Benign Prostate Hypertrophy(BPH)NCT07772232
Comparison of Holmium Laser Enucleation of the Prostate and Robotic Water Jet Ablation for Benign Prostatic Hyperplasia
A study testing Device - HoLEP with MOSES 2.0 and RWJA with Hydros Robotic System in people with Benign Prostate Hypertrophy(BPH) and Lower Urinary Track Symptoms, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH), Lower Urinary Track Symptoms
- What is being tested?
- Device - HoLEP with MOSES 2.0 and RWJA with Hydros Robotic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to 3 Aug 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Houston Methodist
Houston, Texas, 77030
Hazem Elmansy, MD, 346-516-1481, hmelmansy@houstonmethodist.org
Miguel Valdivia y Alvarado, MD, 346-356-3622, mvaldiviayalvarado@houstonmethodist.org
About this study
Official title: 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.
Read the 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.
- Being tested
- Device - HoLEP with MOSES 2.0, RWJA with Hydros Robotic System
- Keywords
- HOLEP, MOSES 2.0, Robotic Waterjet Ablation, Hydros Robotic System, Compare Effectiveness
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device - HoLEP with MOSES 2.0Device
Holmium laser enucleation of the prostate using MOSES 2.0 pulse-modulation technology, performed per institutional standard of care.
RWJA with Hydros Robotic SystemDevice
Device - RWJA (Hydros Robotic System) / Aquablation therapy (often referred to by its commercial name, "Aquablation").
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: RWJA with Hydros Robotic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prostate Volume
Measured via transrectal ultrasound (TRUS); change from baseline.
Measured: Baseline and 12 months post-intervention
Change in Prostate-Specific Antigen (PSA)
Serum PSA level; change from baseline.
Measured: Baseline and 12 months post-intervention
Change in Urinary Flow Rate (Qmax)
Peak urinary flow rate via uroflowmetry; change from baseline.
Measured: Baseline and 12 months post-intervention
Change in Post-Void Residual Volume (PVR)
Bladder scan-measured PVR; change from baseline.
Measured: Baseline and 12 months post-intervention
Secondary outcomes (16)
Incidence and Severity of Adverse Events
Adverse events graded by the Clavien-Dindo classification system.
Measured: From patient hospital discharge through 3 and 12 months post-surgery
Operative Time
Total procedure time, start to finish.
Measured: Day (duration) of surgical procedure
Hemostasis Time
Time required to achieve hemostasis intraoperatively.
Measured: Day (duration) of surgical procedure
Perioperative Change in Hemoglobin
Hemoglobin level change from baseline to immediate postoperative measurement.
Measured: 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.
Measured: From surgery day until catheter removal
Length of Hospital Stay / Discharge Time
Time from surgery to hospital discharge.
Measured: Day of surgical procedure through hospital discharge
Change in IPSS/QoL Score
International Prostate Symptom Score / Quality of Life index.
Measured: Baseline, 3, 6, and 12 months post-surgery
Change in SHIM Score
Sexual Health Inventory for Men.
Measured: Baseline, 3, 6, and 12 months post-surgery
Change in MSHQ-EjD Score
Male Sexual Health Questionnaire - Ejaculatory Dysfunction.
Measured: Baseline, 3, 6, and 12 months post-surgery
Change in Incontinence Outcomes
Incontinence Severity Index (ISI) score and Cough Stress Test (CST) result.
Measured: Baseline, 3, 6, and 12 months post-surgery
Long-Term Durability of Functional Improvements
Composite tracking of IPSS, Qmax, PVR, PSA, and prostate volume.
Measured: 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.
Measured: Through 60 months post-intervention
Reintervention Rate
Repeat procedures or additional therapies for BPH/LUTS.
Measured: Through 60 months post-intervention
Unplanned Healthcare Encounters
Emergency visits, urgent care visits, and add-on clinic visits related to the procedure.
Measured: Through 60 months post-intervention
Incidence of Urethral Stricture Requiring Intervention
New urethral stricture or bladder neck stenosis requiring treatment.
Measured: Through 60 months post-intervention
Unanticipated Advanced Diagnostics
Unplanned MRI, cystoscopy, or prostate cancer biomarker testing.
Measured: Through 60 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start3 Aug 2026 (estimated)
- Primary completion3 Aug 2029 (estimated)
- Study completion3 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772232
- Sponsor's protocol ID
- Pro00041304
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Comparison of Holmium Laser Enucleation of the Prostate With Robotic Water Jet Ablation
- ClinicalTrials.gov ID
- NCT07772232
- Acronym / sponsor ID
- Pro00041304
- Keywords
- HOLEP, MOSES 2.0, Robotic Waterjet Ablation, Hydros Robotic System, Compare Effectiveness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 3 Aug 2029 (estimated)
- Study completion
- 3 Aug 2033 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HoLEP with MOSES 2.0 | Active comparator | Device: Device - HoLEP with MOSES 2.0Holmium laser enucleation of the prostate using MOSES 2.0 pulse-modulation technology, performed per institutional standard of care. |
| RWJA with Hydros Robotic System | Active comparator | Device: RWJA with Hydros Robotic SystemRobotic-assisted waterjet ablation of the prostate using the Hydros Robotic System, performed per institutional standard of care. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device - HoLEP with MOSES 2.0Holmium laser enucleation of the prostate using MOSES 2.0 pulse-modulation technology, performed per institutional standard of care. | Device | HoLEP with MOSES 2.0 |
| RWJA with Hydros Robotic SystemDevice - RWJA (Hydros Robotic System) / Aquablation therapy (often referred to by its commercial name, "Aquablation"). | Device | RWJA with Hydros Robotic System |
Primary outcome
Change in Prostate Volume
Time frame: Baseline and 12 months post-intervention
Measured via transrectal ultrasound (TRUS); change from baseline.
Change in Prostate-Specific Antigen (PSA)
Time frame: Baseline and 12 months post-intervention
Serum PSA level; change from baseline.
Change in Urinary Flow Rate (Qmax)
Time frame: Baseline and 12 months post-intervention
Peak urinary flow rate via uroflowmetry; change from baseline.
Change in Post-Void Residual Volume (PVR)
Time frame: Baseline and 12 months post-intervention
Bladder scan-measured PVR; change from baseline.
16 secondary outcomes
Incidence and Severity of Adverse Events
Time frame: From patient hospital discharge through 3 and 12 months post-surgery
Operative Time
Time frame: Day (duration) of surgical procedure
Hemostasis Time
Time frame: Day (duration) of surgical procedure
Perioperative Change in Hemoglobin
Time frame: Baseline to immediate postoperative period (when patient is in the recovery room post surgery)
Time to Catheter-Free Status
Time frame: From surgery day until catheter removal
Length of Hospital Stay / Discharge Time
Time frame: Day of surgical procedure through hospital discharge
Change in IPSS/QoL Score
Time frame: Baseline, 3, 6, and 12 months post-surgery
Change in SHIM Score
Time frame: Baseline, 3, 6, and 12 months post-surgery
Change in MSHQ-EjD Score
Time frame: Baseline, 3, 6, and 12 months post-surgery
Change in Incontinence Outcomes
Time frame: Baseline, 3, 6, and 12 months post-surgery
Long-Term Durability of Functional Improvements
Time frame: 24, 36, 48, and 60 months post-intervention
Post-Operative Medication Use
Time frame: Through 60 months post-intervention
Reintervention Rate
Time frame: Through 60 months post-intervention
Unplanned Healthcare Encounters
Time frame: Through 60 months post-intervention
Incidence of Urethral Stricture Requiring Intervention
Time frame: Through 60 months post-intervention
Unanticipated Advanced Diagnostics
Time frame: Through 60 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device - HoLEP with MOSES 2.0 and RWJA with Hydros Robotic System in people with Benign Prostate Hypertrophy(BPH) and Lower Urinary Track Symptoms, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hazem Elmansy, MD (346-516-1481, hmelmansy@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prostate Volume (time frame: Baseline and 12 months post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.