Prostate artery embolization for symptomatic benign prostatic hyperplasia

  Last Updated on 6 October, 2017

Sponsor:
Vascular and Interventional Radiology Foundation (www.virf.org)
Department of Imaging and Interventional Radiology, the Chinese University of Hong Kong

 Study design and purpose

This is a prospective single-arm study conducted in accordance to the Declaration of Helsinki and International Conference on Harmonisation-Good Clinical Practice (ICH-GCP).  Eighty patients known to have benign prostatic hyperplasia (BPH) will be recruited.  A signed informed consent will be obtained from each patient.  Prostate artery embolization (PAE) treatment will be given.

The objective of this study is to evaluate the clinical effectiveness and safety of PAE in treating patients with BPH.

Patient selection in Urology Clinic

Patients with International Prostate Symptom Score (IPSS) ≥13, who had been previously on the waiting list for TURP, who had been previously treated with selective a-blockers without success, or those for whom medication is contraindicated, not tolerated or refused.Patients with International Prostate Symptom Score (IPSS) ≥13, who had been previously on the waiting list for TURP, who had been previously treated with selective a-blockers without success, or those for whom medication is contraindicated, not tolerated or refused.

Symptom severity is assessed by using the International Prostate Symptom Score (IPSS: scale of 0 [best] to 35 [worst]).

Erectile function is assessed by using the International Index of Erectile Function (IIEF: score 0- 25, evaluated as severe, moderate, mild-to-moderate, mild and no dysfunction).

Baseline quality of life (QOL) is assessed by using the question, ‘‘If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?’’ QOL score ranges from 0 [delighted] to 6 [terrible].

Urodynamic studies including peak urinary flow rate are performed with the indwelling catheter removed.

PSA level is checked.

Prostatic biopsy is offered to all patients with increased risk of having prostatic malignancy because of a prostate-specific antigen (PSA) level of more than 4 mg/L, persistent rising PSA level, or abnormal digital rectal examination.

Eligibility criteria

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 at a total bladder volume ≥150mL or acute urinary retention.
  7. Patients with evidence of prostatic enlargement determined by digital rectal examination or 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
  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

Study location
Prince of Wales Hospital 

Principal investigators
Professor Simon Chun-Ho Yu