Three year durability of the prostatic urethral lift for BPH: Results of a prospective, multi-center, randomized study

INTRODUCTION AND OBJECTIVES: To present an update of the pivotal, multi-center, randomized, blinded trial of the Prostatic Urethral Lift (PUL) through 3 years. METHODS: Men were eligible for enrollment if they were ≥ 50 years and had symptomatic lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) with American Urological Association Symptom Index (AUASI) ≥ 13, peak flow (Qmax) ≤ 12 ml/ s, and prostate volume 30 - 80 cc. During PUL, small permanent metallic implants were placed to hold lateral lobes in a retracted position and open the prostatic urethra. Randomized data (2:1) from PUL and sham were compared through 3 months, and then subjects in the PUL arm were followed for 3 years. RESULTS: From February to December of 2011, 140 men were treated with PUL in the USA, Canada and Australia. AUASI reduction was 44% by 1 month and sustained at 43% through 3 years (p-value < 0.0001, refer to Table 1). Adverse events were typically mild and transient, with the most frequent being hematuria, dysuria, pelvic pain, urgency and urge incontinence. Sexual function was preserved with no incidence of de novo, sustained erectile or ejaculatory adverse events. Further, sexual function assessments show stable erectile function (Sexual Health Inventory for Men) score and statistically improved ejaculatory (Male Sexual Health Questionnaire for Ejaculatory Dysfunction) scores. There was a low incidence of LUTS retreatment, with only 12 subjects seeking PUL or other procedure over the course of 3 years. CONCLUSIONS: The Prostatic Urethral Lift offers a clinically meaningful improvement in LUTS and urinary flow that can be sustained to 3 years. The procedure is associated with low morbidity and preservation of sexual function. This randomized study protocol provides the longest follow up of PUL to date and will continue to assess durability to 5 years. (Table Presented).