1 Department of Urology, New York Medical College, Valhalla, New York.
2 Department of Urology, Maimonides Medical Center, Brooklyn, New York.
J Endourol. 2019 Jun;33(6):448-454. doi: 10.1089/end.2019.0067. Epub 2019 May 24.
Multiple surgical therapies for benign prostatic hyperplasia (BPH) have been developed to decrease complications and increase provider efficiency. We investigated contemporary BPH treatment device-related adverse events by searching a publicly available database. The Manufacturer and User Facility Device Experience (MAUDE) database was queried for contemporary BPH treatments. All devices were evaluated for malfunction, patient complications, and manufacturer review. The MAUDE adverse event classification system was used to standardize complications. Univariate analysis was performed to identify associations between BPH devices and adverse events. A total of 2567 reports were identified: transurethral resection of the prostate (TURP) 197 (7.67%), holmium laser enucleation of the prostate (HoLEP) 39 (1.52%), GreenLight™ 2315 (90.2%), and UroLift 16 (0.62%). The most common deviations for each modality included cutting loop detachment during TURP 116 (58.9%), morcellator dysfunction for HoLEP 23 (58.9%), tip fracture/detachment for GreenLight (68.8%), and failure to deploy during UroLift 10 (62.5%). Only 18 (0.7%) patients required medical/surgical management (MAUDE II-IV) due to a device complication. No significant relationship was seen between each modality and complications; however, morcellator use (27.8%) was observed in higher grade complications. Manufacturer review occurred in 61.7% of cases, with 41.3% of reviewed cases finding the operator the cause of the malfunction. Each BPH modality investigated had minimal patient harm with over 99% of patients experiencing no complication after device malfunction. Of note, great care should be taken with morcellator use during HoLEP as it had the greatest number of MAUDE II to IV complications among all devices. Manufacturer review revealed that over 40% of cases were due to misuse by the user. Therefore, urologists should select the modalities they are most familiar with to decrease patient harm and prevent device malfunctions.
多种外科疗法已被开发用于治疗良性前列腺增生（BPH），以降低并发症发生率并提高手术效率。我们通过搜索公开可用的数据库来调查当代与 BPH 治疗设备相关的不良事件。通过制造商和用户设施设备体验（MAUDE）数据库查询当代 BPH 治疗设备。对所有设备的故障、患者并发症和制造商审查情况进行评估。使用 MAUDE 不良事件分类系统对并发症进行标准化。采用单变量分析确定 BPH 设备与不良事件之间的关联。共确定了 2567 份报告：经尿道前列腺切除术（TURP）197 份（7.67%），钬激光前列腺剜除术（HoLEP）39 份（1.52%），GreenLight™2315 份（90.2%），UroLift16 份（0.62%）。每种治疗方式最常见的偏差包括 TURP 术中切割环脱落 116 例（58.9%），HoLEP 中组织碎块器功能障碍 23 例（58.9%），GreenLight 中尖端断裂/脱落 192 例（68.8%），UroLift 中未能展开 10 例（62.5%）。仅 18 例（0.7%）患者因设备并发症需要医疗/手术治疗（MAUDE II-IV）。每种治疗方式与并发症之间未见显著关系；然而，组织碎块器的使用（27.8%）与更高级别的并发症相关。61.7%的病例进行了制造商审查，其中 41.3%的审查病例认为是操作人员导致设备故障。调查的每种 BPH 治疗方式都对患者造成了最小的伤害，超过 99%的患者在设备发生故障后没有出现并发症。值得注意的是，在 HoLEP 中使用组织碎块器时应格外小心，因为它是所有设备中 MAUDE II-IV 级并发症发生率最高的。制造商审查显示，超过 40%的病例是由于用户使用不当造成的。因此，泌尿科医生应选择他们最熟悉的治疗方式，以降低患者伤害并防止设备故障。
