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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

Phase 4
18 Years
Open (Enrolling)
Urinary Incontinence

Thank you

Trial Information

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 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.

Subjects will complete an electronic daily pad use diary during the study duration.
Subjects will also be asked to complete several questionnaires during the study.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

The time from the date of first dose to the date of urinary continence

Outcome Description:

Urinary continence will be defined as the first of three consecutive 24 hour days which subject uses 0 pads, or a pad for security which remains completely dry, during the 12 week study

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development


United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

June 2013

Related Keywords:

  • Urinary Incontinence
  • Radical Robotic Arm
  • Post Prostatectomy Incontinence
  • Vesicare
  • YM905
  • Urinary Incontinence



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