Sound waves aim to zap prostate blockage without surgery

NCT ID NCT07194187

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study tests whether high-intensity focused ultrasound (HIFU) can safely and effectively treat urinary symptoms caused by an enlarged prostate. Seventeen men aged 45 to 80 with moderate to severe symptoms will receive a single HIFU treatment using a probe placed in the rectum. Researchers will track symptom scores, urine flow, side effects, and sexual function for six months to see if the procedure offers a needle-free alternative to medication or surgery.

What this could mean

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

Active substance
High-intensity focused ultrasound (HIFU) device
What this could lead to
If it works, HIFU could offer a non-surgical, needle-free option to relieve bothersome urinary symptoms caused by an enlarged prostate.
What could go wrong
This is a very small early study with only 17 men and no comparison group. It may not show clear benefit, and risks like pain or urinary problems are possible.

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 17 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

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

45 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: * Males aged 45 - 80 diagnosed with LUTS due to BOO from BPH. * Prostate size \> 30cc and \< 80cc as measured by transrectal ultrasound (TRUS) or MRI within 1 year prior to treatment. * A documented history of refusal to take medical therapy, inadequate or failed response to medical therapy, or contraindications to medical therapy. * Initial baseline International Prostate Symptom Score (IPSS) greater than or equal to 12 which denotes moderate to severe symptoms. * Baseline peak urinary flow rate (Qmax) of less than 15 mL/s1 * Baseline serum creatinine \< 2 mg/dL within 30 days prior to surgery * Mental capacity, willingness, and ability to sign a study specific informed consent form Exclusion Criteria : * BMI \> 42 * Patients with an obstructing prostatic median lobe as measured by baseline preliminary imaging and/or confirmed on cystoscopy examination. * Patients with latex allergies which would permit latex catheterization perioperatively as silicone catheterization is not recommended during HIFU treatment. * Patients with extensive calcification in the treatment area of the prostate as measured by preoperative imaging with TRUS or MRI and as evaluated by hospital radiology or the principal investigator. Extensive calcification is defined as where the calcification in posterior peripheral zone, which may interfere with experimental treatment procedure, and it is determined by hospital radiologist and further assessed by the PI. * Patient unable to stop anticoagulants, antiplatelet agents, or NSAIDS (including aspirin \> 100mg) prior to treatment which is standard of care. * Patients using immunosuppressants including corticosteroids (except inhalants) who are unable to withhold medications prior to treatment which is standard of care. * Known and documented coagulopathy or platelet disorder * Contraindication to both general and spinal anesthesia which are standard of care. * Severe illness that would prevent complete study participation. * History of active or prior treatments for current/suspected PCa. * Diagnosis of polyneuropathy * Bladder calculi or bladder diverticulum (pouch size \> 20% of full bladder size) * Active infection, including urinary tract infection or prostatitis. * Evidence of hydronephrosis on imaging. * Pre-op urinary catheter uses daily. * Previous urinary tract surgeries such as, but not limited to prior surgery for LUTS, urinary diversion, artificial urinary sphincter, or penile prosthesis. * Diagnosis of clinically significant urethral stricture, meatal stenosis, severe phimosis, or bladder neck contracture * Known damage to the external urinary sphincter. * Open heart surgery or cardiac arrest \< 180 days prior to the date of informed consent * Known illicit substance abuse. * Use of anticholinergics (specifically for bladder problems). Use of general anticholinergics is allowed if they do not have documented adverse urinary side effects. * Dementia or psychiatric conditions which prevent them from completing the required follow up. * Prior pelvic radiotherapy * Participation in another ongoing investigational study that could affect responses. * Unwillingness to accept a transfusion should it be required. * No members of vulnerable populations will be included in our study. * History or current diagnosis of chronic prostatitis. * Diagnosis or prior treatment for chronic pelvic pain syndrome.

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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

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Mount Sinai Union Square

    New York, New York, 10003, United States

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