Masopeh Joel, Garrigan Audra, Heinsimer Kevin, Wiegand Lucas
Department of Urology, University of Central Florida, College of Medicine, Orlando, FL, USA.
Department of Urology, University of South Florida, Tampa, FL, USA.
Transl Androl Urol. 2025 Aug 30;14(8):2129-2134. doi: 10.21037/tau-24-461. Epub 2025 Jul 29.
The Optilume drug-coated balloon is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III trial concludes that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. However, there have been limited studies to show efficacy in the treatment of urethral stricture in the setting of post-radiation patients. This study aimed to clarify the safety and early efficacy of Optilume balloon dilation for urethral strictures in post-radiation patients.
All patients undergoing Optilume balloon dilation with at least 3 months of follow-up were evaluated over 27 months in a retrospective multi-institutional setting. Thirty patients who received pelvic radiation and subsequently developed symptomatic urethral strictures were selected from a total of 246 patients identified with symptomatic urethral strictures. Success was defined as the absence of recurrence of original presenting symptoms, no need for intermittent self-dilation, and no requirement for surgical intervention within the follow-up period for their urethral stricture.
Successful Optilume balloon dilations without recurrence of symptoms were achieved in 24/30 (80%) patients. Failures with recurrence of strictures occurred in 20% (6/30) of cases. At a median follow-up of 353 (range: 91-818) days, 80% (24/30) of radiated patients had successful Optilume balloon dilation. Our data showed that 83% (5/6) of patients who experienced recurrence did so after 12 months. Among radiated patients without baseline incontinence, new stress incontinence developed postoperatively in 20% (3/15), while one patient had improved stress incontinence.
Optilume balloon dilation is a safe mechanism of treatment for urethral stricture disease in radiated patients. Early follow-up data of the treatment of urethral strictures in radiated patients suggests similar efficacy. However, long-term follow-up data is needed.
Optilume药物涂层球囊是一种带有紫杉醇涂层的尿道扩张球囊，它将机械扩张以实现即时症状缓解与局部药物递送相结合，以维持尿道通畅。ROBUST III试验得出结论，Optilume在治疗长度<3 cm的复发性前尿道狭窄方面是安全的，且优于标准的直视内部尿道切开术/扩张术。然而，在放疗后患者中，显示其治疗尿道狭窄疗效的研究有限。本研究旨在阐明Optilume球囊扩张术治疗放疗后患者尿道狭窄的安全性和早期疗效。
在一项回顾性多机构研究中，对所有接受Optilume球囊扩张术且随访至少3个月的患者进行了27个月的评估。从总共246例有症状性尿道狭窄的患者中，选择了30例接受盆腔放疗并随后出现症状性尿道狭窄的患者。成功的定义为在随访期内尿道狭窄的原始症状未复发、无需间歇性自我扩张且无需手术干预。
24/30（80%）的患者成功进行了Optilume球囊扩张且症状未复发。20%（6/30）的病例出现狭窄复发失败。在中位随访353天（范围：91 - 818天）时，80%（24/30）接受放疗的患者Optilume球囊扩张成功。我们的数据显示，6例复发患者中有83%（5/6）在12个月后复发。在无基线尿失禁的放疗患者中，术后新发压力性尿失禁的发生率为20%（3/15），而1例患者的压力性尿失禁有所改善。
Optilume球囊扩张术是治疗放疗后患者尿道狭窄疾病的一种安全方法。放疗后患者尿道狭窄治疗的早期随访数据表明疗效相似。然而，仍需要长期随访数据。
