经尿道留置导尿在骨盆重建术后尿潴留的应用：一项随机对照试验。

Antibiotic Prophylaxis During Catheter-Managed Postoperative Urinary Retention After Pelvic Reconstructive Surgery: A Randomized Controlled Trial.

机构信息

UPMC Magee-Womens Hospital, Pittsburgh, Pennsylvania; MedStar Washington Hospital Center, Washington, DC; Washington University in St. Louis, St. Louis, Missouri; UT Southwestern Medical Center, Dallas, Texas; the University of Iowa Hospitals and Clinics, Iowa City, Iowa; and Advantia Health, Silver Spring, Maryland.

出版信息

Obstet Gynecol. 2019 Oct;134(4):727-735. doi: 10.1097/AOG.0000000000003462.

DOI:10.1097/AOG.0000000000003462

PMID:31503155

Abstract

OBJECTIVE

To estimate whether nitrofurantoin prophylaxis decreases the incidence of culture-documented urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery.

METHODS

This double-blind, placebo-controlled, randomized trial was conducted at five academic institutions. Women with urinary retention after surgery for prolapse or incontinence were randomized to oral nitrofurantoin 100 mg daily during indwelling or clean intermittent self-catheterization. The primary outcome was the incidence of symptomatic urinary tract infection within 6 weeks of surgery, confirmed by culture demonstrating more than 1,000 colony forming units per milliliter of uropathogenic bacteria. Secondary outcomes were adverse symptoms possibly attributable to nitrofurantoin and bacterial resistance to nitrofurantoin. A sample size of 154 would detect a decrease in urinary tract infection incidence from 33% to 13%, with 80% power, two-sided alpha of 0.05, and allow 10% dropout.

RESULTS

Of 154 participants randomized from September 2016 to May 2018, 151 were eligible for analysis: 75 received nitrofurantoin, and 76 received placebo. Demographics were similar between groups. The indication for surgery was prolapse (46%), incontinence (20%), or a combination (34%). Participants were discharged with an indwelling catheter (58%) or performing self-catheterization (42%). Median duration of catheter use was 4 days (interquartile range 3-7). Thirteen women in the nitrofurantoin group and 13 women in the placebo group experienced urinary tract infection (17.3% vs 17.1%, P=.97, relative risk [RR] [95% CI] 1.01 [0.50-2.04]). Adverse symptoms possibly attributable to nitrofurantoin were common in both groups (68% vs 61%, P=.34, RR [95% CI] 1.12 [0.88-1.43]). Resistance to nitrofurantoin was identified in seven urine cultures, four among nitrofurantoin and three among placebo recipients. In total, 52 urine cultures were obtained to evaluate symptoms of urinary tract infection, and only 27 of 52 grew at least 1,000 cfu/mL of uropathogenic bacteria.

CONCLUSION

Daily nitrofurantoin did not reduce the incidence of culture-proven urinary tract infection among women with catheter-managed urinary retention after pelvic reconstructive surgery. Culture confirmed urinary tract infection in only half of symptomatic episodes.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, NCT02727322.

摘要

目的

评估呋喃妥因预防是否能降低盆腔重建术后留置导尿的女性发生有培养证实的尿路感染的发生率。

方法

这项双盲、安慰剂对照、随机试验在五所学术机构进行。因脱垂或尿失禁接受手术且有尿潴留的女性随机接受口服呋喃妥因 100mg/天，持续时间为留置导尿或清洁间歇性自家导尿。主要结局是术后 6 周内出现症状性尿路感染的发生率，通过培养证实尿病原体细菌超过 1000 菌落形成单位/毫升来确认。次要结局是可能归因于呋喃妥因的不良反应和细菌对呋喃妥因的耐药性。154 人的样本量可检测出尿路感染发生率从 33%降至 13%，双侧 α 为 0.05，效能为 80%，允许 10%的脱落率。

结果

2016 年 9 月至 2018 年 5 月，154 名参与者被随机分配，其中 151 人符合分析条件：75 人接受呋喃妥因，76 人接受安慰剂。两组的人口统计学特征相似。手术指征为脱垂（46%）、尿失禁（20%）或两者兼有（34%）。参与者出院时留置导尿管（58%）或自行导尿（42%）。留置导尿管的中位时间为 4 天（四分位间距 3-7）。呋喃妥因组 13 名女性和安慰剂组 13 名女性发生尿路感染（17.3%比 17.1%，P=0.97，相对风险[RR] [95%CI] 1.01 [0.50-2.04]）。两组中可能归因于呋喃妥因的不良反应均很常见（68%比 61%，P=0.34，RR [95%CI] 1.12 [0.88-1.43]）。在 7 份尿液培养物中发现了对呋喃妥因的耐药性，其中 4 份来自呋喃妥因组，3 份来自安慰剂组。共有 52 份尿液培养物用于评估尿路感染症状，其中仅 27 份培养物生长的尿病原体细菌超过 1000cfu/ml。