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机器人辅助与开放性根治性前列腺切除术治疗后尿失禁和勃起功能障碍:一项前瞻性、对照、非随机试验。

Urinary Incontinence and Erectile Dysfunction After Robotic Versus Open Radical Prostatectomy: A Prospective, Controlled, Nonrandomised Trial.

机构信息

Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg and Sahlgrenska University Hospital, Göteborg, Sweden.

Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, Stockholm, Sweden.

出版信息

Eur Urol. 2015 Aug;68(2):216-25. doi: 10.1016/j.eururo.2015.02.029. Epub 2015 Mar 12.

DOI:10.1016/j.eururo.2015.02.029
PMID:25770484
Abstract

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 24h vs one time or more per 24h) at 12 mo. Secondary end points were erectile dysfunction at 12 mo and positive surgical margins.

RESULTS AND LIMITATIONS

At 12 mo after RALP, 366 men (21.3%) were incontinent, as were 144 (20.2%) after RRP. The unadjusted 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 unadjusted OR was 0.81 (95% CI, 0.66–0.98).

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.

摘要

背景

与金标准开放式经耻骨后前列腺切除术(RRP)相比,机器人辅助腹腔镜前列腺切除术(RALP)在长期临床结果方面没有高级别的优越性证据,但已广泛应用。

目的

比较 RALP 与 RRP 术后 12 个月患者报告的尿失禁和勃起功能障碍。

设计、设置和参与者:这是一项在 14 个中心进行的前瞻性、对照、非随机试验,患者接受 RALP 或 RRP 前列腺切除术。收集基线和术后 12 个月的临床记录表格和经过验证的患者问卷。

结果测量和统计分析

使用逻辑回归计算比值比(ORs),并根据可能的混杂因素进行调整。主要终点是术后 12 个月时尿失禁(24 小时内使用少于一片尿布与一次或更多次/24 小时)。次要终点是术后 12 个月勃起功能障碍和阳性切缘。

结果和局限性

在 RALP 术后 12 个月时,366 名男性(21.3%)失禁,RRP 术后 144 名男性(20.2%)失禁。未调整的 OR 为 1.08(95%置信区间[CI],0.87-1.34)。RALP 术后 12 个月时,1200 名男性(70.4%)和 RRP 术后 531 名男性(74.7%)出现勃起功能障碍。未调整的 OR 为 0.81(95%CI,0.66-0.98)。

结论

在瑞典环境中,与 RRP 相比,RALP 治疗前列腺癌在保留勃起功能方面略有优势,而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

我们比较了两种手术技术后患者报告的尿失禁情况。在尿漏率方面没有统计学上的显著改善,但在机器人辅助手术后,勃起功能有了微小的改善。

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