Prostatic urethral lift (PUL) improves lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in “real-world” patients, confirming pivotal clinical trial data, according to a new study.
“This study advances the field by providing a large data set reflective of the real-world BPH patient from which to make evidence-based recommendations,” a team led by Douglas Grier, MD, of Sound Urological Associates in Edmonds, Washington, concluded in a paper published in the Journal of Endourology.
They also observed: “PUL appears to perform well as a routine outpatient procedure in terms of symptom relief, catheter requirement, and perioperative morbidity for all analyzed patient cohorts.”
PUL is a minimally invasive procedure that uses tiny implants to improve urine flow by pulling back obstructing prostatic lobes pressing on the urethra. NeoTract Inc. markets PUL as UroLift. In September 2013, the FDA approved PUL for BPH-related LUTS in men aged 50 years and older. In 2018, the FDA approved its use in men with an obstructive median lobe and men as young as 45 years.
Dr Grier and his colleagues reviewed data from 1413 consecutive patients who underwent PUL in North America and Australia. Investigators divided the patients into those without urinary retention (group A) and those with urinary retention (group B). The average duration of follow-up was 273 days.
Following PUL, the mean International Prostate Symptom Score (IPSS) for group A improved significantly from baseline by at least 8.1 points throughout follow-up, Dr Grier’s team reported. The investigators observed no significant differences between groups A and B follow-up scores.
In addition, within group A, patients with an IPSS baseline of 13 or higher had outcomes similar to participants in the randomized controlled LIFT pivotal trial. Compared with LIFT participants, patients in the current study were older and had lower baseline IPSS.
Age, prostate volume, prior cancer treatment, diabetes status, and site of service did not significantly affect PUL outcomes, Dr Grier’s team noted.
Eure G, Gange S, Walter P, et al. Real-world evidence of prostatic urethral life confirms pivotal clinical study results: 2-year outcomes of a retrospective multicenter study. J Endourol. 2019.