Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
A study to evaluate the safety of the co-administration of solifenacin succinate with
 tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet
 obstruction (BOO).
Inclusion Criteria:

 -  Diagnosed with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction
 (BOO)

 -  BOO indication by a Bladder Outlet Obstruction Index (BOOI) ≥ 20

 -  Patient has a total International Prostate Symptom Score (IPPS) score of ≥ 8
 (Inclusion criteria for Baseline also)

 -  Patient had a maximum urinary flow rate of ≤ 12 mL/sec, with a voided volume of ≥ 120
 mL during free flow in a representative assessment of uroflowmetry.

 Exclusion Criteria:

 -  History of urinary retention in preceding 12 months

 -  Current urinary tract infection (UTI) or symptomatic and recurrent UTI of > 3 episodes
 within 12 months.

 -  Known clinical history or diagnosis of chronic inflammation, stone in bladder or
 ureter, or other causes of outflow tract obstruction

 -  Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except
 non-metastatic basal or squamous cell carcinoma of the skin that had been treated
 successfully

 -  Clinically significant cardiovascular or cerebrovascular diseases within 6 months
 prior to Visit 1