About this trial
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.
Eligibility criteria
Qualifiers
Male, age 50-80 years
International Prostate Symptom Score (IPSS) ≥ 12
Prostate size (TRUS): 50-180 mL
Diagnosis of LUTS due to BPH
Disqualifiers
BMI ≥ 42
History of prostate cancer
Suspected or history of bladder cancer
Active or untreated bladder stones at screening
Trial design
Treatments tested in this trial
- Device - HoLEP with MOSES 2.0
- RWJA with Hydros Robotic System