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Electric pulses may zap prostate troubles without heat

NCT ID NCT07640776

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a procedure called irreversible electroporation (IRE) to treat urinary symptoms caused by an enlarged prostate. About 40 men aged 50 and older with moderate to severe symptoms will receive the treatment. The goal is to see if IRE safely improves urine flow and reduces symptoms without the need for ongoing medication.

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 40 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 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

50 years and older

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 years. 2. Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH). 3. International Prostate Symptom Score (IPSS) ≥13 at screening. 4. Peak urinary flow rate (Qmax) ≤12 mL/sec on non-catheterized free flow with voided volume ≥125 mL. 5. Post-void residual (PVR) ≤250 mL. 6. Prostate volume between 30 cc and 80 cc by transrectal ultrasound (TRUS) or Magnetic Resonance Imaging (MRI). 7. Willing and able to comply with all study procedures and follow-up requirements. 8. Able to provide written informed consent. 9. Life expectancy ≥10 years. Exclusion Criteria: 1. Patients with ≥ Grade Group 2 prostate cancer (≥ Gleason score 7). 2. Patients with Grade Group 1 prostate cancer (Gleason score 6) on active surveillance for less than 1 year. 3. Patients with PSA ≥10 ng/mL or PSA density ≥0.15 ng/mL2. 4. Prior surgical or minimally invasive intervention for BPH (e.g., TURP, Rezūm™, UroLift®, laser therapy). 5. Presence of urethral stricture or bladder neck contracture. 6. Patients with a history of pelvic radiation/irradiation. 7. Patients with compromised renal function (serum creatinine level \>1.8 mg/dL or upper-tract disease). 8. Obstructing median lobe intravesical prostatic protrusion (IPP) with \>1 cm assessed by TRUS or MRI. 9. Active urinary tract infection, prostatitis, or gross hematuria within 3 months of enrollment. 10. Active need of catheterization. 11. Known or suspected neurogenic bladder or underlying neurologic disease affecting bladder function (e.g., Parkinson's disease, multiple sclerosis, stroke with residual urinary symptoms). 12. History of bladder cancer or other urological malignancy. 13. Implanted electrical devices (e.g., pacemaker, defibrillator, neurostimulator) incompatible with IRE energy delivery. 14. Uncorrected bleeding diathesis or current therapeutic anticoagulation that cannot be safely interrupted. 15. Current use of BPH medications unless on a stable dose for ≥6 weeks (alpha-blockers, anticholinergics, beta-3 adrenergic agonists) or ≥6 months (5-alpha reductase inhibitors, phosphodiesterase type 5 inhibitors) prior to baseline, with no planned changes during study follow-up. 16. Prior rectal or pelvic surgery that may interfere with treatment delivery or evaluation. 17. Desire to preserve future fertility. 18. Severe or uncontrolled comorbidities (e.g., NYHA class III/IV heart failure, uncontrolled diabetes, severe pulmonary disease) that, in the opinion of the investigator, would increase study risk or confound outcomes. 19. Participation in another clinical trial involving an investigational drug or device within 30 days prior to enrollment. 20. Patients who are members of a vulnerable population, such as the cognitively challenged or incarcerated, that could expose them to undue influence, coercion, or inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Lower Urinary Tract Symptoms

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 official record

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

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.