Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia
Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia
The objective is to evaluate the clinical effectiveness and safety of PAE in treating
 patients with BPH.
Benign prostatic hyperplasia (BPH), non-malignant enlargement of the prostate, is a common
 condition among elderly men with a prevalence increasing with age. When sufficiently large,
 the hyperplastic nodules compress the urethral canal to cause obstruction of the urethra and
 interfere the normal flow of urine, leading to symptoms of urinary hesitancy, frequent
 urination, increased risk of urinary tract infections and urinary retention. While medication
 is often prescribed as the first treatment option, it often does not adequately restore
 normal urine flow. Many patients being treated with medication may not achieve sustained
 improvement in symptoms, or they may stop taking the medication because of side effects,
 therefore other forms of treatments may be necessary. Although surgery with transurethral
 resection of prostate (TURP) is a benchmark for BPH treatment, it involves insertion of an
 endoscope is inserted through the penis, and removal of the prostate piece by piece. While
 considered a safe technique with a mortality rate below 0.25%, it is not without adverse
 events. The most frequent complications are ejaculatory disorders (up to 80%), early urinary
 incontinence (30 to 40%), acute urinary retention caused by blood clots (2 to 5%), sexual
 impotence (up to 5%), and the need for blood transfusions (0.4 to 7%). Patients who have
 undergone TURP require surgical retreatment for lower urinary tract symptoms in 3 to 14.5% of
 cases. Others include infection and urethral stricture. Therefore TURP is only recommended
 for complicated or severe BPH due to its adverse effects. Prostatic artery embolization (PAE)
 is a potentially promising, minimally invasive alternative procedure for BPH. Results from
 early studies showed that PAE might be a safe and effective treatment for BPH.
Inclusion Criteria:

 1. Age between 50 and 80 years old.

 2. Suffered from lower urinary tract symptoms with International Prostate Symptom Score
 (IPSS) ≥13, despite medical treatment with alpha-blockers for at least 6 months, or

 3. Suffered from lower urinary tract symptoms with International Prostate Symptom Score
 (IPSS) ≥13, for whom medication is contraindicated, not tolerated or refused, or

 4. Patients with history of acute retention of urine with or without previous treatment
 with Alpha-blockers.

 5. Patients with QOL score ≥3.

 6. Patients with Urine flow rate < 15ml/second or acute urinary retention.

 7. Patients with evidence of prostatic enlargement determined by digital rectal
 examination or ultrasonography (USG), with a prostate size of not less than 40 grams.

 Exclusion Criteria:

 1. Active urinary tract infection

 2. Biopsy proven prostate or bladder cancer, or any recent cancer within 5 years other
 than basal or squamous cell skin cancer

 3. Bladder atonia, neurogenic bladder disorder or other neurological disorder that is
 impacting bladder function (e.g. multiple sclerosis, Parkinson's disease, spinal cord
 injuries, etc)

 4. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary
 obstruction due to causes other than BPH, or other potentially confounding bladder or
 urethral disease or condition

 5. Prostate size <40 grams on CT or MRI

 6. Previous non-medical BPH treatment, including surgery, TURP, needle ablation,
 microwave or laser therapy, balloon dilation, stent implantation, or any other
 invasive treatment to the prostate

 7. Any known condition that limits catheter-based intervention or is a contraindication
 to embolization, such as intolerance to a vessel occlusion procedure or severe
 atherosclerosis.

 8. Unable to have MRI imaging (e.g. metal implant including pacemaker, replacement joint,
 etc)

 9. Cardiac condition including congestive heart failure or arrhythmia, uncontrolled
 diabetes mellitus, significant respiratory disease or known immunosuppression which
 required hospitalization within the previous 6 months

 10. Baseline serum creatinine level > 160 umol/L

 11. Known upper tract renal disease

 12. Cystolithiasis or chronic hematuria within 3 months prior to study treatment

 13. Active prostatitis

 14. Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease

 15. History of pelvic irradiation or radical pelvic surgery

 16. Coagulation disturbances not normalized by medical treatment

 17. Known major iliac arterial occlusive disease

 18. Allergy to iodinated contrast agents

 19. Hypersensitivity to gelatin products