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坦索罗辛对比安慰剂预防女性盆底重建术后尿潴留:一项多中心随机对照试验。

Tamsulosin vs placebo to prevent postoperative urinary retention following female pelvic reconstructive surgery: a multicenter randomized controlled trial.

机构信息

Division of Female Pelvic Medicine and Reconstructive Surgery, University Hospitals Cleveland Medical Center, Cleveland, OH; Division of Female Pelvic Medicine and Reconstructive Surgery, MetroHealth Medical Center, Cleveland, OH.

Division of Female Pelvic Medicine and Reconstructive Surgery, University Hospitals Cleveland Medical Center, Cleveland, OH.

出版信息

Am J Obstet Gynecol. 2021 Sep;225(3):274.e1-274.e11. doi: 10.1016/j.ajog.2021.04.236. Epub 2021 Apr 21.

DOI:10.1016/j.ajog.2021.04.236
PMID:33894146
Abstract

BACKGROUND

Postoperative urinary retention is common after female pelvic reconstructive surgery. Alpha receptor antagonists can improve dysfunctional voiding by relaxing the bladder outlet and may be effective in reducing the risk of postoperative urinary retention.

OBJECTIVE

This study aimed to determine whether tamsulosin is effective in preventing postoperative urinary retention in women undergoing surgery for pelvic organ prolapse.

STUDY DESIGN

This was a multicenter, double-blind, randomized controlled trial between August 2018 and June 2020, including women undergoing surgery for pelvic organ prolapse. Patients were excluded from recruitment if they had elevated preoperative postvoid residual volume, history of postoperative urinary retention, or a contraindication to tamsulosin. Those who experienced cystotomy were excluded from analysis. Participants were randomized to a 10-day perioperative course of tamsulosin 0.4 mg vs placebo, beginning 3 days before surgery. A standardized voiding trial was performed on postoperative day 1. The primary outcome was the development of postoperative urinary retention, as defined by the failure of the voiding trial or subsequent need for catheterization to empty the bladder. Secondary outcomes included the rate of urinary tract infection and the impact on lower urinary tract symptoms as measured by the American Urological Association Symptom Index.

RESULTS

Of 119 patients, 57 received tamsulosin and 62 received placebo. Groups were similar in regard to demographics, preoperative prolapse and voiding characteristics, and surgical details. Tamsulosin was associated with a lower rate of postoperative urinary retention than placebo (5 patients [8.8%] vs 16 patients [25.8%]; odds ratio, 0.28; 95% confidence interval, 0.09-81; P=.02). The number needed to treat to prevent 1 case of postoperative urinary retention was 5.9 patients. The rate of urinary tract infection did not differ between groups. American Urological Association Symptom Index scores significantly improved after surgery in both groups (median total score, 14 vs 7; P<.01). Scores related to urinary stream improved more in the tamsulosin group than in placebo (P=.03).

CONCLUSION

In this placebo-controlled trial, tamsulosin use was associated with a reduced risk of postoperative urinary retention in women undergoing surgery for pelvic organ prolapse.

摘要

背景

女性盆腔重建术后常发生尿潴留。α受体拮抗剂通过放松膀胱出口可改善排尿功能障碍,可能有助于降低术后尿潴留的风险。

目的

本研究旨在确定坦索罗辛是否可有效预防盆腔器官脱垂手术患者术后尿潴留。

研究设计

这是一项多中心、双盲、随机对照试验,于 2018 年 8 月至 2020 年 6 月纳入接受盆腔器官脱垂手术的女性患者。如果患者术前残余尿量增加、有术后尿潴留病史或对坦索罗辛禁忌,则将其排除在入组之外。如果患者发生膀胱切开术,则将其从分析中排除。参与者随机接受为期 10 天的围手术期坦索罗辛 0.4 mg 或安慰剂治疗,在术前 3 天开始。术后第 1 天进行标准化排尿试验。主要结局为排尿试验失败或随后需要导尿排空膀胱定义的术后尿潴留的发生。次要结局包括尿路感染的发生率和美国泌尿外科学会症状指数评估的下尿路症状的影响。

结果

在 119 例患者中,57 例接受坦索罗辛治疗,62 例接受安慰剂治疗。两组在人口统计学特征、术前脱垂和排尿特征以及手术细节方面相似。坦索罗辛组术后尿潴留的发生率低于安慰剂组(5 例[8.8%]比 16 例[25.8%];比值比,0.28;95%置信区间,0.09-81;P=.02)。预防 1 例术后尿潴留所需的治疗人数为 5.9 例。两组尿路感染的发生率无差异。两组术后美国泌尿外科学会症状指数评分均显著改善(总分中位数,14 分比 7 分;P<.01)。坦索罗辛组与安慰剂组相比,与尿流相关的评分改善更明显(P=.03)。

结论

在这项安慰剂对照试验中,坦索罗辛的使用与接受盆腔器官脱垂手术的女性术后尿潴留风险降低相关。

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