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

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.

NCT Number	NCT07194187
Lead Sponsor	Icahn School of Medicine at Mount Sinai
Conditions	Bladder Outlet Obstruction, BPH
Enrollment	17 participants
Start Date	2026-09-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2029-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-10