University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts.
University of Texas Health Science Center at San Antonio, San Antonio, Texas.
J Urol. 2014 Feb;191(2):395-404. doi: 10.1016/j.juro.2013.08.027. Epub 2013 Aug 21.
We evaluated the efficacy and safety of flexible dose fesoterodine in medically complex vulnerable elderly subjects with urgency urinary incontinence.
In this 12-week, randomized, double-blind, flexible dose, placebo controlled trial, subjects were community dwelling men and women 65 years old or older. Subjects had scores of 3 or more on the VES-13 (Vulnerable Elders Survey) and 20 or more on the MMSE (Mini-Mental State Examination), and 2 to 15 urgency urinary incontinence episodes and 8 or more micturitions per 24 hours on 3-day baseline diaries. Subjects randomized to fesoterodine received 4 mg once daily for 4 weeks and could then increase to 8 mg based on discussion with the investigator. Subjects receiving 8 mg could decrease the dose to 4 mg at any time (sham escalation and de-escalation for placebo). The primary outcome measure was change in daily urgency urinary incontinence episodes. Secondary outcomes included changes in other diary variables and patient reported quality of life measures. Safety evaluations included self-reported symptoms and post-void residual volume.
A total of 562 patients were randomized (mean age 75 years, 50.4% age 75 years or greater). Subjects had high rates of comorbidities, polypharmacy and functional impairment. At week 12 the fesoterodine group had significantly greater improvements in urgency urinary incontinence episodes per 24 hours (-2.84 vs -2.20, p = 0.002) and most other diary variables and quality of life, as well as a higher diary dry rate (50.8% vs 36.0%, p = 0.002). Adverse effects were generally similar to those of younger populations including risk of urinary retention.
To our knowledge this is the first antimuscarinic study in a community based, significantly older, medically complex elderly population with urgency urinary incontinence. Flexible dose fesoterodine significantly improved urgency urinary incontinence episodes and other outcomes vs placebo, and was generally well tolerated.
我们评估了在患有急迫性尿失禁的医学上复杂的脆弱老年患者中使用灵活剂量非索罗定的疗效和安全性。
在这项为期 12 周、随机、双盲、灵活剂量、安慰剂对照试验中，受试者为 65 岁或以上的社区居住的男性和女性。受试者的 VES-13（脆弱老年人调查）评分为 3 分或以上，MMSE（简易精神状态检查）评分为 20 分或以上，并且在 3 天基线日记中，有 2 至 15 次急迫性尿失禁发作和 8 次或更多次 24 小时排尿。随机分配到非索罗定组的受试者接受 4 毫克每日一次治疗 4 周，然后可以根据与研究者的讨论增加至 8 毫克。接受 8 毫克的受试者可以随时将剂量减少至 4 毫克（安慰剂的模拟升级和降级）。主要观察指标为每日急迫性尿失禁发作次数的变化。次要观察指标包括其他日记变量和患者报告的生活质量指标的变化。安全性评估包括自我报告的症状和残余尿量。
共有 562 名患者被随机分配（平均年龄 75 岁，50.4%年龄 75 岁或以上）。受试者有很高的合并症、多药治疗和功能障碍发生率。在第 12 周，非索罗定组在 24 小时内急迫性尿失禁发作次数的改善显著更大（-2.84 比-2.20，p = 0.002），并且其他日记变量和生活质量的大多数指标以及更高的日记干燥率（50.8%比 36.0%，p = 0.002）。不良反应一般与年轻人群相似，包括尿潴留的风险。
据我们所知，这是第一项在社区为基础、年龄明显较大、医学上复杂的伴有急迫性尿失禁的老年人群中进行的抗毒蕈碱药物研究。灵活剂量非索罗定显著改善急迫性尿失禁发作次数和其他结局，优于安慰剂，且一般耐受性良好。
