Prolieve Transurethral Thermodilatation for Treatment of Symptomatic Benign Prostatic Hyperplasia: 5-Year Results from a Prospective Multicenter Trial.

Abstract

Introduction and Objective: Prolieve® transurethral thermodilatation (TUTD) is the only third-generation transurethral microwave thermotherapy (TUMT) device that incorporates balloon dilation/compression of the prostatic urethra with cooled TUMT, at ≤50 W power. We evaluated its 5-year efficacy in the treatment of symptomatic benign prostatic hyperplasia (BPH) in an open-label prospective multicenter trial. Methods: Eligible patients with American Urological Association symptom index score (AUASS) ≥9, peak urine flow rate (Qmax) <12 mL/s, and prostate size 20-80 g without obstructing median lobe were enrolled. Prolieve TUTD was delivered in the office setting under local anesthesia. AUASS, quality of life (QOL), BPH impact index (BPHII), Qmax, and other measures were assessed at baseline, and at least annually thereafter to year 5. Adverse events (AEs) were recorded. Treatment success over time was analyzed using the Kaplan-Meier method while changes from baseline were evaluated using paired t-tests. Results: Intention to treat population was 225, of whom 220 with a mean (standard deviation) age of 65 (5.9) completed treatment. 187/220 (85%) did not require urethral catheterization. AUAS, QOL, and BPHII scores significantly improved from baseline in ≤3 months, with sustained improvements to year 5. Qmax also significantly improved from baseline at each annual follow-up evaluation. Cumulative 5-year surgical retreatment rate was 14.2% (95% confidence interval 9.5-20.8). Transient urinary urgency and dysuria were the most reported AEs. Conclusions: Prolieve TUTD is a safe and effective treatment option for BPH, with durable long-term improvements in voiding symptoms and urinary flow rates. It has a low catheterization rate and sexual side effects are rare. Clinical Trials.gov Registration Number: NCT02021032.