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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07194187
Status
Not Yet Recruiting

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Conditions

  • BPH
  • Bladder Outlet Obstruction

Eligibility Criteria

Sex
MALE
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Sep 20, 2027
Completion
Sep 20, 2027

Study Design

Enrollment
17 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

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

Primary Outcome Measure

Change in The International Prostate Symptom Score (I-PSS) [ Time Frame: baseline and 6 months post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Union SquareNew YorkNew York10003
Maritza Cales
[email protected]
(212) 844-6239
Michael Palese (PRINCIPAL_INVESTIGATOR)

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By research site
Mount Sinai Union Square· New York, NY

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