Benign Prostatic Hyperplasia (BPH) Clinical Trial
Official title:
Safety and Efficacy of Prostatic Artery 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).
Status | Recruiting |
Enrollment | 12 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Cheng Kung University Hospital | Tainan |
Lead Sponsor | Collaborator |
---|---|
National Cheng-Kung University Hospital | National Cheng Kung University, National Research Program for Biopharmaceuticals, Taiwan, The Industrial Technology Research Institute |
Taiwan,
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patients Survival (Safety) | Survival rate was evaluated since treatment day until the date of death or final observation. | An average of 12 weeks. | |
Secondary | Change on Patient's Symptoms | Change on patients' International Prostate Symptom Score (IPSS) | Before treatment, one and three months after treatment | |
Secondary | Change on Prostate Volume | Prostate volume measured using MRI | Before treatment, one and three months after treatment. | |
Secondary | Change in serum Prostate Specific Antigen (PSA) concentration | Measurement of Prostate Specific Antigen in patients undergoing this treatment. | Before treatment, one and three months after treatment. |
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