Department of Surgery and Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
Department of Surgery, University of Ottawa, Ottawa, Ontario, Canada.
Neurourol Urodyn. 2018 Nov;37(8):2810-2817. doi: 10.1002/nau.23774. Epub 2018 Aug 31.
To determine the effectiveness of mirabegron in patients with neurogenic lower urinary tract dysfunction.
Randomized, double-blind, placebo-controlled study. Canadian patients with spinal cord injury (SCI) or multiple sclerosis (MS) with urinary symptoms and incontinence were recruited. Patients were randomized to mirabegron 25 mg (or an identical placebo) for 2 weeks at which point a dose escalation to mirabegron 50 mg (or an identical placebo) was maintained for 8 weeks. Urodynamics were performed before and after treatment. The primary outcome measure was maximum cystometric capacity (MCC). Intention to treat analysis and ANCOVA models (with adjustment for baseline values) were used and marginal means (MM) are reported; P-value <0.05 was considered significant.
Sixteen (9 SCI and 7 MS) patients were randomized to mirabegron and 16 (10 SCI and 6 MS) to placebo. At study completion, there was no significant difference in MCC between mirabegron and placebo (MM 305 vs 369 mL, P = 0.20). There was no significant difference in volume at first neurogenic detrusor overactivity (NDO, MM 167 vs 137 mL, P = 0.14) and peak pressure of NDO (MM 69 vs 82 cmH O, P = 0.25). There was no significant difference in pad weights or voiding diary parameters. There was a significantly lower symptom burden among those treated with mirabegron (total neurogenic bladder symptom score MM 29 vs 34, P = 0.047).
Among patients with SCI or MS, we demonstrated non-significant trends towards improvement in some urodynamic parameters with mirabegron 50 mg compared to placebo, and a significantly lower neurogenic bladder symptom burden.
评估米拉贝隆治疗神经原性下尿路功能障碍的疗效。
这是一项随机、双盲、安慰剂对照研究。纳入了伴有下尿路症状和尿失禁的加拿大脊髓损伤（SCI）或多发性硬化症（MS）患者。患者随机分为米拉贝隆 25mg（或相同安慰剂）组，治疗 2 周后剂量增至 50mg（或相同安慰剂），维持 8 周。治疗前后行尿动力学检查。主要结局指标为最大膀胱容量（MCC）。采用意向治疗分析和协方差分析模型（基于基线值校正），并报告边缘均数（MM）；P 值＜0.05 认为差异有统计学意义。
16 例（9 例 SCI，7 例 MS）患者随机分配至米拉贝隆组，16 例（10 例 SCI，6 例 MS）患者分配至安慰剂组。研究结束时，米拉贝隆组与安慰剂组的 MCC 无显著差异（MM 305 比 369ml，P＝0.20）。首次神经原性逼尿肌过度活动时的容量（MM 167 比 137ml，P＝0.14）和逼尿肌过度活动时的峰值压力（MM 69 比 82cmH₂O，P＝0.25）也无显著差异。两组间尿垫重量或排尿日记参数无显著差异。米拉贝隆治疗组的症状负担明显降低（总神经原性膀胱症状评分 MM 29 比 34，P＝0.047）。
在 SCI 或 MS 患者中，与安慰剂相比，米拉贝隆 50mg 治疗有改善部分尿动力学参数的非显著趋势，且神经原性膀胱症状负担显著降低。
