Efficacy and safety of Optilume® Paclitaxel-coated urethral dilatation balloon in real-life: Experience in a Spanish Multicenter Study.

Fecha de publicación: 30/10/2024 Fecha Ahead of Print: 30/10/2024

Autores de IIS La Fe

Eduardo José Morán Pascual

Autor
Miguel Ángel Bonillo García

Autor

Participantes ajenos a IIS La Fe

Ballesteros Ruiz C
Campos-Juanatey F
Povo Martín I
Mitjana Biosca S
Gorría Cardesa Ó
Aguilar Guevara JF
García Formoso N
Fernández Pascual E
Martínez Salamanca JI
Martínez Pérez S
Alonso Dorrego JM
Ríos González E
San Cayetano Talegón S
Araujo Suarez AM
Medina Polo J
Viver Clotet L
Vicens Morton AJ
Arce Gil J
Sos Cambras L
Ibáñez Vázquez L
Hermida Gutiérrez J
Moncada Castro EM
Ponce de León Roca J
Torres León L
Martínez-Piñeiro Lorenzo L

Grupos

Urología

Leader

Francisco Boronat Tormo

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. 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.

Datos de la publicación

ISSN/ISSNe:: 2173-5786, 2173-5786
Tipo:: Article
Páginas:: -
DOI:: 10.1016/j.acuroe.2024.10.003

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Keywords

(MeSH); Dilatación uretral; Dilatation; Endoscopic surgical procedures; Estenosis de uretra; Optilume®; Paclitaxel; Reconstructive surgical procedures; Urethral stricture; tratamiento endoscópico