Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)

This is an interventional treatment trial for Benign Prostatic Hypertrophy focused on measuring Prostate Artery Embolization (PAE), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS), PAE, BPH, LUTS, Prostate Artery Embolization, Embospheres Read More

Inclusion Criteria:

• Patients selected for this study must meet all of the following criteria:

  • Age ≥ 50 years
  • Lower urinary tract symptoms secondary to BPH as defined by:
  • IPSS Symptom Index ≥ 12
  • Maximum Uroflow rate (Qmax) of ≤ 12cc per sec
  • Prostate of ≥ 90 gm as determined by MRI or transrectal ultrasound of the prostate (TRUS)

Exclusion Criteria:

• Patients meeting any of the following criteria will be excluded from the study.

  • Age less than 50 years
  • Prostate cancer
  • Bladder cancer
  • Severe, life-threatening allergy to iodinated contrast
  • Bilateral internal iliac artery occlusion
  • Causes of obstruction other than BPH such as stricture disease
  • Neurogenic bladder or other causes of bladder atonia
  • Post void residual greater than 250 cc
  • Any contraindication to embolization, including
  • Patients intolerant to occlusion procedures
  • Vascular anatomy or blood flow that precludes catheter placement or embolic agent injection
  • Presence or likely onset of vasospasm
  • Presence or likely onset of hemorrhage
  • Presence of severe atheromatous disease
  • Presence of feeding arteries smaller than distal branches from which they emerge
  • Presence of collateral vessel pathways potentially endangering normal territories during embolization
  • History of any illness or surgery that might confound the results of the study, which produces symptoms that might be confused with those of the disease process under consideration, or which poses additional risk to the patient.
  • Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
  • Confirmed or suspected bladder cancer
  • Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease
  • Previous pelvic irradiation or radical pelvic surgery
  • Recent (within 3 months) cystolithiasis
  • History or presence of urethral strictures, bladder neck contracture, potentially confounding bladder pathology, or (within 5 years) prostatitis
  • Active urinary tract infection

  • Concomitant medications:

    (i) Use of anti histaminics, anti convulsants, and antispasmodics within 1 week of treatment unless there is documented evidence that the patient has been on the same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study) (ii) Use of alpha blockers, anti-cholinergics, androgens, and gonadotropins-releasing hormonal analogs within 2 months of treatment (iii) Use of 5 alpha reductase inhibitors within 6 months of treatment

  • Compromised renal function (i.e. serum creatinine level greater than 1.8 mg/dl, or upper-tract disease)