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可持续性功能尿道重建可改善机器人辅助根治性前列腺切除术后早期尿控:一项随机对照试验。

Sustainable functional urethral reconstruction improves early urinary continence after robot-assisted radical prostatectomy: a randomised controlled trial.

机构信息

Department of Urology, Changhai Hospital, Naval Medical University, Shanghai, China.

Department of Urology, The Second Affiliated Hospital of Soochow University, Jiangsu, China.

出版信息

BJU Int. 2023 Jun;131(6):720-728. doi: 10.1111/bju.15956. Epub 2023 Jan 9.

Abstract

OBJECTIVE

To evaluate the impact of sustainable functional urethral reconstruction (SFUR) on early recovery of urinary continence (UC) after robot-assisted radical prostatectomy.

PATIENTS AND METHODS

Overall, 96 patients with primary prostate cancer were randomised into the SFUR or standard group (n = 48 each). The primary outcome was the 1-month UC recovery. Secondary outcomes included short-term (≤3 months) UC recovery, urinary function, micturition-related bother, perioperative complications, and oncological outcomes. Kaplan-Meier curves and Cox proportional hazard models were used to assess the 3-month UC recovery. Generalised estimating equations were used to compare postoperative urinary function and micturition-related bother.

RESULTS

The 1-month UC recovery rates, median 24-h pad weights, and median operative time in the SFUR and standard groups were 73% and 49% (P = 0.017), 0 and 47 g (P = 0.001), and 125 and 103 min (P = 0.025), respectively. The UC recovery rates in the SFUR vs standard groups were 53% vs 23% at 1 week (P = 0.003), 53% vs 32% at 2 weeks (P = 0.038), and 93% vs 77% at 3 months (P = 0.025). The median time to UC recovery in the SFUR and standard groups was 5 and 34 days, respectively (log-rank P = 0.006); multivariable Cox regression supported this result (hazard ratio 1.73, 95% confidence interval 1.08-2.79, P = 0.024). Similar results were observed when UC was defined as 0 pads/day. Urinary function (P = 0.2) and micturition-related bother (P = 0.8) were similar at all follow-up intervals. The perioperative complication rates, positive surgical margin rates, and 1-year biochemical recurrence-free survival were comparable between both groups (all P > 0.05).

CONCLUSION

SFUR resulted in earlier UC recovery without compromising postoperative urinary function. Long-term validation and multicentre studies are required to confirm the results of this novel technique.

摘要

目的

评估可持续性功能尿道重建(SFUR)对机器人辅助根治性前列腺切除术后早期尿控(UC)恢复的影响。

患者和方法

共有 96 例原发性前列腺癌患者被随机分为 SFUR 组或标准组(每组 48 例)。主要结局是 1 个月 UC 恢复情况。次要结局包括短期(≤3 个月)UC 恢复情况、尿功能、排尿相关困扰、围手术期并发症和肿瘤学结局。采用 Kaplan-Meier 曲线和 Cox 比例风险模型评估 3 个月 UC 恢复情况。采用广义估计方程比较术后尿功能和排尿相关困扰。

结果

SFUR 组和标准组的 1 个月 UC 恢复率、中位 24 小时垫重和中位手术时间分别为 73%和 49%(P=0.017)、0 和 47g(P=0.001)和 125 和 103min(P=0.025)。SFUR 组与标准组在 1 周时的 UC 恢复率分别为 53%和 23%(P=0.003)、2 周时分别为 53%和 32%(P=0.038)和 3 个月时分别为 93%和 77%(P=0.025)。SFUR 组和标准组的 UC 恢复中位时间分别为 5 天和 34 天(对数秩 P=0.006);多变量 Cox 回归支持这一结果(风险比 1.73,95%置信区间 1.08-2.79,P=0.024)。当 UC 定义为 0 片/天时也观察到类似的结果。在所有随访间隔,尿功能(P=0.2)和排尿相关困扰(P=0.8)相似。两组的围手术期并发症发生率、切缘阳性率和 1 年生化无复发生存率相当(均 P>0.05)。

结论

SFUR 可实现早期 UC 恢复,而不影响术后尿功能。需要进行长期验证和多中心研究来确认这项新技术的结果。

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