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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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.