Adult and Pediatric Urology and Urogynecology, Omaha, Nebraska.
University of California, Irvine, California.
J Urol. 2020 Jan;203(1):185-192. doi: 10.1097/JU.0000000000000458. Epub 2019 Jul 26.
Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented.
A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants.
At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events.
The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.
骶神经调节是一种指南推荐的治疗方法，适用于保守治疗失败的尿功能障碍和粪便失禁患者。历史上，骶神经调节是使用不可充电设备进行的，其平均使用寿命为 4.4 年。由于电池耗尽，需要手术更换植入的神经刺激器。植入长寿命的植入式神经刺激器可以消除更换手术的需要，潜在地降低患者的手术风险和医疗保健成本。Axonics r-SNM 系统™是一种小型可充电骶神经调节系统，旨在提供至少 15 年的治疗。ARTISAN-SNM（Axonics®骶神经调节系统用于治疗急迫性尿失禁）研究是一项使用可充电骶神经调节治疗急迫性尿失禁的关键研究。本文介绍了 6 个月的结果。
共有 129 名符合条件的急迫性尿失禁患者接受了治疗。所有参与者均采用带叉的导线和可充电骶神经调节系统进行非分期手术植入。使用 3 天膀胱日记、经过验证的 ICIQ-OABqol（国际尿失禁咨询问卷-过度活动膀胱生活质量）问卷和参与者满意度问卷收集疗效数据。治疗应答者定义为与基线相比，急迫性尿失禁发作减少 50%或更多的参与者。我们对所有植入的参与者进行了按治疗分析。
在 6 个月时，90%的参与者为治疗应答者。平均±SE 每天急迫性尿失禁发作次数从基线时的 5.6±0.3 减少到 1.3±0.2。参与者在 ICIQ-OABqol 问卷上的得分提高了 34 分，具有临床意义。没有与设备相关的严重不良事件。
Axonics r-SNM 系统安全有效，90%的参与者在急迫性尿失禁症状方面获得了临床和统计学上的显著改善。
