Shock therapy for BPH: new electrical ablation may spare sex life
NCT ID NCT07572097
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
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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
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About 288 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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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
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50 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
Only the study team decides who joins. These are the ways to reach them.
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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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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Prostate surgery Trade-Off: better urination vs. sexual function
- New device aims to ease enlarged prostate for years
- New prostate injection aims to help men pee better
- New prostate surgery may keep ejaculation intact
- Cheaper bladder test could replace costly MRI scans