Objective: We prospectively conducted a European multi-center study to assess the safety and efficacy of injecting dehydrated ethanol using a specialized injection system for the treatment of BPH.
Methods: Patients with symptomatic BPH were enrolled and evaluated to undergo transurethral ethanol ablation of the prostate for their BPH condition. Procedures were performed using the ProstaJect device. Treatment dosages were based on prostate volume, prostatic urethral length and median lobe involvement. Follow-up evaluations were done at four days and one, three, six and 12 months.
Results: One-hundred fifteen symptomatic patients underwent the transurethral ethanol ablation procedure and ninety-four patients have been followed and evaluated for the entire 12-month post-treatment period. The average prostate volume was 45.9 g, and average ethanol injected was 14 ml. Post-operatively, 98% of patients voided spontaneously four days following treatment. Significant reduction in reported lower urinary tract symptoms was evidenced at the one-month follow-up visit and maintained through 12 months follow-up, with International Prostate Symptom (IPSS) and Quality of Life (QoL) scores decreased by more than 50%. Peak flow rates (Q(max)) improved by 35% by the three-month evaluation and these results were sustained through to 12-months follow-up. The average prostate volume reduction was 16%. Adverse events included discomfort or irritative voiding symptoms in 26% of patients, hematuria in 16%, with retrograde ejaculation, and erectile dysfunction reported in less than 3% of patients. The majority of these events required no intervention. Two patients experienced serious adverse events (bladder necrosis) and underwent open surgery that included a urinary diversion and a ureteral implantataion. During the one year follow- up, 7% of patients required a trans-urethral resection of prostate (TURP).
Conclusions: This preliminary multi-center data, representing the largest reported cohort to date, suggests that TEAP may be considered an effective minimally invasive treatment option for lower urinary tract symptoms secondary to BPH. Analyses of safety lead to a procedure modification for needle placement more distal from the bladder neck. Objective reduction in symptoms was not correlated in prostate volume reduction suggesting a non-purely mechanical effect.