Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)
Conditions
Keywords
Lower Urinary Tract Symptoms (LUTS), Benign Prostatic Hyperplasia (BPH)
Brief summary
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.
Interventions
DEVICEIrreversible Electroporation
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.
Sponsors
Angiodynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male, age ≥50 years. 2. Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH). 3. International Prostate Symptom Score (IPSS) ≥13 at screening. 4. Peak urinary flow rate (Qmax) ≤12 mL/sec on non-catheterized free flow with voided volume ≥125 mL. 5. Post-void residual (PVR) ≤250 mL. 6. Prostate volume between 30 cc and 80 cc by transrectal ultrasound (TRUS) or Magnetic Resonance Imaging (MRI). 7. Willing and able to comply with all study procedures and follow-up requirements. 8. Able to provide written informed consent. 9. Life expectancy ≥10 years.
Exclusion criteria
1. Patients with ≥ Grade Group 2 prostate cancer (≥ Gleason score 7). 2. Patients with Grade Group 1 prostate cancer (Gleason score 6) on active surveillance for less than 1 year. 3. Patients with PSA ≥10 ng/mL or PSA density ≥0.15 ng/mL2. 4. Prior surgical or minimally invasive intervention for BPH (e.g., TURP, Rezūm™, UroLift®, laser therapy). 5. Presence of urethral stricture or bladder neck contracture. 6. Patients with a history of pelvic radiation/irradiation. 7. Patients with compromised renal function (serum creatinine level \>1.8 mg/dL or upper-tract disease). 8. Obstructing median lobe intravesical prostatic protrusion (IPP) with \>1 cm assessed by TRUS or MRI. 9. Active urinary tract infection, prostatitis, or gross hematuria within 3 months of enrollment. 10. Active need of catheterization. 11. Known or suspected neurogenic bladder or underlying neurologic disease affecting bladder function (e.g., Parkinson's disease, multiple sclerosis, stroke with residual urinary symptoms). 12. History of bladder cancer or other urological malignancy. 13. Implanted electrical devices (e.g., pacemaker, defibrillator, neurostimulator) incompatible with IRE energy delivery. 14. Uncorrected bleeding diathesis or current therapeutic anticoagulation that cannot be safely interrupted. 15. 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. 16. Prior rectal or pelvic surgery that may interfere with treatment delivery or evaluation. 17. Desire to preserve future fertility. 18. 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. 19. Participation in another clinical trial involving an investigational drug or device within 30 days prior to enrollment. 20. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of device-related adverse events (AEs) through 6 months post-procedure | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Immediately after the procedure | The technical success of the procedure, defined to be successful energy delivery per the treating physician |
| Incidence and severity of device-related adverse events (AEs) through 12 months post-procedure | From treatment 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 |
| Incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 6 months post-procedure | From treatment 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 |
| Incidence, relatedness, seriousness, and severity of all adverse events (AEs) through 12 months post-procedure | From treatment 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. |
| Rate of ablations that were completed successfully per the treating physician | Immediately after the procedure | Rate of ablations that were completed successfully per the treating physician |
| Change in IPSS from baseline to 1, 3, 12, 24, 36, 48 and 60 months post-procedure | 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 |
| Change in IPSS Quality of Life (IPSS-QoL) score from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months | 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 |
| Change in maximum urinary flow rate (Qmax) from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months | 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. |
| Change in post-void residual (PVR) urine volume from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months | 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 prostate volume from baseline to 6, 12, 24, 36, 48 and 60 months | 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 |
| Incidence of unplanned BPH-related interventions within 12 months following the procedure | From treatment through 12 months post-procedure | Incidence of unplanned BPH-related interventions (e.g., catheterization, medication initiation, surgery) within 12 months following the 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 | From 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 |
| 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 | 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 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 | 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 |
Contacts
CONTACTElizabeth Manning Sr. Director, Clinical Affairs
Outcome results
None listed