Comparison of Holmium Laser Enucleation of the Prostate and Robotic Water Jet Ablation for Benign Prostatic Hyperplasia

Overview

This study compares two FDA-approved surgical treatments for benign prostatic hyperplasia (BPH): Holmium Laser Enucleation of the Prostate (HoLEP) with MOSES 2.0 technology and Robotic Water Jet Ablation (RWJA) using the Hydros Robotic System. Men with BPH and prostate volumes between 50 and 180 mL will be randomly assigned to one of the two procedures. The study will measure changes in prostate volume, PSA, urinary flow, and bladder emptying at 12 months, along with safety, sexual function, continence, and healthcare utilization outcomes, which will be followed for up to 5 years after surgery.

This prospective, randomized controlled trial is designed to compare the safety, effectiveness, and long-term durability of Holmium Laser Enucleation of the Prostate (HoLEP) utilizing MOSES 2.0 technology with Robotic Water Jet Ablation (RWJA) performed using the Hydros Robotic System for the treatment of benign prostatic hyperplasia (BPH). The trial will enroll 100 men aged 50 to 80 years who present with moderate-to-severe lower urinary tract symptoms secondary to BPH and prostate volumes between 50 and 180 mL. Participants will be randomized in a 1:1 ratio to receive either HoLEP or RWJA and will be monitored for five years following treatment. The primary objective is to compare objective measures of treatment efficacy and durability at 12 months, specifically changes in prostate volume, prostate-specific antigen (PSA) levels, urinary flow rate (Qmax), and post-void residual urine volume (PVR). Secondary objectives include assessment of perioperative outcomes, safety profiles, patient-reported urinary and sexual function, treatment durability, reintervention rates, and healthcare resource utilization. Outcomes will be measured using validated instruments, such as the International Prostate Symptom Score (IPSS), Sexual Health Inventory for Men (SHIM), Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD), and Incontinence Severity Index (ISI). Although both procedures are established and FDA-approved therapies for BPH, direct comparative evidence is limited. This study seeks to address this evidence gap by generating high-quality comparative effectiveness data to inform clinical decision-making and patient counseling. The results may clarify the relative benefits and tradeoffs of each procedure, particularly in terms of symptom improvement, preservation of sexual function, durability of treatment response, and long-term healthcare utilization.