Phase I/II Examination of Transurethral Ethanol Ablation of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Purpose: We assessed the safety of transurethral ethanol ablation of the prostate as a treatment for men with symptomatic benign prostatic hyperplasia and determined the efficacy of this procedure. Materials and Methods: We performed a multicenter randomized trial on 79 men, 50 to 79 years old, who had drug refractory voiding symptoms (International Prostate Symptom Score greater than 12) and prostate volumes of 30 to 80 cc. Ethanol was injected transurethrally into the prostate with a curved cystoscopic needle in men randomly assigned to 1 of 3 doses: 15%, 25% or 40% of prostate volume by transrectal ultrasound. Followup evaluations were performed 1, 3 and 6 months later. Postoperative cystoscopy was performed on all patients to evaluate ablation extent and extraprostatic effects. Transrectal ultrasound volume determinations were obtained before and 6 months after transurethral ethanol ablation of the prostate. Results: Adverse events were generally mild or moderate, and included hematuria (42.9%), irritative voiding symptoms (40.3%), pain/discomfort (25.6%) and urinary retention (22.1%). No serious adverse events were reported. Statistically significant improvements were seen in International Prostate Symptom Score, quality of life, maximum flow rate and prostate volume reduction (p <0.05). Improvements were consistently observed across the 3 groups without an apparent dose effect. Conclusions: In this randomized clinical trial transurethral ethanol ablation of the prostate was safe and effective at 6-month followup. No serious adverse events were encountered. Although ethanol can safely ablate prostatic tissue, further studies will be necessary before widespread clinical application.