Chancellor M B, Kianifard F, Beamer E, Mongay L, Ebinger U, Hicks G, Delconte A
Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Int J Clin Pract. 2008 Apr;62(4):606-13. doi: 10.1111/j.1742-1241.2008.01714.x.
This study assessed the benefit of adding behavioural modification to darifenacin treatment for overactive bladder (OAB).
The ABLE trial was a randomised, open-label, parallel-group, multicentre study of 12 weeks of darifenacin treatment [with voluntary up-titration from 7.5 mg once daily (qd) to 15 mg qd at week 2] alone or in combination with a Behavioural Modification Programme (BMP) for men and women with dry or wet OAB. Efficacy was assessed as the change in the number (per day) of micturitions (primary variable), urge urinary incontinence (UUI) episodes, urgency episodes, pads used and nocturnal voids. Health-related quality of life (HRQoL) was also evaluated. Tolerability and safety assessments included adverse events and the number of discontinuations.
Of 592 patients screened, 395 were randomised, 190 to darifenacin alone and 205 to darifenacin + BMP. At baseline, the majority of subjects were dry (mean 2.8 and three UUI episodes per day in the darifenacin and darifenacin + BMP groups respectively). At study end, darifenacin alone and darifenacin + BMP both produced significant reductions from baseline in median numbers of micturitions, UUI episodes, urgency episodes and nocturnal voids (all p < 0.05), but not in the number of pads used. HRQoL also improved. There were no significant differences between treatment groups in efficacy or HRQoL variables.
Darifenacin treatment provides a degree of normalisation of micturition variables and improvement in HRQoL that cannot be further enhanced by behavioural therapy of the type used in this study. Whether behavioural modification would add benefit over darifenacin treatment in patients with more pronounced incontinence problems remains to be determined.
本研究评估了在多索茶碱治疗膀胱过度活动症（OAB）的基础上增加行为矫正的益处。
ABLE试验是一项随机、开放标签、平行组、多中心研究，对患有干性或湿性OAB的男性和女性进行为期12周的多索茶碱治疗[可自愿在第2周从每日一次7.5毫克（qd）上调至15毫克qd]，单独使用多索茶碱或联合行为矫正计划（BMP）。疗效评估指标为排尿次数（每天）的变化（主要变量）、急迫性尿失禁（UUI）发作次数、尿急发作次数、使用的尿垫数量和夜间排尿次数。还评估了与健康相关的生活质量（HRQoL）。耐受性和安全性评估包括不良事件和停药数量。
在592例筛查患者中，395例被随机分组，190例单独使用多索茶碱，205例使用多索茶碱+BMP。在基线时，大多数受试者为干性（多索茶碱组和多索茶碱+BMP组分别平均每天有2.8次和3次UUI发作）。在研究结束时，单独使用多索茶碱和多索茶碱+BMP均使排尿次数、UUI发作次数、尿急发作次数和夜间排尿次数的中位数较基线有显著减少（均p<0.05），但尿垫使用数量未减少。HRQoL也有所改善。治疗组之间在疗效或HRQoL变量方面无显著差异。
多索茶碱治疗可使排尿变量达到一定程度的正常化，并改善HRQoL，而本研究中使用的行为疗法无法进一步增强这种效果。对于失禁问题更明显的患者，行为矫正是否会比多索茶碱治疗带来更多益处仍有待确定。
