Sakalis Vasileios, Sfiggas Vasileios, Vouros Ioannis, Salpiggidis George, Papathanasiou Athanasios, Apostolidis Apostolos
Department of Urology, Agios Pavlos General Hospital, Thessaloniki, Greece.
Department of Urology, Hippokration General Hospital, Thessaloniki, Greece.
Int Neurourol J. 2021 Mar;25(1):69-76. doi: 10.5213/inj.2040188.094. Epub 2020 Dec 31.
Several trials have shown that in men with overactive bladder (OAB) and benign prostate enlargement (BPE), the combination of an α-blocker with an anticholinergic is superior to α-blocker monotherapy. The purpose of this study is to explore whether urodynamic detrusor overactivity (DO) affects clinical outcomes in men with BPE and OAB.
This is a post hoc analysis of a prospective, randomized trial, designed to evaluate the changes of morphometric parameters of the prostate following monotherapy or combination therapy in men with BPE-OAB. The initial study recruited men aged ≥50 years, with BPE and predominantly storage lower urinary tract symptoms (LUTS). Patients were randomized to receive tamsulosin monotherapy or a combination of tamsulosin and solifenacin for 26 weeks. All participants completed a 3-day bladder diary and the International Prostate Symptom Score (IPSS), and then underwent pressure-flow and ultrasonographic studies. Data were stratified and analysed based on the urodynamic observation of DO at baseline (DO vs. non-DO). The primary endpoint was the mean change in urgency episodes from baseline. Secondary outcomes were the changes in nocturia, total IPSS, and urodynamic parameters.
Sixty-nine men were initially randomized, but only 60 men were included in this analysis. Urgency episodes significantly improved in men with DO who received combination therapy compared to the DO monotherapy subgroup (P=0.04) or to the non-DO combination treatment subgroup (P=0.038). Nocturia also improved in the DO combination treatment subgroup as compared to the non-DO combination subgroup (P=0.037). The 24-hour frequency and total IPSS significantly improved from baseline without significant differences among the subgroups.
The present study suggests that baseline DO could be a prognostic factor for a better response to combination therapy over monotherapy in men with BPE and storage LUTS.
多项试验表明，对于膀胱过度活动症（OAB）合并良性前列腺增生（BPE）的男性患者，α受体阻滞剂与抗胆碱能药物联合使用优于α受体阻滞剂单药治疗。本研究的目的是探讨尿动力学逼尿肌过度活动（DO）是否会影响BPE和OAB男性患者的临床结局。
这是一项对前瞻性随机试验的事后分析，该试验旨在评估BPE - OAB男性患者接受单药治疗或联合治疗后前列腺形态学参数的变化。最初的研究招募了年龄≥50岁、患有BPE且主要表现为储尿期下尿路症状（LUTS）的男性患者。患者被随机分为接受坦索罗辛单药治疗或坦索罗辛与索利那新联合治疗26周。所有参与者均完成了为期3天的膀胱日记和国际前列腺症状评分（IPSS），然后接受了压力 - 流率和超声检查。根据基线时DO的尿动力学观察结果（DO与非DO）对数据进行分层和分析。主要终点是尿急发作次数相对于基线的平均变化。次要结局是夜尿症、总IPSS和尿动力学参数的变化。
最初有69名男性被随机分组，但本分析仅纳入了60名男性。与DO单药治疗亚组（P = 0.04）或非DO联合治疗亚组相比，接受联合治疗的DO男性患者的尿急发作次数显著改善（P = 0.038）。与非DO联合亚组相比，DO联合治疗亚组的夜尿症也有所改善（P = 0.037）。从基线开始，24小时排尿频率和总IPSS显著改善，各亚组之间无显著差异。
本研究表明，基线DO可能是BPE和储尿期LUTS男性患者联合治疗比单药治疗反应更好的一个预后因素。
