Abstract：
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).
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.
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.
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.
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.
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.
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.
摘要：
目的：通过非劣效性随机对照试验（NCT03916536），比较B-TUEP和ThuLEP与HoLEP治疗大症状良性前列腺梗阻（BPO）的疗效和发病率。
方法：在2019年2月至2020年8月期间，从一个中心招募了155名患者。所有的BPO均具有>80cc的前列腺大小。这些病例被随机分配到HoLEP，ThuLEP或B-TUEP使用计算机以1：1：1的比例生成随机表格。参与者,研究人员和操作人员在手术日期之前对小组分配不知情.此后,随访1、3、6、12个月。主要结果是6个月时的Qmax评分。次要结果包括其他功能性泌尿参数的评估，围手术期记录,和不良事件。
结果：在6个月和12个月时，有138例和120例患者可用于分析。在6个月和12个月时，两组之间的Qmax没有统计学上的显着差异（P=0.4；P=0.7）。IPSS没有显著差异，QoL,或PVR。上次随访时PSA降低中位数（IQR）相似{4.7（2.2-7.1）；HoLEP后5.6（2.3-9.5）和5（3.4-10），分别为ThuLEP和B-TUEP}。眼球摘除时间,眼球摘除效率和辅助动作差异无统计学意义（分别为P=0.1、0.8和0.07）。一年，前列腺大小>120cc的患者显示IPSS显著改善,有利于HoLEP和ThuLEP(P=0.01).低、高级别不良反应分别为31例和5例，组间差异无统计学意义。
结论：ThuLEP和B-TUEP作为HoLEP治疗大型BPO是安全有效的。显著的PSA降低表示在三种方法中有效的腺瘤摘除。该研究提供了客观证据，证明内窥镜前列腺摘除术是一种技术，而不是能量依赖性程序。
方法：在2019年2月至2020年8月期间，从一个中心招募了155名患者。所有的BPO均具有>80cc的前列腺大小。这些病例被随机分配到HoLEP，ThuLEP或B-TUEP使用计算机以1：1：1的比例生成随机表格。参与者,研究人员和操作人员在手术日期之前对小组分配不知情.此后,随访1、3、6、12个月。主要结果是6个月时的Qmax评分。次要结果包括其他功能性泌尿参数的评估，围手术期记录,和不良事件。
结果：在6个月和12个月时，有138例和120例患者可用于分析。在6个月和12个月时，两组之间的Qmax没有统计学上的显着差异（P=0.4；P=0.7）。IPSS没有显著差异，QoL,或PVR。上次随访时PSA降低中位数（IQR）相似{4.7（2.2-7.1）；HoLEP后5.6（2.3-9.5）和5（3.4-10），分别为ThuLEP和B-TUEP}。眼球摘除时间,眼球摘除效率和辅助动作差异无统计学意义（分别为P=0.1、0.8和0.07）。一年，前列腺大小>120cc的患者显示IPSS显著改善,有利于HoLEP和ThuLEP(P=0.01).低、高级别不良反应分别为31例和5例，组间差异无统计学意义。
结论：ThuLEP和B-TUEP作为HoLEP治疗大型BPO是安全有效的。显著的PSA降低表示在三种方法中有效的腺瘤摘除。该研究提供了客观证据，证明内窥镜前列腺摘除术是一种技术，而不是能量依赖性程序。
