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 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. 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.
Subject(s)
Laser Therapy , Lasers, Solid-State , Prostatic Hyperplasia , Transurethral Resection of Prostate , Male , Humans , Prostate/surgery , Lasers, Solid-State/therapeutic use , Thulium/therapeutic use , Quality of Life , Prostate-Specific Antigen , Treatment Outcome , Prostatic Hyperplasia/complications , Transurethral Resection of Prostate/methods , Laser Therapy/methods , HolmiumABSTRACT
OBJECTIVE: To test the non-inferiority of bipolar transurethral vaporization of the prostate (TUVP) compared to GreenLight laser (GL) photoselective vaporization of the prostate (PVP) for reduction of benign prostatic hyperplasia-related lower urinary tract symptoms in a randomized trial. METHODS: Eligible patients with prostate volumes of 30-80 mL were randomly allocated to GL-PVP (n = 58) or bipolar TUVP (n = 61). Non-inferiority of symptom score (International Prostate Symptom Score [IPSS]) at 24 months was evaluated. All peri-operative variables were recorded and compared. Urinary (IPSS, maximum urinary flow rate and post-void residual urine volume) and sexual (International Index of Erectile Function-15) outcome measures were evaluated at 1, 4, 12 and 24 months. Need for retreatment and complications, change in PSA level and health resources-related costs of both procedures were recorded and compared. RESULTS: Baseline and peri-operative variables were similar in the two groups. At 1, 4, 12 and 24 months, 117, 116, 99 and 96 patients, respectively, were evaluable. Regarding urinary outcome measures, there was no significant difference between the groups. The mean ± sd IPSS at 1 and 2 years was 7.1 ± 3 and 7.9 ± 2.9 (P = 0.8), respectively, after GL-PVP and 6.3 ± 3.1 and 7.2 ± 2.8, respectively, after bipolar TUVP (P = 0.31). At 24 months, the mean difference in IPSS was 0.7 (95% confidence interval -0.6 to 2.3; P = 0.6). The median (range) postoperative PSA reduction was 64.7 (25-99)% and 65.9 (50-99)% (P = 0.006) after GL-PVP, and 32.1 (28.6-89.7)% and 39.3 (68.8-90.5)% (P = 0.005) after bipolar TUVP, at 1 and 2 years, respectively. After 2 years, retreatment for recurrent bladder outlet obstruction was reported in eight (13.8%) and 10 (16.4%) patients in the GL-PVP and bipolar TUVP groups, respectively (P = 0.8). The mean estimated cost per bipolar TUVP procedure was significantly lower than per GL-PVP procedure after 24 months (P = 0.01). CONCLUSIONS: In terms of symptom control, bipolar TUVP was not inferior to GL-PVP at 2 years. Durability of the outcome needs to be tracked. The greater cost of GL-PVP compared with bipolar TUVP is an important concern.
Subject(s)
Laser Therapy , Prostatectomy/methods , Prostatic Hyperplasia/surgery , Urinary Bladder Neck Obstruction/surgery , Aged , Humans , Male , Middle Aged , Prostatic Hyperplasia/complications , Severity of Illness Index , Time Factors , Transurethral Resection of Prostate , Treatment Outcome , Urinary Bladder Neck Obstruction/etiologyABSTRACT
OBJECTIVE: To assess the non-inferiority of Low-power Holmium laser enucleation of the prostate (LP-HoLEP) to high-power (HP-HoLEP) for enucleation efficiency pertaining to the advantages of lower cost and minimal postoperative dysuria, storage symptoms, and negative sexual impact. PATIENTS AND METHODS: HoLEP was performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP (61 patients) and 2J/50Hz for HP-HoLEP (60 patients). Two surgeons with different experience performed equal number of both procedures. Non-inferiority of enucleation efficiency (enucleated weight/min) was evaluated. All perioperative parameters were recorded and compared. Dysuria was assessed at 2 weeks by dysuria visual analog scale, urinary (Q.max and IPSS) and sexual (sexual health inventory for men score) outcome measures were evaluated at 1, 4, and 12 months. RESULTS: Baseline and perioperative parameters were comparable between the two groups. Mean enucleation efficiency was 1.42±0.6 vs 1.47±0.6 gm/min, Pâ¯=â¯.6 following LP-HoLEP and HP-HoLEP, respectively. Patients reported postoperative dysuria similarly in both groups as per dysuria visual analog scale. There was significant comparable improvement in IPSS (international prostate symptom score) and Q.max in both groups at different follow-up points. At one year, median IPSS and Q.max were comparable in both groups (Pâ¯=â¯.4 and .7 following LP-HoLEP and HP-HoLEP, respectively). Median postoperative reduction in prostate specific antigen was 89% (42:99) following LP-HoLEP vs 81% (62:94) after HP-HoLEP, Pâ¯=â¯.92. Both groups showed comparable perioperative and late postoperative complications. There were no statistically significant changes in the last follow-up sexual health inventory for men score in comparison to baseline score. CONCLUSION: LP-HoLEP is non-inferior to HP-HoLEP in terms of all efficiency parameters regardless level of surgeon experience.