One-year outcomes of the ARTISAN-SNM study with the Axonics System for the treatment of urinary urgency incontinence
One-year outcomes of the ARTISAN-SNM study with the Axonics System for the treatment of urinary urgency incontinence
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DOI：
10.1002/nau.24376
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发表时间：
2020-04-27
影响因子：
2
通讯作者：
Lane, Felicia
中科院分区：
文献类型：
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作者：
Benson, Kevin;McCrery, Rebecca;Lane, Felicia
目的 骶神经调节 (SNM) 是一种指南推荐的治疗排尿功能障碍的方法，包括尿急、急迫性尿失禁、非梗阻性尿失禁以及大便失禁。 Axonics (R) 系统是一种小型化可充电 SNM 系统，旨在提供至少 15 年的治疗，预计将显着减少翻修手术，因为它不需要像不可充电 SNM 系统那样频繁更换。 ARTISAN-SNM 研究是一项旨在治疗急迫性尿失禁 (UUI) 患者的关键研究。报告了 1 年的临床结果。 方法 共有 129 名符合条件的 UUI 患者接受治疗。所有参与者都在一次手术中植入了四极带齿导线和神经刺激器。使用 3 天膀胱日记、经过验证的生活质量调查问卷 (ICIQ-OABqol) 和参与者满意度调查问卷收集疗效数据。治疗有效者被定义为与基线相比 UUI 发作减少≥ 50% 的参与者。对所有 129 名参与者的数据进行了分析。结果 1 年时，89% 的参与者对治疗有反应。每天平均 UUI 发作次数从基线时的 5.6 +/- 0.3 次减少到 1.4 +/- 0.2 次。参与者在 ICIQ-OABqol 问卷上的总体临床有意义的改善为 34 分。所有研究参与者 (100%) 都能在 1 年后为其设备充电，96% 的参与者表示充电频率和持续时间是可以接受的。没有发生与设备相关的严重不良事件。 结论 Axonics 系统在 1 年时是安全有效的，89% 的参与者的 UUI 症状在临床和统计学上均得到显着改善。
Aims Sacral neuromodulation (SNM) is a guideline-recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics (R) System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non-rechargeable SNM system. The ARTISAN-SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1-year are presented.Methods A total of 129 eligible UUI patients were treated. All participants were implanted with a quadripolar tined lead and neurostimulator in a single procedure. Efficacy data were collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a participant satisfaction questionnaire. Therapy responders were defined as participants with >= 50% reduction in UUI episodes compared to baseline. Data were analyzed on all 129 participants.Results At 1 year, 89% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 +/- 0.3 at baseline to 1.4 +/- 0.2. Participants experienced an overall clinically meaningful improvement of 34 points on the ICIQ-OABqol questionnaire. All study participants (100%) were able to recharge their device at 1 year, and 96% of participants reported that the frequency and duration of recharging was acceptable. There were no serious device-related adverse events.Conclusions The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.