Urinary Incontinence and Erectile Dysfunction After Robotic Versus Open Radical Prostatectomy: A Prospective, Controlled, Nonrandomised Trial
Urinary Incontinence and Erectile Dysfunction After Robotic Versus Open Radical Prostatectomy: A Prospective, Controlled, Nonrandomised Trial
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DOI：
10.1016/j.eururo.2015.02.029
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发表时间：
2015-08-01
期刊：
影响因子：
23.4
通讯作者：
Steineck, Gunnar
中科院分区：
文献类型：
--
作者：
Haglind, Eva;Carlsson, Stefan;Steineck, Gunnar
背景：机器人辅助的腹腔镜前列腺癌根治术(RALP)已得到广泛应用，但与开腹耻骨后前列腺癌根治术(RRP)(金标准)相比，在长期临床结果方面没有更好的证据。目的：比较RALP或RRP术后12个月患者报告的尿失禁和勃起功能障碍。设计、背景和对象：这是一项前瞻性、对照、非随机试验，患者在14个中心使用RALP或RRP进行前列腺切除术。收集基线和术后12个月的临床记录表和有效的患者问卷。结果测量和统计分析：用Logistic回归计算优势比(OR)，并调整可能的混杂因素。主要终点为12mo时尿失禁(尿垫每24 h更换1次或1次以上)。次要终点是12个月时勃起功能障碍和手术切缘阳性。结果和限制：在2625名符合条件的男性中，2431名(93%)可以评估为主要终点。在RALP后12个月，366名男性(21.3%)出现大小便失禁，144名男性(20.2%)出现大小便失禁。调整后的OR为1.08(95%可信区间为0.87~1.34)。在RALP后12个月和RRP后分别有1200人(70.4%)和531人(74.7%)出现勃起功能障碍。调整后的OR值为0.81(95%CI，0.66~0.98)。两组间手术切缘阳性率无显著差异：RALP组为21.8%，RRP组为20.9%(调整后OR：1.09；95%CI，0.87-1.35)。非随机设计是一个限制。结论：在瑞典的设置中，与RRP相比，RALP治疗前列腺癌在保留勃起功能方面是适度有益的，在尿失禁或手术切缘方面没有统计学上的显著差异。患者总结：我们比较了患者报告的前列腺切除术后尿失禁与两种手术方法。尿漏发生率在统计学上没有显著改善，但机器人辅助手术后勃起功能略有改善。(C)2015年欧洲泌尿外科协会。爱思唯尔出版公司(Elsevier B.V.)
Background: Robot-assisted laparoscopic radical prostatectomy (RALP) has become widely used without high-grade evidence of superiority regarding long-term clinical outcomes compared with open retropubic radical prostatectomy(RRP), the gold standard.Objective: To compare patient-reported urinary incontinence and erectile dysfunction 12 mo after RALP or RRP.Design, setting, and participants: This was a prospective, controlled, nonrandomised trial of patients undergoing prostatectomy in 14 centres using RALP or RRP. Clinical-record forms and validated patient questionnaires at baseline and 12 mo after surgery were collected.Outcome measurements and statistical analyses: Odds ratios (ORs) were calculated with logistic regression and adjusted for possible confounders. The primary end point was urinary incontinence (change of pad less than once in 24 h vs one time or more per 24 h) at 12 mo. Secondary end points were erectile dysfunction at 12 mo and positive surgical margins.Results and limitations: Of 2625 eligible men, 2431 (93%) could be evaluated for the primary end point. At 12 mo after RALP, 366 men (21.3%) were incontinent, as were 144 (20.2%) after RRP. The adjusted OR was 1.08 (95% confidence interval [CI], 0.87-1.34). Erectile dysfunction was observed in 1200 men (70.4%) 12 mo after RALP and 531 (74.7%) after RRP. The adjusted OR was 0.81 (95% CI, 0.66-0.98). The frequency of positive surgical margins did not differ significantly between groups: 21.8% in the RALP group and 20.9% in the RRP group (adjusted OR: 1.09; 95% CI, 0.87-1.35). The nonrandomised design is a limitation.Conclusions: In a Swedish setting, RALP for prostate cancer was modestly beneficial in preserving erectile function compared with RRP, without a statistically significant difference regarding urinary incontinence or surgical margins.Patient summary: We compared patient-reported urinary incontinence after prostatectomy with two types of surgical technique. There was no statistically significant improvement in the rate of urinary leakage, but there was a small improvement regarding erectile function after robot-assisted operation. (C) 2015 European Association of Urology. Published by Elsevier B.V.