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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
The time from the date of first dose to the date of urinary continence
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
12 weeks
No
Medical Director
Study Director
Astellas Pharma Global Development
United States: Food and Drug Administration
905-UC-050
NCT01371994
August 2011
June 2013
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 |