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.
Male, age 50-80 years
International Prostate Symptom Score (IPSS) ≥ 12
Prostate size (TRUS): 50-180 mL
Diagnosis of LUTS due to BPH
BMI ≥ 42
History of prostate cancer
Suspected or history of bladder cancer
Active or untreated bladder stones at screening
Parallel
Device - HoLEP with MOSES 2.0
DeviceHolmium laser enucleation of the prostate using MOSES 2.0 pulse-modulation technology, performed per institutional standard of care.
RWJA with Hydros Robotic System
DeviceDevice - RWJA (Hydros Robotic System) / Aquablation therapy (often referred to by its commercial name, "Aquablation").
Change in Prostate Volume
Measured via transrectal ultrasound (TRUS); change from baseline.
Change in Prostate-Specific Antigen (PSA)
Serum PSA level; change from baseline.
Change in Urinary Flow Rate (Qmax)
Peak urinary flow rate via uroflowmetry; change from baseline.
Change in Post-Void Residual Volume (PVR)
Bladder scan-measured PVR; change from baseline.
Incidence and Severity of Adverse Events
Adverse events graded by the Clavien-Dindo classification system.
Operative Time
Total procedure time, start to finish.
Hemostasis Time
Time required to achieve hemostasis intraoperatively.
Perioperative Change in Hemoglobin
Hemoglobin level change from baseline to immediate postoperative measurement.
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