An interventional study of Device - HoLEP with MOSES 2.0 and RWJA with Hydros Robotic System in Benign Prostate Hypertrophy(BPH) and Lower Urinary Track Symptoms, sponsored by The Methodist Hospital Research Institute. Not yet recruiting at 1 site in United States. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by The Methodist Hospital Research Institute · Not applicable, Interventional, and Other
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.
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 100 is close to the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →The Methodist Hospital Research Institute is the lead sponsor of 160 studies on the registry; 59 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 18 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Robotic-assisted waterjet ablation of the prostate using the Hydros Robotic System, performed per institutional standard of care.
Device: RWJA with Hydros Robotic System
Holmium laser enucleation of the prostate using MOSES 2.0 pulse-modulation technology, performed per institutional standard of care.
Device - RWJA (Hydros Robotic System) / Aquablation therapy (often referred to by its commercial name, "Aquablation").
Change in Prostate Volume
Measured via transrectal ultrasound (TRUS); change from baseline.
Time frame: Baseline and 12 months post-intervention
Change in Prostate-Specific Antigen (PSA)
Serum PSA level; change from baseline.
Time frame: Baseline and 12 months post-intervention
Change in Urinary Flow Rate (Qmax)
Peak urinary flow rate via uroflowmetry; change from baseline.
Time frame: Baseline and 12 months post-intervention
Change in Post-Void Residual Volume (PVR)
Bladder scan-measured PVR; change from baseline.
Time frame: Baseline and 12 months post-intervention
Incidence and Severity of Adverse Events
Adverse events graded by the Clavien-Dindo classification system.
Time frame: From patient hospital discharge through 3 and 12 months post-surgery
Operative Time
Total procedure time, start to finish.
Time frame: Day (duration) of surgical procedure
Hemostasis Time
Time required to achieve hemostasis intraoperatively.
Time frame: Day (duration) of surgical procedure
Perioperative Change in Hemoglobin
Hemoglobin level change from baseline to immediate postoperative measurement.
Time frame: 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.
Time frame: From surgery day until catheter removal
Length of Hospital Stay / Discharge Time
Time from surgery to hospital discharge.
Time frame: Day of surgical procedure through hospital discharge
Change in IPSS/QoL Score
International Prostate Symptom Score / Quality of Life index.
Time frame: Baseline, 3, 6, and 12 months post-surgery
Change in SHIM Score
Sexual Health Inventory for Men.
Time frame: Baseline, 3, 6, and 12 months post-surgery
Change in MSHQ-EjD Score
Male Sexual Health Questionnaire - Ejaculatory Dysfunction.
Time frame: Baseline, 3, 6, and 12 months post-surgery
Change in Incontinence Outcomes
Incontinence Severity Index (ISI) score and Cough Stress Test (CST) result.
Time frame: Baseline, 3, 6, and 12 months post-surgery
Long-Term Durability of Functional Improvements
Composite tracking of IPSS, Qmax, PVR, PSA, and prostate volume.
Time frame: 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.
Time frame: Through 60 months post-intervention
Reintervention Rate
Repeat procedures or additional therapies for BPH/LUTS.
Time frame: Through 60 months post-intervention
Unplanned Healthcare Encounters
Emergency visits, urgent care visits, and add-on clinic visits related to the procedure.
Time frame: Through 60 months post-intervention
Incidence of Urethral Stricture Requiring Intervention
New urethral stricture or bladder neck stenosis requiring treatment.
Time frame: Through 60 months post-intervention
Unanticipated Advanced Diagnostics
Unplanned MRI, cystoscopy, or prostate cancer biomarker testing.
Time frame: Through 60 months post-intervention
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Aug 2029, 36 months later.
Of 152 non-industry interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 36 months is above that.
Counting every sponsor, half of 203 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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