Justo Quintas Juan, García Rojo Esther, García Gómez Borja, Lista Mateos Fernando, Otta Oshiro Renan J, Peña Vallejo Elena, Manfredi Celeste, Bozzini Giorgio, Rodríguez Antolín Alfredo, Romero-Otero Javier
Department of Urology, HM Hospitales, Madrid, Spain.
ROC Clinic, Madrid, Spain.
Minerva Urol Nephrol. 2025 Feb;77(1):111-119. doi: 10.23736/S2724-6051.24.05871-3. Epub 2025 Feb 11.
The aim of this study was to compare the efficacy and safety of Aquablation with those of holmium laser enucleation of the prostate (HoLEP) for the treatment of patients with benign prostatic hyperplasia (BPH).
Prospective comparative non-randomized multicenter study conducted between July 2021 and July 2023, consecutive patients undergoing BPH surgery were enrolled to each group. Patients had moderate to severe lower urinary tract symptoms (LUTS), International Prostate Symptom Score (IPSS) ≥8, maximum urinary flow rate (Qmax) ≤15 mL/s, prostate volume ≥30 mL ≤120 mL, and BPH medical therapy failure. Primary outcome was short-term efficacy measured by IPSS, IPSS-QoL, Qmax, post-void residual volume (PVR), prostate-specific antigen (PSA); secondary outcome was safety (intra and post-operative complications, ejaculatory dysfunction, continence, blood transfusions). A six-month follow-up was performed.
Of 150 patients (75:75) enrolled, both groups showed improvements (P<0.05) in IPSS, IPSS-QoL, Qmax, and PVR at six months. No significant differences were observed between HoLEP and Aquablation in IPSS (7.6±6.9 vs. 5.05±4.9 points, P=0.11), IPSS-QoL (1.7±1.6 vs. 1.3±1.6 points, P=0.16), Qmax (28.6±8.8 vs. 23.8±9.3 mL/sec, P=0.12), and PVR (7.2±8.2 vs. 20.3±22.6 mL, P=0.19) at six months. No intraoperative complications occurred. Postoperative hemoglobin drop was higher in Aquablation group (2.6±1.33 vs. 0.4±0.67 g/dL, P<0.001), with no statistically significant differences in transfusion rate (1.3 vs. 1.3%, P=0.31). Ejaculatory dysfunction rate was significantly lower in Aquablation (6,6%) than HoLEP (89.3%, P<0.001). Mean prostate volume was (mean±SD) 81.8±37.4 and 71.9±34.8 mL (P=0.08) in HoLEP and Aquablation groups, respectively. Holep demonstrated a smaller prostate volume after treatment (18.1±6.5 vs. 46.5±25.02 mL P<0.001) as well as a significantly greater reduction and lower levels of PSA (1.2±1.4 vs. 2.65±2.8 ng/mL, P<0.001). Aquablation demonstrated significantly shorter tissue removal time (5.5±2.4 vs. 22.4±9.8 min, P<0.001), but no difference in total operative time (49.1±15 vs. 43.9±26.8 min, P=0.052).
HoLEP and Aquablation show similar effectiveness and safety for BPH-related-LUTS at 6 months. Aquablation has lower ejaculatory dysfunction rates. Larger randomized trials and with longer follow-up time are needed for validation.
本研究旨在比较水刀前列腺切除术与钬激光前列腺剜除术(HoLEP)治疗良性前列腺增生(BPH)患者的疗效和安全性。
2021年7月至2023年7月进行的前瞻性比较非随机多中心研究,将接受BPH手术的连续患者纳入每组。患者有中度至重度下尿路症状(LUTS),国际前列腺症状评分(IPSS)≥8,最大尿流率(Qmax)≤15 mL/s,前列腺体积≥30 mL≤120 mL,且BPH药物治疗失败。主要结局是通过IPSS、IPSS-QoL、Qmax、排尿后残余尿量(PVR)、前列腺特异性抗原(PSA)测量的短期疗效;次要结局是安全性(术中和术后并发症、射精功能障碍、尿失禁、输血)。进行了为期6个月的随访。
在纳入的150例患者(75:75)中,两组在6个月时IPSS、IPSS-QoL、Qmax和PVR均有改善(P<0.05)。HoLEP组和水刀前列腺切除术组在6个月时的IPSS(7.6±6.9对5.05±4.9分,P=0.11)、IPSS-QoL(1.7±1.6对1.3±1.6分,P=0.16)、Qmax(28.6±8.8对23.8±9.3 mL/秒,P=0.12)和PVR(7.2±8.2对20.3±22.6 mL,P=0.19)方面未观察到显著差异。术中未发生并发症。水刀前列腺切除术组术后血红蛋白下降更高(2.6±1.33对0.4±0.67 g/dL,P<0.001),输血率无统计学显著差异(1.3%对1.3%,P=0.31)。水刀前列腺切除术的射精功能障碍率显著低于HoLEP(6.6%对89.3%,P<0.001)。HoLEP组和水刀前列腺切除术组的平均前列腺体积分别为(均值±标准差)81.8±37.4和71.9±34.8 mL(P=0.08)。HoLEP术后前列腺体积较小(18.1±6.5对46.5±25.02 mL,P<0.001),PSA降低幅度显著更大且水平更低(1.2±1.4对2.65±2.8 ng/mL,P<0.001)。水刀前列腺切除术的组织切除时间显著更短(5.5±2.4对22.4±9.8分钟,P<0.001),但总手术时间无差异(49.1±15对43.9±26.8分钟,P=0.052)。
HoLEP和水刀前列腺切除术在6个月时对BPH相关LUTS显示出相似的有效性和安全性。水刀前列腺切除术的射精功能障碍率更低。需要更大规模的随机试验和更长时间的随访来验证。