Status:
UNKNOWN
Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia
Lead Sponsor:
National Cheng-Kung University Hospital
Collaborating Sponsors:
The Industrial Technology Research Institute
National Cheng Kung University
Conditions:
Lower Urinary Tract Symptom
Benign Prostatic Hyperplasia (BPH)
Eligibility:
MALE
50+ years
Phase:
NA
Brief Summary
In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy and safety of microspheres (T-ACE Beads).
Detailed Description
T-ACE Beads can be used for prostatic arterial embolization safely and efficiently. Furthermore, investigator's microspheres has advantageous characteristics in biodegradability, drug delivery capabil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03239652
Start Date
January 1 2017
End Date
June 30 2020
Last Update
October 17 2019
Active Locations (1)
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1
National Cheng Kung University Hospital
Tainan, Taiwan