Prospective Randomized Controlled Comparison of Holmium Laser Enucleation of the Prostate With Robotic Water Jet Ablation
The Methodist Hospital Research Institute
Summary
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.
Description
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 an…
Eligibility
- Age range
- 50–80 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Male, age 50-80 years 2. International Prostate Symptom Score (IPSS) ≥ 12 3. Prostate size (TRUS): 50-180 mL 4. Diagnosis of LUTS due to BPH 5. Uroflow Qmax ≤ 15 mL/sec 6. Mentally capable, able to comply with study procedures, written informed consent provided 7. Able to follow study instructions and complete all required visits Exclusion Criteria: 1. BMI ≥ 42 2. History of prostate cancer 3. Suspected or history of bladder cancer 4. Active or untreated bladder stones at screening 5. Indwelling catheter for more than 3 months before baseline 6. Active urinary tract i…
Interventions
- DeviceDevice - HoLEP with MOSES 2.0
Holmium laser enucleation of the prostate using MOSES 2.0 pulse-modulation technology, performed per institutional standard of care.
- DeviceRWJA with Hydros Robotic System
Device - RWJA (Hydros Robotic System) / Aquablation therapy (often referred to by its commercial name, "Aquablation").
Location
- Houston MethodistHouston, Texas