FDA approves integrated sacral neuromodulation system for urinary urge incontinence

尿急性尿失禁（UUI）是一种严重影响患者生活质量的泌尿系统疾病，传统治疗方法存在一定局限。近年来，随着医疗技术的进步，新型治疗手段不断涌现。近日，美国食品药品监督管理局（FDA）批准了Neuspera Medical公司开发的集成骶神经调节系统（iSNM），为UUI患者提供了新的治疗选择，标志着该领域的重要进展。

iSNM系统采用了一种无需植入电池的智能神经刺激器，通过外部贴片进行每日约2小时的治疗，充电方式类似于智能手机。这一设计避免了传统骶神经调节（SNM）中因电池更换而需要手术的问题。在关键的SANS-UUI二期临床试验中，128名UUI患者接受了治疗，其中84.2%实现了至少50%的漏尿减少，84%的患者症状改善超过75%，42%的患者完全无漏尿。此外，患者的生活质量显著提高，达到3.5倍的临床改善。这些数据表明，iSNM系统在疗效和安全性方面均表现出色，与传统SNM相当。

此次FDA批准为UUI患者带来了更便捷、安全的治疗方案，同时也为相关领域的研究提供了新的方向。未来，随着更多临床数据的积累，iSNM系统有望成为UUI治疗的首选方案之一。同时，该技术的创新模式可能推动其他慢性疾病的非侵入式治疗发展，进一步提升患者治疗体验。

来源: urologytimes

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参考文献

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