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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
N/A
Open (Enrolling)
Male
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
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

Type of Study:

Interventional

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:

No

Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

905-UC-050

NCT ID:

NCT01371994

Start Date:

August 2011

Completion Date:

June 2013

Related Keywords:

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

Name

Location

Henry Ford Hospital Detroit, Michigan  48202
Virginia Mason Medical Center Seattle, Washington  98111
University of Rochester Medical Center Rochester, New York  14642
City of Hope National Medical Center Los Angeles, California  91010
Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Urology San Antonio Research San Antonio, Texas  78229
Radiological Associates of Sacramento Medical Group, Inc. Sacramento, California  95815
Georgia Urology Atlanta, Georgia  30342
Urology Clinics of North Texas Dallas, Texas  75231
Northwestern University Chicago, Illinois  60611
University of Florida Gainesville, Florida  32610-0277
Cleveland Clinic Cleveland, Ohio  44195
Connecticut Clinical Research Center Waterbury, Connecticut  06708-2652
Northeast Indiana Research Fort Wayne, Indiana  46804-4128
University of Wisconsin Hospital Madison, Wisconsin  53792
Winter Park Urology Associates Orlando, Florida  32803
The Urology Group Cincinnati, Ohio  45212
Southwest Urology Parma, Ohio  44129
Urology Centers Of Alabama Homewood,, Alabama  35205
Oregon Health and Science University Portland, Oregon  97201
University of California, Irvine Orange, California  92868
Wake Forest University School of Medicine Winston-Salem, North Carolina  27157-1023
Alaska Clinical Research Center Anchorage, Alaska  99508
Volunteer Research Group Knoxville, Tennessee  37920
Southeastern Research Group Tallahassee, Florida  32308
Hudson Valley Urology, PC Poughkeepsie, New York  12601
Urology of Indiana Indianapolis, Indiana  46254
Southeast Urology Network Memphis, Tennessee  38119
Urology Associates Denver, Colorado  80210
University Urology Associates New York, New York  10016
Lahey Clinic Medical Center Burlington, Massachusetts  01805
Brooklyn Urology Research Group Brooklyn, New York  11215
The Iowa Clinic Des Moines, Iowa  50309
Springfield Clinic Springfield, Illinois  62703
Urology Center of Colorado Denver, Colorado  80211
Urologic Surgeons of Washington Washington, District of Columbia  20006
AdvanceMed Research Lawrenceville, New Jersey  08648
Methodist Hospital Research Institute Houston, Texas  77030
Tower Urology Los Angeles, California  90048
University of California, San Diego Moores Cancer Center San Diego, California  92093
East Coast Institute for Research Jacksonville, Florida  32223
Urologic Consultants of Southeastern Pennsylvania Philadelphia, Pennsylvania  19004
Grove Hill Medical Center New Britain, Connecticut  
Delaware Valley Urology Sewell, New Jersey  08080
Spectrum Health Medical Group Grand Rapids, Michigan  69546
Carolina Clinical Trials Concord, North Carolina  28025
Urology Research Network Hialeah, Florida  33149
Peninsula Urology Center Atherton, California  94027
University of California Davis, Department of Urology Sacramento, California  95817
Advanced Urology Parker, Colorado  80134
Urology Associates of Norwalk Norwalk, Connecticut  06859
Specialist In Urology Naples, Florida  34102
University of Chicago Medical Chicago, Illinois  60637
The University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Tulane University School of Medicine, Department of Urology New Orleans, Louisiana  70112
Adult and Pediatric Urology Group Sartell, Minnesota  56377
South Nevada Aids Research Las Vegas, Nevada  89106
Urology Group of New Jersey West Orange, New Jersey  07052
Community Care Physicians PC Albany, New York  12208
Long Island Jewish Health System, The Arthur Smith Institute for Urology New Hyde Park, New York  11040
Weill Cornell Medical College Department of Urology New York, New York  10065
AMP Urology Syracuse, New York  13210
Pharma Resources East Providence, Rhode Island  02915
Academic Urologists Chattanooga, Tennessee  37403
UT Southwestern Med. Center Dallas, Texas  75390
Methodist Urology Associates Houston, Texas  77094
Swedish Urology Group Seattle, Washington  98104
CAMC Institute Clinical Trial Center Charleston, West Virginia  25304
Urological Associates of Southern Arizona Tucson, Arizona  85715
Five Valley Urology Missoula, Montana  59808
Cary Urology Cary, North Carolina  27511
Associated Urologists of North Carolina Raleigh, North Carolina  27607
Romius Institute of Northwest Ohio Toledo, Ohio  43615