Roehrborn Claus G, Abrams Paul, Rovner Eric S, Kaplan Steven A, Herschorn Sender, Guan Zhonghong
The University of Texas Southwestern Medical Center, Dallas, TX 75390-911, USA.
BJU Int. 2006 May;97(5):1003-6. doi: 10.1111/j.1464-410X.2006.06068.x.
A group of authors from the USA evaluated the efficacy and tolerability of tolterodine extended-release on objective and subjective endpoints in men with an overactive bladder. They found that it significantly reduced incontinent episodes and improved patient perception of treatment benefit in men with an overactive bladder
To evaluate the efficacy and tolerability of tolterodine extended-release (ER) on objective and subjective endpoints in men with overactive bladder (OAB) and urgency urinary incontinence (UI). PATIENTS AND METHODS This was a post hoc analysis of data collected from men with OAB enrolled in a 12-week, double-blind, placebo-controlled trial of tolterodine ER (4 mg once daily; tolterodine ER registration trial) and included men with urinary frequency (> or =8 micturitions/24 h) and urgency UI (> or =5 episodes/week). UI episodes were assessed using 7-day bladder diaries. Patient perception of treatment benefit was evaluated after 12 weeks. Adverse events (AEs) were recorded throughout the study.
In all, 163 men with OAB (placebo, 86; tolterodine ER, 77; mean age 65 years) were evaluated. Baseline demographics and clinical characteristics were similar for the two treatment groups. Compared with placebo, tolterodine ER significantly reduced weekly UI episodes (median % change, -71% vs - 40%, P < 0.05; mean numeric change, - 11.9 vs -5.9, P = 0.02). Men receiving tolterodine ER had fewer micturitions/24 h, but this was not a significant difference from placebo (median % change, -12% vs - 4%, P = 0.22). Significantly more men treated with tolterodine-ER (63%) than placebo-treated men (46%) reported a benefit of treatment after 12 weeks (P = 0.04). The most commonly reported AEs associated with tolterodine-ER vs placebo were dry mouth (16% vs 7%), constipation (4% vs 9%), dyspepsia (4% vs 1%), dizziness (5% vs 1%), and somnolence (3% vs 1%). One of the men receiving tolterodine ER had symptoms suggestive of urinary retention that led to his withdrawal from the study. None of the men had acute urinary retention requiring catheterization.
In men with OAB and urgency UI, tolterodine ER was well tolerated and significantly reduced episodes of urgency UI, and improved patient perception of treatment benefit.
一组来自美国的作者评估了托特罗定缓释制剂对膀胱过度活动症男性患者客观和主观终点指标的疗效及耐受性。他们发现，托特罗定缓释制剂能显著减少尿失禁发作次数，并改善膀胱过度活动症男性患者对治疗益处的感知。
评估托特罗定缓释制剂（ER）对膀胱过度活动症（OAB）伴急迫性尿失禁（UI）男性患者客观和主观终点指标的疗效及耐受性。
这是一项对参与托特罗定ER（4毫克，每日一次；托特罗定ER注册试验）12周双盲、安慰剂对照试验的OAB男性患者收集的数据进行的事后分析，纳入了尿频（≥8次排尿/24小时）和急迫性UI（≥5次发作/周）的男性患者。使用7天膀胱日记评估UI发作次数。12周后评估患者对治疗益处的感知。在整个研究过程中记录不良事件（AE）。
总共评估了163例OAB男性患者（安慰剂组86例；托特罗定ER组77例；平均年龄65岁）。两个治疗组的基线人口统计学和临床特征相似。与安慰剂相比，托特罗定ER显著减少了每周UI发作次数（中位数变化百分比，-71%对-40%，P<0.05；平均数值变化，-11.9对-5.9，P = 0.02）。接受托特罗定ER治疗的男性患者24小时内排尿次数减少，但与安慰剂组相比差异不显著（中位数变化百分比，-12%对-4%，P = 0.22）。12周后，报告治疗有益的接受托特罗定ER治疗的男性患者（63%）显著多于接受安慰剂治疗的男性患者（46%）（P = 0.04）。与托特罗定ER相比，安慰剂组最常报告的AE分别为口干（16%对7%）、便秘（4%对9%）、消化不良（4%对1%）、头晕（5%对1%）和嗜睡（3%对1%）。一名接受托特罗定ER治疗的男性患者出现提示尿潴留的症状，导致其退出研究。所有男性患者均未发生需要导尿的急性尿潴留。
在患有OAB和急迫性UI的男性患者中，托特罗定ER耐受性良好，能显著减少急迫性UI发作次数，并改善患者对治疗益处的感知。
