Benign prostatic hyperplasia
Conditions
Interventions
Experimental group:100-300um 8Spheres conformal embolic microspheres
Control group:100-300um Polyvinyl alcohol(PVA)
Sponsors
Affiliated Hospital of Traditional Chinese Medicine, Southwest Medical University
Eligibility
Sex/Gender
Male
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Men over 60 years old with definite diagnosis of BPH; 2.After more than 6 months of medication, there were still moderate to severe LUTS; 3.They have sexual dysfunction or are willing to bear the risk of embolization; 4.The maximum urinary flow rate was less than 12 ml/s; 5.Acute urinary retention symptoms occurred; 6.For mild to moderate LUTS patients whose maximal uroflow rate was less than 12 ml/s and other treatments were ineffective; 7.The volume of prostate was more than 30ml, and TURP (Transurethral prostatectomy) could not be performed; 8.Patients who refused surgical treatment; 9.The organ function level must meet the following requirements: Absolute neutrophil count(ANC)>=1.0 x 10^9/L; Hemoglobin (Hgb) >= 8g/dl (80g/L); Platelet count (PLT) >= 75000/µL (75x10^9/L); Renal function: Creatinine clearance rate > 30 ml/min; Liver function: Serum bilirubin < 1.5 x upper limit of normal value (i.e. < 42 µmol/L); ALT and / or AST <= 3 x upper limit of normal value (ALT <= 150 IU/L; AST <= 120IU/L); 10.Physical ECOG <= 2 points; 11.Understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with malignant prostate cancer confirmed by biopsy; 2.MRI showed that the patients had severe iliac atherosclerosis or tortuosity; 3.The diverticulum of bladder(>5cm) or bladder stone (>2cm); 4.Chronic renal failure (glomerular filtration rate 12mg/dl); 5.Urinary tract infection in active period; 6.Abnormal coagulation function; 7.Bladder dysfunction caused by neurologic diseases; 8.Chronic bladder dysfunction; 9.Patients with prostate specific antigen > 40ng/dl (except for malignant tumors excluded by biopsy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score;Life Quality Score;Maximum Flow Rate;Residual Urine Volume; | — |
Countries
China
Contacts
Public ContactXu Yanneng
Affiliated Hospital of Traditional Chinese Medicine, Southwest Medical University
Outcome results
None listed