24-month durability after crossover to the prostatic urethral lift from randomised, blinded sham

Purpose To evaluate the 2 year effectiveness of the Prostatic Urethral Lift (PUL) procedure in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) assessed through a crossover study. Methods Fifty-three patients underwent sham procedure as part of the blinded, randomized L.I.F.T. study at 19 centers and elected to enroll in this crossover study. The crossover procedure involved placement of permanent implants (UroLift® System) into the prostatic lateral lobes. Patients were followed for 3 months after sham and then 2 years after crossover PUL with assessments of urinary symptom relief, quality of life, urinary flow rate, sexual function, and adverse events. Results At 2 years after crossover PUL, International Prostate Symptom Score (IPSS), quality of life, BPH Impact Index, and peak flow rate improved 36%, 40%, 54%, and 77% from baseline, respectively. Each IPSS parameter on average improved significantly from baseline (p<0.005) and remained stable throughout follow up. Symptom response after sham indicated initial improvement at 1 month with significant decay by 3 months. Adverse events were typically mild to moderate and patients returned rapidly to normal activity. Four patients (8%) required intervention with transurethral resection of the prostate and 1 patient required additional PUL implants within the two year period. There were no reported instances of de novo, sustained erectile or ejaculatory dysfunction. Conclusions PUL procedure is associated with rapid symptom relief, increased urinary flow rate and quality of life improvement that remain stable over two years. Morbidity is low and sexual function is preserved. This article is protected by copyright. All rights reserved.