Thulium fiber laser versus Holmium laser enucleation of the prostate: 24-month outcomes from a prospective randomized non-inferiority trial

Clinical Snapshot

Key Findings

• P Value: p=0.03 for non-inferiority; p<0.001 for within-group improvements

• Effect Size: IPSS: 21→3 (ThuFLEP) vs 20→4 (HoLEP); QoL: 4→1 (both groups)

• Primary Outcome: Non-inferiority of ThuFLEP vs HoLEP confirmed for IPSS and QoL reduction at 24 months

• Nnt Or Sensitivity: Not calculable from available data - both treatments highly effective with >85% achieving clinically meaningful IPSS improvement

• Confidence Interval: Not reported in abstract

Clinical Application

Both ThuFLEP and HoLEP require specialised laser equipment and surgical expertise. Learning curve considerations important for implementation Both procedures available in major Australian centres. May be relevant for PBS consideration given demonstrated efficacy and potential for reduced medication dependence (89.4% to 7.7% reduction) Men with moderate to severe benign prostatic obstruction requiring surgical intervention, particularly those with IPSS >15 and significant QoL impairment

Abstract

PURPOSE: To compare 24-month outcomes of Thulium fiber laser enucleation of the prostate (ThuFLEP) and Holmium laser enucleation of the prostate (HoLEP). METHODS: A 24-month follow-up analysis of a prospective randomized trial including 150 patients (ThuFLEP n = 74, HoLEP n = 76) was conducted. Primary outcome was non-inferior International Prostate Symptom Score (IPSS) and quality of life (QoL) reduction. Secondary outcomes included urinary continence, medication use reduction, erectile and ejaculatory function, and late adverse events. RESULTS: At 24 months, non-inferiority of ThuFLEP regarding IPSS and QoL was confirmed (p = 0.03). Median IPSS improved from 21 preoperatively to 3 after ThuFLEP and from 20 to 4 after HoLEP (p < 0.001), with no significant intergroup differences at any time point (all p > 0.1). Median QoL improved from 4 to 1 in both groups (p < 0.001), likewise without significant differences at any time point (all p > 0.3). Continence rates improved from 74.0% preoperatively to 90.0%, pad usage decreased from 89.8% to 25.4% and ICIQ-SF decreased from 5 to 3 points (all p < 0.001), without intergroup differences (all p > 0.1). Use of medication for lower urinary tract symptoms decreased from 89.4% to 7.7% (p < 0.001). Ejaculatory function declined, while ejaculation-related bother remained unchanged and erectile function improved modestly, all without intergroup differences (all p > 0.1). Three late adverse events occurred exclusively in the ThuFLEP group, without statistical significance (p > 0.1). CONCLUSION: ThuFLEP remains non-inferior to HoLEP for patient-reported functional outcomes at 24 months and demonstrates comparable safety, continence, medication use reduction, and sexual function results over time. Both techniques represent effective, durable and safe surgical options for treating benign prostatic obstruction. TRIAL REGISTRATION NUMBER: DRKS00032699 (18.09.2023, retrospectively registered).

References

1. 1.Filzmayer, M., Cano Garcia, C., Traumann, M. I., Müller, M. J., Humke, C., Mandel, P. C., Kluth, L. A., Becker, A., Chun, F. K-H., & Kosiba, M. (2026). Thulium fiber laser versus Holmium laser enucleation of the prostate: 24-month outcomes from a prospective randomized non-inferiority trial. World Journal of Urology. https://doi.org/10.1007/s00345-021-03705-6