BPHNCT07572097
High-Frequency Irreversible Electroporation vs Standard of Care for Benign Prostatic Hyperplasia
A study testing H-FIRE in people with BPH, run by Shanghai East Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- BPH
- What is being tested?
- H-FIRE
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2026to 5 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: High-Frequency Irreversible Electroporation vs Standard of Care for Benign Prostatic Hyperplasia: Adaptive Platform Study
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.
Read more
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
- Being tested
- H-FIRE, Surgical Standard of Care (TURP or HoLEP)
- Keywords
- BPH, h-fire, turp, holep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-FIREProcedure or surgery
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.
Surgical Standard of Care (TURP or HoLEP)Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Surgical Standard of Care (TURP or HoLEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Secondary outcomes (7)
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).
Measured: 1,3,6,12 months
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.
Measured: Baseline, 1, 3, 6, and 12 months
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).
Measured: Baseline, 1, 3, 6, and 12 months
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.
Measured: Baseline, 1, 3, 6, and 12 months
Change from Baseline in Post-Void Residual (PVR) Urine Volume
Post-void residual (PVR) urine volume measured via transabdominal ultrasound immediately after a voluntary void. Lower values indicate better bladder emptying.
Measured: Baseline, 1, 3, 6, and 12 months
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Adverse events will be systematically recorded and graded. Surgical complications will be classified using the Clavien-Dindo Classification system. General medical adverse events and genitourinary symptoms will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Key Adverse Events of Special Interest (AESI) include urethral stricture, transient/permanent incontinence, and retrograde ejaculation.
Measured: Up to 12 months post-procedure
Incremental Cost-Effectiveness Ratio (ICER)
The ICER will be calculated from a societal perspective as the incremental cost per Quality-Adjusted Life Year (QALY) gained. QALYs will be derived from the EQ-5D-5L utility index scores. Lower ICER values indicate a more cost-effective intervention.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start5 May 2026 (estimated)
- Primary completion5 May 2028 (estimated)
- Study completion5 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572097
- Sponsor's protocol ID
- 2026056
- Status last verified
- Mar 2026
- First submitted
- 29 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Frequency Irreversible Electroporation vs Standard of Care for Benign Prostatic Hyperplasia: Adaptive Platform Study
- ClinicalTrials.gov ID
- NCT07572097
- Acronym / sponsor ID
- 2026056
- Conditions
- BPH
- Keywords
- BPH, h-fire, turp, holep
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 5 May 2026 (estimated)
- Primary completion
- 5 May 2028 (estimated)
- Study completion
- 5 May 2029 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H-FIRE | Experimental | Procedure: H-FIREParticipants 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. |
| Shared Control Arm: Standard of Care | Active comparator | Procedure: Surgical Standard of Care (TURP or HoLEP)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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H-FIREHigh-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. | Procedure or surgery | H-FIRE |
| 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 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). | Procedure or surgery | Shared Control Arm: Standard of Care |
Primary outcome
Change from Baseline in International Prostate Symptom Score (IPSS)
Time frame: Baseline and 12 months
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.
7 secondary outcomes
Proportion of Participants Achieving the "BPH Trifecta"
Time frame: 1,3,6,12 months
Change from Baseline in International Index of Erectile Function (IIEF-5) Score
Time frame: Baseline, 1, 3, 6, and 12 months
Change from Baseline in Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) Short Form Score
Time frame: Baseline, 1, 3, 6, and 12 months
Change from Baseline in Maximum Urinary Flow Rate (Qmax)
Time frame: Baseline, 1, 3, 6, and 12 months
Change from Baseline in Post-Void Residual (PVR) Urine Volume
Time frame: Baseline, 1, 3, 6, and 12 months
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 12 months post-procedure
Incremental Cost-Effectiveness Ratio (ICER)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing H-FIRE in people with BPH, run by Shanghai East Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanghai East hospital ethics committee (+86-021-38804518, siwei_bao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in International Prostate Symptom Score (IPSS) (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.