Department of Urology, Osaka Medical College, Osaka, Japan.
Department of Urology, Osaka Medical College, Osaka, Japan.
Urology. 2014 Aug;84(2):405-11. doi: 10.1016/j.urology.2014.04.025. Epub 2014 Jun 21.
To assess whether bipolar transurethral resection of the prostate using the TURis (Olympus, Tokyo, Japan) system demonstrates comparable efficacy and safety reporting 36 months of follow-up findings.
The trial was registered at University hospital Medical Information Network Clinical Trials Registry in Japan (trial number UMIN 000010801). Patients were randomly selected to undergo transurethral resection of the prostate using either the TURis or the conventional monopolar technique. Primary end points were safety according to operation time, decline of sodium and hemoglobin levels, clot retention, and catheterization time. Secondary end points were efficacy findings for patients after 36 months of follow-up.
A total of 136 patients were enrolled. Mean operation times were significantly prolonged in the TURis group (68.4 and 79.5 minutes for monopolar and TURis groups, respectively; P = .048). No significant differences in the decline of hemoglobin, hematocrit, and perioperative transfusion rates between groups were seen, whereas clot retention (grade 2) after the treatment seemed to occur more often in the monopolar group (7 of 62 [12.3%] in monopolar group vs 1 of 63 [1/8%] in TURis group; P = .061). No case presented symptomatic transurethral resection syndrome in either groups.
Continued efficacy at 36 months after the treatment could be confirmed for the first time in TURis system, which also seems to be preferable as they produced more clinically favorable outcomes. Nevertheless, the TURis system required significantly more resection time, which might not entirely be a panacea for the treatment of benign prostatic obstruction, especially for patients having larger prostatic volumes.
评估使用 TURis(奥林巴斯,东京,日本)系统进行双相经尿道前列腺切除术在 36 个月随访结果中是否具有相当的疗效和安全性报告。
该试验在日本大学医院医疗信息网络临床试验注册中心(临床试验编号 UMIN 000010801)注册。患者随机选择接受经尿道前列腺切除术,分别采用 TURis 或传统的单极技术。主要终点是根据手术时间、钠和血红蛋白水平下降、血块保留和导管插入时间评估安全性。次要终点是 36 个月随访后患者的疗效发现。
共纳入 136 例患者。TURis 组的平均手术时间明显延长(单极组和 TURis 组分别为 68.4 和 79.5 分钟;P =.048)。两组血红蛋白、血细胞比容和围手术期输血率下降无显著差异,而治疗后血块保留(2 级)似乎更常见于单极组(单极组 62 例中有 7 例[12.3%],TURis 组 63 例中有 1 例[1/8%];P =.061)。两组均无症状性经尿道前列腺切除综合征病例。
首次在 TURis 系统中证实治疗 36 个月后的持续疗效,并且该系统似乎更可取,因为它们产生了更有利的临床结果。然而,TURis 系统需要明显更长的切除时间,这可能不完全是治疗良性前列腺梗阻的万能药,特别是对于前列腺体积较大的患者。