Initial human feasibility study of DC Ablation as a treatment for benign prostatic hyperplasia: 6 month follow-up data

Direct current (DC) ablation is a novel non-thermal technology that causes focused coagulative necrosis in the lateral lobes of the prostate to treat benign prostatic hyperplasia (BPH). The necrosis is caused by a zone of non-physiologic pH which is created in a predictable pattern around each electrode in which a direct current is applied during treatment. The objective of this study was to optimize treatment parameters and assess treatment tolerability using transurethral DC ablation as an office-based treatment for BPH. Primary inclusion criteria were defined to include patients with a prostate volume of > 30 ml, and an AUA Symptom Score ≥ 12. Sixteen patients with lower urinary tract symptoms due to BPH were treated with the Ionix Medical´s NeuFlo BPH DC ablation treatment system, which utilizes 4 electrodes deployed into the prostate to create lesions on each side of the urethra with a single catheter positioning. Patients were evaluated for safety and preliminary efficacy data at 1 week, and 1, 3, and 6 months post-treatment with a standard urological evaluation. Gadolinium enhanced MRIs were taken to evaluate the induced necrosis from the treatment after 1 week. Treatment was tolerated well with only mild discomfort due to catheter placement and mild urinary urgency. 31% of patients could not detect the delivery of treatment. MRIs confirmed large lateral and posterior regions of necrosis measuring 2.0 × 1.3 × 2.0 cm from the bladder neck to mid prostate with minimal urethral interaction in the patients treated with 36 coulombs. AUA scores in this group were 22.9 ± 3.4 at baseline, 13.1 ± 3.8 at 1 week, 11.8 ± 3.7 at 1 month, 10.7 ± 6.2 at 3 months, and 10.6 ± 5.0 at 6 months (all values p <; 0.001). This demonstrates a rapid, significant reduction in AUA symptom scores from baseline which was maintained throughout the study. Observed adverse events included the expected transient dysuri- , hematuria, urinary urgency, and bladder spasms. Transurethral DC ablation was demonstrated to be a comfortable BPH treatment with sustained symptomatic improvements realized 1 week post-treatment.