[?]benign prostatic hyperplasia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male patients with benign prostatic hyperplasia (BPH) aged 50 to 85 years; 2. Prostatic volume 30~120ml; 3. The international prostate symptom score (IPSS) was greater than or equal to 12 points; 4. The maximum urinary flow rate (Qmax) was less than or equal to 15 ml / s; 5. Prostate specific antigen (PSA) was less than that of 10ng/mL (4-10ng/mL excluded prostate cancer). The subjects voluntarily participated and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Abnormal cardiopulmonary function, abnormal coagulation mechanism or other systemic diseases, unable to tolerate anesthesia and surgery; 2. The middle lobe hyperplasia is obvious, IPP > 2cm (intravesial prostatic protru-sion,IPP, prostatic protrusion into the bladder distance); 3. 1 M alpha receptor blockers or androgen drugs; 4. Prostate cancer, malignant tumor of urinary system; 5. Patients with a history of prostate and urethral surgery; 6. Abnormal urination disease unrelated to BPH; 7. Patient with severe urethral stricture who is unable to perform the operation; 8. Acute urinary tract infection, acute prostatitis, etc.; 9. Neurogenic bladder; 10. People with high allergies and known allergies to this clinical study; 11. Those who participated in other clinical trials within 3 months; 12. Patients whose clinicians consider it unsuitable to be involved.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International prostatic symptom scale (IPSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| maximum urinary flow rate (QmaX);residual urine volume (RUV);quality of life score (urinary symptom disturbance score, QOL);types and degree of urinary incontinence after operation (International Incontinence Association recommended 1h pad test);operative time;operative bleeding volume;postoperative bladder irrigation time;postoperative indwelling catheter time;postoperative hospitalization time; | — |
Countries
China
Contacts
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology