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NOT YET RECRUITING
NCT07772232
NA

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

Sponsor: The Methodist Hospital Research Institute

View on ClinicalTrials.gov

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.

Official title: Prospective Randomized Controlled Comparison of Holmium Laser Enucleation of the Prostate With Robotic Water Jet Ablation

Key Details

Gender

MALE

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-08-03

Completion Date

2033-08-03

Last Updated

2026-08-19

Healthy Volunteers

No

Interventions

DEVICE

Device - HoLEP with MOSES 2.0

Holmium laser enucleation of the prostate using MOSES 2.0 pulse-modulation technology, performed per institutional standard of care.

DEVICE

RWJA with Hydros Robotic System

Device - RWJA (Hydros Robotic System) / Aquablation therapy (often referred to by its commercial name, "Aquablation").

Locations (1)

Houston Methodist

Houston, Texas, United States