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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Urinary Track Symptoms; Benign Prostate Hypertrophy(BPH)
• Intervention / Treatment: Device: Device - HoLEP with MOSES 2.0; Device: RWJA with Hydros Robotic System

Detailed 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 and will be monitored for five years following treatment.

The primary objective is to compare objective measures of treatment efficacy and durability at 12 months, specifically changes in prostate volume, prostate-specific antigen (PSA) levels, urinary flow rate (Qmax), and post-void residual urine volume (PVR). Secondary objectives include assessment of perioperative outcomes, safety profiles, patient-reported urinary and sexual function, treatment durability, reintervention rates, and healthcare resource utilization. Outcomes will be measured using validated instruments, such as the International Prostate Symptom Score (IPSS), Sexual Health Inventory for Men (SHIM), Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD), and Incontinence Severity Index (ISI).

Although both procedures are established and FDA-approved therapies for BPH, direct comparative evidence is limited. This study seeks to address this evidence gap by generating high-quality comparative effectiveness data to inform clinical decision-making and patient counseling. The results may clarify the relative benefits and tradeoffs of each procedure, particularly in terms of symptom improvement, preservation of sexual function, durability of treatment response, and long-term healthcare utilization.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hazem Elmansy, MD; Phone Number: 346-516-1481; Email: hmelmansy@houstonmethodist.org
• Study Contact Backup: Name: Miguel Valdivia y Alvarado, MD; Phone Number: 346-356-3622; Email: mvaldiviayalvarado@houstonmethodist.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist
      • Contact: Hazem Elmansy, MD; Phone Number: 346-516-1481; Email: hmelmansy@houstonmethodist.org
      • Contact: Miguel Valdivia y Alvarado, MD; Phone Number: 346-356-3622; Email: mvaldiviayalvarado@houstonmethodist.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 infection
7. History of urethral stricture or bladder neck stenosis
8. Damage to the external urethral sphincter
9. Previous prostate surgery or lower urinary tract surgery
10. Use of obligatory anticoagulants (if not stoppable) or known coagulopathy (except ASA 100 mg/d)
11. Contraindications to general and spinal anesthesia
12. Any condition that could interfere with study participation or outcomes, per investigator judgment
13. Lacks legal or mental capacity to consent
14. Simultaneous participation in another therapeutic urological trial
15. Known or persistent abuse of medication, drugs, or alcohol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	Device: RWJA with Hydros Robotic System; Device - RWJA (Hydros Robotic System) / Aquablation therapy (often referred to by its commercial name, "Aquablation").

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and Severity of Adverse Events	Adverse events graded by the Clavien-Dindo classification system.	From patient hospital discharge through 3 and 12 months post-surgery
Operative Time	Total procedure time, start to finish.	Day (duration) of surgical procedure
Hemostasis Time	Time required to achieve hemostasis intraoperatively.	Day (duration) of surgical procedure
Perioperative Change in Hemoglobin	Hemoglobin level change from baseline to immediate postoperative measurement.	Baseline to immediate postoperative period (when patient is in the recovery room post surgery)
Time to Catheter-Free Status	Duration from end of surgery to catheter removal.	From surgery day until catheter removal
Length of Hospital Stay / Discharge Time	Time from surgery to hospital discharge.	Day of surgical procedure through hospital discharge
Change in IPSS/QoL Score	International Prostate Symptom Score / Quality of Life index.	Baseline, 3, 6, and 12 months post-surgery
Change in SHIM Score	Sexual Health Inventory for Men.	Baseline, 3, 6, and 12 months post-surgery
Change in MSHQ-EjD Score	Male Sexual Health Questionnaire - Ejaculatory Dysfunction.	Baseline, 3, 6, and 12 months post-surgery
Change in Incontinence Outcomes	Incontinence Severity Index (ISI) score and Cough Stress Test (CST) result.	Baseline, 3, 6, and 12 months post-surgery
Long-Term Durability of Functional Improvements	Composite tracking of IPSS, Qmax, PVR, PSA, and prostate volume.	24, 36, 48, and 60 months post-intervention
Post-Operative Medication Use	Number of prescriptions written and filled (initial fills and refills), e.g., alpha-blockers, 5-alpha reductase inhibitors.	Through 60 months post-intervention
Reintervention Rate	Repeat procedures or additional therapies for BPH/LUTS.	Through 60 months post-intervention
Unplanned Healthcare Encounters	Emergency visits, urgent care visits, and add-on clinic visits related to the procedure.	Through 60 months post-intervention
Incidence of Urethral Stricture Requiring Intervention	New urethral stricture or bladder neck stenosis requiring treatment.	Through 60 months post-intervention
Unanticipated Advanced Diagnostics	Unplanned MRI, cystoscopy, or prostate cancer biomarker testing.	Through 60 months post-intervention

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): August 3, 2029
• Study Completion (Estimated): August 3, 2033

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: August 14, 2026
• First Posted (Actual): August 19, 2026

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: HOLEP; MOSES 2.0; Robotic Waterjet Ablation; Hydros Robotic System; Compare Effectiveness
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: Pro00041304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No