A randomized trial of holmium laser vs thulium laser vs bipolar enucleation of large prostate glands.

ABSTRACT

OBJECTIVE: To compare the outcome and morbidity of bipolar transurethral enucleation of the prostate (B-TUEP) and thulium laser enucleation of the prostate (ThuLEP) with those of holmium laser enucleation of the prostate (HoLEP) in the treatment of large symptomatic benign prostatic obstruction (BPO) through a non-inferiority randomized controlled trial (NCT03916536). PATIENTS AND METHODS: A total of 155 patients were recruited from a single centre between February 2019 and August 2020. All had BPO, with a prostate volume ≥80 ml. Patients were randomly assigned to HoLEP, ThuLEP or B-TUEP using computer-generated random tables in a 111 ratio. Participants, investigators and surgeons were blinded to group assignment until the date of the operation. Thereafter, the patients were followed up at 1, 3, 6 and 12 months. The primary outcome was maximum urinary flow rate (Qmax ) at 6 months. Secondary outcomes included assessment of other functional urinary variables, peri-operative records, and adverse events. RESULTS: There were 138 and 120 patients available for analysis at 6 and 12 months. There was no significant difference in Qmax between the groups at 6 and 12 months (P = 0.4 and P = 0.7, respectively), and no significant difference regarding International Prostate Symptom Score (IPSS), quality of life (QoL) or postvoid residual urine volume (PVR). The median (interquartile range) prostate-specific antigen (PSA) reductions (ng/ml) were similar in the three groups at last follow-up point (4.7 [2.2-7.1]; 5.6 [2.3-9.5] and 5 [3.4-10] after HoLEP, ThuLEP and B-TUEP, respectively). Differences in enucleation time, enucleation efficiencies and auxiliary manoeuvres were statistically insignificant (P = 0.1, 0.8 and 0.07, respectively). At 1 year, patients with prostate volumes >120 ml showed significant IPSS improvement in favour of HoLEP and ThuLEP (P = 0.01). Low- and high-grade adverse effects were recorded in 31 and five cases, respectively, with no statistically significant difference between the groups. CONCLUSIONS: We conclude that ThuLEP and B-TUEP are as safe and effective as HoLEP for the treatment of large-sized BPO. Significant PSA reductions indicate that there was effective adenoma enucleation with all three approaches. The study provides objective evidence that endoscopic enucleation of the prostate is a technique rather than energy dependent procedure.