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

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: Amount of time required from the start to the end of the HIFU procedure, the total operation 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: Number of days required for foley catheter after the procedure.

Categorical ablation zones: Defined as the prostate area involved in HIFU ablation, including the peripheral, transitional, or central zone. This outcome will be recorded as a categorical variable based on the anatomical region(s) of the prostate targeted by the ablation.

Patient's post-op pain level will be assessed using the M-GUPI pain questionnaire: a pain questionnaire to assess their postoperative pain. Total score of the M-GUPI will be analyzed along with patients' use of opioid pain medication to assess patient pain levels at discharge after HIFU procedure.

The M-GUPI questionnaire has 10 pain items (total pain subscale score 0-23), 2 urinary symptom items (total urinary subscale score 0-10), and 3 QOL items (total QOL subscale score 0-12). As with the NIH-CPSI, the scores from each item are summed for a total score that ranges from 0 to 45, higher scores indicate greater severity.

Symptoms and urinary flow improvement are assessed through changes in IPSS scores: Difference in IPSS scores at 1 month, 3 months, and 12 months post-treatment compared to pre-op baseline. IPSS score is a standardized questionnaire for assessing urinary flow. The total score can range from 0 to 35 (asymptomatic to very symptomatic). It classifies patients' symptomatology as follows: Mild (symptom score ≤ 7), Moderate (score 8-19), and Severe (score 20-35).

Symptoms and urinary flow improvement are assessed through changes in Qmax .

Qmax is the maximum flow rate of urine, measured in milliliters per second (ml/s). A Qmax value below 15 ml/s may suggest urinary issues

Symptoms and urinary flow improvement are assessed through changes in PVR. PVR is the amount of urine left in the bladder after urination.

Effectiveness of HIFU is assessed through changes in the type of BPH medications and proportions of patients who are taking BPH medications following treatment compared to pre-op baseline BPH medications at discharge after HIFU procedure, 1 week, 1-, 3-, 6-, and 12- month post op follow up. Types of BPH medications include Flomax, Uroxatral, Cardura, Rapaflo, Hytrin, Proscar, Propecia, Avodart.

Effectiveness of HIFU is assessed through change from pre-op baseline PSA to PSA at 6-month and 12-month post op.

Prostate-specific antigen (PSA) is a protein produced by prostate cells. The PSA test is done to help screen for and monitor prostate cancer in men.

Effectiveness of HIFU is assessed through change from pre-op baseline prostate measurement to 6- to 12- month post-op. Pre-op baseline measurement will be defined as within 1 year prior to the HIFU BPH procedure. This will be performed through transrectal ultrasound or MRI scan to measure the size of prostate gland and assess the calcification level of prostate. If patients have both imaging results, MRI values will be favored for more accurate assessment. Post operative imaging will be assessed in between 6 to 12 months post-op and compared with the pre-op baseline imaging result. Differences of the prostate size and calcification level between 6-12 months post-op versus pre-op baseline will be collected.

Effectiveness of HIFU is assessed through re-operation rate at 12 months: number of BPH procedures that patient required after the HIFU procedure.

Difference in erectile or ejaculation dysfunction in patients who are sexually active in baseline pre-op:

Difference in IIEF score at 3-months post-op minus pre-op baseline and at 6-month post-op minus pre-op baseline. The International Index of Erectile Function is a validated questionnaire used to assess patients' erectile function and is standard of care to assess prior to and following BOO treatment to measure treatment success and complications. Erectile dysfunction severity is classified as follows based on the score: 1-10 indicates severe dysfunction; 11-16, moderate dysfunction; 17-21, mild to moderate dysfunction; 22-25, mild dysfunction; and 26-30, no dysfunction. Total score ranges from 15-75, total score indicates better health outcomes.

Difference in erectile or ejaculation dysfunction in patients who are sexually active in baseline pre-op: Difference in MSHQ-EjD scores at 3-months post-op minus baseline and at 6-month post-op minus pre-op baseline. The Male Sexual Health Questionnaire- Ejaculatory Dysfunction is a validated questionnaire used to assess patients' ejaculatory function and is standard of care to assess prior to and following BOO treatment to measure treatment success and complications. Scores range from 0 to 20, higher scores indicate better health outcomes. Scores below 8 suggest potential ejaculatory dysfunction, including premature or delayed ejaculation. Scores between 9 and 12 indicate moderate concerns that may not meet clinical criteria for dysfunction. Scores above 12 generally reflect normal ejaculatory function with minimal concerns.