Pilot data of our phase IV clinical trial (pre/post study design) highlighted a beneficial effect of intradetrusor onabotulinumtoxinA (200 IU) injections to reduce autonomic dysreflexia (AD) in individuals with chronic spinal cord injury (SCI) at T6 or above. After trial completion, we assessed whether our primary expectation (i.e., decrease of AD severity in 50% of participants during urodynamics [UDS]) was met. Secondary outcome measures were reduction of spontaneous AD in daily life as well as amelioration of AD-related and urinary incontinence-related quality of life (QoL). In addition, we conducted injury-level–dependent analysis—i.e., cervical and upper thoracic—to explore group-specific treatment efficacy. Post-treatment, AD severity decreased in 82% (28/34) of all participants during UDS and in 74% (25/34) in daily life assessed with 24-h ambulatory blood pressure monitoring. In addition, urinary incontinence-related QoL was improved, cystometric capacity was increased, and maximum detrusor pressure during storage was reduced (all p < 0.001). Further, the treatment was well tolerated, with only minor complications (grade I [n = 7] and II [n = 7]) in accordance with the Clavien-Dindo classification recorded in 11 individuals (cervical n = 9, upper thoracic n = 2). Injury-level–dependent analysis revealed lower incidence (cervical n = 15/23, upper thoracic n = 6/11) and lesser severity (cervical p = 0.009; upper thoracic p = 0.06 [Pearson r = −0.6, i.e., large effect size]) of AD during UDS. Further, reduced AD severity in daily life, improved urinary incontinence-related QoL, greater cystometric capacity, and lower maximum detrusor pressure during storage (all p < 0.05) were found in both groups post-treatment. Intradetrusor onabotulinumtoxinA injections are an effective and safe second-line treatment option that ameliorates AD while improving lower urinary tract function and urinary incontinence-related QoL in individuals with cervical and upper thoracic SCI.

中文翻译：

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Intradetrusor OnabotulinumtoxinA 注射可改善自主神经反射异常，同时改善颈椎和上胸脊髓损伤患者的下尿路功能和尿失禁相关的生活质量。

我们的 IV 期临床试验（研究前/研究后设计）的试点数据强调了内渗剂 onabotulinumtoxinA (200 IU) 注射对减少 T6 或以上慢性脊髓损伤 (SCI) 个体自主神经反射异常 (AD) 的有益作用。试验完成后，我们评估了我们的主要期望（即，在尿动力学 [UDS] 期间 50% 的参与者的 AD 严重程度降低）是否得到满足。次要结果指标是日常生活中自发性 AD 的减少以及 AD 相关和尿失禁相关的生活质量 (QoL) 的改善。此外，我们进行了损伤水平依赖性分析——即颈椎和上胸椎——以探索特定组的治疗效果。后处理，在 UDS 期间，82% (28/34) 的所有参与者和 74% (25/34) 的日常生活中通过 24 小时动态血压监测评估的 AD 严重程度下降。此外，尿失禁相关 QoL 得到改善，膀胱容量增加，储存期间最大逼尿肌压力降低（所有p  < 0.001)。此外，处理的耐受性良好，只有轻微的并发症（级I [ Ñ  = 7]和II [ Ñ  = 7]）中根据记录在11个人（在Clavien-Dindo分类宫颈Ñ  = 9，上胸Ñ  = 2）。损伤水平依赖性分析显示发生率较低（宫颈n  = 15/23，上胸椎n  = 6/11）和较轻的严重程度（宫颈p  = 0.009；上胸椎p  = 0.06 [Pearson r = -0.6，即，UDS 期间 AD 的大效应量])。此外，在 治疗后的两组中都发现日常生活中 AD 严重程度降低、尿失禁相关 QoL 改善、膀胱容量增加和储存期间最大逼尿肌压力降低（所有p < 0.05）。Intradetrusor onabotulinumtoxinA 注射是一种有效且安全的二线治疗选择，可改善 AD，同时改善颈椎和上胸 SCI 患者的下尿路功能和尿失禁相关 QoL。