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

Abstract

ObjectiveTo 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 MethodsA 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 1:1:1 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.ResultsThere 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.ConclusionsWe 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.