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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 160 participants or records.
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