Department of Urology, Vanderbilt University, Nashville, Tennessee, USA.
J Urol. 2010 Mar;183(3):1092-7. doi: 10.1016/j.juro.2009.11.014. Epub 2010 Jan 25.
We explored the impact of once daily tadalafil on urodynamic measures in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia via invasive and noninvasive urodynamic studies.
We conducted a multicenter, randomized, double blind, placebo controlled clinical trial comparing once daily tadalafil 20 mg vs placebo during 12 weeks in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia with or without bladder outlet obstruction. Invasive and noninvasive urodynamics, International Prostate Symptom Score and general safety were assessed. The primary study end point was change in detrusor pressure at maximum urinary flow rate.
Urodynamic measures remained largely unchanged during the study with no statistically significant or clinically adverse difference between tadalafil and placebo in change in detrusor pressure at maximum urinary flow rate (mean difference between treatments -2.2 cm H(2)O, p = 0.33) or any other urodynamic parameter assessed including maximum urinary flow rate, maximum detrusor pressure, bladder outlet obstruction index or bladder capacity (all measures p > or = 0.13). Treatment with tadalafil resulted in significant improvements in International Prostate Symptom Score (mean difference between treatments -4.2, p < 0.001). Tadalafil was generally well tolerated with the majority of adverse events being mild to moderate in severity and few patients discontinuing due to adverse events (tadalafil 2.0%, placebo 1.0%).
Treatment with tadalafil once daily for lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia showed no negative impact on bladder function as measured by detrusor pressure at maximum urinary flow rate or on any other urodynamic parameter assessed. Nonetheless men receiving tadalafil reported significant improvements in International Prostate Symptom Score with an adverse events profile similar to other recent studies of tadalafil for lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia.
通过侵入性和非侵入性尿动力学研究，探讨每日一次他达拉非对临床良性前列腺增生症继发下尿路症状患者的尿动力学指标的影响。
我们进行了一项多中心、随机、双盲、安慰剂对照的临床试验，比较了每日一次他达拉非 20mg 与安慰剂在 12 周内对伴有或不伴有膀胱出口梗阻的临床良性前列腺增生症继发下尿路症状患者的疗效。评估了侵入性和非侵入性尿动力学、国际前列腺症状评分和一般安全性。主要研究终点是最大尿流率时逼尿肌压力的变化。
在研究期间，尿动力学指标基本保持不变，他达拉非与安慰剂在最大尿流率时逼尿肌压力的变化（治疗组间平均差异-2.2cmH2O，p=0.33）或任何其他评估的尿动力学参数（包括最大尿流率、最大逼尿肌压力、膀胱出口梗阻指数或膀胱容量）均无统计学显著或临床不良差异（所有指标 p≥0.13）。他达拉非治疗可显著改善国际前列腺症状评分（治疗组间平均差异-4.2，p＜0.001）。他达拉非的耐受性总体良好，大多数不良事件的严重程度为轻度至中度，少数患者因不良事件停药（他达拉非 2.0%，安慰剂 1.0%）。
每日一次他达拉非治疗临床良性前列腺增生症继发下尿路症状，对最大尿流率时逼尿肌压力或任何其他评估的尿动力学参数均无不良影响。尽管如此，接受他达拉非治疗的患者报告称，国际前列腺症状评分显著改善，其不良事件谱与其他最近关于他达拉非治疗临床良性前列腺增生症继发下尿路症状的研究相似。
