Benign Prostatic Hyperplasia, BPH
Conditions
Interventions
treatment group:Transurethral enucleation of the prostate using an superpulsed thulium fiber laser treatment machine
control group:Transurethral enucleation of the prostate using a continuous-wave thulium fiber laser machine
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Male patients aged 50-85 years old who meet the diagnostic criteria for benign prostatic hyperplasia (BPH) and require surgical intervention; 2. Preoperative I-PSS score >=8; 3. Preoperative maximal urinary flow rate =150 ml; 5. Agree to participate in the clinical trial and have signed the informed consent form; 6. Able to communicate well with the investigator and comply with the requirements of the trial protocol. (6) Can communicate well with the investigator and comply with the requirements of the trial program.
Exclusion criteria
Exclusion criteria: 1. Those with urethral strictures that prevented placement of surgical instruments. 2. Total PSA>10ng/ml or total PSA between 4-10ng/ml and free PSA/total PSA<0.16, combined with a malignant puncture result. 3. Combined with coagulation dysfunction, platelet <80×10^9/L. 4. Combined with uncontrolled urinary tract infection. 5. Combined with neurogenic bladder. 6. Combination of malignant tumors; 7. Urodynamic diagnosis includes bladder neck sclerosis, bladder weakness, dysregulation of detrusor/urethral sphincter, and unstable bladder. 8. Patients with surgical contraindications, such as severe heart and lung diseases. 9. Elderly dementia, brain atrophy, acute phase or sequelae of cerebrovascular disease, and cognitive impairment. 10. Patients who have previously undergone suprapubic fistula due to benign prostatic hyperplasia. 11. Those who fail to effectively control local or systemic bacterial infections during the acute phase. 12. Patients with combined shock and critical illness who cannot cooperate with the operation and evaluate the effect. 13. Individuals with mental and neurological disorders who cannot collaborate with doctors. 14. Participated in other clinical trials one month prior to the trial. 15. Other conditions that the investigator considers inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score, IPSS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Qmax;Postvoid Residual, PVR;blood routine examination;Incidence of postoperative complications;Equipment safety evaluation; | — |
Countries
China
Contacts
Public ContactShujie Xia
Shanghai General Hospital
Outcome results
None listed