Benign Prostate Hypertrophy(BPH), Lower Urinary Track Symptoms
Conditions
Keywords
HOLEP, MOSES 2.0, Robotic Waterjet Ablation, Hydros Robotic System, Compare Effectiveness
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.
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.
Interventions
DEVICEDevice - HoLEP with MOSES 2.0
Holmium laser enucleation of the prostate using MOSES 2.0 pulse-modulation technology, performed per institutional standard of care.
DEVICERWJA with Hydros Robotic System
Device - RWJA (Hydros Robotic System) / Aquablation therapy (often referred to by its commercial name, "Aquablation").
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Patients are blind for the first 3 months after the intervention
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Flow Rate (Qmax) | Baseline and 12 months post-intervention | Peak urinary flow rate via uroflowmetry; change from baseline. |
| Change in Post-Void Residual Volume (PVR) | Baseline and 12 months post-intervention | Bladder scan-measured PVR; change from baseline. |
| Change in Prostate Volume | Baseline and 12 months post-intervention | Measured via transrectal ultrasound (TRUS); change from baseline. |
| Change in Prostate-Specific Antigen (PSA) | Baseline and 12 months post-intervention | Serum PSA level; change from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis Time | Day (duration) of surgical procedure | Time required to achieve hemostasis intraoperatively. |
| Perioperative Change in Hemoglobin | Baseline to immediate postoperative period (when patient is in the recovery room post surgery) | Hemoglobin level change from baseline to immediate postoperative measurement. |
| Time to Catheter-Free Status | From surgery day until catheter removal | Duration from end of surgery to catheter removal. |
| Length of Hospital Stay / Discharge Time | Day of surgical procedure through hospital discharge | Time from surgery to hospital discharge. |
| Change in IPSS/QoL Score | Baseline, 3, 6, and 12 months post-surgery | International Prostate Symptom Score / Quality of Life index. |
| Change in SHIM Score | Baseline, 3, 6, and 12 months post-surgery | Sexual Health Inventory for Men. |
| Change in MSHQ-EjD Score | Baseline, 3, 6, and 12 months post-surgery | Male Sexual Health Questionnaire - Ejaculatory Dysfunction. |
| Change in Incontinence Outcomes | Baseline, 3, 6, and 12 months post-surgery | Incontinence Severity Index (ISI) score and Cough Stress Test (CST) result. |
| Long-Term Durability of Functional Improvements | 24, 36, 48, and 60 months post-intervention | Composite tracking of IPSS, Qmax, PVR, PSA, and prostate volume. |
| Post-Operative Medication Use | Through 60 months post-intervention | Number of prescriptions written and filled (initial fills and refills), e.g., alpha-blockers, 5-alpha reductase inhibitors. |
| Reintervention Rate | Through 60 months post-intervention | Repeat procedures or additional therapies for BPH/LUTS. |
| Incidence of Urethral Stricture Requiring Intervention | Through 60 months post-intervention | New urethral stricture or bladder neck stenosis requiring treatment. |
| Unplanned Healthcare Encounters | Through 60 months post-intervention | Emergency visits, urgent care visits, and add-on clinic visits related to the procedure. |
| Unanticipated Advanced Diagnostics | Through 60 months post-intervention | Unplanned MRI, cystoscopy, or prostate cancer biomarker testing. |
| Incidence and Severity of Adverse Events | From patient hospital discharge through 3 and 12 months post-surgery | Adverse events graded by the Clavien-Dindo classification system. |
| Operative Time | Day (duration) of surgical procedure | Total procedure time, start to finish. |
Countries
United States
Contacts
CONTACTHazem Elmansy, MD
CONTACTMiguel Valdivia y Alvarado, MD
Outcome results
None listed