PURPOSE We report the 5-year study closeout results for the ROBUST I trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) for men with short, recurrent bulbar urethral strictures. MATERIALS AND METHODS Adult men with recurrent bulbar urethral strictures ≤ 2 cm long and lumen < 12F were included in the study and treated with the Optilume DCB. Outcome measures included symptom questionnaires, maximum urinary flow rate, postvoid residual, and freedom from repeat intervention. Functional success was defined as improvement in International Prostate Symptom Score ≥ 50% without re-treatment. RESULTS Fifty-three men were enrolled and treated, and 31 subjects completed all follow-up. Functional success was achieved in 58% (25/43) patients at 5 years. Average International Prostate Symptom Score improved from a mean of 25.2 at baseline to 7.2 at 5 years (P < .001). Freedom from repeat intervention was maintained through 5 years at 71.7% estimated by Kaplan-Meier. Maximum urinary flow rate improved from 5.0 mL/s at baseline to 19.9 (P < .01), and average postvoid residual was reduced from 141.4 mL to 59.5 mL (P < .01) at 5 years of follow-up. Erectile function remained unaffected. There were no serious treatment-related adverse events. CONCLUSIONS In this challenging cohort of men with failed prior endoscopic treatment, the Optilume DCB shows sustained improvement in subjective and objective voiding parameters at 5 years. Optilume is a safe and effective treatment option for appropriately selected men with recurrent bulbar urethral stricture who wish to avoid urethroplasty. Results are in line with the ROBUST III randomized controlled trial that will continue follow-up through 5 years. CLINICAL TRIAL NO. NCT03014726.

中文翻译：

---

使用 Optilume 药物涂层球囊治疗复发性延髓尿道狭窄的长期结果：ROBUST I 研究的五年结果。


目的 我们报告了 ROBUST I 试验的 5 年研究收尾结果，该试验评估了 Optilume 药物涂层球囊 （DCB） 对短而复发性延髓狭窄男性的安全性和有效性。材料和方法 患有复发性延髓尿道狭窄 ≤ 2 cm 长和管腔 < 12F 的成年男性被纳入研究并接受 Optilume DCB 治疗。结局指标包括症状问卷、最大尿流率、排尿后残余和无重复干预。功能成功定义为国际前列腺症状评分改善 ≥ 50% 而无需再次治疗。结果 入组并治疗 53 例男性，31 例受试者完成所有随访。58% （25/43） 的患者在 5 年时取得了功能成功。平均国际前列腺症状评分从基线时的平均值 25.2 提高到 5 年时的 7.2 （P < .001）。Kaplan-Meier 估计的 71.7% 保持了 5 年无重复干预。最大尿流率从基线时的 5.0 mL/s 提高到 19.9 （P < .01），平均排尿后残余尿量从 141.4 mL 降低到 59.5 mL （P < .01） 在 5 年随访中。勃起功能不受影响。没有严重的治疗相关不良事件。结论 在这个既往内窥镜治疗失败的具有挑战性的男性队列中，Optilume DCB 显示 5 年时主观和客观排尿参数持续改善。Optilume 是一种安全有效的治疗选择，适用于希望避免尿道成形术的适当选择的复发性延髓狭窄男性。结果与 ROBUST III 随机对照试验一致，该试验将持续随访 5 年。临床试验编号 NCT03014726。