Choo M-S, Doo C K, Lee K-S
Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Int J Clin Pract. 2008 Feb;62(2):191-6. doi: 10.1111/j.1742-1241.2007.01652.x. Epub 2007 Dec 7.
Open-label study to evaluate the effect of tolterodine extended-release (ER) on symptom-specific patient-reported goal achievement (PGA) of overactive bladder (OAB) symptoms in females.
Eligible patients who had frequency >or= 8 and urgency >or= 2 episodes per 24 h with or without urgency incontinence were treated with 12-week tolterodine ER (4 mg once daily). Primary end-point was the rate of PGA by a visual analogue scale compared with initial expectation with treatment. At baseline, patients were asked to set their personal goals for each OAB symptom with treatment. Secondary efficacy variables were changes in symptom severity, voiding diary and patient perception of bladder condition (PPBC), global impression of improvement (GII), and willingness to continue treatment.
A total of 56 patients were entered. The median rate of symptom-specific PGA and reductions in symptom severity were for frequency (60%, 45%), episodes of urgency 60%, 55%), urge incontinence (80%, 71%), nocturia (50%, 52%) and tenesmus (30%, 26%) after 12 weeks treatment. There was a significant improvement in all OAB symptoms in voiding diary. Thirty-five patients (62.5%) experienced an improvement of >or= 2 points in PPBC. Thirty (53.6%) and 22 (39.3%) of patients reported much and little improvement of their symptoms in GII. A total of 41 (73.2%) patients wanted to continue taking the medication at the end of the study.
Most OAB patients reported improvement of their OAB symptoms with 12-week tolterodine ER 4 mg treatment. There was a significant achievement of symptom-specific goal on the key OAB symptoms. But, PGA did not correlate with objective outcomes.
开展一项开放标签研究，以评估托特罗定缓释制剂（ER）对女性膀胱过度活动症（OAB）症状特异性患者报告的目标达成情况（PGA）的影响。
符合条件的患者，即每24小时排尿频率≥8次且尿急≥2次，伴有或不伴有急迫性尿失禁，接受为期12周的托特罗定ER（每日一次，4毫克）治疗。主要终点是通过视觉模拟量表得出的PGA率，并与治疗初期的预期进行比较。在基线时，要求患者为每种OAB症状设定治疗目标。次要疗效变量包括症状严重程度的变化、排尿日记、患者对膀胱状况的感知（PPBC）、总体改善印象（GII）以及继续治疗的意愿。
共纳入56例患者。治疗12周后，症状特异性PGA的中位数率以及症状严重程度的降低情况如下：排尿频率（60%，45%）、尿急发作次数（60%，55%）、急迫性尿失禁（80%，71%）、夜尿症（50%，52%）和里急后重（30%，26%）。排尿日记中所有OAB症状均有显著改善。35例患者（62.5%）的PPBC改善≥2分。30例患者（53.6%）和22例患者（39.3%）在GII中报告症状有很大改善和有一定改善。共有41例患者（73.2%）在研究结束时希望继续服用该药物。
大多数OAB患者报告，接受12周4毫克托特罗定ER治疗后，其OAB症状有所改善。关键OAB症状的症状特异性目标有显著达成。但是，PGA与客观结果不相关。
