Benign Prostate Hyperplasia
Conditions
Interventions
Group A:receive 0.2mg tamsulosin and 4mg placebo 2, once a day
Group B:receive 4mg tolterodine and 0.2mg placebo 1, once a day
Group C:receive 4mg tolterodine and 0.2mg tamsulosin, once a day
Group D:received 0.2mg placebo1 and 4mg placebo2, once a day
Sponsors
Peking University Shougang Hospital
Eligibility
Sex/Gender
Male
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male, 50 years and older; 2. Diagnosed as benigh prostate hyperplasia(BPH)and had a prostate volume >=25ml; 3. The total international prostate symptom score of 12 or higher and, the international prostate symptom score quantity-of-life item score of 3 or higher; 4. Voluntarily attend this study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Suffered from neurogenic bladder; 2. With other low urinary obstruction causes except benign prostate hyperplasis; 3. Postvoid residual volume >=200ml, abnormal renal function, or maximum urinary flow rate =2 times, or have proofs of bladder decompensation; 5. Have received invasive treatments for BPH; 6. Serum PSA>=10.0ng/ml, or diagnosed as carcinoma of prostate; 7. Take alpha 1-antibody block agent within 2 weeks, anticholine drugs or saw palmetto drugs within 1 month (patients who wish to attend the study must perform wash-out for 2 weeks, 1 month, respectively); 8. Used 5 alpha-reducase inhibitor within 3 months (patients wish to attend the study must perform wash-out for 3 month); 9. With other contraindications of tolterodine or tamsulosin; 10. With severe systemic diseases or mental disorder; 11. Cannot insist on regular follow-up for psychological, social, domestic or physical reasons; 12. Unwilling to sign informed consent or refuse to cooperation; 13. With other causes misfit as a volunteer discovered by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum urinary flow rate and average urinary flow rate;prostate volume, prostate transitional zone volume and transitional zone index;IPSS and QOL scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| residual urine;serum PS; | — |
Countries
China
Contacts
Public ContactJianliang Cai
Outcome results
None listed