Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations
Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations
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DOI：
10.1016/j.cct.2009.07.001
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发表时间：
2009-11-01
影响因子：
2.2
通讯作者：
Tennstedt, Sharon L.
中科院分区：
文献类型：
--
作者：
Nager, Charles W.;Brubaker, Linda;Tennstedt, Sharon L.
背景和目的：尿动力学研究(UDS)通常在压力性尿失禁(SUI)手术前获得，尽管缺乏证据表明UDS信息对预后有实际影响。这项非劣势随机临床试验的主要目的是确定妇女是否有症状。与有BOE和UDS(UDS ARM)的女性相比，在SUI手术前只接受基本办公室评估(BOE)的简单SUI患者(无UDS臂)的治疗结果并不差。次要目标是：1)确定医生使用术前UDS结果改变临床和手术决策的频率，2)比较大小便失禁结果的改善程度，3)确定与不实施UDS相比，实施UDS的增量成本和效用。方法：在最初的基础办公室评估之后，同意参与研究的计划手术的无并发症SUI的女性将被随机分为接受术前UDS和不接受UDS的患者。治疗将由外科医生利用他们可以获得的所有数据来计划和执行。我们将比较基础办公室评估(无UDS)的结果与基础办公室评估和术前UDS的结果。结果：12个月后将使用对泌尿生殖系统窘迫问卷和患者全球指数改善的反应来衡量主要结果。
Background and purpose: Urodynamic studies (UDS) are routinely obtained prior to surgery for stress urinary incontinence (SUI) despite a lack of evidence that UDS information has an actual impact on outcome. The primary aim of this non-inferiority randomized clinical trial is to determine whether women with symptomatic. uncomplicated SUI who undergo only a basic office evaluation (BOE) prior to SUI surgery (No UDS arm) have non-inferior treatment outcomes compared to women who have BOE and UDS (UDS arm). Secondary aims are: 1) to determine how often physicians use preoperative UDS results to alter clinical and surgical decision-making, 2)to compare the amount of improvement in incontinence outcomes, and 3) to determine the incremental cost and utility of performing UDS compared with not performing UDS.Methods: After an initial basic office evaluation, women planning surgery for uncomplicated SUI who consent to study participation will be randomized to receive preoperative UDS or No UDS. Treatment will be planned and performed by the surgeon utilizing all the data available to them. We will compare results from the basic office evaluation (No UDS) with results from the basic office evaluation and preoperative UDS.Results: The primary outcome will be measured at 12 months using responses to the Urogenital Distress Inventory and the Patient Global Index-improvement.