• Evaluate the effect of 12 weeks of treatment of solifenacin succinate over time on the symptom bother domain in subjects with Overactive Bladder (OAB) syndrome as assessed by the overactive bladder questionnaire (OAB-q) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Evaluate the effect of 12 weeks of treatment of solifenacin succinate over time on the health related quality of life (HRQL) in subjects with OAB as assessed by the subject reported HRQL utilizing the OAB-q [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Evaluate the effect of 12 weeks of treatment of solifenacin succinate on a global assessment of bladder condition as measured by the Patient Perception of Bladder Condition (PPBC) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Evaluate subject satisfaction with treatment of solifenacin succinate using a Treatment Satisfaction Visual Analog Scale (TS-VAS) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Evaluate the effect of 12 weeks of treatment of solifenacin succinate on the symptoms of OAB as assessed by 3-day micturition diary [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Evaluate the effect of VESIcare® on symptom bother for subjects with OAB

Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into VESIcare® (solifenacin succinate) or placebo group.

The study duration consists of a screening period which includes a minimum of a 14 day treatment free wash-out period. Subjects meeting the baseline criteria will have a 12 week treatment period. Maximum total study duration is 15 weeks: 2 3 week screening / washout period; 12 week double-blind treatment.

Primary efficacy will be based on OAB-q symptom bother score.

• Drug: Solifenacin succinate
• Drug: Placebo

Inclusion Criteria:

• Ambulatory male or female subject ≥ 18 years of age and able to use the toilet without difficulty
• History of OAB symptoms for ≥ 3 months
• An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary
• Subjects are bothered by symptoms as reflected by PPBC ≥3

Exclusion Criteria:

• Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stones; uncontrolled narrow angle glaucoma; urinary or gastric retention
• Recurrent urinary tract infection (UTI) of > 3 episodes within the last 3 months or evidence of a urinary tract infection at Baseline Visit (Visit 2)
• Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
• History of renal or hepatic impairment(2 x Upper Limit of Normal(ULN) values in parameters and considered clinically significant by the investigator
• History of diagnosed gastrointestinal obstruction disease
• Subject has a known diagnosis or history of carcinoma (including prostate cancer) except non metastatic basal or squamous cell carcinoma of the skin that has been successfully treated or previous pelvis radiation within the past five years
• Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics