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

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.

Interventions

• Device High Intensity Focused Ultrasound
  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

Primary outcome measures

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

Secondary outcome measures (12)

• Frequency and proportions of adverse events and all cause hospitalization [Time frame: within the first 30 days after the HIFU intervention]
• Operation time [Time frame: approximately 45-120 minutes]
• Ablation time [Time frame: average 15-45 minutes]
• Catheterization times [Time frame: 1 week post-procedure, or until the patient passes the trial of void]
• Categorical Ablation Zones (Peripheral, Transitional, or Central Prostate Zones) [Time frame: During procedure]
• Male-Genitourinary Pain Index (M-GUPI) pain questionnaire [Time frame: at discharge after HIFU procedure (expected time: Post-op Day 1), 1-week and 1-month post-op]
• Changes in IPSS scores [Time frame: Baseline, 1-, 3-, 12- months post-treatment]
• Changes in maximum flow rate (Qmax) [Time frame: Baseline, 1-, 3-, 6-, 12- months post-treatment]
• Changes in Post-Void Residual (PVR) [Time frame: Baseline, 1-, 3-, 6-, 12- months post-treatment]
• Changes in the type of BPH medications [Time frame: Baseline, 1 week, 1-, 3-, 6-, and 12- month post-treatment]
• Change in Prostate Specific Antigen (PSA) level. [Time frame: Baseline, 6-, and 12- month post-treatment]
• Change in Prostate measurement [Time frame: Baseline, 6-, and 12- month post-treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• Mount Sinai Union Square — New York

Identifiers

NCT: NCT07194187 · STUDY-24-00513

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗