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

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT07772232
Status
Not Yet Recruiting

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Conditions

  • Benign Prostate Hypertrophy(BPH)
  • Lower Urinary Track Symptoms

Eligibility Criteria

Sex
MALE
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Device - HoLEP with MOSES 2.0 — DEVICE
    Holmium laser enucleation of the prostate using MOSES 2.0 pulse-modulation technology, performed per institutional standard of care.
  • RWJA with Hydros Robotic System — DEVICE
    Device - RWJA (Hydros Robotic System) / Aquablation therapy (often referred to by its commercial name, "Aquablation").

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Aug 3, 2026
Status verified
Aug 2026
Primary completion
Aug 3, 2029
Completion
Aug 3, 2033

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: HoLEP with MOSES 2.0
    Holmium laser enucleation of the prostate using MOSES 2.0 pulse-modulation technology, performed per institutional standard of care.
  • Active Comparator: RWJA with Hydros Robotic System
    Robotic-assisted waterjet ablation of the prostate using the Hydros Robotic System, performed per institutional standard of care.

Primary Outcome Measure

Change in Prostate Volume [ Time Frame: Baseline and 12 months post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston MethodistHoustonTexas77030
Hazem Elmansy, MD
[email protected]
346-516-1481
Miguel Valdivia y Alvarado, MD
[email protected]
346-356-3622

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By research site
Houston Methodist· Houston, TX

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