benign prostatic hyperplasia
Conditions
Interventions
1:transperineal percutaneous laser ablation
2:transurethral resection of the prostate, TURP
Sponsors
Shanghai Jiaotong University Affiliated Sixth People's Hospital
Eligibility
Sex/Gender
Male
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Patients with LUTS caused by BPH who are ineffective or unsuitable for medical treatment judged by the clinician; (2) Male aged over 50 years; (3) IPSS degree moderate or above; (4) 30ml = the prostate volume measured by TRUS = 100ml; (5) Qmax = 15mL/s; (6) Post-urination residue = 50ml.
Exclusion criteria
Exclusion criteria: (1) Urethral stenosis; (2) Previous prostate, bladder or urethral surgery; (3) Dysuria caused by bladder dysfunction; (4) History of long term indwelling catheter; (5) BPH with mainly medial lobe hyperplasia (Intravesical Prostate Projection = 10mm); Transabdominal bladder ultrasonography revealed bladder calculi or obvious bladder tumor; (6) Prostate cancer patients proved by pathology; PSA > 4ng/ml and PSAD= 0.15 ng/ml2 and exclude the factor of iatrogenic injury; (7) Patients with known neurological disorders, e.g., multiple sclerosis, Parkinsons disease, or known history of spinal cord injury; (8) Post rectal surgery or patients with anal atresia; (9) Patients with severe coagulation disorders or with infection; (10) Patients are participating in another clinical study or have been enrolled in another clinical study 4 weeks before randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in IPSS relative to baseline levels at 3 months postoperatively;complication rate within 3 months after surgery ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Qmax [3 months, 6 months, 12 months after treatment];Residual urine [3 months, 6 months, 12 months after treatment];clinically significant post-treatment changes in vital signs (heart rate, respiration, blood pressure), ECG and laboratory tests (liver and kidney function, blood routine) determined by the investigator or his designee;Quality of life score [3 months, 6 months, 12 months after treatment];European five-dimensional health scale score EQ-5D [3 months, 6 months after treatment];intraoperative blood loss;VAS pain score;postoperative urinary catheter retention time;surgical success rate; | — |
Countries
China
Contacts
Public ContactHu Bing, Fu Qiang
Shanghai Jiaotong University Affiliated Sixth People's Hospital
Outcome results
None listed