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
{"title":"Efficacy and safety of Optilume® paclitaxel-coated urethral dilatation balloon in real-life: experience in a Spanish multicenter study.","authors":"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","doi":"10.1016/j.acuroe.2024.10.003","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>The Optilume® Paclitaxel-coated urethral dilatation balloon is an alternative to conventional endoscopic treatments that combines mechanical dilatation with local delivery of paclitaxel.</p><p><strong>Objective: </strong>To describe the success rate and analyze the safety of the device in real clinical practice. To evaluate possible predictors of treatment failure.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Treatment with Optilume® has been shown to be safe and effective in short-term routine clinical practice.</p>","PeriodicalId":94291,"journal":{"name":"Actas urologicas espanolas","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Actas urologicas espanolas","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.acuroe.2024.10.003","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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.
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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