International Collaboration on Repair Discoveries (ICORD), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Department of Urology, University Hospital Basel, University of Basel, Basel, Switzerland.
J Neurotrauma. 2023 May;40(9-10):1020-1025. doi: 10.1089/neu.2022.0333. Epub 2022 Oct 25.
The aim of this prospective phase IIa, open-label exploratory, pre-post study was to determine the efficacy of fesoterodine (i.e., 12-week treatment period) to ameliorate autonomic dysreflexia (AD) in individuals with chronic SCI (> 1-year post-injury) at or above the sixth thoracic spinal segment, with confirmed history of AD and neurogenic detrusor overactivity (NDO). Twelve participants (four females, eight males; median age 42 years) completed this study and underwent urodynamics, 24-h ambulatory blood pressure monitoring (ABPM), and urinary incontinence-related quality of life (QoL) measures at baseline and on-treatment. The Montreal Cognitive Assessment (MoCA) and Neurogenic Bowel Dysfunction (NBD) score were used to monitor cognitive and bowel function, respectively. Compared with baseline, fesoterodine improved lower urinary tract (LUT) function, that is, increased cystometric capacity (205 vs. 475 mL, = 0.002) and decreased maximum detrusor pressure (44 vs. 12 cm HO, = 0.009). NDO was eliminated in seven (58%) participants. Severity of AD events during urodynamics (40 vs. 27 mm Hg, = 0.08) and 24-h ABPM (59 vs. 36 mm Hg, = 0.05) were both reduced, yielding a large effect size ( = -0.58). AD Frequency (14 vs. 3, = 0.004) during 24-h ABPM was significantly reduced. Urinary incontinence-related QoL improved (68 vs. 82, = 0.02), however, cognitive ( = 0.2) and bowel function ( = 0.4) did not change significantly. In conclusion, fesoterodine reduces the magnitude and frequency of AD, while improving LUT function and urinary incontinence-related QoL in individuals with chronic SCI without negatively affecting cognitive or bowel function.
本前瞻性 IIa 期、开放标签、探索性、前后研究的目的是确定非索罗定（即 12 周治疗期）在损伤后 1 年以上、第六胸椎以上的慢性 SCI 患者中改善自主神经反射障碍（AD）的疗效，这些患者有 AD 和神经源性逼尿肌过度活动（NDO）的明确病史。12 名参与者（4 名女性，8 名男性；中位年龄 42 岁）完成了这项研究，并在基线和治疗期间接受了尿动力学、24 小时动态血压监测（ABPM）和与尿失禁相关的生活质量（QoL）测量。蒙特利尔认知评估（MoCA）和神经源性肠道功能障碍（NBD）评分用于监测认知和肠道功能。与基线相比，非索罗定改善了下尿路（LUT）功能，即增加了膀胱测压容量（205 比 475ml， = 0.002）和降低了最大逼尿肌压力（44 比 12cmHO， = 0.009）。7 名（58%）参与者的 NDO 被消除。尿动力学时 AD 事件的严重程度（40 比 27mmHg， = 0.08）和 24 小时 ABPM（59 比 36mmHg， = 0.05）均降低，具有较大的效应量（ = -0.58）。24 小时 ABPM 时 AD 频率（14 比 3， = 0.004）显著降低。与尿失禁相关的 QoL 得到改善（68 比 82， = 0.02），但认知（ = 0.2）和肠道功能（ = 0.4）没有显著变化。总之，非索罗定可降低慢性 SCI 患者 AD 的严重程度和频率，同时改善 LUT 功能和与尿失禁相关的 QoL，而不会对认知或肠道功能产生负面影响。
