benign prostatic hyperplasia (BPH)/LUTs
Conditions
Interventions
A:Tolterodine SR 4mg/d + Doxazosin GITS 0.4mg/d
B:Tolterodine SR 4mg/d + Tamsulosin
Sponsors
Qingdao university affiliated hosptial
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: Men 50 years and older with a total IPSS of 12 or higher; an IPSS quality-of-life (QOL) item score of 3 or higher; and a self-rated bladder condition of "some moderate problems", "severe problems", or "many severe problems" based on the Patient Perception of Bladder Condition question. 19 Additional inclusion criteria are micturition frequency (more than 8 micturitions per 24 hours) and urgency (more than 3 micturitions with urgency rating more than 3 per 24 hours) for 3 or more months.
Exclusion criteria
Exclusion criteria: Men with clinically significant bladder outlet obstruction (defined as a postvoid residual volume more than 200mL and maximum urinary flow rate less than 5 mL/s), or serum prostate-specific antigen of more than 10 ng/mL with risk of prostate cancer are excluded. Other exclusion criteria included history of postural hypotension or syncope; significant hepatic or renal disease; some neurologic conditions (eg, multiple sclerosis, spinal cord injury, Parkinson disease); prostate cancer; prostate surgery or other intervention; history of acute urinary retention requiring catheterization; use of an indwelling catheter or selfcatheterization program; bladder outlet obstruction due to causes other than BPH; or any condition for which antimuscarinicuse is contraindicated. Men treated with an alpha-receptor antagonist within 2 weeks; antimuscarinic, antispasmodic, sawpalmetto, or electrostimulation within 1 month; any investigational drug within 2 months; or a 5alpha-reductase inhibitor within 3 months of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPSS;Qmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| residual urine; | — |
Contacts
Public ContactYanwei Cao
Outcome results
None listed