Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia
Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia
In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy
 and safety of microspheres (T-ACE Beads).
T-ACE Beads can be used for prostatic arterial embolization safely and efficiently.
 Furthermore, investigator's microspheres has advantageous characteristics in
 biodegradability, drug delivery capability, and cost-effectiveness. After the clinical trial,
 we anticipate introducing a new microsphere for Lower Urinary Tract Symptom/Benign prostatic
 hyperplasia patients, which is beneficial to the participants in precise medicine as well as
 in the pharmaceutical and medical device industry.
Inclusion Criteria:

 A. Men ≥ 50 years of age. Healthy patients or volunteers without diagnosis of Lower urinary
 tract symptoms (LUTS) / Benign prostatic hyperplasia (BPH) will not be included.

 B. Patients diagnosed of LUTS / BPH，International Prostate Symptom Score > 12 with mild to
 severe symptom of LUTS.

 C. Prostate volume > 50 mL.

 D. Urinary flow rate <15 mL / sec.

 E. Ineffectiveness after 6 months of previous medical treatment, or the side effects are
 too difficult to tolerate.

 Exclusion Criteria:

 If patients meet any of the following criteria they may not be entered into the study:

 A. Major pelvic disease, or other malignancies.

 B. Prostate specific antigen of serum > 10 ng/mL, malignant tumor not yet rule out
 (prostate specific antigen PSA>10 ng/mL).

 C. Had Prostate surgery.

 D. Chronic bacterial prostatitis.

 E. Renal dysfunction or bladder diverticulum stones caused by prostate disease obstruction.

 F. Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical
 trials under physicians' consideration.

 G. White Blood Cell< 2000 or Severe thrombocytopenia（Platelet count <50,000/μL)，or blood
 coagulation abnormalities uncorrectable .

 H. Unable to follow-up by MRI 3 times.

 I. Unable to follow-up by ultrasound or CT scan.

 J. Unwilling to sign a written informed consent form.

 K. Allergic to Iodine or other injections.

 L. Acute bacterial prostatitis.

 M. Patients with active urinary tract infections or recurrent urinary tract infections
 (>2/years), prostatitis, or interstitial cystitis.

 N. Cases of biopsy proven prostate, bladder, or urethral cancer.

 O. Patients with glomerular filtration rates less than 40 who are not already on dialysis.

 P. Patients with bilateral internal iliac arterial occlusion.

 Q. Patients with causes of bladder obstruction not due to BPH (eg urethral stricture,
 bladder neck contraction, etc).

 R. Patients with neurogenic or bladder atonia.

 S. Patients where embolization is not possible distal to collateral vessels feeding
 non-prostatic tissue.

 T. Patients with major neurologic illnesses which could have symptoms that may be similar
 to or confused for BPH (eg multiple sclerosis, Shy-Drager syndrome, spinal cord injury,
 etc.).

 U. Patients with urethral stents.

 V. Other than hemorrhoidectomy or pelvic irradiation, patients who have undergone prior
 rectal surgery.

 W. Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase
 inhibitors in the month prior to prostatic artery embolization.

 X. Allergic to pharmaceutical excipients related to Microspheres.