Division of Urology, Caritas-St. Elizabeth's Medical Center, Tufts University Medical School, Boston, MA 02135, USA.
Int J Clin Pract. 2009 Jun;63(6):973-6. doi: 10.1111/j.1742-1241.2009.02065.x. Epub 2009 May 4.
It has been assumed that a patient's underlying baseline overactive bladder (OAB) incontinence severity is predictive of the resulting efficacy of pharmacological treatment. The objective of this study was to stratify and analyse the effects of baseline incontinence disease severity on the treatment outcome of the percentage of patients continent (PPC) during treatment with once-daily trospium chloride 60 mg extended release (XR).
A post hoc analysis was conducted on pooled data from two 12-week, randomised, double-blind phase III studies in the USA in which 1165 patients with baseline urgency, and an average of >or= 1 urge urinary incontinence (UUI) episode/day and >or= 10 toilet voids/day on a 3-day bladder diary, received once-daily trospium chloride 60 mg XR (n = 578) or placebo (n = 587). Patients were stratified by the mean number of UUIs/day (1.0, > 1.0-2.0, > 2.0-5.0 or > 5.0) at baseline. The efficacy parameter that was analysed was complete continence (defined as no UUIs on a 3-day bladder diary collected at week 12 of treatment).
Baseline UUI levels were inversely correlated with the week 12 PPC (p < 0.0001). Post-treatment PPCs were higher with trospium chloride XR vs. placebo at all degrees of severity. Complete continence was achieved in 75% of trospium chloride XR recipients with 1.0 UUI/day at baseline and 48% of those with > 1.0-2.0 UUIs/day at baseline.
These findings support the assumption that baseline incontinence severity affects the likelihood of achieving continence from OAB therapy, and that patients with less severe OAB (e.g. 1 UUI/day) can expect higher 'dry rates' following treatment (e.g. up to 75%) than those with more severe OAB. This information can provide a useful tool for the physician and patient in establishing expectations during therapy.
人们认为患者基础的膀胱过度活动症（OAB）失禁严重程度是预测药物治疗效果的因素。本研究的目的是对基线失禁严重程度进行分层分析，以评估每日一次托特罗定 60mg 控释片（XR）治疗期间患者的治疗结局（治疗后完全尿控的患者比例，PPC）。
对两项美国的 12 周、随机、双盲 III 期研究的汇总数据进行了事后分析，共纳入 1165 例基线有尿急症状，平均 3 天排尿日记中至少 1 次急迫性尿失禁（UUI）发作/天和至少 10 次厕所排尿/天的患者，接受每日一次托特罗定 60mg XR（n = 578）或安慰剂（n = 587）治疗。根据基线时每日 UUI 次数（1.0、>1.0-2.0、>2.0-5.0 或 >5.0）对患者进行分层。分析的疗效参数为完全尿控（定义为治疗 12 周时收集的 3 天排尿日记中无 UUI）。
基线 UUI 水平与治疗 12 周时的 PPC 呈负相关（p < 0.0001）。与安慰剂相比，托特罗定 XR 治疗后的 PPC 在所有严重程度中均更高。基线每日 UUI 为 1.0 时，托特罗定 XR 治疗组的完全尿控率为 75%，基线每日 UUI 为 >1.0-2.0 时，完全尿控率为 48%。
这些发现支持以下假设，即基线失禁严重程度影响 OAB 治疗的尿控可能性，并且 OAB 较轻（例如，每日 1 次 UUI）的患者治疗后（例如，高达 75%）实现“干率”的可能性更高。这些信息可以为医生和患者在治疗期间建立预期提供有用的工具。
