A Study to Assess Efficacy and Safety With VESIcare® to Improve Urinary Continence in Subjects After Robotic Assisted Radical Prostatectomy

Inclusion Criteria:

• Subject is ambulatory
• Subject is willing and able to complete the daily pad use diary, American Urology Association Symptom Score (AUASS) with Bother Score, the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), and the Work Productivity and Activity Impairment Questionnaire (WPAI)
• Subject has not used any medication for over-active bladder symptoms for at least 14 days prior to enrollment
• Subject has been diagnosed with prostate cancer, treated by Robotic Assisted Radical Prostatectomy, is voiding spontaneously and has urinary incontinence one week after removal of the indwelling catheter which requires management with 2 to 10 pads inclusive per day (24 hour days) for 7 consecutive days

Exclusion Criteria:

• Subject has evidence of severe neurologic damage post-prostatectomy
• Subject has evidence of chronic urologic inflammation such as interstitial cystitis and bladder stone; uncontrolled narrow angle glaucoma; urinary or gastric retention or neurogenic bladder
• Subject has a clinically significant history of hepatic or renal impairment (2 X Upper Limit of Normal (ULN) values in ALT, AST or creatinine clearance < 30 ml/min)
• Subject has history of diagnosed gastrointestinal obstruction disease
• Subject has any prior history of local radiation therapy to the prostate or rectum or any prior hormonal therapy or has planned such therapy during study conduct
• Subject has known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics
• Subject has been treated with any investigational drug within last 30 days
• Subject has a history of a clinically significant illness or medical condition that would preclude participation in the study
• Subject has been diagnosed with New York Heart Association Class III and IV heart failure
• Subject has the following peri-operative laboratory results: ALT > 2.0 ULN, AST > 2.0 ULN, serum creatinine > 1.5 mg/L, blood glucose > 130 mg/dL, BUN > 23 mg/dL.
• Subject has severe hypertension on peri-operative evaluation which is defined as a sitting systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg, and which is not corrected
• Subject has electrolytes (sodium, potassium, chloride or bicarbonate) that are not in normal range and clinically significant as determined by the investigator in the perioperative period. Subject can be eligible if electrolytes are corrected to within normal range prior to randomization
• Subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives, whichever is longer, prior to the initiation of Screening