Investigating Medication vs. Prostatic Urethral Lift: 3-Month Results of the IMPACT Trial

Abstract BACKGROUND: Randomized controlled trials (RCTs) comparing minimally invasive surgical therapies (MISTs), such as Prostatic Urethral Lift (PUL), with tamsulosin for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) are limited. METHODS : The Investigating Medication versus Prostatic Urethral Lift: Assessment and Comparison of Therapies (IMPACT) trial is a prospective, multicenter, 1-to-1 nonblinded RCT conducted in men with symptomatic BPH randomized to PUL or tamsulosin 0.4 mg daily. The primary endpoint was 3-month International Prostate Symptom Score (IPSS) change. Secondary endpoints included Quality-of-Life (QoL), sexual function, adverse events (AEs), and medicationadherence. RESULTS : 259 subjects were randomized (PUL n = 128, tamsulosin n = 131). Baseline demographics were similar between groups. PUL mean IPSS improved by 40 and 46 percent at 1 and 3 months versus 18 and 16 percent with tamsulosin (p < 0.001). QoL improved by 37 and 47 percent with PUL versus 11 and 24 percent with tamsulosin (p < 0.001). AEs were generally mild to moderate in both groups, and sexual function was preserved. Ninety-one percent of subjects self-reported medication adherence at 3 months while only 80 percent were adherent on pill counts. CONCLUSIONS : PUL produced greater symptom improvement and more favorable quality-of-life outcomes than tamsulosin at 3 months in the largest-to-date RCT of MIST versus medication for BPH.