A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence
Intervention: solifenacin succinate; Placebo
Intervention description: oral; oral
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 640.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Radical Robotic Arm; Vesicare; Post Prostatectomy Incontinence; YM905

Summary:

      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.
    

Eligibility criteria:

        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.