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

N/ANot Yet RecruitingNCT07194187

Icahn School of Medicine at Mount Sinai17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Bladder Outlet Obstruction

Eligibility

Sex: MALEMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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. * Diagnosis of polyneuropathy * Bladder calculi or bladder diverticulum (pouch size \> 20% of full bladder size) * Active infection, including urinary tract infection or prostatitis. * Evidence of hydronephrosis on imaging. * Pre-op urinary catheter uses daily. * Previous urinary tract surgeries such as, but not limited to prior surgery for LUTS, urinary diversion, artificial urinary sphincter, or penile prosthesis. * Diagnosis of clinically significant urethral stricture, meatal stenosis, severe phimosis, or bladder neck contracture * Known damage to the external urinary sphincter. * Open heart surgery or cardiac arrest \< 180 days prior to the date of informed consent * Known illicit substance abuse. * Use of anticholinergics (specifically for bladder problems). Use of general anticholinergics is allowed if they do not have documented adverse urinary side effects. * Dementia or psychiatric conditions which prevent them from completing the required follow up. * Prior pelvic radiotherapy * Participation in another ongoing investigational study that could affect responses. * Unwillingness to accept a transfusion should it be required. * No members of vulnerable populations will be included in our study. * History or current diagnosis of chronic prostatitis. * Diagnosis or prior treatment for chronic pelvic pain syndrome.

Outcomes

Primary Outcomes

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).

Time frame: baseline and 6 months post-treatment

Secondary Outcomes

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.

Time frame: within the first 30 days after the HIFU intervention

Operation time

Operation time: Amount of time required from the start to the end of the HIFU procedure, the total operation time

Time frame: approximately 45-120 minutes

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.

Time frame: average 15-45 minutes

Catheterization times

Catheterization times: Number of days required for foley catheter after the procedure.

Time frame: 1 week post-procedure, or until the patient passes the trial of void

Categorical Ablation Zones (Peripheral, Transitional, or Central Prostate Zones)

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.

Time frame: During procedure

Male-Genitourinary Pain Index (M-GUPI) pain questionnaire

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.

Time frame: at discharge after HIFU procedure (expected time: Post-op Day 1), 1-week and 1-month post-op

Changes in IPSS scores

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).

Time frame: Baseline, 1-, 3-, 12- months post-treatment

Changes in maximum flow rate (Qmax)

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

Time frame: Baseline, 1-, 3-, 6-, 12- months post-treatment

Changes in Post-Void Residual (PVR)

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

Time frame: Baseline, 1-, 3-, 6-, 12- months post-treatment

Changes in the type of BPH medications

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.

Time frame: Baseline, 1 week, 1-, 3-, 6-, and 12- month post-treatment

Change in Prostate Specific Antigen (PSA) level.

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.

Time frame: Baseline, 6-, and 12- month post-treatment

Change in Prostate measurement

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.

Time frame: Baseline, 6-, and 12- month post-treatment

Number of BPH procedures

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

Time frame: 12- month post-treatment

Change in the International Index of Erectile Function (IIEF) questionnaire

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.

Time frame: Baseline, 3- and 6- months post treatment

Change in the Male Sexual Health Questionnaire- Ejaculatory Dysfunction (MSHQ-EjD)

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.