A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy

A Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase 4, Multicenter Study to Assess Efficacy and Safety of VESIcare® (Solifenacin Succinate) to Improve Urinary Continence of Subjects After Robotic Assisted Radical Prostatectomy

The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of solifenacin succinate versus placebo in participants who are incontinent after Robotic Assisted Radical Prostatectomy.

This study will also assess the effect of 12 weeks of treatment with solifenacin succinate versus placebo on quality of life (QOL) as measured by questionnaires.

The study duration includes a 14-day treatment free wash-out period. The maximum total study duration is 15 weeks (2-3 week screening/washout period and a 12 week treatment period). The Baseline, Week 4, and Week 8 visits will be telephone contact visits.

Participants will complete an electronic daily pad use diary during the study

duration. Participants will also be asked to complete several questionnaires during the study.

Inclusion Criteria:

• Ambulatory
• 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)

• Has not used any medication for over-active bladder symptoms for at least 14 days prior to enrollment
• 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:

• Evidence of severe neurologic damage post-prostatectomy
• Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stone; uncontrolled narrow angle glaucoma; urinary or gastric retention or neurogenic bladder
• Symptomatic for urinary tract infection or has a urine culture result which requires treatment as determined by the investigator.
• Clinically significant history of hepatic or renal impairment (2 X Upper Limit of Normal (ULN) values in alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine clearance < 30 ml/min)
• History of diagnosed gastrointestinal obstruction disease
• 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
• Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics
• Treated with any investigational drug within last 30 days
• History of a clinically significant illness or medical condition that would preclude participation in the study
• Diagnosed with New York Heart Association Class III and IV heart failure
• Any of 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, blood urea nitrogen (BUN) > 23 mg/dL.
• 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
• Electrolytes (sodium, potassium, chloride or bicarbonate) that are not in normal range and clinically significant as determined by the investigator in the perioperative period. Can be eligible if electrolytes are corrected to within normal range prior to randomization
• 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.