Optilume® 紫杉醇涂层尿道扩张球囊在现实生活中的有效性和安全性:西班牙多中心研究的经验。

C Ballesteros Ruiz, F Campos-Juanatey, I Povo Martín, S Mitjana Biosca, Ó Gorría Cardesa, J F Aguilar Guevara, N García Formoso, E Fernández Pascual, J I Martínez Salamanca, S Martínez Pérez, J M Alonso Dorrego, E Ríos González, S San Cayetano Talegón, A M Araujo Suarez, E Moran Pascual, M Á Bonillo García, J Medina Polo, L Viver Clotet, A J Vicens Morton, J Arce Gil, L Sos Cambras, L Ibáñez Vázquez, J Hermida Gutiérrez, E M Moncada Castro, J Ponce de León Roca, L Torres León, L Martínez-Piñeiro Lorenzo
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引用次数: 0

摘要

简介:Optilume® 紫杉醇涂层尿道扩张球囊是传统内窥镜治疗的替代方法,它将机械扩张与紫杉醇局部给药相结合:描述该设备在实际临床实践中的成功率并分析其安全性。评估治疗失败的可能预测因素:回顾性多中心研究,对象是在常规临床实践中被诊断为尿道狭窄并接受 Optilume® 球囊治疗的患者。按照标准做法,在术前、术后 3 个月、6 个月和 12 个月通过流量计、问卷调查(PROM 和 IPSS)和膀胱镜检查收集数据。手术成功的定义是没有后续的尿道操作,Qmax > 10 ml/s。结果:2021 年 5 月至 2024 年 4 月期间,在西班牙 12 家医院接受 Optilume® 治疗的 238 名患者被纳入研究。对其中至少随访 3 个月的 156 名患者进行了分析。中位狭窄长度:1.5 厘米(0.5 - 5.3),主要位于球部尿道(87.7%)。其中,12.8%的患者曾接受过盆腔放疗,81.4%的患者曾接受过尿道操作。据报告,14.2%的患者出现了术后并发症。治疗成功率为 73.8%,中位随访时间为 8 个月(5-12 个月)。没有发现狭窄复发的预测因素。位于后尿道的狭窄复发率高于前尿道(42.9% 对 24.6%,P = 0.126)。结论:使用 Optilume® 治疗尿道狭窄的效果良好:结论:在短期常规临床实践中,使用 Optilume® 治疗已被证明是安全有效的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and safety of Optilume® paclitaxel-coated urethral dilatation balloon in real-life: experience in a Spanish multicenter study.

Introduction: The Optilume® Paclitaxel-coated urethral dilatation balloon is an alternative to conventional endoscopic treatments that combines mechanical dilatation with local delivery of paclitaxel.

Objective: To describe the success rate and analyze the safety of the device in real clinical practice. To evaluate possible predictors of treatment failure.

Materials and methods: Retrospective multicenter study in patients diagnosed with urethral stricture and treated with an Optilume® balloon in routine clinical practice. Data were collected from flowmetry, questionnaires (PROM and IPSS) and cystoscopy before surgery, and 3, 6 and 12 months after the procedure, according to standard practice. Surgical success was defined as the absence of subsequent urethral manipulation and a Qmax >10 ml/s.

Results: 238 patients treated with Optilume® in 12 Spanish hospitals between May 2021 and April 2024 were included in the study. Of these, 156 who had a minimum follow-up of 3 months, were analyzed. Median stricture length: 1.5 cm (0.5-5.3), mainly in bulbar urethra (87.7%). Of the total, 12.8% of patients had a history of pelvic radiotherapy, and 81.4% had undergone prior urethral manipulation. Postoperative complications were reported in 14.2% of the total. The treatment success rate was 73.8%, with a median follow-up of 8 months (5-12). No predictors of stricture recurrence were identified. Recurrence rates were higher in strictures located in the posterior versus anterior urethra (42.9% vs. 24.6%, p = 0.126). No significant differences were observed between patients with and without prior urethral manipulation.

Conclusion: Treatment with Optilume® has been shown to be safe and effective in short-term routine clinical practice.

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