Laser vs. water jet: which surgery for enlarged prostate is better?

NCT ID NCT07772232

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial compares two FDA-approved surgeries for benign prostatic hyperplasia (BPH), a condition where the prostate enlarges and causes urinary problems. Men aged 50-80 with moderate-to-severe symptoms and prostate sizes between 50 and 180 mL will be randomly assigned to receive either HoLEP with MOSES 2.0 technology or robotic water jet ablation (Aquablation). The study will measure changes in prostate volume, PSA levels, urinary flow, and bladder emptying at 12 months, and will track safety, sexual function, continence, and healthcare use for up to 5 years. The goal is to see which procedure offers better outcomes and fewer complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Two surgical procedures: HoLEP (holmium laser enucleation) and robotic water jet ablation (Aquablation)
What this could lead to
If successful, this trial could help doctors choose the best surgical option for men with enlarged prostates, improving symptom relief and quality of life.
What could go wrong
This is a single trial with 100 participants, and results may not apply to all men. Both procedures carry surgical risks, including bleeding, infection, or urinary issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Houston Methodist

    Houston, Texas, 77030, United States

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