The Prostafix Water Electrolysis System offers a minimally invasive solution for managing lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), utilizing direct current energy through interstitial needles to ablate prostate tissue via water electrolysis and pH shifts. This international, multi-center study evaluated the system’s safety and efficacy in a day-only setting under topical anesthesia. The study enrolled 49 participants aged over 45 years with prostate volumes between 25 cm³ and 55 cm³ across sites in Singapore and New Zealand. Outcomes were assessed at baseline, one week, six weeks, and three months post-treatment. At three months, patients experienced a mean 9.5-point (43.8%) reduction in the International Prostate Symptom Score (IPSS), indicating significant symptom improvement. Most participants (84.8%) required little to no catheterization post-procedure, with only one needing catheterization for more than three days.
Adverse events (AEs) were predominantly mild (91.1%), with 68% unrelated to the device or procedure. The most common AEs included worsening LUTS (16.5%) and hypertonic bladder (7.6%), while no severe adverse events (SAEs) were attributed to the device. MRI scans from 14 patients confirmed the creation of necrotic lesions within one week of treatment, with consistent findings across follow-ups. No serious device-related complications were observed. The study demonstrated that the Prostafix System is well-tolerated, safe, and effective in reducing LUTS, with initial outcomes supporting its potential as an office-based alternative for BPH management. These findings highlight the need for further investigation to confirm long-term efficacy and safety.
