Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)

This study will be a prospective, non-randomized study in 40 subjects at up to five clinical sites in the United States. A total of 40 subjects will be treated with IRE and followed for evaluation of primary and secondary endpoints at 6 months post-treatment. Long-term follow-up will continue through 5 years post-treatment for secondary endpoints.

Inclusion criteria

• Male, age ≥50 years.
• Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH).
• International Prostate Symptom Score (IPSS) ≥13 at screening.
• Peak urinary flow rate (Qmax) ≤12 mL/sec on non-catheterized free flow with voided volume ≥125 mL.
• Post-void residual (PVR) ≤250 mL.
• Prostate volume between 30 cc and 80 cc by transrectal ultrasound (TRUS) or Magnetic Resonance Imaging (MRI).
• Willing and able to comply with all study procedures and follow-up requirements.
• Able to provide written informed consent.
• Life expectancy ≥10 years.

Exclusion criteria

• Patients with ≥ Grade Group 2 prostate cancer (≥ Gleason score 7).
• Patients with Grade Group 1 prostate cancer (Gleason score 6) on active surveillance for less than 1 year.
• Patients with PSA ≥10 ng/mL or PSA density ≥0.15 ng/mL2.
• Prior surgical or minimally invasive intervention for BPH (e.g., TURP, Rezūm™, UroLift®, laser therapy).
• Presence of urethral stricture or bladder neck contracture.
• Patients with a history of pelvic radiation/irradiation.
• Patients with compromised renal function (serum creatinine level >1.8 mg/dL or upper-tract disease).
• Obstructing median lobe intravesical prostatic protrusion (IPP) with >1 cm assessed by TRUS or MRI.
• Active urinary tract infection, prostatitis, or gross hematuria within 3 months of enrollment.
• Active need of catheterization.
• Known or suspected neurogenic bladder or underlying neurologic disease affecting bladder function (e.g., Parkinson's disease, multiple sclerosis, stroke with residual urinary symptoms).
• History of bladder cancer or other urological malignancy.
• Implanted electrical devices (e.g., pacemaker, defibrillator, neurostimulator) incompatible with IRE energy delivery.
• Uncorrected bleeding diathesis or current therapeutic anticoagulation that cannot be safely interrupted.
• 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.
• Prior rectal or pelvic surgery that may interfere with treatment delivery or evaluation.
• Desire to preserve future fertility.
• 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.
• Participation in another clinical trial involving an investigational drug or device within 30 days prior to enrollment.
• 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.