To evaluate the efficacy and safety of high-frequency irreversible electroporation for ablation of benign prostatic hyperplasia.
160 subjects were randomly assigned to the test group to receive ablation and the control group to receive 0. 2 mg/day tamsulosin. The maximum urinary flow rate (Qmax), prostate volume and International Prostate Symptom Score (IPSS) and International Index of Erectile Function 5-item (IIEF-5) score were evaluated before treatment and 1, 3, and 12 months after treatment. Differences inter-group and changes intra-group over different follow-up periods were evaluated, and adverse events were recorded. At the same time, patients were divided into three groups according to tertile method of the baseline prostate volume, and the above indicators were also analyzed.
Qmax improvement in the test group and control group at 1, 3 and 12 months were 1.22±5.50 mL/s and 1.75±4.29 mL/s, 8.41±8.23 mL/s and 2.61±5.53 mL/s, 7.67±7.63 ml/s and 4.31±6.76 ml/s, respectively. IPSS improvement in the test group at 3 and 12 months were significantly higher than that in the control group, except for 1 month. Similarly, the reduction in prostate volume at 3 months was also observed. The incidences of adverse events were low in both groups. Subgroup analysis showed that there were no statistical differences in key indicators among subgroups.
Qmax, prostate volume, IPSS were improved in the test group during 12-month follow-up, and the safety profile was favorable. H-FIRE ablation demonstrated significant efficacy and safety for all patients with large, medium and small prostate volumes.
Urology. 2025 Mar 21 [Epub ahead of print]
Zhen Tong, Zhihong Yang, Baijun Dong, Benkang Shi, Qianyuan Zhuang, Yuanwei Li, Min Gong, Xiaoming Xu, Shengcai Zhou, Xulai Tao, Xinxing Du, Yanhao Dong, Haifeng Wang, Jian Huang, Wei Xue
Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. Electronic address: ., Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. Electronic address: ., Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. Electronic address: ., Department of Urology, Qilu Hospital of Shandong University, Jinan, China. Electronic address: ., Department of Urology, Tongji Hospital Tongji Medical College of HUST, Wuhan, China. Electronic address: ., Department of Urology, Hunan Provincial Hospital, Changsha, China. Electronic address: ., Department of Urology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China. Electronic address: ., Department of Urology, Hwa Mei Hospital, University of Chinese Academy of Sciences, Ningbo, China. Electronic address: ., Department of Urology, Yiyuan County People's Hospital, Zibo, China. Electronic address: ., Department of Urology, Yiyuan County People's Hospital, Zibo, China. Electronic address: ., Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. Electronic address: ., Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. Electronic address: ., Department of Urology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: ., Department of Urology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. Electronic address: ., Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. Electronic address: .