Staskin David R, Te Alexis E
Female Urology and Voiding Dysfunction, Weill Medical College of Cornell University, New York, NY 10021. USA.
BJU Int. 2006 Jun;97(6):1256-61. doi: 10.1111/j.1464-410X.2006.06150.x.
To evaluate urinary symptom relief in women with mixed urinary incontinence (MUI) treated for up to 52 weeks with solifenacin succinate for overactive bladder (OAB), as MUI is a complex and distressing condition reported by about a third of incontinent women, and with confirmed efficacy in OAB-related urge incontinence, anticholinergic agents are a reasonable therapeutic option for such women.
Patients with OAB (mean of > or = 8 voids/24 h, plus > or = 1 incontinence episode or > or = 1 urgency episode/24 h) were pooled from four studies. A subgroup of 1041 patients reporting MUI at baseline were evaluated over 12 weeks in a double-blind, placebo-controlled study, and up to a further 40 weeks in 433 in an open-label solifenacin treatment (5 mg and 10 mg). Voiding frequency, episodes of incontinence and urgency, and volume voided per void, were collected from voiding diaries completed during the 3 days before each study visit.
Patients with a history of MUI treated with solifenacin for up to 12 weeks had statistically significant reductions in voiding frequency and episodes of incontinence and urgency vs placebo. In all, 43% and 49% (at 5 mg and 10 mg, respectively) of patients with a history of MUI regained continence after 12 weeks, vs 33% with placebo. Among patients in the open-label study with mixed symptoms, 52% reported regaining continence, and 34% reported resolution of symptomatic urgency based on diary reporting at study end. Sustained improvements in quality of life and high satisfaction ratings accompanied symptom improvements.
Significant reductions in OAB-related frequency, incontinence and urgency were reported after 12 weeks of solifenacin treatment in patients with a history of MUI. Symptom improvement in this subgroup was maintained during long-term treatment. These findings support the therapeutic potential of solifenacin for treating symptoms of MUI and the need to re-evaluate classically defined MUI.
评估琥珀酸索利那新治疗膀胱过度活动症（OAB）长达52周的女性混合性尿失禁（MUI）患者的尿路症状缓解情况，因为MUI是一种复杂且令人苦恼的病症，约三分之一的失禁女性患有该病症，且琥珀酸索利那新已证实对与OAB相关的急迫性尿失禁有效，抗胆碱能药物是这类女性的合理治疗选择。
从四项研究中汇集了OAB患者（平均每24小时排尿次数≥8次，加上每24小时≥1次失禁发作或≥1次尿急发作）。在一项双盲、安慰剂对照研究中，对1041名在基线时报告有MUI的患者亚组进行了12周的评估，在433名患者中进行了长达40周的开放标签索利那新治疗（5毫克和10毫克）。从每次研究访视前3天完成的排尿日记中收集排尿频率、失禁和尿急发作次数以及每次排尿量。
接受索利那新治疗长达12周的有MUI病史的患者，与安慰剂相比，排尿频率、失禁和尿急发作次数在统计学上有显著降低。总体而言，有MUI病史的患者中，分别有43%和49%（5毫克和10毫克剂量组）在12周后恢复了控尿，而安慰剂组为33%。在开放标签研究中有混合症状的患者中，52%报告恢复了控尿，34%报告在研究结束时根据日记报告症状性尿急得到缓解。症状改善伴随着生活质量的持续改善和高满意度评分。
有MUI病史的患者在接受索利那新治疗12周后，与OAB相关的频率、失禁和尿急显著降低。该亚组的症状改善在长期治疗中得以维持。这些发现支持了索利那新治疗MUI症状的治疗潜力以及重新评估经典定义的MUI的必要性。
