University of Vermont Medical Center, Burlington, VT, USA.
Tauranga Urology Research, Tauranga, New Zealand.
BJU Int. 2019 Apr;123(4):651-660. doi: 10.1111/bju.14426. Epub 2018 Jul 26.
To test the hypothesis that benign prostatic hyperplasia (BPH) robotic surgery with aquablation would have a more pronounced benefit in certain patient subgroups, such as men with more challenging anatomies (e.g. large prostates, large middle lobes) and men with moderate BPH.
We conducted prespecified and post hoc exploratory subgroup analyses from a double-blind, multicentre prospective randomized controlled trial that compared transurethral resection of the prostate (TURP) using either standard electrocautery vs surgery using robotic waterjet (aquablation) to determine whether certain baseline factors predicted more marked responses after aquablation as compared with TURP. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo persistent grade 1 or grade ≥2 surgical complications.
For men with larger prostates (50-80 g), the mean IPSS reduction was four points greater after aquablation than after TURP (P = 0.001), a larger difference than the overall result (1.8 points; P = 0.135). Similarly, the primary safety endpoint difference (20% vs 46% [26% difference]; P = 0.008) was greater for men with large prostate compared with the overall result (26% vs 42% [16% difference]; P = 0.015). Postoperative anejaculation was also less common after aquablation compared with TURP in sexually active men with large prostates (2% vs 41%; P < 0.001) vs the overall results (10% vs 36%; P < 0.001). Exploratory analysis showed larger IPSS changes after aquablation in men with enlarged middle lobes, men with severe middle lobe obstruction, men with a low baseline maximum urinary flow rate, and men with elevated (>100) post-void residual urine volume.
In men with moderate-to-severe lower urinary tract symptoms attributable to BPH and larger, more complex prostates, aquablation was associated with both superior symptom score improvements and a superior safety profile, with a significantly lower rate of postoperative anejaculation. The standardized, robotically executed, surgical approach with aquablation may overcome the increased outcome variability in more complex anatomy, resulting in superior symptom score reduction.
验证假设，即良性前列腺增生（BPH）的机器人手术与水刀消融术相比，在某些特定患者亚组中会有更显著的益处，例如解剖结构更具挑战性的患者（例如前列腺较大、中叶较大）和中度 BPH 患者。
我们进行了一项双盲、多中心前瞻性随机对照试验的预设和事后探索性亚组分析，该试验比较了经尿道前列腺切除术（TURP）中使用标准电切术与使用机器人水射流（水刀消融术）的手术，以确定某些基线因素是否预示着水刀消融术比 TURP 后有更显著的反应。主要疗效终点为 6 个月时国际前列腺症状评分（IPSS）的降低。主要安全性终点是发生 Clavien-Dindo 持续 1 级或≥2 级手术并发症。
对于前列腺较大（50-80 克）的男性，水刀消融术后 IPSS 平均降低 4 分，明显大于 TURP 术后（P=0.001），这一差异大于总体结果（1.8 分；P=0.135）。同样，前列腺较大的男性的主要安全性终点差异（20%比 46%[26%差异]；P=0.008）大于总体结果（26%比 42%[16%差异]；P=0.015）。与总体结果相比（10%比 36%；P<0.001），前列腺较大的活跃男性术后逆行射精也较少见。
对于有中重度下尿路症状的 BPH 患者和前列腺较大、更复杂的患者，水刀消融术不仅能显著改善症状评分，还能显著提高安全性，术后逆行射精的发生率显著降低。与 TURP 相比，标准化、机器人执行的水刀消融术具有更好的安全性，对于解剖结构更复杂的患者，可能会克服结果变异性增加的问题，从而实现更显著的症状评分降低。
