The main goal of this study is to evaluate the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System for treatment of enlarged prostate (BPH) symptoms. The study will involve up to 250 male participants who have urinary problems caused by BPH and whom are greater than 40 years of age in up to 30 investigational centers across the US,Canada and European Union.
≥ 45 years of age on the day of enrollment.
Symptom Score: Baseline IPSS score ≥13
Flow Rate: Single uroflow test with a minimum voided volume ≥ 125 mL and a Qmax ≥ 5 mL/sec and ≤ 12 mL/s
Residual: ultrasound-determined PVR of ≤ 250 mL
History of clinically significant heart failure (NYHA III/IV)
Uncontrolled arrhythmia.
Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, or any cardiac surgery within 180 days of enrollment.
Uncontrolled hypertension
Crossover
Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System
DeviceAfter the participant receives anesthesia, the Investigator will proceed with placement of the ALPFA GRAIL PFA Catheter into the prostate via a standard flexible cystoscope. Visualization of the prostatic urethra will determine the number of balloons that are exposed and inflated. When the catheter has been properly positioned, the ALPFA GRAIL PFA Console will be activated and one PFA application will be delivered. The Investigator will assess if the catheter needs to be repositioned and additional ablation applications delivered, as necessary. Once ablation is complete, the catheter balloons will be deflated, and the catheter will be withdrawn from the urethra. Participants will then have follow-up visits with health checks as planned for this study.
Control Device: Sham flexible cystoscopy
DeviceParticipants will receive mock treatment with a flexible cystoscope with a working channel that is at least 6.9F in diameter. The cystoscope will be inserted and treatment script initiated. Once the script is completed, the cystoscope will be removed and procedural details captured on the relevant CRF. Participants will then have follow-up visits with health checks as planned for this study.
Safety-Incidence of Serious Device-or Procedure-Related Adverse Events (Composite Safety Endpoint)
The primary safety endpoint is the proportion of participants experiencing one or more of the following serious device-related or procedure-related adverse events: Internal Tears: Any accidental holes or tears in the rectum, bladder, or digestive tract. Abnormal Connections (Fistula): The development of an unintended opening or passage between the rectum and the tube that carries urine (urethra). Inability to Urinate: A new, ongoing problem where a participant cannot empty their bladder and requires a tube (catheter) for more than 28 days after the procedure. Leaking Urine: New or persistent "stress incontinence," which is the accidental leaking of urine during physical activity, coughing, or sneezing. Severe Bleeding: Any bleeding serious enough to require a blood transfusion or a follow-up surgery to stop it. Injury to the urinary tube (urethra) or the lining of the prostate (capsule) that is severe enough to require surgery.
Effectiveness-Change from Baseline in International Prostate Symptom Score (IPSS) at 3 Months.
The International Prostate Symptom Score (IPSS) is a 7-item questionnaire (score range 0-35) where higher scores indicate more severe symptoms. Success is defined as the Treatment group showing a 25% greater relative improvement in mean score compared to the Control group
Effectiveness-Durability of Treatment Effect: Percent Change in International Prostate Symptom Score (IPSS) at 12 Months
This endpoint evaluates the long-term effectiveness of the ALPFA GRAIL PFA System. It is calculated as the mean percentage change in the total International Prostate Symptom Score (IPSS) score from the start of the study (baseline) to the 12-month follow-up for participants in the treatment group.
Additional Study Goals
1.Comparison of Symptom Improvement (at 3 Months) Researchers will compare the average change in prostate symptoms between the group that received the study treatment and the control group. This helps show if the treatment provides more relief than the standard comparison.
Success Stories (Responder Rate)
2\. Number of "Success Stories" (Responder Rate) The study will count how many participants had a meaningful improvement in their symptoms. A "responder" (a success) is defined as a person whose symptoms improved by at least 30% three months after the treatment.
Improvement in Urine Flow
3\. Improvement in Urine Flow (Qmax) Researchers will measure the strength of the participant's urine flow. They will compare the average change in flow strength from the start of the study to three months later between the treatment group and the control group.
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