Efficacy and safety of high-frequency irreversible electroporation in benign prostatic hyperplasia: a randomized controlled, open-labelled, multicenter clinical study.

Abstract

Objective: To evaluate the efficacy and safety of high-frequency irreversible electroporation for ablation of benign prostatic hyperplasia.

Materials and methods: 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.

Results: 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.

Conclusions: 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.