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Shock therapy for BPH: new electrical ablation may spare sex life

NCT ID NCT07572097

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new procedure called H-FIRE for men with an enlarged prostate (BPH). Instead of using heat like standard surgeries, H-FIRE uses short electrical pulses to destroy blocking tissue while sparing nerves and muscles. The trial will enroll 288 men aged 50 and older, randomly assigning them to H-FIRE or standard surgery. The goal is to see if H-FIRE can relieve urinary symptoms just as well while better preserving sexual function and bladder control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High-Frequency Irreversible Electroporation (H-FIRE) procedure
What this could lead to
If successful, H-FIRE could offer men with enlarged prostate a surgery that relieves urinary symptoms without causing sexual side effects like loss of ejaculation.
What could go wrong
This is an early-stage study with no prior large-scale results. The procedure may not be as effective as standard surgery, and electrical ablation carries risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 288 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. Exclusion Criteria: 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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