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

NCT07572097 | Not Yet Recruiting DMC

• 1 other identifier: 2026056
• Study Type: interventional
• Target: 288
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

BPH

Keywords

BPH; h-fire; turp; holep

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in International Prostate Symptom Score (IPSS)

  The IPSS is a validated 7-item questionnaire assessing lower urinary tract symptoms. The total score ranges from 0 to 35. Higher scores indicate more severe symptoms (0-7: mildly symptomatic; 8-19: moderately symptomatic; 20-35: severely symptomatic). A decrease in the score indicates symptomatic improvement.

  Baseline and 12 months

Secondary Outcomes (7)

• Proportion of Participants Achieving the "BPH Trifecta"

  1,3,6,12 months

• Change from Baseline in International Index of Erectile Function (IIEF-5) Score

  Baseline, 1, 3, 6, and 12 months

• Change from Baseline in Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) Short Form Score

  Baseline, 1, 3, 6, and 12 months

• Change from Baseline in Maximum Urinary Flow Rate (Qmax)

  Baseline, 1, 3, 6, and 12 months

• Change from Baseline in Post-Void Residual (PVR) Urine Volume

  Baseline, 1, 3, 6, and 12 months

Study Arms (2)

H-FIRE

EXPERIMENTAL

Participants randomized to this arm will undergo High-Frequency Irreversible Electroporation (H-FIRE). The procedure is performed under general anesthesia with deep neuromuscular blockade. Using transrectal ultrasound (TRUS) guidance and a transperineal template, electrodes are positioned to bracket the transition zone. The H-FIRE generator delivers microsecond-pulsed electric fields to induce non-thermal apoptosis of the obstructing prostatic adenoma. To maintain the PROBE (Prospective Randomized Open-label Blinded-Endpoint) design and keep outcome assessors blinded to the surgical approach, all participants in this arm will also receive a sham perineal dressing for 3 days and continuous bladder irrigation for at least 24 hours post-procedure.

Procedure: H-FIRE

Shared Control Arm: Standard of Care

ACTIVE COMPARATOR

Participants randomized to this arm will receive the surgical Standard of Care (SoC), stratified by baseline prostate volume. For prostates 30-80 mL, surgeons will perform either Transurethral Resection of the Prostate (TURP) or Holmium Laser Enucleation of the Prostate (HoLEP). For prostates \>80-150 mL, HoLEP is mandated. Procedures aim for complete anatomical removal of the obstructing adenoma. To maintain the PROBE (Prospective Randomized Open-label Blinded-Endpoint) design and mask the transurethral approach from blinded outcome assessors, all participants in this arm will also receive a sham perineal dressing for 3 days and continuous bladder irrigation for at least 24 hours post-procedure.

Procedure: Surgical Standard of Care (TURP or HoLEP)

Interventions

H-FIRE PROCEDURE

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 inducing cellular apoptosis rather than coagulative necrosis. This unique non-thermal mechanism is designed to effectively ablate obstructing prostatic adenoma while sparing the collagenous architecture of neurovascular bundles and the external sphincter.

H-FIRE

Surgical Standard of Care (TURP or HoLEP) PROCEDURE

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 is strictly mandated. Both procedures are performed under anesthesia with the clinical goal of achieving complete anatomical removal of the obstructing adenoma (resection to the surgical capsule for TURP, or anatomical enucleation for HoLEP).

Shared Control Arm: Standard of Care

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai East Hospital: lead

MeSH Terms

Interventions

Transurethral Resection of Prostate

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Shanghai East hospital ethics committee

CONTACT

+86-021-38804518; siwei_bao@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 7, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): May 5, 2028
• Study Completion (Estimated): May 5, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-03