From the Unity Point Health, Waterloo, IA.
Canterbury Urology Research Trust, Christchurch.
Female Pelvic Med Reconstr Surg. 2022 May 1;28(5):287-292. doi: 10.1097/SPV.0000000000001105. Epub 2022 Sep 22.
The eCoin (Valencia Technologies Corporation, Valencia, CA) is a battery-powered, nickel-sized and shaped neuromodulation device for the treatment of overactive bladder, and it is implanted in the lower leg in a short office or outpatient procedure under local anesthesia. A follow-on trial was conducted to evaluate the feasibility, safety, and efficacy of eCoin reimplantation.
This was a prospective, single-arm, open-label study, including 23 participants with refractory urgency urinary incontinence (UUI) who were previously participants in the eCoin clinical feasibility trial. This follow-on study was conducted at 7 sites in the United States and New Zealand. Participants were reimplanted with a new eCoin device and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 12 weeks and 24 weeks postactivation, were compared with baseline.
Participants of the study were considered responders if they reported a ≥ 50% reduction from baseline in episodes of UUI on a 3-day voiding diary. At 12 weeks of treatment, 74% (95% confidence interval [CI], 52%-90%) of participants were considered responders. At 24 weeks of treatment, 82% (95% CI, 60%-95%) of participants were considered responders with 36% (95% CI, 20%-57%) of participants achieving complete continence. There were no device-related serious adverse events reported during the study.
The reimplantation of eCoin was both safe and effective in treating UUI associated with overactive bladder syndrome. The demonstrated significant reduction or resolution of symptoms with no serious safety concern suggests that eCoin is a convenient and maintainable therapeutic device.
eCoin（瓦伦西亚技术公司，瓦伦西亚，加利福尼亚州）是一种电池供电的、类似镍币大小和形状的神经调节装置，用于治疗膀胱过度活动症，它在小腿下部通过局部麻醉进行短时间的办公室或门诊手术植入。进行了一项后续试验，以评估 eCoin 再植入的可行性、安全性和疗效。
这是一项前瞻性、单臂、开放性标签研究，包括 23 名以前参加过 eCoin 临床可行性试验的难治性急迫性尿失禁（UUI）患者。这项后续研究在美国和新西兰的 7 个地点进行。参与者接受了新的 eCoin 装置的再植入，并在 4 周后激活。在激活后 12 周和 24 周收集膀胱日记数据和经过验证的生活质量工具，并与基线进行比较。
如果参与者在 3 天排尿日记中报告 UUI 发作次数减少了≥50%，则被认为是有反应者。在治疗的 12 周时，74%（95%置信区间[CI]，52%-90%）的参与者被认为是有反应者。在治疗的 24 周时，82%（95%CI，60%-95%）的参与者被认为是有反应者，其中 36%（95%CI，20%-57%）的参与者达到完全尿控。在研究期间，没有报告与设备相关的严重不良事件。
eCoin 的再植入在治疗与膀胱过度活动症相关的 UUI 方面既安全又有效。症状显著减少或缓解，且没有严重的安全问题，这表明 eCoin 是一种方便且可维持的治疗装置。
