PD24-08 PROSTATIC URETHRAL LIFT (PUL) SYMPTOM AND SEXUAL FUNCTION RESULTS MAINTAINED IN THE TREATMENT OF ALL TYPES OF PROSTATE ENLARGEMENT INCLUDING OBSTRUCTIVE MIDDLE LOBE

Abstract

INTRODUCTION AND OBJECTIVES: The evidence showing that the Prostatic Urethral Lift (PUL) delivers excellent results with low morbidity has been based on studies of men with lateral lobe enlargement only (LL). The MedLift trial was undertaken as an FDA extension of the L.I.F.T. randomized study to determine the safety and effectiveness of PUL for obstructive middle lobe (OML). The results were combined with those from the L.I.F.T. study to understand the effect of PUL across all types of prostate enlargement as would be seen in the clinical setting. METHODS: Inclusion criteria for OML patients were the same as those from the L.I.F.T. study except for requiring OML: age ≥ 50, International Prostate Symptom Score (IPSS) ≥ 13, peak flow rate (Qmax) ≤ 12 ml/s and prostate volume 30‐80cc. Symptom relief, quality of life (QoL), BPH Impact Index, Qmax, sexual function, and adverse events were evaluated through 12 months for OML patients. An analysis of the combined L.I.F.T. LL only with MedLift OML cohorts was conducted on symptom response and sexual function. RESULTS: When combining OML with LL patients, the combined cohort responded with ≥ 11 point IPSS, ≥ 2.3 point QoL, and ≥ 70% Qmax improvement at 1, 3, 6 and 12 months. Further, >70% of combined cohort subjects experienced IPSS improvement ≥ 8 points through 12 months. In sexually active men, 45% of men (35/78) improved the minimal clinically important difference (MCID) in erectile function as measured by IIEF‐EF at 3 months and 40% (31/77) achieved the threshold at 12 months (Table 1) MSHQ‐EjD function and bother for the combination cohort were significantly improved by at least 30% from baseline at all timepoints (p‐values ranged between 0.01 and