Department of Urological Sciences, University of British Columbia, Stone Centre at Vancouver General Hospital, Vancouver, British Columbia, Canada.
Department of Urology, University of Washington School of Medicine, Seattle, Washington.
J Urol. 2024 Oct;212(4):580-589. doi: 10.1097/JU.0000000000004091. Epub 2024 Sep 10.
This study reports on a prospective, multicenter, single-arm, clinical trial utilizing the SonoMotion (San Mateo, California) Break Wave lithotripsy (BWL) device to fragment urinary stones.
Patients with a urinary stone underwent a single treatment of 30 minutes and peak negative pressure of 4.5 to 8 MPa. Subjects were contacted and outcomes assessed at 7, 14, and 35 days after treatment, with clinical follow-up and CT imaging 70 ± 14 days postprocedure. The primary objectives were to assess the safety (hematomas, complications, etc) and effectiveness of BWL (any fragmentation, residual fragments ≤4 mm or ≤2 mm, and completely stone-free rate) as assessed via noncontrast CT-kidneys, ureters, and bladder.
Forty-four patients with a ureteral (43%) or renal (57%) stone were treated across 5 centers. Stone fragmentation occurred in 88% of cases; 70% had fragments ≤ 4 and 51% ≤ 2 mm, while 49% were completely stone free on CT; no serious adverse events were reported. Eighty-six percent of patients received either no analgesic medication at all (50%) or minor analgesia (36%). After determining optimal therapy settings, 36 patients were treated and the effectiveness improved exhibiting fragmentation in 92% (33/36), residual fragments ≤ 4 mm in 75% and 58% with fragments ≤ 2 mm with 58% completely stone free. Effectiveness was less in subjects with lower pole stones with 81% fragmentation, 71% having fragments ≤ 4 mm, 29% with fragments ≤ 2 mm, and 29% completely stone free; of distal ureteral stone patients, 89% were completely stone free.
BWL offered safe and effective noninvasive stone therapy requiring little to no anesthesia and was carried out successfully in nonoperative environments.
ClinicalTrials.gov identifier: NCT03811171.
本研究报告了一项前瞻性、多中心、单臂、临床研究，使用 SonoMotion（加利福尼亚州圣马特奥）Break Wave 碎石（BWL）设备对尿结石进行碎石。
患有尿石症的患者接受了单次 30 分钟治疗，峰值负压为 4.5 至 8MPa。在治疗后 7、14 和 35 天与患者联系并评估结果，在术后 70±14 天进行临床随访和 CT 成像。主要目标是评估 BWL 的安全性（血肿、并发症等）和有效性（任何碎石、残留碎片≤4mm 或≤2mm，以及完全无结石率），通过非对比 CT 肾、输尿管和膀胱进行评估。
5 家中心共治疗了 44 例输尿管（43%）或肾结石（57%）患者。88%的病例发生了结石碎裂；70%的碎片≤4mm，51%的碎片≤2mm，49%的患者在 CT 上完全无结石；未报告严重不良事件。86%的患者根本不需要（50%）或只需轻微镇痛（36%）。在确定最佳治疗方案后，对 36 例患者进行了治疗，有效性提高，92%（33/36）出现碎裂，75%和 58%的碎片≤4mm，58%的完全无结石。下极结石患者的有效性较低，81%的患者出现碎裂，71%的患者有碎片≤4mm，29%的患者有碎片≤2mm，29%的患者完全无结石；远侧输尿管结石患者，89%的患者完全无结石。
BWL 提供了安全有效的非侵入性结石治疗方法，几乎不需要麻醉，并且可以在非手术环境中成功进行。
ClinicalTrials.gov 标识符：NCT03811171。
