Tauranga Urology Research, Tauranga, New Zealand.
Frimley Park Hospital, Frimley Health Foundation Trust, Surrey, United Kingdom.
J Urol. 2018 May;199(5):1252-1261. doi: 10.1016/j.juro.2017.12.065. Epub 2018 Jan 31.
We compared the safety and efficacy of Aquablation and transurethral prostate resection for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia.
In a double-blind, multicenter, prospective, randomized, controlled trial 181 patients with moderate to severe lower urinary tract symptoms related to benign prostatic hyperplasia underwent transurethral prostate resection or Aquablation. The primary efficacy end point was the reduction in International Prostate Symptom Score at 6 months. The primary safety end point was the development of Clavien-Dindo persistent grade 1, or 2 or higher operative complications.
Mean total operative time was similar for Aquablation and transurethral prostate resection (33 vs 36 minutes, p = 0.2752) but resection time was lower for Aquablation (4 vs 27 minutes, p <0.0001). At month 6 patients treated with Aquablation and transurethral prostate resection experienced large I-PSS improvements. The prespecified study noninferiority hypothesis was satisfied (p <0.0001). Of the patients who underwent Aquablation and transurethral prostate resection 26% and 42%, respectively, experienced a primary safety end point, which met the study primary noninferiority safety hypothesis and subsequently demonstrated superiority (p = 0.0149). Among sexually active men the rate of anejaculation was lower in those treated with Aquablation (10% vs 36%, p = 0.0003).
Surgical prostate resection using Aquablation showed noninferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction. Larger prostates (50 to 80 ml) demonstrated a more pronounced superior safety and efficacy benefit. Longer term followup would help assess the clinical value of Aquablation.
我们比较了 Aquablation 与经尿道前列腺切除术治疗良性前列腺增生相关下尿路症状的安全性和疗效。
在一项双盲、多中心、前瞻性、随机、对照试验中，181 例中重度良性前列腺增生相关下尿路症状患者接受了经尿道前列腺切除术或 Aquablation 治疗。主要疗效终点是 6 个月时国际前列腺症状评分（IPSS）的降低。主要安全性终点是出现 Clavien-Dindo 持续 1 级或 2 级或更高的手术并发症。
Aquablation 和经尿道前列腺切除术的平均总手术时间相似（33 分钟与 36 分钟，p = 0.2752），但 Aquablation 的切除时间更短（4 分钟与 27 分钟，p <0.0001）。在 6 个月时，接受 Aquablation 和经尿道前列腺切除术治疗的患者的 I-PSS 均有显著改善。预设的研究非劣效性假设得到满足（p <0.0001）。接受 Aquablation 和经尿道前列腺切除术的患者中，分别有 26%和 42%发生了主要安全性终点，这符合研究的主要非劣效性安全性假设，随后显示出优越性（p = 0.0149）。在有性生活的男性中，接受 Aquablation 治疗的患者中出现逆行射精的比例较低（10%比 36%，p = 0.0003）。
使用 Aquablation 的前列腺切除术与经尿道前列腺切除术相比，在缓解症状方面不劣效，但性功能障碍的风险较低。更大的前列腺（50 至 80ml）表现出更显著的安全和疗效优势。更长时间的随访将有助于评估 Aquablation 的临床价值。
