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

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.

Inclusion criteria

• Male, age 50-80 years
• International Prostate Symptom Score (IPSS) ≥ 12
• Prostate size (TRUS): 50-180 mL
• Diagnosis of LUTS due to BPH
• Uroflow Qmax ≤ 15 mL/sec
• Mentally capable, able to comply with study procedures, written informed consent provided
• Able to follow study instructions and complete all required visits

Exclusion criteria

• BMI ≥ 42
• History of prostate cancer
• Suspected or history of bladder cancer
• Active or untreated bladder stones at screening
• Indwelling catheter for more than 3 months before baseline
• Active urinary tract infection
• History of urethral stricture or bladder neck stenosis
• Damage to the external urethral sphincter
• Previous prostate surgery or lower urinary tract surgery
• Use of obligatory anticoagulants (if not stoppable) or known coagulopathy (except ASA 100 mg/d)
• Contraindications to general and spinal anesthesia
• Any condition that could interfere with study participation or outcomes, per investigator judgment
• Lacks legal or mental capacity to consent
• Simultaneous participation in another therapeutic urological trial
• Known or persistent abuse of medication, drugs, or alcohol