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Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence.
The Journal of Urology ( IF 5.9 ) Pub Date : 2024-11-25 , DOI: 10.1097/ju.0000000000004328
John P F A Heesakkers,Philip Toozs-Hobson,Suzette E Sutherland,Alex Digesu,Cindy L Amundsen,Rebecca J McCrery,Stefan De Wachter,Emily R Kean,Frank Martens,Kevin Benson,Kimberly L Ferrante,Kevin J Cline,Osvaldo F Padron,Laura Giusto,Felicia L Lane,Lambertus P W Witte,Roger R Dmochowski

PURPOSE The BlueWind Medical Device, Revi, is a novel implantable tibial neuromodulation system powered by an external, battery-operated wearable that facilitates individually tailored stimulation to provide treatment for urgency urinary incontinence (ie, overactive bladder wet). The Revi System is the first Food and Drug Administration-cleared implantable neuromodulation device which can be used without prior failure with more conservative treatment options. Two-year follow-up results of the OASIS study are presented. MATERIALS AND METHODS The Revi System was implanted in 151 female participants. The primary efficacy and safety endpoints were assessed at 6 and 12 months, after which participants either consented to extend follow-up for long-term assessment of treatment durability and safety or they chose to exit the study. RESULTS Ninety-seven participants completed the 24-month assessment, and of these, 79% were therapy responders (≥50% reduction in urgency urinary incontinence episodes, demonstrated on a 3-day voiding diary). Importantly, therapeutic response was durable, with comparable effectiveness at 6, 12, and 24 months (response rates of 78%, 82%, and 79%, respectively). Participants who completed both the 6- and 24-month assessment had similar demographics and treatment results at the 6-month visit, indicating that these results at 24 months are representative of the overall study population. In addition, high satisfaction and patient impression of improvement were reported, with 97% (88/91) of the participants satisfied with the therapy and 80% (78/97) feeling "much better" or "very much better." There were no serious adverse events related to the device or the procedure through 24 months. CONCLUSIONS Two-year results demonstrate durable efficacy, high patient satisfaction, and a very favorable safety profile. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER NCT03596671.

中文翻译:


使用 Revi 系统治疗急迫性尿失禁的关键 OASIS 研究的两年疗效和安全性结果。



目的 BlueWind 医疗设备 Revi 是一种新型植入式胫骨神经调控系统,由外部电池供电的可穿戴设备供电,可促进个性化定制的刺激,为急迫性尿失禁(即膀胱湿性过度活动症)提供治疗。Revi 系统是第一个获得美国食品和药物管理局批准的植入式神经调控装置,可以在没有先前失败的情况下使用更保守的治疗方案。介绍了 OASIS 研究的两年随访结果。材料和方法 Revi 系统植入 151 名女性参与者。在 6 个月和 12 个月时评估主要疗效和安全性终点,之后参与者同意延长随访以长期评估治疗持久性和安全性,或者选择退出研究。结果 97 名参与者完成了 24 个月的评估,其中 79% 是治疗反应者 (急迫性尿失禁发作减少 ≥50%,在 3 天的排尿日记中证明)。重要的是,治疗反应是持久的,在 6 、 12 和 24 个月时具有相当的有效性 (反应率分别为 78% 、 82% 和 79%)。完成 6 个月和 24 个月评估的参与者在 6 个月访视时具有相似的人口统计学和治疗结果,表明这些结果在 24 个月时代表了整个研究人群。此外,报告了高满意度和患者对改善的印象,97% (88/91) 的参与者对治疗感到满意,80% (78/97) 感觉“好多了”或“非常好”。在 24 个月内没有与该设备或手术相关的严重不良事件。 结论 两年结果表明疗效持久、患者满意度高和非常有利的安全性。试用注册:CLINICALTRIALS.GOV 标识符 NCT03596671。
更新日期:2024-11-25
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