Electric pulses may zap prostate troubles without heat
NCT ID NCT07640776
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.
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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 40 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 2031
An estimate. End dates often move.
- Lead sponsor
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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
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50 years and older
- 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: 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.
As listed by the trial registrant
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How to take part
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The official record
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A doctor treating you
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