Benign Prostatic Hyperplasia (BPH)
Conditions
Interventions
Treatment Group:The treatment group underwent prostate ablation using the Prostatic Thermal Vapor Ablation System combined with the Disposable Prostatic Thermal Vapor Ablation Catheter, both manufactu
Control Group:The control group underwent prostate ablation using the Rezum generator by Boston Scientific in conjunction with the Rezum Delivery Device.
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
Male
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Male patients aged = 50 years. 2.Patients with symptomatic benign prostatic hyperplasia (BPH) who are scheduled to receive prostate thermal steam ablation treatment . 3.Patients with contraindications to drug therapy, or those who refuse drug therapy, or those with suboptimal response to drug therapy. 4.International Prostate Symptom Score (IPSS) of = 8 points . 5.Maximum urinary flow rate (Qmax) of < 15 ml/sec (with a single voided volume = 125 ml) . 6.Post-void residual urine volume (PVR) of = 250 ml . 7.Prostate volume ranging from 30 cm³ to 80 cm³ (inclusive) . 8.Patients who understand the trial objectives, voluntarily agree to participate in the trial, and sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1.Patients with a history of unstable angina pectoris, myocardial infarction, transient ischemic attack (TIA), or stroke within the past 6 months. 2.Patients complicated with bladder, urethral, or ureteral calculi. 3.Patients with unresolved complications from previous prostate biopsy. 4.Patients with an indwelling urinary catheter for more than 3 months. 5.Patients who have taken antiplatelet or anticoagulant drugs (excluding low-dose aspirin = 81 mg/day) within the past 10 days. 6.Patients who have taken antihistamines, anticonvulsants, or antispasmodics within the past 7 days, unless there is documentation of a stable dosage for at least 6 months. 7.Patients with coagulation dysfunction, i.e., those with bleeding tendency or active bleeding, and abnormal coagulation function test results (prothrombin time [PT] or thrombin time [TT] prolonged by > 3 seconds, or activated partial thromboplastin time [APTT] prolonged by > 10 seconds). 8.Patients with New York Heart Association (NYHA) functional class III or higher cardiac function. 9.Patients with poorly controlled diabetes mellitus (glycated hemoglobin = 8.5%). 10.Patients with clinically suspected or pathologically confirmed prostate cancer. 11.Patients complicated with cardiac arrhythmias that cannot be controlled by medications or medical devices. 12.Patients with unhealed previous rectal surgery (excluding hemorrhoidectomy) or a history of rectal disease. 13.Patients complicated with severe systemic diseases (e.g., severe respiratory diseases requiring hospitalization, immunosuppressive diseases). 14.Patients complicated with urethral stricture, bladder neck contracture, or abnormal urethral anatomy that impedes the insertion and use of medical devices. 15.Patients complicated with gross hematuria. 16.Patients with known stents or other implants in the urethra or prostate, or those with a penile prosthesis implanted. 17.Patients with a history of invasive prostate interventions (e.g., radiofrequency ablation, microwave/laser therapy, balloon dilation, urethral sphincter implantation, etc.), pelvic radiotherapy, or radical pelvic surgery. 18.Patients with known uncontrolled urinary tract infections. 19.Patients with known acute prostatitis or epididymitis. 20.Patients with known multiple sclerosis, Parkinson's disease, or other neurological disorders that affect bladder, sphincter, or detrusor muscle function. 21.Patients who are currently participating in other interventional drug or medical device clinical trials and have not completed the primary endpoint assessment. 22.Patients deemed unsuitable for participation in this clinical trial by the investigators for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International prostate symptom score, IPSS; | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life, QOL;Maximum urinary flow rate, Qmax;post void residual, PVR;International Index of Erectile Function-Erectile Function, IIEF-EF;Male Sexual Health Questionnaire Ejaculatory Dysfunction, MSHQ-EjD;Prostate Volume, PV;Device Operational Performance; | — |
Countries
China
Contacts
Public ContactShudong Zhang
Peking University Third Hospital
Outcome results
None listed