Prostate Diseases
Conditions
Interventions
Modified plow-shaped electrode (PKEP) group:Prostate Enucleation Using the Modified Plow-Shaped Electrode (PKEP)
B-TURP group:Removal of an enlarged prostate using bipolar transurethral resection of the prostate
HoLEP Group:Prostate enucleation using a holmium laser
Sponsors
Fuzhou University Affiliated Provincial Hospital
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >=50 years, 30 ml, =8; 4. Qmax =4 mg/dl with biopsy ruling out prostate cancer); 6. Patient meets surgical indications for BPH [Urinary retention >=2 episodes; Ineffective medical therapy; Recurrent hematuria; Recurrent urinary tract infections; Bladder outlet obstruction secondary to bladder stones; Secondary upper urinary tract hydronephrosis (with renal impairment—first relieve obstruction, then operate after renal function recovery)] 7. Signed written informed consent from the patient (including consent to randomization and treatment)
Exclusion criteria
Exclusion criteria: 1. ASA classification > Grade 3 2. Patients currently receiving antimicrobial therapy or glucocorticoid treatment; 3. Patients on anticoagulant therapy who, based on comprehensive preoperative assessment, may be at high risk for complications; 4. Renal impairment: Serum creatinine (sCr) >1.5 × upper limit of normal (ULN); 5. Hepatic impairment: AST and ALT >2.5 × ULN; total bilirubin >1.5 × ULN; 6. History of neurogenic lower urinary tract dysfunction; 7. Patients with urethral stricture; 8. Patients with severe pulmonary, cardiovascular, or hematologic disease contraindicating anesthesia and surgery; 9. Concurrent participation in any other clinical study; 10. Any of the following conditions within 12 months prior to study entry: myocardial infarction, poorly controlled angina pectoris, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, and deep vein thrombosis or pulmonary embolism persisting for 6 months; 11. Previous bladder outlet surgery; 12. Suffering from clinically significant acute illness; 13. Patient taking medications deemed by the principal investigator to interfere with participation in this trial; 14. Known central nervous system or peripheral nervous system disease; 15. Patients with any clinical evidence of prostate cancer; 16. HIV-positive status or any other immunocompromising condition; 17. Psychiatric disorder/mental illness/known cognitive impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average blood loss (estimated blood loss); | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative and postoperative complications and incidence rate;Postoperative catheterization duration;Hospital length of stay;Preoperative and postoperative PSA;Preoperative and postoperative IPSS;Maximum urinary flow rate (Qmax);Postoperative residual urine volume (PVR);Overall health-related quality of life (SF-36, ICS, SHIM, EuroQoL);IIEF-5 (erectile function);Safety outcomes (including: average blood loss, blood transfusion status, resected prostate volume, TUR syndrome, acute urinary retention, urinary incontinence, urethral stricture, bladder neck contracture, retrograde ejaculation); | — |
Countries
China
Contacts
Public ContactWu Jinfeng
Fuzhou University Affiliated Provincial Hospital
Outcome results
None listed