Benign prostatic hyperplasia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) male patients aged 50-80 years with benign prostatic hyperplasia (BPH) who have failed conservative treatment; (2) patients with prostate volume of 30~120ml; (3) international prostate symptom score (IPSS) >=10; (4) Urodynamic study indicates bladder outlet obstruction (BOO); (5) the maximum urine flow rate (Qmax) is less than 15ml/s; (6) prostate-specific antigen (PSA) < 10ng/mL (4-10ng/mL need to exclude prostate cancer); (7) subject is informed and voluntarily signs the informed consent.
Exclusion criteria
Exclusion criteria: (1) patients with abnormal cardiopulmonary function, abnormal coagulation function or other systemic diseases, who cannot tolerate anesthesia and surgery; (2) patients with obvious hyperplasia of the middle prostate gland and IPP>2cm confirmed by ultrasonography; (3) patients with prostate cancer or urinary malignant tumors; (4) patients with a history of prostate and urethral surgery; (5) dysuria that is not related to BPH; (6) patients with severe urethral stricture who cannot complete the operation; (7) patients with neurogenic bladder; (8) acute urinary tract infection, acute prostatitis or other infections; (9) high allergic constitution and allergy to the products of this clinical study; (10) participating in other clinical trials within 3 months; (11) other patients not suitable for the test considered by clinicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urodynamic study;QOL;VAS;Urine pad test;Bladder flushing time;Indwelling catheter time;Postoperative hospitalization time; | — |
Countries
China
Contacts
Beijing Chao-Yang Hospital, Capital Medical University