Benign Prostatic Hyperplasia (BPH)REBOUNDNCT07592299
To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic Benign Prostate Hyperplasia (BPH) Also Known as an Enlarged Prostate.
A study testing Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System in people with Benign Prostatic Hyperplasia (BPH), run by ALPFA Medical at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2032
- Phase
- Interventional
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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Study subjects are required to meet all the following inclusion criteria to participate in this study as determined by the Investigator:
- ≥ 45 years of age on the day of enrollment.
- Symptomatic BPH meeting all of the following criteria determined within 30 days preceding enrollment and after fulfilling the concomitant medication washout period(s):
- Symptom Score: Baseline IPSS score ≥13
- Flow Rate: Uroflow test with a pre-void bladder volume ≥150 mL (confirmed by bladder scan),Single uroflow test with a minimum voided volume ≥ 125 mL and a Qmax ≥ 5 mL/sec and ≤ 15 mL/s
- Residual: ultrasound-determined PVR of ≤ 250 mL
- Prostate size 25-150 g, measured by transrectal ultrasound.
- Willing and able to provide consent and comply with study requirements.
Exclusion Criteria:Subjects will be excluded from the study if they meet any one of the following exclusion criteria, as determined by the Investigator:
- Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:
- Cardiovascular:
- 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 (> 160 mmHg systolic or > 95 mmHg diastolic on repeat measurements)
- Renal: Serum creatinine > 2.0 mg/dL or any history of renal dialysis or renal transplant.
- Metabolic: Clinically uncontrolled diabetes mellitus or a baseline HbA1c ≥ 8.0%, or clinically significant liver disease.
- Non-urologic cancer: Active malignancy, or within 3 years of enrollment, a history of treated malignancy now in full remission, except basal cell or squamous cell carcinoma of the skin.
- Respiratory: Severe lung disease or respiratory illness requiring hospitalization.
- Immunosuppression: Known immunosuppression, including but not limited to AIDS, immunosuppressive medication, or current chemotherapy.
- Transplant: Solid organ or hematologic transplant or currently being evaluated for an organ transplant.
- Substance abuse: Active alcoholism or drug addiction.
- Sleep apnea: Known moderate to severe obstructive sleep apnea that is untreated or therapy non-compliant
- Urologic conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:
- Operative: Previous prostate surgery or interventional procedure, including but not limited to BPH surgery, radiation, laser, prostate arterial embolism, balloon dilatation, or hyperthermic treatment, or prostate biopsy within 40 days of the Index Procedure.
- Infection: Urinary tract infection (UTI) (105 CFU/mL) within 90 days of enrollment or >3 UTIs within the year prior to enrollment.
- Incontinence: History of urinary incontinence.
- Retention: Requires indwelling catheter or intermittent catheterization to void or had an episode of spontaneous urinary retention within 30 days of enrollment.
- Prostatitis: History of prostatitis or chronic pelvic pain syndrome (CPPS) within 2 years of enrollment.
- Cystolithiasis: Active bladder stones
- Neurogenic bladder: Neurogenic or atonic bladder or sphincter, including etiologies of uncontrolled diabetes, Parkinson's disease, multiple sclerosis, cerebrovascular accident, or polyneuropathy.
- Anatomic abnormality: Prior or current urethral stricture, meatal stenosis, bladder neck contracture, or other urologic anatomic abnormalities that would interfere with planned treatment or confound subsequent assessment.
- Implants: Any urinary tract implants including stents, sutures, penile implants, or artificial sphincters.
- Hematuria: Hematuria without a known contributing factor within 90 days of the Index Procedure.
- Bladder cancer: Actively being treated or suspected cancer of the bladder.
- Prostate cancer:
- Confirmed or history of prostate cancer
- Baseline PSA > 15 ng/mL within 30 days of enrollment
- If PSA is between 4.0 ng/mL and 15 ng/mL, prostate cancer must be ruled out with a negative biopsy or an MRI (≤PIRADS-3) within 12 months prior to enrollment.
- Prior pelvic or rectal interventions:
- Previous pelvic irradiation or radical pelvic surgery
- Previous rectal surgery (other than hemorrhoidectomy) or a history of rectal disease that may be impacted by Index Procedure.
- Peri-procedural anticoagulation: Unable to stop anti-platelet or anticoagulation treatment for the Index Procedure per site standard of care.
- Subjects who cannot or will not comply with the following washout medication requirements within the time period specified prior to enrollment:
- 24-Hours:
- i. Taking phenylephrine or pseudoephedrine within 24 hours of the Baseline evaluation and Index Procedure.
- 1 Week:
- i. Antihistamine, anticonvulsant, or antispasmodics medications within 1 week of enrollment unless documented on a stable (unchanged) dose for 180 days prior to enrollment.
- 2 Weeks:
- i. Use of alpha blockers or daily dosage of PDE5 inhibitors (tadalafil [Cialis]) for BPH within 2 weeks prior to enrollment.
- ii. Use of anticholinergics or beta-3 adrenergic receptor agonists (e.g., mirabegron, vibegron) within 2 weeks prior to enrollment, unless documented on a stable dose for 30 days prior to enrollment.
- 3 Months:
- i. Taking estrogen, drugs producing androgen suppression, or androgens within 90 days prior to enrollment, unless documented on a stable dosage for at least 180 days prior to enrollment.
- ii. Use of Type II 5-alpha reductase inhibitor medication (e.g., finasteride [Proscar, Propecia]) within 90 days of enrollment OR anticipated use within the first 12 months of follow-up.
- 6 Months:
- i. Use of any Type I 5-alpha reductase inhibitor medication (e.g., dutasteride [Avodart]) within 180 days prior to enrollment OR anticipate use within the first 12 months of follow-up.
- ii. Taking tricyclic antidepressants that are not on a stable dose for the 180 days prior to enrollment OR anticipate stopping or changing treatment in the first 12 months of follow-up.
- Subjects who wish to maintain their fertility.
- Current or anticipated enrollment in any other randomized or interventional clinical study (registry or retrospective studies permitted).
- Vulnerable populations, including individuals who are incarcerated or institutionalized.Any physical, psychological, or developmental impairment (e.g., developmental delay) that, in the investigator's opinion, would compromise the subject's ability to provide informed consent, comply with study procedures, or complete patient-reported outcome measures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Conrad Pearson Clinic
Germantown, Tennessee, 38138
Whitney Ford (Munn), Whitney.Ford@conradpearson.com
Dr. Adam Stewart, M.D
About this study
Official title: A Prospective Randomized Pivotal Trial of the ALPFA Medical Prostate Ablation System Compared With Cystoscopy in Men With Symptomatic Benign Prostatic Hyperplasia
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.
Read the detailed description
This study aims to test how safe and effective the ALPFA BPH PFA System is for treating men over age 40 who have urinary problems caused by an enlarged prostate (BPH).The study will involve up to 250 participants in up to 30 investigational centers across the US, Canada, and European Union.
Men who agree to join the study will have health checks before treatment. Those who meet the study eligibility criteria including medication washout requirements,will be placed by chance into one of two groups. Two out of three men will receive treatment with the ALPFA BPH PFA System. One out of three men will receive a sham procedure that looks like treatment but does not deliver treatment.Participants will be followed for longer term safety and effectiveness for a total of 5 years post treatment with the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System.
Patients and site personnel administering follow-up assessments will be blinded to the randomized treatment through completion of the 3-month follow-up visit.
After 3 months, participants will be told which group they were in. Men who were in the sham group may choose to receive treatment with the ALPFA BPH PFA System. Men in the sham group who do not choose treatment by 6 months will no longer take part in the study.
All men who receive treatment will have follow-up visits at 2 weeks, 4 weeks, 3 months, 6 months, and 12 months. After that, they will be checked once a year for up to 5 years.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System, Control Device: Sham flexible cystoscopy
- Keywords
- enlarged prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) SystemDevice
After 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 cystoscopyDevice
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Device | Active comparator | Men who join the study will first have a health check to see if they can take part. If they meet the study requirements and have stopped any restricted medications, they will be assigned by chance to a treatment group and treated with the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System(Treatment) per their randomized assignment. Participants will then have follow-up visits with health checks as planned for this study Receives: Device: Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System |
| Control Device | Sham comparator | Men who join the study will first have a health check to see if they can take part. If they meet the study requirements and have stopped any restricted medications, they will be assigned by chance to a control group and treated with sham flexible cystoscopy (Control) per their randomized assignment. Participants will then have follow-up visits with health checks as planned for this study Receives: Device: Control Device: Sham flexible cystoscopy |
| Crossover Cohort | Other | Control Arm (Sham) patients can receive treatment with the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System after their 3-month follow-up assessments are completed, and participant symptom profile necessaites treatment and alll protocol defined enrollment criteria are met. The study visit follow-up schedule will restart and the subject will be followed for 60 months post ALPFA GRAIL™ Pulsed Field Ablation (PFA) System(Treatment)Unless treated with the ALPFA GRAIL™ Pulsed Field Ablation(PFA)System, the subject will be exited from the study once they have completed their 3-month follow-up visit. Receives: Device: Treatment Device: The ALPFA Medical (ALPFA) GRAIL™ Pulsed Field Ablation (PFA) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 event through 12 months post-procedure
Measured: Through 12 months post-procedure
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
Measured: Baseline to 3 months post-procedure
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.
Measured: Baseline to 12 months post-procedure
Secondary outcomes (3)
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.
Measured: 3 months
Success Stories (Responder Rate)
- 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.
Measured: 3 months
Improvement in Urine Flow
- 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, multi-center, multinational, 2:1 randomized, double-blinded, sham-controllled clinical trial of the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System. Following unblinding, sham-controlled patients may elect to receive treatment with the ALPFA GRAIL™ Pulsed Field Ablation (PFA)System or exit the study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALPFA Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Bilal Chughtai, Principal investigator, The Smith Institute of Urology/Northwell HealthDr. Dean Elterman, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592299
- Sponsor's protocol ID
- CS00004
- Acronym
- REBOUND
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No