Glickman Urologic and Kidney Institute, The Cleveland Clinic, Cleveland, OH, USA.
BJU Int. 2011 Feb;107(4):598-602. doi: 10.1111/j.1464-410X.2010.09586.x. Epub 2010 Sep 24.
To assess the onset of efficacy of fesoterodine 4 mg once daily on overactive bladder (OAB) symptoms after 1 week of treatment.
This was a prespecified analysis of data collected during the first week of a 12-week, open-label, single-arm, flexible-dose study of fesoterodine. Eligible subjects were adult men and women (aged ≥ 18 years) who reported urinary frequency (eight or more micturitions per 24 h) and urgency (three or more episodes per 24 h) in 5-day bladder diaries at baseline, and dissatisfaction with previous tolterodine or tolterodine extended-release treatment received within 2 years of screening. All subjects received fesoterodine 4 mg once daily during the first 4 weeks of treatment (with an optional dose increase to fesoterodine 8 mg after week 4). Early onset of efficacy of fesoterodine 4 mg was assessed based on changes from baseline to week 1 in variables recorded in 5-day bladder diaries, including total micturitions, urgency episodes, urgency urinary incontinence (UUI) episodes and nocturnal micturitions. Urgency and severe urgency episodes were defined as those rated ≥ 3 and ≥ 4, respectively, on the five-point Urinary Sensation Scale (USS) (1 = no urgency, 5 = UUI); frequency-urgency sum (a combined measure of micturition frequency and urgency) was defined as the sum of all USS ratings.
All bladder diary variables, including total and nocturnal micturitions, UUI episodes, urgency episodes, severe urgency episodes and frequency-urgency sum per 24 h, were significantly improved (all P < 0.0001) after 1 week of treatment with fesoterodine 4 mg compared to baseline. The diary-dry rate at week 1 (i.e. subjects with at least one UUI episode at baseline who subsequently reported no UUI episodes on week 1 diary) was 38%.
In this open-label study of subjects with OAB who had been previously treated and dissatisfied with tolterodine, fesoterodine 4 mg showed a rapid onset of efficacy at 1 week.
评估非索罗定 4 毫克每日 1 次治疗 1 周后对膀胱过度活动症（OAB）症状的疗效起始时间。
这是一项非索罗定 12 周、开放性、单臂、剂量灵活研究的第 1 周数据的预先指定分析。合格的受试者为成年男女（年龄≥18 岁），他们在基线时的 5 天膀胱日记中报告了尿频（每天 8 次或以上排尿）和尿急（每天 24 小时内 3 次或以上发作），并且对之前接受的托特罗定或托特罗定延长释放治疗不满意在筛选前 2 年内。所有受试者在前 4 周的治疗中接受非索罗定 4 毫克每日 1 次（第 4 周后可选择剂量增加至非索罗定 8 毫克）。根据基线至第 1 周的 5 天膀胱日记中记录的变量（包括总排尿次数、尿急发作、急迫性尿失禁（UUI）发作和夜间排尿次数）的变化，评估非索罗定 4 毫克的早期疗效。尿急和严重尿急发作的定义分别为尿感觉量表（USS）的 3 分和 4 分（1=无尿急，5=UUI）；频-急总和（排尿频率和尿急的综合测量）定义为所有 USS 评分的总和。
与基线相比，所有膀胱日记变量，包括总和夜间排尿次数、UUI 发作、尿急发作、严重尿急发作以及 24 小时内的频-急总和，在接受非索罗定 4 毫克治疗 1 周后均显著改善（均 P<0.0001）。第 1 周的日记干燥率（即基线时有至少 1 次 UUI 发作但随后在第 1 周日记中报告无 UUI 发作的受试者）为 38%。
在这项针对先前接受过托特罗定治疗且对其不满意的 OAB 患者的开放性研究中，非索罗定 4 毫克在 1 周时显示出快速疗效。
