High-Frequency Irreversible Electroporation vs Standard of Care for Benign Prostatic Hyperplasia

Официальное название

High-Frequency Irreversible Electroporation vs Standard of Care for Benign Prostatic Hyperplasia: Adaptive Platform Study

Обзор

The study aims to find a better surgical treatment for men with an enlarged prostate (Benign Prostatic Hyperplasia, or BPH) that effectively relieves urinary symptoms without sacrificing sexual function. Currently, standard surgeries like TURP or HoLEP are very effective at opening the blocked urinary channel. However, because they use heat or mechanical energy to remove prostate tissue, they often cause unwanted side effects, most notably the loss of normal ejaculation (retrograde ejaculation) and potential impacts on erectile function. This study is testing a novel, minimally invasive technology called High-Frequency Irreversible Electroporation (H-FIRE). Instead of using heat to burn or cut the tissue, H-FIRE delivers ultra-short electrical pulses to destroy the blocking prostate tissue. This "non-thermal" (heat-free) approach is uniquely designed to spare the delicate nerves, blood vessels, and muscles surrounding the prostate, which are critical for preserving normal sexual function and bladder control. In this clinical trial, 288 men aged 50 and older with moderate-to-severe BPH symptoms will be randomly assigned to receive either the investigational H-FIRE procedure or the Standard of Care surgery (TURP or HoLEP). The main goal of the study is to prove that H-FIRE is just as effective as standard surgery in relieving lower urinary tract symptoms over 12 months. More importantly, the study will evaluate if H-FIRE is superior in helping patients achieve the "BPH Trifecta"-meaning the patient successfully achieves significant symptom relief, maintains perfect bladder control (uses zero pads), AND fully preserves normal ejaculation. By utilizing this new tissue-sparing technology, the trial hopes to offer aging men a treatment option that restores their urinary health while fully protecting their overall quality of life.

Вмешательства

• Процедура H-FIRE
  High-Frequency Irreversible Electroporation (H-FIRE) is a novel, non-thermal, tissue-selective ablation technique. Under transrectal ultrasound (TRUS) guidance, 19-gauge monopolar electrodes are inserted transperineally via a template to bracket the prostatic transition zone. The H-FIRE generator delivers ultrashort bursts of high-voltage microsecond-pulsed electric fields . This rapidly destabilizes the transmembrane potential, creating permanent nanoscale pores in the cell membrane and inducin
• Процедура Surgical Standard of Care (TURP or HoLEP)
  The Standard of Care (SoC) intervention comprises guideline-endorsed transurethral surgical procedures for benign prostatic obstruction. The specific surgical modality is strictly mandated by baseline prostate volume stratification to ensure optimal therapeutic efficacy. For prostates measuring 30 to 80 mL, surgeons perform either Transurethral Resection of the Prostate (TURP, Monopolar or Bipolar) or Holmium Laser Enucleation of the Prostate (HoLEP). For larger prostates (\>80 to 150 mL), HoLEP

Первичные конечные точки

• Change from Baseline in International Prostate Symptom Score (IPSS) [Срок оценки: Baseline and 12 months]

Вторичные конечные точки (7)

• Proportion of Participants Achieving the "BPH Trifecta" [Срок оценки: 1,3,6,12 months]
• Change from Baseline in International Index of Erectile Function (IIEF-5) Score [Срок оценки: Baseline, 1, 3, 6, and 12 months]
• Change from Baseline in Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) Short Form Score [Срок оценки: Baseline, 1, 3, 6, and 12 months]
• Change from Baseline in Maximum Urinary Flow Rate (Qmax) [Срок оценки: Baseline, 1, 3, 6, and 12 months]
• Change from Baseline in Post-Void Residual (PVR) Urine Volume [Срок оценки: Baseline, 1, 3, 6, and 12 months]
• Incidence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to 12 months post-procedure]
• Incremental Cost-Effectiveness Ratio (ICER) [Срок оценки: 12 months]

Критерии участия

Критерии включения

Moderate-to-severe symptoms, defined as IPSS ≥13. Prostate volume (PV) between 30 and 150 ml, measured by multi-parametric MRI (mpMRI) or Transrectal Ultrasound (TRUS).

Maximum urinary flow rate (Qmax) ≤15 ml/s. Note: To ensure validity, the voided volume during uroflowmetry must be ≥125 ml; tests with lower volumes must be repeated.

Competency to provide informed consent and comply with long-term follow-up.

Критерии исключения

Suspected or histologically confirmed prostate cancer. Patients with PSA >4 ng/ml must undergo mpMRI; those with PI-RADS ≥3 lesions require a negative biopsy before enrolment.

Neurogenic bladder, detrusor underactivity, or active urinary tract infection (UTI).

Previous prostate surgery, pelvic irradiation, urethral stricture, or bladder neck contracture.

Presence of metallic implants incompatible with H-FIRE pulse delivery (e.g., non-compatible pacemakers).

Inability to safely discontinue anticoagulation if required by the assigned surgical protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07572097 · 2026056

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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