Kaplan Steven A, Pichardo Merycarla, Rijo Edwin, Espino Gustavo, Lay Ramon Rodriguez, Estrella Rafael
Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY, United States.
URUS, Santo Domingo, Dominican Republic.
Can Urol Assoc J. 2024 Nov;18(11):E319-E325. doi: 10.5489/cuaj.8737.
The purpose of this study was to gather initial safety and efficacy data with the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
A total of 80 men with moderate-to-severe LUTS secondary to BPH were enrolled and treated with the Optilume BPH Catheter System. Symptoms were evaluated using the International Prostate Symptom Score (IPSS) and Benign Prostatic Hyperplasia-Impact Index (BPH-II). Improvement in urinary flow and relief of obstruction was evaluated by way of peak urinary flow rate (Qmax) and postvoid residual urine volume (PVR). Subjects were prospectively queried for adverse events at each study visit, and relatedness to the study device was evaluated by the investigators, as well as centrally adjudicated by the study principal investigator.
Previous reports of symptom improvement in this cohort were maintained through four-year followup, with a significant reduction in IPSS and IPSS quality of life maintained through four years (-12.1, -2.8, respectively). Clinically meaningful improvement in Qmax was maintained in the majority of subjects, with an average improvement from baseline of +5.6 mL/sec. No treatment-related adverse events were reported in the long-term followup period.
Long-term followup through four years for subjects treated with the Optilume BPH Catheter System indicates durable outcomes in symptom improvement and functional improvement in flow rate. These results indicate the unique mechanism of action for Optilume BPH successfully achieves an immediate mechanical effect that is maintained long-term through incorporation of paclitaxel to maintain patency.
本研究的目的是收集Optilume良性前列腺增生导管系统治疗良性前列腺增生（BPH）继发下尿路症状（LUTS）的初步安全性和有效性数据。
共纳入80例BPH继发中重度LUTS的男性患者，采用Optilume良性前列腺增生导管系统进行治疗。使用国际前列腺症状评分（IPSS）和良性前列腺增生影响指数（BPH-II）评估症状。通过最大尿流率（Qmax）和排尿后残余尿量（PVR）评估尿流改善和梗阻缓解情况。在每次研究访视时前瞻性询问受试者不良事件，由研究者评估与研究器械的相关性，并由研究主要研究者进行集中判定。
该队列先前报告的症状改善情况在四年随访中得以维持，IPSS及IPSS生活质量在四年中均显著降低（分别降低12.1和2.8）。大多数受试者的Qmax保持了具有临床意义的改善，平均较基线提高了+5.6 mL/秒。长期随访期间未报告与治疗相关的不良事件。
对接受Optilume良性前列腺增生导管系统治疗的受试者进行的四年长期随访表明，在症状改善和流速功能改善方面有持久的结果。这些结果表明，Optilume良性前列腺增生独特的作用机制成功实现了即时机械效应，并通过加入紫杉醇维持通畅而长期保持。
