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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50-80
SponsorThe Methodist Hospital Research Institute

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

Treatment groups

100 Participants
are divided into 2 treatment groups