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 dysuria, 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.