PD56-07 HOLEP VS MOLEP, FIRST PROSPECTIVE RANDOMIZED TRIAL ON 140 PATIENTS

Abstract

INTRODUCTION AND OBJECTIVE: BPH is a common condition in older men. Several techniques use laser energy to resect, enucleate or ablate hyperplastic prostate tissue. Holmium laser is used for HoLEP (H). MoLEP(M) is a usage of HoLEP technique that endorsea modified laser pulse with Moses™ technology (Lumenis®). We did a prospectie randomized trial on H vs.M to expand assess data on safety and efficacy of M enucleation in BPH treatment. METHODS: This is a single‐centre trial was a single‐centre open‐label phase 3 trial, approved by our local committee and conducted in Treviglio (BG), Italy. Patients were men with moderate to severe BPH‐associated symptoms refractory or intolerant to medical therapy or with acute or chronic urinary retention and prostate volume of >80 ml, and enroled if they agreed to participate the trial; were excluded if had previous surgery, or suspected for prostate cancer, untreated urinary infection, of neurological bladder or had severe cardiovascular. 140 patients(70/70 H/M) patients were randomized preoperatively in a 1:1 fashion to H‐arm or M‐arm. All the procedures were performed by a single experienced operator using the traditional 3 lobes technique, the only difference was the use of MOSES™ technology in M's arm. Primary endpoints were the evaluation of the difference in operation time and laser time, The secondary endpoints was safety. Comparisons of means in the paired sample was performedwith a two‐tail T‐test(α power of 0.05 to observe a 10% difference in time of enucleation). RESULTS: Median age, basal PSA and prostate volume were similar. Mean laser duration was 5 minute shorter in arm B (36.4 vs 31.5 min.; P=.01) There was also a reduced laser fiber consuming (P