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ThuFLEP non-inferior to HoLEP for benign prostatic obstruction symptom relief at 24 months

ThuFLEP non-inferior to HoLEP for benign prostatic obstruction symptom relief at 24 months
Photo by Europeana / Unsplash
Key Takeaway
Consider ThuFLEP and HoLEP as comparable surgical options for benign prostatic obstruction symptom relief.

This randomized non-inferiority trial enrolled 150 patients with benign prostatic obstruction, assigning 74 to thulium fiber laser enucleation of the prostate (ThuFLEP) and 76 to holmium laser enucleation of the prostate (HoLEP). The primary outcome was non-inferior International Prostate Symptom Score (IPSS) and quality of life (QoL) reduction over 24.0 months.

Median IPSS improved from 21 preoperatively to 3 after ThuFLEP and from 20 to 4 after HoLEP (p < 0.001 within group; all p > 0.1 intergroup). Median QoL improved from 4 to 1 in both groups (p < 0.001 within group; all p > 0.3 intergroup). Continence rates improved from 74.0% preoperatively to 90.0% (p < 0.001). Pad usage decreased from 89.8% to 25.4% (p < 0.001). ICIQ-SF scores decreased from 5 to 3 points (p < 0.001). Medication use decreased from 89.4% to 7.7% (p < 0.001).

Ejaculatory function declined, with all intergroup p > 0.1. Erectile function improved modestly, with all intergroup p > 0.1. Three late adverse events occurred exclusively in the ThuFLEP group (p > 0.1). Safety was reported as comparable.

Key limitations include the lack of reported funding or conflicts and the absence of specified limitations in the source data. The study did not report serious adverse events or discontinuations.

Practice relevance is that both techniques represent effective, durable, and safe surgical options for treating benign prostatic obstruction, based on this single trial.

Study Details

Study typeRct
Sample sizen = 150
EvidenceLevel 2
Follow-up24.0 mo
PublishedApr 2026
View Original 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).
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