Programming settings and recharge interval in a prospective study of a rechargeable sacral neuromodulation system for the treatment of overactive bladder
Programming settings and recharge interval in a prospective study of a rechargeable sacral neuromodulation system for the treatment of overactive bladder
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DOI：
10.1002/nau.23476
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发表时间：
2018-02-01
影响因子：
2
通讯作者：
Elneil, Sohier
中科院分区：
文献类型：
--
作者：
Blok, Bertil;Van Kerrebroeck, Philip;Elneil, Sohier
目的RELAX-OAB研究旨在确认Axonics r-SNM系统的安全性、有效性和技术性能，Axonics r-SNM系统是一种在欧洲和加拿大获批用于治疗膀胱和肠功能障碍的小型可充电SNM系统。这篇文章的目的是描述研究对象的能力充电的可充电神经刺激器，并记录他们的神经刺激器程序设置和充电间隔随着时间的推移。这些结果代表了完成3个月随访的48例受试者的3个月充电经验。充电间隔估计使用治疗刺激设置和受试者的经验进行了评估，使用questionnaire. ResultsForty七四十八（98%）的受试者能够成功地充电他们的设备之前，在植入后1个月内随访。植入后3个月，98%的受试者能够在随访访视前充电。所有受试者的平均刺激幅度为1.8 mA（1.1 mA）。共有69%的受试者的充电间隔为14天（充电间隔时间），98%的受试者的充电间隔为7天。没有充电相关的不良事件occurrence.ConclusionsStudy受试者能够充电的Axonics r-SNM系统和刺激设置提供2周的治疗充电之间的大多数科目。受试者满意度表示受试者对可充电SNM治疗满意。
AimsThe RELAX-OAB study is designed to confirm the safety, efficacy, and technical performance of the Axonics r-SNM System, a miniaturized, rechargeable SNM system approved in Europe and Canada for the treatment of bladder and bowel dysfunction. The purpose of this article is to describe study subjects' ability to charge the rechargeable neurostimulator and to document their neurostimulator program settings and recharge interval over time.MethodsFifty-one OAB patients were implanted in a single-stage procedure. These results represent the 3-month charging experience for 48 subjects who completed the 3-month follow-up. Recharge intervals were estimated using therapy stimulation settings and subject experience was evaluated using questionnaires.ResultsForty-seven of forty-eight (98%) subjects were able to successfully charge their device prior to follow-up within 1-month post-implant. At 3-month post-implant, 98% of subjects were able to charge prior to their follow-up visit. Average stimulation amplitude across all subjects was 1.8mA (1.1mA). A total of 69% of subjects had 14-day recharge intervals (time between charging) and 98% of subjects had 7-day recharge interval. No charging related adverse events occurred.ConclusionsStudy subjects were able to charge the Axonics r-SNM System and stimulation settings provided 2 weeks of therapy between recharging for most subjects. Subject satisfaction indicates that subjects are satisfied with rechargeable SNM therapy.