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

Abstract

OBJECTIVE: To evaluate the 24-month 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.

PATIENTS AND METHODS: In all, 53 patients underwent a sham procedure as part of the blinded, randomised L.I.F.T. (Luminal Improvement Following prostatic Tissue approximation for the treatment of LUTS secondary to BPH) study at 19 centres and elected to enrol 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 the sham procedure and then for 24 months after crossover to PUL, with assessments of urinary symptom relief, quality of life (QoL), urinary flow rate, sexual function, and adverse events.

RESULTS: At 24 months after crossover to PUL, the International Prostate Symptom Score (IPSS), QoL, BPH Impact Index, and maximum urinary 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 the sham procedure 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 one patient required additional PUL implants within the 24-month period. There were no reported instances of de novo sustained erectile or ejaculatory dysfunction.

CONCLUSIONS: The PUL procedure is associated with rapid symptom relief, increased urinary flow rate and QoL improvement that remain stable over 24 months. Morbidity is low and sexual function is preserved.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.