Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms
Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms
Clinical study to examine the efficacy, safety and tolerability of combination therapy of
 tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin
 hydrochloride in the treatment of males with LUTS associated with BPH with a substantial
 storage component.
Inclusion Criteria:

 -  Voiding and storage symptoms diagnosed as LUTS associated with BPH for ≥ 3 months

 -  A total International Prostate Symptom Score (IPSS) of ≥13

 -  A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120 mL
 during free flow

 -  A micturition frequency of ≥8 and at least 2 episodes of urgency with Patient
 Perception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3
 day micturition diary (at randomization)

 Exclusion Criteria:

 -  Any significant Post Void Residual volume (>150 mL)

 -  A prostate with estimated weight ≥75 ml as assessed by transvesical or transrectal
 ultrasound

 -  Evidence of a symptomatic urinary tract infection