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

NCT07772232 | Not Yet Recruiting FDA Device

• 1 other identifier: Pro00041304
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Prostate Hypertrophy(BPH); Lower Urinary Track Symptoms

Keywords

HOLEP; MOSES 2.0; Robotic Waterjet Ablation; Hydros Robotic System; Compare Effectiveness

Outcome Measures

Primary Outcomes (4)

• Change in Prostate Volume

  Measured via transrectal ultrasound (TRUS); change from baseline.

  Baseline and 12 months post-intervention

• Change in Prostate-Specific Antigen (PSA)

  Serum PSA level; change from baseline.

  Baseline and 12 months post-intervention

• Change in Urinary Flow Rate (Qmax)

  Peak urinary flow rate via uroflowmetry; change from baseline.

  Baseline and 12 months post-intervention

• Change in Post-Void Residual Volume (PVR)

  Bladder scan-measured PVR; change from baseline.

  Baseline and 12 months post-intervention

Secondary Outcomes (16)

• Incidence and Severity of Adverse Events

  From patient hospital discharge through 3 and 12 months post-surgery

• Operative Time

  Day (duration) of surgical procedure

• Hemostasis Time

  Day (duration) of surgical procedure

• Perioperative Change in Hemoglobin

  Baseline to immediate postoperative period (when patient is in the recovery room post surgery)

• Time to Catheter-Free Status

  From surgery day until catheter removal

Study Arms (2)

HoLEP with MOSES 2.0

ACTIVE COMPARATOR

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

Device: Device - HoLEP with MOSES 2.0

RWJA with Hydros Robotic System

ACTIVE COMPARATOR

Robotic-assisted waterjet ablation of the prostate using the Hydros Robotic System, performed per institutional standard of care.

Device: RWJA with Hydros Robotic System

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.

HoLEP with MOSES 2.0

RWJA with Hydros Robotic System DEVICE

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

RWJA with Hydros Robotic System

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: Males aged 50 to 80 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, age 50-80 years
• International Prostate Symptom Score (IPSS) ≥ 12
• Prostate size (TRUS): 50-180 mL
• Diagnosis of LUTS due to BPH
• Uroflow Qmax ≤ 15 mL/sec
• Mentally capable, able to comply with study procedures, written informed consent provided
• Able to follow study instructions and complete all required visits

You may not qualify if:

• BMI ≥ 42
• History of prostate cancer
• Suspected or history of bladder cancer
• Active or untreated bladder stones at screening
• Indwelling catheter for more than 3 months before baseline
• Active urinary tract infection
• History of urethral stricture or bladder neck stenosis
• Damage to the external urethral sphincter
• Previous prostate surgery or lower urinary tract surgery
• Use of obligatory anticoagulants (if not stoppable) or known coagulopathy (except ASA 100 mg/d)
• Contraindications to general and spinal anesthesia
• Any condition that could interfere with study participation or outcomes, per investigator judgment
• Lacks legal or mental capacity to consent
• Simultaneous participation in another therapeutic urological trial
• Known or persistent abuse of medication, drugs, or alcohol

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Hazem Elmansy, MD

CONTACT

346-516-1481; hmelmansy@houstonmethodist.org

Miguel Valdivia y Alvarado, MD

CONTACT

346-356-3622; mvaldiviayalvarado@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are blind for the first 3 months after the intervention
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: August 19, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): August 3, 2029
• Study Completion (Estimated): August 3, 2033
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)