FDA批准集成骶骨神经调节系统治疗尿路冲动性失禁

尿路冲动性失禁（UUI）是一种常见的泌尿系统疾病，严重影响患者的生活质量。骶神经调节（SNM）是UUI的一种有效治疗方法，但传统的SNM系统需要植入电池，存在电池寿命有限、需要手术更换以及相关并发症等问题，限制了其广泛应用。Neuspera Medical公司开发的集成骶神经调节（iSNM）系统为UUI的治疗带来了新的希望。

该iSNM系统采用无电池设计，通过外部椎间盘进行无线充电和启动治疗，每天只需佩戴约2小时，避免了传统SNM系统电池相关的并发症和手术负担。一项关键的2期临床试验（SANS-UUI）结果显示，iSNM系统在治疗UUI方面疗效显著。该研究纳入128名UUI患者，结果显示84.2%的患者实现了至少50%的紧急泄漏减少，与传统SNM研究结果相当；更有84%的患者UUI症状减少了75%以上，42%的患者实现了完全干燥。此外，患者的生活质量也得到了3.5倍的临床显着改善。

FDA批准iSNM系统用于治疗UUI，标志着UUI治疗领域取得了重大进展。这项新技术有望为UUI患者提供更安全、便捷和有效的治疗选择，显著改善患者的生活质量。未来的研究将进一步评估iSNM系统的长期疗效和安全性，并探索其在其他泌尿系统疾病中的应用潜力。

来源: urologytimes

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参考文献

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