A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH
A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH
The study will examine the efficacy,safety and tolerability of combination therapy of
 tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin
 in the treatment of males with LUTS associated with BPH.
Placebo Solifenacin succinate Tamsulosin hydrochloride Tamsulosin hydrochloride + solifenacin
 succinate

 The primary comparison will be the combination treatment with tamsulosin hydrochloride
 monotherapy.

 Other comparisons will be:

 Placebo and combination treatment. Solifenacin monotherapy and combination treatment
Inclusion Criteria:

 -  male patients with LUTS associated with BPH diagnosed > 3 months

 -  IPSS score > 13

 -  voiding and storage symptoms

 -  maximum flow rate of > 4 mL/s and < 15 mL/s

 Exclusion Criteria:

 -  post void residual volume > 200 mL

 -  symptomatic urinary tract infection