Benign Prostatic Hyperplasia
Conditions
Interventions
Diode laser:Diode laser surgery
PKEP:PKEP
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
Male
Age
55 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. aged 55-80 years, men; 2. diagnosis of lower urinary tract symptoms due to benign prostatic obstruction; 3. with any of the following conditions: (1) The International Prostate Symptom Score (IPSS=12), and the quality of life score (QOL) = 4 points; (2) The maximum urinary flow rate (Qmax) is less than 15ml/s (=150ml); (3) The effect of drug treatment is not good; (4) The recurrent urinary retention (more than once); (5) The Schafer grade= 2; 4. Subject is classified ASA I, II, or III; 5. the patient agreed to participate in this trial, and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. there is operation contraindications of transurethral prostatic hyperplasia resection; 2. Subject has a life expectancy <2 yr; 3. Subject is currently enrolled in or plans to enrol in any other study; 4. Subject has a neurogenic bladder or other neurologic disorder that may affects bladder function, Such as cerebral vascular accident, Parkinson, multiple sclerosis, spinal cord injury, spinal cord lesions, etc.; 5. Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use; 6. Subject has history urethral stricture or bladder neck contracture within the last 6 months; 7. Subject has history of lower urinary tract surgery; 8. Subject has diagnosis of prostate cancer; 9. Combined with advanced malignant tumor or chronic wasting disease; 10. Combined with serious heart,lung disease or severe mental disorder; 11. Has an active infection; 12. Subject has a disorder of the coagulation cascade or disorders that affect platelet count or function; 13. Can not finished the follow-up for poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Qmax at one year postoperatively;IPSS; | — |
Secondary
| Measure | Time frame |
|---|---|
| operative time;the time of enucleation;the time of morcellation;tissue weight of prostate;Blood loss during surgery;HGB, HCT, Serum Electrolyte, PSA;Time of bladder irrigation;catheterization time;hospital stay days;The number of electric cutting rings and laserl fibers used in the operation;QOL;IIEF-5;Rigiscan penis hardness;Postoperative prostate volume and Residual urine volume;PSA;Urine flow dynamics and urethral pressure;complications;reintervention rates; | — |
Countries
China
Contacts
Public ContactChunxiao Liu
Outcome results
None listed