Sound waves aim to zap prostate blockage without surgery
NCT ID NCT07194187
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
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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
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About 17 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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45 to 80 years
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mount Sinai Union Square
New York, New York, 10003, United States
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Other studies related to the condition(s) this trial covers.
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