and safe for BPH treatment, with comparable functional outcomes and complication rates at 6 months. Further research is needed to confirm these findings.