Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia
NCT ID: NCT03239652
Last Updated: 2019-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2017-01-01
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Taiwan ACE Beads microspheres
The maximum use of dosage will not exceed 100 milligrams. The embolization procedure usually lasts less than an hour.
Taiwan ACE Beads
Similar with conventional Transcatheter Arterial chemo-embolization, radiologist use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.
Interventions
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Taiwan ACE Beads
Similar with conventional Transcatheter Arterial chemo-embolization, radiologist use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.
Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
MALE
No
Sponsors
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The Industrial Technology Research Institute
OTHER
National Cheng Kung University
OTHER
National Research Program for Biopharmaceuticals, Taiwan
OTHER
National Cheng-Kung University Hospital
OTHER
Responsible Party
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Principal Investigators
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Yuh-Shyan Tsai, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, National Cheng Kung University Hospital, College of medicine, National Cheng Kung University, Tainan 70403, Taiwan
Locations
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National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Liu YS, Lin XZ, Tsai HM, Tsai HW, Chen GC, Chen SF, Kang JW, Chou CM, Chen CY. Development of biodegradable radiopaque microsphere for arterial embolization-a pig study. World J Radiol. 2015 Aug 28;7(8):212-9. doi: 10.4329/wjr.v7.i8.212.
Noor A, Fischman AM. Prostate Artery Embolization as a New Treatment for Benign Prostate Hyperplasia: Contemporary Status in 2016. Curr Urol Rep. 2016 Jul;17(7):51. doi: 10.1007/s11934-016-0608-0.
Other Identifiers
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A-BR-105-055
Identifier Type: -
Identifier Source: org_study_id
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