Benign Prostate Hyperplasia
Conditions
Interventions
Urowell group:Prostatic Urethral Lift
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
Male
Age
53 Years to 71 Years
Inclusion criteria
Inclusion criteria: 1. Age>=50 years old, male; 2. IPSS>12; 3. Qmax<=15ml/s(125 ml urine); 4. Voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Acute urinary tract infection; 2. Gross hematuria; 3. Prostate volume>80 mL; 4. Difficulty in inserting instruments; 5. Developed bacterial prostatitis within 3 months; 6. Serum Prostate Specific Antigen (PSA)>10ug/L; 7. Bladder dysfunction caused by neurogenic bladder or other factors; 8. Operation History of Transurethral resection of the prostate (TURP) or laser surgery; 9. Complicated with serious cardiovascular disease; 10. Use of anticoagulants within 3 days (excluding aspirin less than 100 mg); 11. Patients allergic to nickel titanium or stainless steel; 12. The patient has participated in clinical trials other than registration studies within 3 months; 13. Other circumstances 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;Post-void residual volume, PVR;Quality of Life, QOL;Sexual Health Inventory for Men, SHIM;Male Sexual Health Questionnaire for Ejaculatory Dysfunction, MSHQ-EjD;MSHQ-Bother;Immediate postoperative success rate;Device performance evaluation; | — |
Countries
China
Contacts
Public ContactCheng Fan
Renmin Hospital of Wuhan University
Outcome results
None listed