Benign prostatic hyperplasia
Conditions
Interventions
Sponsors
First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
Male
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Benign prostatic hyperplasia (BPH) patients aged 50 to 85 years; 2. Prostate volume 30-120 ml; 3. If the International Prostate Symptom Score (IPSS) is greater than or equal to 12 points; 4. When the maximum urinary flow rate (Qmax) is less than 15 ml/s. 5. One of the following surgical indications was met: 1) Residual urine volume (PVR) greater than or equal to 50 ml; 2) Recurrent urinary retention; 3) Recurrent hematuria; 4) Poor efficacy of drug treatment; 5) Recurrent urinary tract infection; 6) Bladder calculi; 7) Secondary upper urinary tract hydrops (with or without renal impairment); 8) Prostate specific antigen (PSA) less than 10 ng/mL (4-10 ng/mL excludes prostate cancer); 9) Subjects were informed and voluntarily signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: (1) Those with abnormal cardiopulmonary function, abnormal coagulation mechanism or other systemic diseases who cannot tolerate anesthesia and surgery; (2) Proliferation of the middle lobe was obvious, IPP > 2cm (intravesical prostatic protru sion, IPP, distance of prostate protru sion to bladder); (3) patients with a history of prostate and urethral surgery; (4) Patients with severe urethral stricture who can not complete the operation; (5) Acute urinary tract infection, acute prostatitis and other infections; (6) Urinary disorders unrelated to BPH; (7) High allergic constitution and known allergies to the products of this clinical study; (8) refusing to sign the informed consent; (9) Those who participated in other clinical trials within 3 months; (10) Other patients with clinical or laboratory conditions considered by some researchers should not participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Qmax;PVR;QOL;VAS;1H urinary pad test;Bladder flushing time;Indwelling catheterization time;Postoperative hospital stay; | — |
Countries
China
Contacts
Public ContactLingwu Chen
First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed