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High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

NCT07194187•Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - 80 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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.
+18 more criteria

Locations (1)

Mount Sinai Union Square

New York, New York, United States

Key Dates

Start Date

January 12, 2026

Primary Completion Date

September 20, 2027

Completion Date

September 20, 2027

Last Updated

December 12, 2025

Enrollment

ESTIMATED participants

Conditions

Bladder Outlet ObstructionBPH

Interventions

High Intensity Focused Ultrasound

DEVICE

Contacts

Monali Fatterpekar

CONTACT

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

Ping Ting Yan

CONTACT

PingTing.Yan@mountsinai.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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