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侵入性尿动力学研究在治疗排尿功能障碍男性下尿路症状(LUTS)中的应用。

Invasive urodynamic studies for the management of lower urinary tract symptoms (LUTS) in men with voiding dysfunction.

作者信息

Clement Keiran David, Burden Helena, Warren Katherine, Lapitan Marie Carmela M, Omar Muhammad Imran, Drake Marcus J

机构信息

Cochrane Incontinence Group, University of Aberdeen, Aberdeen, UK, AB25 2ZD.

出版信息

Cochrane Database Syst Rev. 2015 Apr 28;2015(4):CD011179. doi: 10.1002/14651858.CD011179.pub2.

Abstract

BACKGROUND

Invasive urodynamic tests are used to investigate men with lower urinary tract symptoms (LUTS) and voiding dysfunction to determine a definitive objective diagnosis. The aim is to help clinicians select the treatment that is most likely to be successful. These investigations are invasive and time-consuming.

OBJECTIVES

To determine whether performing invasive urodynamic investigation, as opposed to other methods of diagnosis such as non-invasive urodynamics or clinical history and examination alone, reduces the number of men with continuing symptoms of voiding dysfunction. This goal will be achieved by critically appraising and summarising current evidence from randomised controlled trials related to clinical outcomes and cost-effectiveness. This review is not intended to consider whether urodynamic tests are reliable for making clinical diagnoses, nor whether one type of urodynamic test is better than another for this purpose.The following comparisons were made.• Urodynamics versus clinical management.• One type of urodynamics versus another.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, issue 10), MEDLINE (1 January 1946 to Week 4 October 2014), MEDLINE In-Process and other non-indexed citations (covering 27 November 2014; all searched on 28 November 2014), EMBASE Classic and EMBASE (1 January 2010 to Week 47 2014, searched on 28 November 2014), ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (searched on 1 December 2014 and 3 December 2014, respectively), as well as the reference lists of relevant articles.

SELECTION CRITERIA

Randomised and quasi-randomised trials comparing clinical outcomes in men who were and were not investigated with the use of invasive urodynamics, or comparing one type of urodynamics against another, were included. Trials were excluded if they did not report clinical outcomes.

DATA COLLECTION AND ANALYSIS

Three review authors independently assessed trial quality and extracted data.

MAIN RESULTS

We included two trials, but data were available for only 339 men in one trial, of whom 188 underwent invasive urodynamic studies. We found evidence of risk of bias, such as lack of outcome information for 24 men in one arm of the trial.Statistically significant evidence suggests that the tests did change clinical decision making. Men in the invasive urodynamics arm were more likely to have their management changed than men in the control arm (proportion with change in management 24/188 (13%) vs 0/151 (0%), risk ratio (RR) 39.41, 95% confidence interval (CI) 2.42 to 642.74). However, the quality of the evidence was low.Low-quality evidence indicates that men in the invasive urodynamics group were less likely to undergo surgery as treatment for voiding LUTS (164/188 (87%) vs 151/151 (100%), RR 0.87, 95% CI 0.83 to 0.92).Investigators observed no difference in urine flow rates before and after surgery for LUTS (mean percentage increase in urine flow rate, 140% in invasive urodynamic group vs 149% in immediate surgery group, P value = 0.13). Similarly, they found no differences between groups with regards to International Prostate Symptom Score (IPSS) (mean percentage decrease in IPSS score, 58% in invasive urodynamics group vs 59% in immediate surgery group, P value = 0.22).No evidence was available to demonstrate whether differences in management equated to improved health outcomes, such as relief of symptoms of voiding dysfunction or improved quality of life.No evidence from randomised trials revealed the adverse effects associated with invasive urodynamic studies.

AUTHORS' CONCLUSIONS: Although invasive urodynamic testing did change clinical decision making, we found no evidence to demonstrate whether this led to reduced symptoms of voiding dysfunction after treatment. Larger definitive trials of better quality are needed, in which men are randomly allocated to management based on invasive urodynamic findings or to management based on findings obtained by other diagnostic means. This research will show whether performance of invasive urodynamics results in reduced symptoms of voiding dysfunction after treatment.

摘要

背景

侵入性尿动力学检查用于评估有下尿路症状(LUTS)和排尿功能障碍的男性,以确定明确的客观诊断。目的是帮助临床医生选择最有可能成功的治疗方法。这些检查具有侵入性且耗时。

目的

确定与其他诊断方法(如非侵入性尿动力学或仅依靠临床病史和检查)相比,进行侵入性尿动力学检查是否能减少有持续排尿功能障碍症状的男性数量。这一目标将通过严格评估和总结来自随机对照试验的有关临床结果和成本效益的现有证据来实现。本综述无意探讨尿动力学检查对做出临床诊断是否可靠,也无意探讨一种尿动力学检查是否比另一种更适合此目的。进行了以下比较。

• 尿动力学检查与临床管理。

• 一种尿动力学检查与另一种尿动力学检查。

检索方法

我们检索了Cochrane对照试验中心注册库(CENTRAL)(2014年第10期)、MEDLINE(1946年1月1日至2014年10月第4周)、MEDLINE在研及其他未索引引文(涵盖2014年11月27日;均于2014年11月28日检索)、EMBASE经典版和EMBASE(2010年1月1日至2014年第47周,于2014年11月28日检索)、ClinicalTrials.gov和世界卫生组织国际临床试验注册平台(WHO ICTRP)(分别于2014年12月1日和2014年12月3日检索),以及相关文章的参考文献列表。

入选标准

纳入比较接受和未接受侵入性尿动力学检查的男性临床结果,或比较一种尿动力学检查与另一种尿动力学检查的随机和半随机试验。未报告临床结果的试验被排除。

数据收集与分析

三位综述作者独立评估试验质量并提取数据。

主要结果

我们纳入了两项试验,但只有一项试验中有339名男性的数据可用,其中188人接受了侵入性尿动力学研究。我们发现存在偏倚风险的证据,例如试验的一组中有24名男性缺乏结果信息。

具有统计学意义的证据表明,这些检查确实改变了临床决策。侵入性尿动力学组的男性比对照组的男性更有可能改变治疗方案(治疗方案改变的比例为24/188(13%)对0/151(0%),风险比(RR)39.41,95%置信区间(CI)2.42至642.74)。然而,证据质量较低。

低质量证据表明,侵入性尿动力学组的男性作为治疗排尿LUTS的手术可能性较小(164/188(87%)对151/151(100%),RR 0.87,95%CI 0.83至0.92)。

研究人员观察到LUTS手术后两组的尿流率无差异(侵入性尿动力学组尿流率平均增加百分比为140%,即刻手术组为149%,P值=0.13)。同样,他们发现两组在国际前列腺症状评分(IPSS)方面无差异(侵入性尿动力学组IPSS评分平均降低百分比为58%,即刻手术组为59%,P值=0.22)。

没有证据表明管理上的差异是否等同于健康结果的改善,如排尿功能障碍症状的缓解或生活质量的提高。

随机试验中没有证据揭示侵入性尿动力学研究的不良反应。

作者结论

尽管侵入性尿动力学检查确实改变了临床决策,但我们没有证据表明这是否导致治疗后排尿功能障碍症状减轻。需要进行更大规模、质量更好的确定性试验,将男性随机分配至基于侵入性尿动力学检查结果的治疗方案或基于其他诊断方法结果的治疗方案。这项研究将表明进行侵入性尿动力学检查是否会导致治疗后排尿功能障碍症状减轻。

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