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.
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.
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.
Single group
High Intensity Focused Ultrasound
DeviceHigh 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.
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).
Frequency and proportions of adverse events and all cause hospitalization
Adverse events, probably, or possibly related to the device or surgical procedure, including any all-cause hospitalization within 30 days post-op. Frequencies and proportions of adverse events will be reported in patients likely and unlikely related to the device or surgical procedure.
Operation time
Operation time: Amount of time required from the start to the end of the HIFU procedure, the total operation time
Ablation time
Ablation time: Amount of time required for HIFU to ablate the benign prostatic tissue. Defined as the time from the first HIFU firing until the time of the last HIFU firing.
Catheterization times
Catheterization times: Number of days required for foley catheter after the procedure.
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