Han Ji-Yeon, Lee Kyu-Sung, Park Won Hee, Park Choal Hee, Lee Jeong Gu, Lee Jeong Zoo, Kim Duk Yoon, Na Yong Gil, Kwon Dong Deuk, Choo Myung-Soo
Department of Urology, Pusan National University Yangsan Hospital, Yangsan, Korea.
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
PLoS One. 2014 Nov 17;9(11):e112063. doi: 10.1371/journal.pone.0112063. eCollection 2014.
Patients with overactive bladder (OAB) often have trouble perceiving urgency because of difficulties in distinguishing between urgency and desire to void. Empirical antimuscarinic treatment of patients with frequency only may be reasonable if conservative management has failed. We compared the efficacy of solifenacin in patients with frequency with or without urgency.
This multicenter, 12-week, open-label, comparative, non-inferiority clinical trial assessed whether the solifenacin efficacy for frequency without urgency is non-inferior to its efficacy for frequency with urgency. All patients had micturition frequency ≥ 8 voids/day with or without urgency. Primary efficacy variable: daily frequency change at 12 weeks relative to baseline. Secondary efficacy variables: change at 12 weeks relative to baseline in Patients' Perception of Bladder Condition (PPBC), OAB Symptom Score (OABSS), and Benefit, Satisfaction, Willingness to continue (BSW) questionnaire.
Of the 286 enrolled patients, 240 (83.9%) completed the study (without urgency n = 115; with urgency n = 125). Full dataset analysis revealed that the groups without and with urgency exhibited significant reductions in daily micturition frequency of -2.49 ± 0.35 (mean ± standard error) and -2.63 ± 0.37, respectively. The lower limit of the 95% two-sided CI of the comparison of the two group means was -1.14, which is smaller than the -0.8 margin of clinical equivalence. The two groups did not differ in improvement in PPBC, OABSS, or BSW scores. Both tolerated the treatment well.
It was not possible to verify that the solifenacin efficacy for frequency alone was non-inferior to its efficacy for OAB. Nevertheless, solifenacin tended to be effective for frequency regardless of urgency.
ClinicalTrials.gov NCT00979472.
膀胱过度活动症（OAB）患者常因难以区分尿急和排尿欲望而在感知尿急方面存在困难。如果保守治疗失败，仅对尿频患者进行经验性抗毒蕈碱治疗可能是合理的。我们比较了索利那新在有或无尿急的尿频患者中的疗效。
这项多中心、为期12周、开放标签、比较性、非劣效性临床试验评估了索利那新对无尿急尿频的疗效是否不劣于其对有尿急尿频的疗效。所有患者排尿频率≥8次/天，有或无尿急症状。主要疗效变量：12周时相对于基线的每日排尿频率变化。次要疗效变量：12周时相对于基线的患者膀胱状况感知（PPBC）、OAB症状评分（OABSS）以及益处、满意度、继续治疗意愿（BSW）问卷的变化。
在286名入组患者中，240名（83.9%）完成了研究（无尿急n = 115；有尿急n = 125）。完整数据集分析显示，无尿急组和有尿急组的每日排尿频率分别显著降低了-2.49±0.35（均值±标准误）和-2.63±0.37。两组均值比较的95%双侧置信区间下限为-1.14，小于临床等效性的-0.8界限。两组在PPBC、OABSS或BSW评分改善方面无差异。两组对治疗的耐受性均良好。
无法证实索利那新单独对尿频的疗效不劣于其对OAB的疗效。然而，无论有无尿急，索利那新对尿频往往都有效。
ClinicalTrials.gov NCT00979472。
