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Optilume药物涂层球囊在膀胱颈狭窄和膀胱尿道吻合口狭窄治疗中的超说明书用药

Off-label Use of the Optilume Drug-coated Balloon in the Treatment of Bladder Neck Stenosis and Vesicourethral Anastomosis Stenosis.

作者信息

Tosev Georgi, Damgov Ivan, Kuehhas Franklin, Borgmann Hendrik, Struck Julian, Salem Johannes, Kuru Timur H

机构信息

Mannheim Urology, Mannheim, Germany.

Department of Urology, University Hospital Heidelberg, Heidelberg, Germany.

出版信息

Eur Urol Open Sci. 2025 Apr 11;75:101-105. doi: 10.1016/j.euros.2025.03.002. eCollection 2025 May.

DOI:10.1016/j.euros.2025.03.002
PMID:40276006
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12018579/
Abstract

UNLABELLED

Bladder neck stenosis (BNS) and vesicourethral anastomosis stenosis (VUAS) are uncommon but clinically significant complications following transurethral surgery and radical prostatectomy (RP), often presenting important clinical challenges because of high recurrence rates with standard treatments. We retrospectively evaluated the efficacy of the Optilume paclitaxel-coated balloon in managing recurrent BNS and VUAS. Sixteen patients who had undergone open or robotic RP, transurethral resection of the prostate, or GreenLight laser photoselective vaporization of the prostate were assessed. At 12 mo after BNS/VUAS surgery, the International Prostate Symptom Score (IPSS), postvoid residual volume (PVR), and freedom from repeat intervention were evaluated. All patients remained free from repeat intervention and anatomic recurrence at 1-yr follow-up. Among the 16 patients (seven with preexisting incontinence), 12-mo follow-up demonstrated stable continence with no worsening, and all patients reported high satisfaction and willingness to repeat the procedure. Significant improvements in scores were observed for IPSS ( < 0.001;  = 16) and IPSS quality of life ( = 4.75,  < 0.001;  = 16), while PVR did not change significantly ( = 0.442;  = 8). These findings suggest that the Optilume paclitaxel-coated balloon is an effective off-label treatment for recurrent BNS and VUAS as applied in two urology practices in Germany, corroborating evidence from randomized controlled trials on the treatment of anterior urethral strictures.

PATIENT SUMMARY

We evaluated off-label use of the new drug-coated Optilume balloon for treatment of recurrent narrowing of the bladder neck or VA (vesicourethral anastomosis; surgical join between the bladder and urethra) in patients who had previously undergone prostate surgery. Our findings show that this treatment significantly improved urinary function assessed 1 year after the procedure and prevented the need for further surgeries.

摘要

未标注

膀胱颈狭窄(BNS)和膀胱尿道吻合口狭窄(VUAS)是经尿道手术和根治性前列腺切除术(RP)后不常见但具有临床意义的并发症,由于标准治疗的高复发率,常常带来重要的临床挑战。我们回顾性评估了Optilume紫杉醇涂层球囊治疗复发性BNS和VUAS的疗效。对16例接受开放或机器人辅助RP、经尿道前列腺切除术或绿激光选择性汽化前列腺术的患者进行了评估。在BNS/VUAS手术后12个月,评估国际前列腺症状评分(IPSS)、排尿后残余尿量(PVR)以及无需再次干预的情况。所有患者在1年随访时均未再次干预且无解剖学复发。在这16例患者(7例既往有尿失禁)中,12个月随访显示尿失禁情况稳定且未恶化,所有患者均表示高度满意并愿意再次接受该治疗。IPSS评分(P<0.001;n = 16)和IPSS生活质量评分(P = 4.75,P<0.001;n = 16)有显著改善,而PVR无显著变化(P = 0.442;n = 8)。这些发现表明,Optilume紫杉醇涂层球囊作为一种非标签治疗方法,在德国的两家泌尿外科实践中应用于复发性BNS和VUAS是有效的,这与关于前尿道狭窄治疗的随机对照试验证据相符。

患者总结

我们评估了新型药物涂层Optilume球囊在先前接受过前列腺手术的患者中治疗膀胱颈或VA(膀胱尿道吻合口;膀胱与尿道之间的手术连接)复发性狭窄的非标签使用情况。我们的研究结果表明,这种治疗在术后1年显著改善了评估的排尿功能,并避免了进一步手术的需要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a082/12018579/4c2c651a9d09/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a082/12018579/4c2c651a9d09/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a082/12018579/4c2c651a9d09/gr1.jpg

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