Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)RELIEFNCT07640776
Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)
A study testing Irreversible Electroporation in people with Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH), run by Angiodynamics, Inc..
Trial summary
This study will evaluate the safety and effectiveness of using Irreversible Electroporation (IRE) for the treatment of symptomatic benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Irreversible Electroporation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jun 2031
- 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
- Male, age ≥50 years.
- Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH).
- International Prostate Symptom Score (IPSS) ≥13 at screening.
- Peak urinary flow rate (Qmax) ≤12 mL/sec on non-catheterized free flow with voided volume ≥125 mL.
- Post-void residual (PVR) ≤250 mL.
- Prostate volume between 30 cc and 80 cc by transrectal ultrasound (TRUS) or Magnetic Resonance Imaging (MRI).
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- Willing and able to comply with all study procedures and follow-up requirements.
- Able to provide written informed consent.
- Life expectancy ≥10 years.
Who cannot join
- Patients with ≥ Grade Group 2 prostate cancer (≥ Gleason score 7).
- Patients with Grade Group 1 prostate cancer (Gleason score 6) on active surveillance for less than 1 year.
- Patients with PSA ≥10 ng/mL or PSA density ≥0.15 ng/mL2.
- Prior surgical or minimally invasive intervention for BPH (e.g., TURP, Rezūm™, UroLift®, laser therapy).
- Presence of urethral stricture or bladder neck contracture.
- Patients with a history of pelvic radiation/irradiation.
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- Patients with compromised renal function (serum creatinine level >1.8 mg/dL or upper-tract disease).
- Obstructing median lobe intravesical prostatic protrusion (IPP) with >1 cm assessed by TRUS or MRI.
- Active urinary tract infection, prostatitis, or gross hematuria within 3 months of enrollment.
- Active need of catheterization.
- Known or suspected neurogenic bladder or underlying neurologic disease affecting bladder function (e.g., Parkinson's disease, multiple sclerosis, stroke with residual urinary symptoms).
- History of bladder cancer or other urological malignancy.
- Implanted electrical devices (e.g., pacemaker, defibrillator, neurostimulator) incompatible with IRE energy delivery.
- Uncorrected bleeding diathesis or current therapeutic anticoagulation that cannot be safely interrupted.
- Current use of BPH medications unless on a stable dose for ≥6 weeks (alpha-blockers, anticholinergics, beta-3 adrenergic agonists) or ≥6 months (5-alpha reductase inhibitors, phosphodiesterase type 5 inhibitors) prior to baseline, with no planned changes during study follow-up.
- Prior rectal or pelvic surgery that may interfere with treatment delivery or evaluation.
- Desire to preserve future fertility.
- Severe or uncontrolled comorbidities (e.g., NYHA class III/IV heart failure, uncontrolled diabetes, severe pulmonary disease) that, in the opinion of the investigator, would increase study risk or confound outcomes.
- Participation in another clinical trial involving an investigational drug or device within 30 days prior to enrollment.
- Patients who are members of a vulnerable population, such as the cognitively challenged or incarcerated, that could expose them to undue influence, coercion, or inability to provide informed consent.
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
This study will evaluate the safety and effectiveness of using Irreversible Electroporation (IRE) for the treatment of symptomatic benign prostatic hyperplasia (BPH).
Read the detailed description
This study will be a prospective, non-randomized study in 40 subjects at up to five clinical sites in the United States. A total of 40 subjects will be treated with IRE and followed for evaluation of primary and secondary endpoints at 6 months post-treatment. Long-term follow-up will continue through 5 years post-treatment for secondary endpoints.
- Being tested
- Irreversible Electroporation
- Keywords
- Lower Urinary Tract Symptoms (LUTS), Benign Prostatic Hyperplasia (BPH)
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible ElectroporationDevice
Treatment with the NanoKnife System for ablation of prostate tissue. The procedure will be performed under general anesthesia using transrectal ultrasound (TRUS) guidance. Electrodes will be placed transperineally into predefined treatment zones of the prostate based on imaging and prostate anatomy. Treatment planning will be tailored to target the transition zone bilaterally while preserving key structures, including the neurovascular bundles, external sphincter, and urethra. Electrical pulses will be delivered according to device specifications to achieve focal non-thermal ablation of tissue.
| Study group | Role | What they receive |
|---|---|---|
| Irreversible Electroporation | Experimental | Treatment with the NanoKnife System Receives: Device: Irreversible Electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of device-related adverse events (AEs) through 6 months post-procedure
The primary safety endpoint is the incidence and severity of device-related adverse events (AEs) through 6 months post-procedure, categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: From treatment through 6 months post-procedure
Mean change in International Prostate Symptom Score (IPSS) from baseline to 6 months post-procedure
The primary effectiveness endpoint is the mean change in International Prostate Symptom Score (IPSS) from baseline to 6 months post-procedure, assessing improvement in lower urinary tract symptoms attributable to benign prostatic hyperplasia (BPH)
Measured: From baseline through 6 months post-procedure
Secondary outcomes (14)
Technical success
The technical success of the procedure, defined to be successful energy delivery per the treating physician
Measured: Immediately after the procedure
Incidence and severity of device-related adverse events (AEs) through 12 months post-procedure
The incidence and severity of device-related adverse events (AEs) through 12 months post-procedure, categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: From treatment through 12 months post-procedure
Incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 6 months post-procedure
The incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 6 months post-procedure, categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: From treatment through 6 months post-procedure
Incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 12 months post-procedure
The incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 12 months post-procedure, categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: From treatment through 12 months post-procedure
Rate of ablations that were completed successfully per the treating physician
Rate of ablations that were completed successfully per the treating physician
Measured: Immediately after the procedure
Change in IPSS from baseline to 1, 3, 12, 24, 36, 48 and 60 months post-procedure
Change in IPSS from baseline to 1, 3, 12, 24, 36, 48 and 60 months post-procedure, assessing durability of symptom improvement over time
Measured: From baseline to 1, 3, 12, 24, 36, 48 and 60 months post-procedure
Change in IPSS Quality of Life (IPSS-QoL) score from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in IPSS Quality of Life (IPSS-QoL) score from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Measured: From baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in maximum urinary flow rate (Qmax) from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in maximum urinary flow rate (Qmax) from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months, measured by non-invasive uroflowmetry.
Measured: From baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in post-void residual (PVR) urine volume from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in post-void residual (PVR) urine volume from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Measured: From baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months.
Change in prostate volume from baseline to 6, 12, 24, 36, 48 and 60 months
Change in prostate volume as assessed by transrectal ultrasound (TRUS) or MRI from baseline to 6, 12, 24, 36, 48 and 60 months
Measured: From baseline to 6, 12, 24, 36, 48 and 60 months
Incidence of unplanned BPH-related interventions within 12 months following the procedure
Incidence of unplanned BPH-related interventions (e.g., catheterization, medication initiation, surgery) within 12 months following the procedure
Measured: From treatment through 12 months post-procedure
Change in sexual function as measured by the International Index of Erectile Function (IIEF-5) at baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in sexual function as measured by the International Index of Erectile Function (IIEF-5) at baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Measured: From baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in ejaculatory dysfunction as measured by the Male Sexual Health Questionnaire - Ejaculation Short Form (MSHQ-EjD-SF) at baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in ejaculatory dysfunction as measured by the Male Sexual Health Questionnaire - Ejaculation Short Form (MSHQ-EjD-SF) at baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Measured: From baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in health-related quality of life (HRQoL) as measured by the EQ-5D-5L and EQ VAS instrument from baseline to 6, 12, 24, 36, 48 and 60 months
Change in health-related quality of life (HRQoL) as measured by the EQ-5D-5L and EQ VAS instrument from baseline to 6, 12, 24, 36, 48 and 60 months
Measured: From baseline to 6, 12, 24, 36, 48 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- More trials run by Angiodynamics, Inc.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angiodynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640776
- Sponsor's protocol ID
- 2025-ONC-03
- Acronym
- RELIEF
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT07640776
- Acronym / sponsor ID
- RELIEF / 2025-ONC-03
- Keywords
- Lower Urinary Tract Symptoms (LUTS), Benign Prostatic Hyperplasia (BPH)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Angiodynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 11 Jun 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.
This study will evaluate the safety and effectiveness of using Irreversible Electroporation (IRE) for the treatment of symptomatic benign prostatic hyperplasia (BPH).
Detailed description
This study will be a prospective, non-randomized study in 40 subjects at up to five clinical sites in the United States. A total of 40 subjects will be treated with IRE and followed for evaluation of primary and secondary endpoints at 6 months post-treatment. Long-term follow-up will continue through 5 years post-treatment for secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irreversible Electroporation | Experimental | Device: Irreversible ElectroporationTreatment with the NanoKnife System |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male, age ≥50 years.
- Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH).
- International Prostate Symptom Score (IPSS) ≥13 at screening.
- Peak urinary flow rate (Qmax) ≤12 mL/sec on non-catheterized free flow with voided volume ≥125 mL.
- Post-void residual (PVR) ≤250 mL.
Key exclusion criteria (20 listed)
- Patients with ≥ Grade Group 2 prostate cancer (≥ Gleason score 7).
- Patients with Grade Group 1 prostate cancer (Gleason score 6) on active surveillance for less than 1 year.
- Patients with PSA ≥10 ng/mL or PSA density ≥0.15 ng/mL2.
- Prior surgical or minimally invasive intervention for BPH (e.g., TURP, Rezūm™, UroLift®, laser therapy).
- Presence of urethral stricture or bladder neck contracture.
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 |
|---|---|---|
| Irreversible ElectroporationTreatment with the NanoKnife System for ablation of prostate tissue. The procedure will be performed under general anesthesia using transrectal ultrasound (TRUS) guidance. Electrodes will be placed transperineally into predefined treatment zones of the prostate based on imaging and prostate anatomy. Treatment planning will be tailored to target the transition zone bilaterally while preserving key structures, including the neurovascular bundles, external sphincter, and urethra. Electrical pulses will be delivered according to device specifications to achieve focal non-thermal ablation of tissue. | Device | Irreversible Electroporation |
Primary outcome
Incidence and severity of device-related adverse events (AEs) through 6 months post-procedure
Time frame: From treatment through 6 months post-procedure
The primary safety endpoint is the incidence and severity of device-related adverse events (AEs) through 6 months post-procedure, categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Mean change in International Prostate Symptom Score (IPSS) from baseline to 6 months post-procedure
Time frame: From baseline through 6 months post-procedure
The primary effectiveness endpoint is the mean change in International Prostate Symptom Score (IPSS) from baseline to 6 months post-procedure, assessing improvement in lower urinary tract symptoms attributable to benign prostatic hyperplasia (BPH)
14 secondary outcomes
Technical success
Time frame: Immediately after the procedure
Incidence and severity of device-related adverse events (AEs) through 12 months post-procedure
Time frame: From treatment through 12 months post-procedure
Incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 6 months post-procedure
Time frame: From treatment through 6 months post-procedure
Incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 12 months post-procedure
Time frame: From treatment through 12 months post-procedure
Rate of ablations that were completed successfully per the treating physician
Time frame: Immediately after the procedure
Change in IPSS from baseline to 1, 3, 12, 24, 36, 48 and 60 months post-procedure
Time frame: From baseline to 1, 3, 12, 24, 36, 48 and 60 months post-procedure
Change in IPSS Quality of Life (IPSS-QoL) score from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Time frame: From baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in maximum urinary flow rate (Qmax) from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Time frame: From baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in post-void residual (PVR) urine volume from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months
Time frame: From baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months.
Change in prostate volume from baseline to 6, 12, 24, 36, 48 and 60 months
Time frame: From baseline to 6, 12, 24, 36, 48 and 60 months
Incidence of unplanned BPH-related interventions within 12 months following the procedure
Time frame: From treatment through 12 months post-procedure
Change in sexual function as measured by the International Index of Erectile Function (IIEF-5) at baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Time frame: From baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in ejaculatory dysfunction as measured by the Male Sexual Health Questionnaire - Ejaculation Short Form (MSHQ-EjD-SF) at baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Time frame: From baseline and 1, 3, 6, 12, 24, 36, 48 and 60 months
Change in health-related quality of life (HRQoL) as measured by the EQ-5D-5L and EQ VAS instrument from baseline to 6, 12, 24, 36, 48 and 60 months
Time frame: From baseline to 6, 12, 24, 36, 48 and 60 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 11 Jun 2026.
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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 Irreversible Electroporation in people with Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH), run by Angiodynamics, Inc..
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 9 inclusion and 20 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 11 Jun 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 Elizabeth Manning Sr. Director, Clinical Affairs (339-237-2765, liz.manning@angiodynamics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of device-related adverse events (AEs) through 6 months post-procedure (time frame: From treatment through 6 months post-procedure). The study lists 2 primary outcomes in all. 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 11 Jun 2026.