Benign Prostatic Hyperplasia (BPH)
Conditions
Interventions
Experimental group:The experimental group underwent prostate ablation using disposable steep pulse ablation electrode needles produced by Hunan Endovascular Device Co.,Ltd., in conjunction with steep
Control group:The control group was treated with the standard drug for benign prostatic hyperplasia (BPH)
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
Male
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Male, aged >=45 years and =30 cm^3 and =12; 5.Post-void residual volume (PVR) =5 mL/s and =125 mL; 7.The subject or their legally authorized representative is able to understand the study purpose, willing to comply with the interventional procedure and follow-up visits, and voluntarily agrees to participate by providing written informed consent.
Exclusion criteria
Exclusion criteria: 1.Subjects with a confirmed or prior history of prostate cancer. (Patients requiring biopsy must undergo prostate biopsy; those with biopsy results indicating benign prostatic hyperplasia may be enrolled.); 2.Presence of any condition other than BPH that may cause lower urinary tract symptoms or alter urinary flow, as determined by the investigator (e.g., neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute/chronic prostatitis, acute/chronic urinary tract infection); 3.Current diagnosis of bladder or prostatic urethral stones; 4.History of spontaneous urinary retention within 6 months prior to enrollment; 5.Urinary incontinence due to impaired sphincter function, or severe urge incontinence; 6.Presence of macroscopic hematuria at screening; 7.Implantation of cardiac pacemakers, implantable defibrillators, metal pelvic or hip replacements, or any component of an implanted neurostimulation system (regardless of its operational status); 8.Presence of an artificial urinary sphincter or stent in the urethra or prostate, or a penile prosthesis; 9.Previous invasive prostate therapies (e.g., radiofrequency ablation, balloon dilation, microwave therapy, laser therapy, transurethral resection, prostatic urethral stent, lift procedure); 10.History of pelvic radiotherapy or radical pelvic surgery; 11.Occurrence of major cardiovascular or cerebrovascular events within 3 months prior to enrollment, including heart failure, unstable angina, myocardial infarction, transient ischemic attack, or stroke; 12.Use of alpha-blockers, phosphodiesterase type 5 inhibitors (PDE-5Is), muscarinic receptor antagonists, beta-3 agonists, or anticholinergic drugs within 4 weeks prior to baseline assessment; 13.Use of estrogen-based agents, androgen suppression therapy, or anabolic steroids within 3 months prior to baseline assessment; 14.Use of type II 5-alpha reductase inhibitors within 3 months prior to baseline assessment; 15.Use of any 5-alpha reductase inhibitors within 6 months prior to baseline assessment; 16.Use of antiplatelet or anticoagulant therapy (except low-dose aspirin) within 10 days prior to treatment; 17.Use of antihistamines within 7 days prior to treatment; 18.History of epilepsy; 19.Known hematologic disorders, abnormalities, or coagulation dysfunction; 20.Severe hepatic or renal impairment: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal; serum creatinine >3.0 mg/dL (266 µmol/L) or on dialysis; 21.Contraindications to surgery or anesthesia, or known allergy to nickel, titanium, or stainless steel; 22.Life expectancy <1 year; 23.Participation in another investigational drug or device clinical trial within 3 months prior to screening, ongoing participation, or planned participation during the study period; 24.Any other condition considered by the investigator to make the subject unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum urinary flow rate;Post-void residual urine volume;Prostate volume;Quality of life score;International Index of Erectile Function score ;Device handling performance evaluation; | — |
Countries
China
Contacts
Public ContactLong Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed