High-Frequency Irreversible Electroporation vs Standard of Care for Benign Prostatic Hyperplasia
ConditionBPH
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorShanghai East Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
H-FIRE
Procedure/SurgeryHigh-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.
Surgical Standard of Care (TURP or HoLEP)
Procedure/SurgeryThe 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).
Treatment groups
288 Participants
are divided into 2 treatment groupsGroup A: H-FIREExperimental treatment 1 intervention
Group B: Shared Control Arm: Standard of CareActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and 12 monthsSecondary outcomes
1
Proportion of Participants Achieving the "BPH Trifecta"
The "BPH Trifecta" is a composite success endpoint defined as the simultaneous achievement of three criteria: (i) Effective de-obstruction (IPSS reduction \>=50% from baseline or total score \<8); (ii) Social Continence (0 pads/day); and (iii) Preservation of Ejaculation (MSHQ-EjD Function Score \>=2).
Time frame
1,3,6,12 months2
Change from Baseline in International Index of Erectile Function (IIEF-5) Score
The IIEF-5 is a validated questionnaire assessing erectile dysfunction. Total scores range from 1 to 25. Higher scores indicate better erectile function and lesser severity of dysfunction.
Time frame
Baseline, 1, 3, 6, and 12 months3
Change from Baseline in Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) Short Form Score
The MSHQ-EjD Short Form assesses ejaculatory function. The function domain score ranges from 1 to 15. Higher scores indicate better ejaculatory function (greater frequency, strength, and volume).
Time frame
Baseline, 1, 3, 6, and 12 months4
Change from Baseline in Maximum Urinary Flow Rate (Qmax)
Maximum urinary flow rate (Qmax) evaluated via uroflowmetry. Assessed with a minimum voided volume requirement of 125 mL. Higher values indicate better urinary flow and less obstruction.
Time frame
Baseline, 1, 3, 6, and 12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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