Department of Obstetrics, Gynecology, and Reproductive Science, Mount Sinai School of Medicine, New York, NY 10463, USA.
Int J Clin Pract. 2009 Dec;63(12):1702-14. doi: 10.1111/j.1742-1241.2009.02209.x.
The aim of this study was to evaluate the efficacy of solifenacin on symptom bother using the Overactive Bladder Questionnaire (OAB-q).
In VIBRANT, a double-blind, US-based trial, patients with OAB for > or = 3 months received flexibly dosed solifenacin or placebo for 12 weeks. At baseline and 4-week intervals, patients completed the OAB-q [symptom bother and health-related quality of life (HRQL) scales] and 3-day bladder diaries; other patient-reported outcome measures were also assessed at baseline and week 12. The primary efficacy end-point was the change from baseline to end of treatment (EOT) on the OAB-q Symptom Bother scale. Adverse events (AEs) were monitored.
At EOT, solifenacin (n = 377) vs. placebo (n = 374) significantly improved mean symptom bother (-29.9 vs. -20.4, p < 0.0001), HRQL total (25.3 vs. 16.7, p < 0.0001) and all HRQL domain scores (Ps < 0.0001). Solifenacin vs. placebo significantly improved daily episodes of urgency, incontinence and frequency but not nocturia. Significant separation from placebo was evident as early as week 4. Overall, significantly more solifenacin vs. placebo patients reported treatment benefit (84% vs. 63%), satisfaction (80% vs. 59%) and willingness to continue (79% vs. 60%; Ps< 0.0001). Treatment-related AEs in solifenacin vs. placebo patients were dry mouth (13% vs. 2%), constipation (8% vs. 2%) and dry eye (2% vs. 0.3%).
As early as week 4 and through EOT, flexibly dosed solifenacin significantly improved OAB symptom bother and HRQL as well as the symptoms of urgency, frequency and incontinence compared with placebo. Significantly more solifenacin patients reported treatment benefit and satisfaction at week 12 compared with placebo.
本研究旨在使用膀胱过度活动症问卷（OAB-q）评估索利那新的疗效。
在 VIBRANT 中，一项基于美国的双盲试验中，患有 > 或 = 3 个月的 OAB 患者接受了灵活剂量的索利那新或安慰剂治疗 12 周。在基线和 4 周间隔，患者完成了 OAB-q[症状困扰和健康相关生活质量（HRQL）量表]和 3 天膀胱日记；还在基线和第 12 周评估了其他患者报告的结局测量。主要疗效终点是 OAB-q 症状困扰量表从基线到治疗结束（EOT）的变化。监测不良事件（AE）。
在 EOT 时，索利那新（n = 377）与安慰剂（n = 374）相比，平均症状困扰显著改善（-29.9 对-20.4，p < 0.0001），HRQL 总分（25.3 对 16.7，p < 0.0001）和所有 HRQL 领域评分（p < 0.0001）。与安慰剂相比，索利那新显著改善了每日尿急、尿失禁和尿频的发作次数，但不影响夜尿症。早在第 4 周就出现了与安慰剂的显著分离。总体而言，与安慰剂相比，更多的索利那新患者报告了治疗益处（84%对 63%）、满意度（80%对 59%）和继续治疗的意愿（79%对 60%；p < 0.0001）。与安慰剂相比，索利那新患者出现的与治疗相关的不良事件有口干（13%对 2%）、便秘（8%对 2%）和眼干（2%对 0.3%）。
从第 4 周开始，通过 EOT，与安慰剂相比，灵活剂量的索利那新显著改善了 OAB 症状困扰和 HRQL 以及尿急、尿频和尿失禁的症状。与安慰剂相比，更多的索利那新患者在第 12 周报告了治疗益处和满意度。
