Eficacia y seguridad del balón de dilatación uretral Optilume® en la práctica clínica real: análisis multicéntrico en España

IF 1.2 4区医学 Q3 UROLOGY & NEPHROLOGY

Actas urologicas espanolas Pub Date : 2025-01-01 DOI:10.1016/j.acuro.2024.07.002

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. Martínez-Piñeiro Lorenzo

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引用次数: 0

Abstract

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.

Material 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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Optilume®尿路扩张球在实际临床实践中的有效性和安全性：西班牙的多中心分析

Optilume®紫杉醇涂层尿道扩张球囊是传统内窥镜治疗的替代方案，结合了机械扩张和局部紫杉醇输送。目的描述该装置在实际临床应用中的成功率，并分析其安全性。评估治疗失败的可能预测因素。材料与方法回顾性多中心研究诊断为尿道狭窄并在常规临床实践中使用Optilume®球囊治疗的患者。术前、术后3个月、6个月和12个月通过血流测定、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和Qmax；10毫升/秒。研究纳入了2021年5月至2024年4月期间在12家西班牙医院接受Optilume®治疗的238例患者。其中156人至少随访3个月，进行了分析。中位狭窄长度：1.5 cm(0.5 ~ 5.3)，以球尿道狭窄为主（87.7%）。其中12.8%的患者有盆腔放疗史，81.4%的患者既往有尿道操作史。术后并发症发生率为14.2%。治疗成功率为73.8%，中位随访8个月（5-12）。没有发现狭窄复发的预测因素。后尿道狭窄的复发率高于前尿道狭窄（42.9%比24.6%,p = 0.126）。在有和没有事先尿道操作的患者之间没有观察到显著差异。结论在短期的常规临床实践中，Optilume治疗是安全有效的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Actas urologicas espanolas UROLOGY & NEPHROLOGY-

CiteScore

1.90

自引率

0.00%

发文量

审稿时长

46 days

期刊介绍： Actas Urológicas Españolas is an international journal dedicated to urological diseases and renal transplant. It has been the official publication of the Spanish Urology Association since 1974 and of the American Urology Confederation since 2008. Its articles cover all aspects related to urology. Actas Urológicas Españolas, governed by the peer review system (double blinded), is published online in Spanish and English. Consequently, manuscripts may be sent in Spanish or English and bidirectional free cost translation will be provided.