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

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.

Multicentre prospective crossover study of the 'prostatic urethral lift' for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.

OBJECTIVE: To assess the clinical effect of the 'prostatic urethral lift' (PUL) on lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) through a crossover design study. PATIENTS AND METHODS: Men aged ≥ 50 years with an International Prostate Symptom Score of ≥ 13, a maximum urinary flow rate (Qmax) of ≤ 12 mL/s, and a prostate of 30-80 mL were enrolled into a crossover study after completing a prospective, randomised, controlled, 'blinded' pivotal study in which they were control subjects receiving a sham procedure. Patients were followed for 1 year after crossover PUL at 19 centres in the USA, Canada and Australia. The sham procedure involved rigid cystoscopy with simulated active treatment sounds. PUL involved placing permanent UroLift® (NeoTract, Inc., Pleasanton, CA, USA) implants into the lateral lobes of the prostate to enlarge the urethral lumen. Urinary symptom relief, health-related quality of life (HRQL) impact, urinary flow parameters, sexual function, and adverse events were assessed and compared between the sham and PUL using paired statistical analysis. RESULTS: Symptom, flow, HRQL and sexual function assessments showed response improvements from baseline results, similar to results from other published studies, and most parameters were markedly improved after PUL vs the sham procedure in the same patients. Symptom, flow, and HRQL improvements were durable over the 12 months of the study. Adverse events associated with the procedure were typically transient and mild to moderate; one patient (2%) required re-intervention with transurethral resection of the prostate in the first year. There were no occurrences of de novo, sustained ejaculatory or erectile dysfunction. CONCLUSION: The PUL can be performed under local anaesthesia, causes minimal associated perioperative complications, allows patients to quickly return to normal activity, provides rapid and durable improvement in symptoms, and preserves sexual function.