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

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.