High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction

NCT07194187 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: STUDY-24-00513
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To assess the efficacy of HIFU therapy for benign prostatic tissue ablation in patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction (BOO) that caused by Benign prostatic hyperplasia (BPH). The primary objective of the study is to determine the efficacy of HIFU therapy by assessing the changes in IPSS score in 6-month post HIFU procedure for BPH with compared to baseline. The secondary objectives of this study are as follow:

• To assess any adverse events related to the procedure or device.
• To assess the operation related characteristics including: total operation time and ablation time required in HIFU procedure for BPH, total catheterization time after the HIFU procedure for BPH, and categorical ablation zone
• To assess the patient's post operative pain level at different post op time points.
• To assess the urinary flow and symptoms improvement by studying the changes in IPSS, Qmax, and PVR at different post op time points compared to the baseline.
• To assess the effectiveness of HIFU by studying the changes in PSA levels, types of medication for BPH or any urologic condition, proportion of patients who are taking BPH medication, prostate volume, and prostate calcification level and the reoperation rate within 12-month post-op.
• To assess changes in patients' sexual function at different post op time points. The hypothesis is that a HIFU ablation is a safe and effective treatment for patients with LUTS due to BOO from BPH.

Conditions

Bladder Outlet Obstruction; BPH

Keywords

High-intensity focused ultrasound; Interventional; Single Arm; benign prostatic hyperplasia treatment; International Prostate Symptom Score; Device Safety

Outcome Measures

Primary Outcomes (1)

• Change in The International Prostate Symptom Score (I-PSS)

  The International Prostate Symptom Score (I-PSS) is designed to assess severity of symptoms in benign prostatic hypertrophy. It is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 with higher score indicating more symptomatic. It classifies patients' symptomatology as follows: Mild (symptom score ≤ 7), Moderate (score 8-19), and Severe (score 20-35).

  baseline and 6 months post-treatment

Secondary Outcomes (15)

• Frequency and proportions of adverse events and all cause hospitalization

  within the first 30 days after the HIFU intervention

• Operation time

  approximately 45-120 minutes

• Ablation time

  average 15-45 minutes

• Catheterization times

  1 week post-procedure, or until the patient passes the trial of void

• Categorical Ablation Zones (Peripheral, Transitional, or Central Prostate Zones)

  During procedure

Study Arms (1)

Participants with benign prostatic hyperplasia

EXPERIMENTAL

HIFU therapy for benign prostatic tissue ablation in patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction

Device: High Intensity Focused Ultrasound

Interventions

High Intensity Focused Ultrasound DEVICE

High Intensity Focused Ultrasound (HIFU) works with an image-guided transrectal probe that utilizes 3-10 MHz ultrasound waves at very high powers (200W). These waves can be very precisely directed at target tissue. Through both thermal and mechanical forces (shearing motion and mechanical energy leading to hyperthermia) the focal point core temperature can be raised significantly (\> 80°C) leading to coagulative necrosis to the target tissue while sparing surrounding tissue. The degree of tissue injury is based on the temperature and the duration of exposure, with the cooling off time allowing for the heat to dissipate to prevent the damage to surrounding tissues. The most common device involves a transrectal transducer with ultrasound guidance that can be performed under either general or spinal anesthesia. The device has been FDA approved to be used in ablation of prostatic tissue since 2018.

Also known as: HIFU

Participants with benign prostatic hyperplasia

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged 45 - 80 diagnosed with LUTS due to BOO from BPH.
• Prostate size \> 30cc and \< 80cc as measured by transrectal ultrasound (TRUS) or MRI within 1 year prior to treatment.
• A documented history of refusal to take medical therapy, inadequate or failed response to medical therapy, or contraindications to medical therapy.
• Initial baseline International Prostate Symptom Score (IPSS) greater than or equal to 12 which denotes moderate to severe symptoms.
• Baseline peak urinary flow rate (Qmax) of less than 15 mL/s1
• Baseline serum creatinine \< 2 mg/dL within 30 days prior to surgery
• Mental capacity, willingness, and ability to sign a study specific informed consent form

You may not qualify if:

• BMI \> 42
• Patients with an obstructing prostatic median lobe as measured by baseline preliminary imaging and/or confirmed on cystoscopy examination.
• Patients with latex allergies which would permit latex catheterization perioperatively as silicone catheterization is not recommended during HIFU treatment.
• Patients with extensive calcification in the treatment area of the prostate as measured by preoperative imaging with TRUS or MRI and as evaluated by hospital radiology or the principal investigator. Extensive calcification is defined as where the calcification in posterior peripheral zone, which may interfere with experimental treatment procedure, and it is determined by hospital radiologist and further assessed by the PI.
• Patient unable to stop anticoagulants, antiplatelet agents, or NSAIDS (including aspirin \> 100mg) prior to treatment which is standard of care.
• Patients using immunosuppressants including corticosteroids (except inhalants) who are unable to withhold medications prior to treatment which is standard of care.
• Known and documented coagulopathy or platelet disorder
• Contraindication to both general and spinal anesthesia which are standard of care.
• Severe illness that would prevent complete study participation.
• History of active or prior treatments for current/suspected PCa.
• Diagnosis of polyneuropathy
• Bladder calculi or bladder diverticulum (pouch size \> 20% of full bladder size)
• Active infection, including urinary tract infection or prostatitis.
• Evidence of hydronephrosis on imaging.
• Pre-op urinary catheter uses daily.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Union Square

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Male Urogenital Diseases

Study Officials

• Michael Palese, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monali Fatterpekar

CONTACT

(212) 241-0751; monali.fatterpekar@mountsinai.org

Ping Ting Yan

CONTACT

PingTing.Yan@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Site Chair Department of Urology

Model Details: This is a single-arm study evaluating the efficacy and safety of the device. All participants will be treated at the same center and will receive the same intervention and follow-up protocol.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 26, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): September 20, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. For individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link tbd).

Locations

US (1)