Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
BJU Int. 2010 Jun;105(11):1565-70. doi: 10.1111/j.1464-410X.2009.09050.x. Epub 2009 Nov 12.
To investigate the effects of a daily regimen of propiverine 20 mg in patients with an overactive bladder (OAB), focused on improving urgency, as the clinical efficacy of treatment for OAB should be measured in terms of urgency, the cornerstone symptom of OAB.
Eligible patients aged > or = 18 years with symptoms of OAB were enrolled in this multicentre, prospective, parallel, double-blind, placebo-controlled trial. Of 264 patients (mean age 52.2 years), 221 who had efficacy data available from baseline and at least one on-treatment visit with >75% compliance with medication were analysed (142 in the propiverine group and 79 in the placebo group). All patients were randomized to receive a placebo or 20 mg propiverine once daily in a 12-week study. They completed a 3-day voiding diary before visits during the study period, including the severity of urgency associated with every voiding, using the Indevus Urgency Severity Scale and the Urgency Perception Score. The patients' overall self-evaluation of treatment benefits at the end of the study, and safety data, were also collected.
The daily urgency episodes reduced significantly from baseline to 12 weeks on propiverine treatment, compared with placebo (-46.0% vs -31.3%, P = 0.005). Secondary endpoints, including sum of urgency severity per 24 h, urgency severity per void, and daytime voiding frequency, were also improved significantly in the propiverine group. Overall, of those patients treated with propiverine, 38.7% rated their treatment as providing 'much benefit', compared with 15.2% of the placebo group (P = 0.025). Adverse events reported by 32 (22.5%) and 10 (12.7%) patients in the propiverine and placebo group were all tolerable. However, this is a short-term study using only one fixed regimen.
Propiverine 20 mg once-daily could be an effective treatment for patients with OAB, by improving urgency.
研究每日普罗维林 20 毫克治疗膀胱过度活动症（OAB）患者的疗效，重点关注改善急迫性，因为 OAB 的治疗效果应根据急迫性（OAB 的主要症状）来衡量。
本多中心、前瞻性、平行、双盲、安慰剂对照试验纳入了年龄≥18 岁且具有 OAB 症状的合格患者。264 例患者（平均年龄 52.2 岁）中，221 例有基线和至少一次治疗访视的数据，且药物依从性≥75%，进行了分析（普罗维林组 142 例，安慰剂组 79 例）。所有患者均被随机分配接受安慰剂或普罗维林 20mg 每日一次治疗，为期 12 周。在研究期间的访视前，他们完成了 3 天的排尿日记，包括使用 Indevus 急迫严重程度量表和急迫感知评分评估每次排尿时急迫的严重程度。患者在研究结束时对治疗益处的总体自我评估以及安全性数据也被收集。
与安慰剂组相比，普罗维林组的每日急迫发作次数从基线显著减少至 12 周（-46.0%比-31.3%，P=0.005）。次要终点，包括 24 小时内急迫严重程度总和、每次排尿时的急迫严重程度和白天排尿频率，也在普罗维林组中得到显著改善。总的来说，在接受普罗维林治疗的患者中，38.7%的患者认为治疗“非常有益”，而安慰剂组的比例为 15.2%（P=0.025）。普罗维林组和安慰剂组分别有 32 例（22.5%）和 10 例（12.7%）患者报告了不良反应，均为可耐受。然而，这是一项仅使用一种固定方案的短期研究。
普罗维林 20mg 每日一次可能是治疗 OAB 的有效方法，可通过改善急迫性来实现。
