Komura Kazumasa, Inamoto Teruo, Takai Tomoaki, Uchimoto Taizo, Saito Kenkichi, Tanda Naoki, Minami Koichiro, Oide Rintaro, Uehara Hirofumi, Takahara Kiyoshi, Hirano Hajime, Nomi Hayahito, Kiyama Satoshi, Watsuji Toshikazu, Azuma Haruhito
Department of Urology, Osaka Medical College, Osaka, Japan.
BJU Int. 2015 Apr;115(4):644-52. doi: 10.1111/bju.12831. Epub 2014 Oct 24.
To assess whether bipolar transurethral resection of the prostate (B-TURP) using the TURis system has a similar level of efficacy and safety to that of the traditional monopolar transurethral resection of the prostate (M-TURP), and to evaluate the impact of the TURis system on postoperative urethral stricture rates over a 36-month follow-up period.
A total of 136 patients with benign prostatic obstruction were randomised to undergo either B-TURP using the TURis system or conventional M-TURP, and were regularly followed for 36 months after surgery. The primary endpoint was safety, which included the long-term complication rates of postoperative urethral stricture. The secondary endpoint was the follow-up measurement of efficacy.
In peri-operative findings, no patient in either treatment group presented with transurethral resection syndrome, and the decline in levels of haemoglobin and hematocrit were similar. The mean operation time was significantly extended in the TURis treatment group compared with the M-TURP group (79.5 vs 68.6 min; P = 0.032) and postoperative clot retention was more likely to be seen after M-TURP (P = 0.044). Similar efficacy findings were maintained throughout 36 months, but a significant difference in postoperative urethral stricture rates between groups was detected (6.6% in M-TURP vs 19.0% in TURis; P = 0.022). After stratifying patients according to prostate volume, there was no significant difference between the two treatment groups with regard to urethral stricture rates in patients with a prostate volume ≤ 70 mL (3.8% in M-TURP vs 3.8% in TURis), but in the TURis group there was a significantly higher urethral stricture rate compared with the M-TURP group in patients with a prostate volume >70 mL (20% in TURis vs 2.2% in M-TURP; P = 0.012). Furthermore, the mean operation time for TURis was significantly longer than for M-TURP for the subgroup of patients with a prostate volume > 70 mL (99.6 vs 77.2 min; P = 0.011), but not for the subgroup of patients with a prostate volume ≤ 70 mL.
The TURis system seems to be as efficacious and safe as conventional M-TURP except that there was a higher incidence of urethral stricture in patients with larger preoperative prostate volumes.
评估使用TURis系统进行双极经尿道前列腺切除术(B-TURP)与传统单极经尿道前列腺切除术(M-TURP)的疗效和安全性水平是否相似,并评估TURis系统在36个月随访期内对术后尿道狭窄发生率的影响。
总共136例良性前列腺梗阻患者被随机分为接受使用TURis系统的B-TURP或传统的M-TURP,并在术后定期随访36个月。主要终点是安全性,包括术后尿道狭窄的长期并发症发生率。次要终点是疗效的随访测量。
在围手术期结果中,两个治疗组均无患者出现经尿道切除综合征,血红蛋白和血细胞比容水平的下降相似。与M-TURP组相比,TURis治疗组的平均手术时间显著延长(79.5对68.6分钟;P = 0.032),且M-TURP术后更易出现术后血块潴留(P = 0.044)。在整个36个月中维持了相似的疗效结果,但检测到两组之间术后尿道狭窄发生率存在显著差异(M-TURP组为6.6%,TURis组为19.0%;P = 0.022)。根据前列腺体积对患者进行分层后,前列腺体积≤70 mL的患者中,两个治疗组在尿道狭窄发生率方面无显著差异(M-TURP组为3.8%,TURis组为3.8%),但在前列腺体积>70 mL的患者中,TURis组的尿道狭窄发生率显著高于M-TURP组(TURis组为20%,M-TURP组为2.2%;P = 0.012)。此外,前列腺体积>70 mL的患者亚组中,TURis的平均手术时间显著长于M-TURP(99.6对77.2分钟;P = 0.011),但前列腺体积≤70 mL的患者亚组并非如此。
TURis系统似乎与传统的M-TURP一样有效和安全,只是术前前列腺体积较大的患者尿道狭窄发生率较高。