Benign Prostate Hyperplasia
Conditions
Interventions
Arm 1:Complete Prostatectomy (Laparoscopic/Robot-Assisted Laparoscopic)
Arm 2:Transurethral resection of the prostate (plasma or laser ablation)
Sponsors
Department of Urology, Huashan Hospital, Fudan University
Eligibility
Sex/Gender
Male
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 45 years = age = 75 years 2. Patients must meet both of the following two categories of conditions: 1)Diagnosed with benign prostatic hyperplasia, and the disease severity has met any two of the following surgical indications (according to the “Chinese Urology and Andrology Disease Diagnosis and Treatment Guidelines (2019 Edition)”): a) Recurrent hematuria b) History of acute urinary retention c) IPSS score = 20 points d) Residual urine volume = 50ml e) Maximum urinary flow rate = 4 points iii) Have undergone BRCA1/2 mutation gene testing and indicated mutation. 3. Patients who voluntarily participate and sign the informed consent form, and can cooperate to complete the entire trial process
Exclusion criteria
Exclusion criteria: 1)With severe infectious diseases such as bacteremia and sepsis. 2)Severe coagulation dysfunction. 3)Patients with severe heart, brain, lung, liver, kidney and other diseases who cannot tolerate surgery. 4)Patients with other malignant tumors. 5)Patients who clearly express concerns about postoperative side effects such as urinary incontinence and erectile dysfunction 6)Concomitant use of prohibited drugs, including systemic anti-tumor drugs and immunosuppressants. 7)Participated in other clinical trials within the last 3 months. 8)Other situations that the researcher considers inappropriate to participate in this clinical trial. 9)Patients with fertility and sexual life requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score;peak of urine flow rate;Postvoid Residual; | — |
Secondary
| Measure | Time frame |
|---|---|
| Malignant tumor;Diagnosis of prostate cancer;Postoperative adverse events; | — |
Countries
China
Contacts
Public ContactHaowen Jiang
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed