BPH
Conditions
Interventions
Control Group:bleomycin
test group:CalliSpheres
Sponsors
Department of Interventional Radiology, Chinese PLA General Hospital
Eligibility
Sex/Gender
Male
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Aged over 50 years old; 2. Drug treatment for more than 6 months ineffective; 3. Moderate-to-severe lower urinary tract obstruction symptoms due to benign prostatic hyperplasia: Quality of life score (QoL) >3 points, International Prostate Symptom Score (IPSS) >18 points, maximum urinary flow rate (Qmax) 50 mL; 5. Prostate-specific antigen (PSA) >4 ng/mL or prostate MRI prompts malignant tumors, prostate biopsy is required to exclude malignant lesions; 6. Those who are unsuitable or unwilling to undergo surgical treatment due to combined underlying diseases.
Exclusion criteria
Exclusion criteria: 1. Prostate malignant tumor; 2. Allergic to iodine-containing contrast agents; 3. Those who have received PAE treatment in the past; 4. Previous surgical resection of the prostate; 5. Combined with severe urinary tract infection (active stage); 6. Neurogenic bladder or detrusor dysfunction; 7. Urethral stricture; 8. Chronic renal failure; 9. Severe abnormal coagulation function; 10. Those with mental disorders who cannot cooperate; 11. Huge bladder stones (>5 cm); 12. Those who are not expected to complete postoperative follow-up; 13. Those who have metal implants (such as: steel plates, etc.) in the body cannot perform MRI scans.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prostate volume; | — |
Countries
China
Contacts
Public ContactYuan Bing
Department of Interventional Radiology, Chinese PLA General Hospital
Outcome results
None listed