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Astellas Study ID
905-UC-050

A Study to Assess Efficacy and Safety with Solifenacin Succinate to Improve Urinary continence after Robotic Assisted Radical Prostatectomy

Astellas Study ID
905-UC-050
Clinicaltrials.gov ID
NCT01371994
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study 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.

Additional Study Details

Phase
4
Product
N/A
Product
solifenacin succinate
Placebo
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment number
640
Show Additional Study Details

Study documents

Scientific Results Summary
Available Language(s): English
Download Document(s)
Plain Language Summary
Available Language(s): English
Download Document(s)

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Would you like more information about clinical trial sites that are recruiting participants for A Study to Assess Efficacy and Safety with Solifenacin Succinate to Improve Urinary continence after Robotic Assisted Radical Prostatectomy? Contact us by filling out your information to the right and we’ll respond to you.

  • A caregiver
  • A healthcare provider
  • A parent
  • A patient
  • A patient advocate
  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Kazakhstan
  • Latvia
  • Lebanon
  • Lithuania
  • Macedonia
  • Malaysia
  • Mexico
  • Montenegro
  • Morocco
  • Netherlands
  • New Zealand
  • Norway
  • Panama
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

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    Locations

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    Completed
    Five Valley Urology
    Missoula, Montana, United States, 59808
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    Completed
    Northwestern University
    Chicago, IL, United States, 60611
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    Urologic Surgeons of Washington
    Washington, DC, United States, 20036
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    Urology Group of New Jersey
    West Orange, New Jersey, United States, 07052
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    Completed
    Academic Urologists
    Chattanooga, TN, United States, 37403
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    Completed
    Radiological Associates of Sacramento Medical Group, Inc.
    Sacramento, California, United States, 95815
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    Urology Associates
    Englewood, Colorado, United States, 80113
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    Swedish Urology Group
    Seattle, WA, United States, 98104
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    Associated Urologists of North Carolina
    Raleigh, North Carolina, United States, 27607
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    Completed
    Urology Center of Colorado
    Denver, CO, United States, 80211
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    Completed
    Tulane University School of Medicine, Department of Urology
    New Orleans, LA, United States, 70112
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    Alaska Clinical Research Center
    Anchorage, Alaska, United States, 99508
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    University Health Network/ Princess Margaret Hospital
    Toronto, Ontario, Canada, M5G 2M9
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    Brooklyn Urology Research Group
    Brooklyn, New York, United States, 11215
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    Urology Research Network
    Hialeah, FL, United States, 33016
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    University of Chicago Medical
    Chicago, IL, United States, 60637
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    Completed
    Urology San Antonio Research
    San Antonio, Texas, United States, 78229
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    Winter Park Urology Associates
    Orlando, FL, United States, 32803
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    Completed
    Robert Wood Johnson Medical School
    New Brunswick, New Jersey, United States, 08901
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    Completed
    University of Rochester Medical Center
    Rochester, NY, United States, 14642
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    Withdrawn
    Specialist In Urology
    Naples, FL, United States, 34102
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    Completed
    Community Care Physicians PC
    Albany, New York, United States, 12208
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    Completed
    Hudson Valley Urology, PC
    Poughkeepsie, NY, United States, 12601
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    Withdrawn
    City of Hope National Medical Center
    Duarte, CA, United States, 91010
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    Completed
    East Coast Institute for Research
    Jacksonville, Florida, United States, 32204
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    Completed
    University of Wisconsin Hospital
    Madison, WI, United States, 53792
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    Completed
    Urology Centers of Alabama
    Homewood, Alabama, United States, 35209
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    Completed
    University Urology Associates
    New York, New York, United States, 10016
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    Completed
    Delaware Valley Urology
    Mt. Laurel, New Jersey, United States, 08043
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    Withdrawn
    Carolina Clinical Trials
    Concord, NC, United States, 28025
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    Withdrawn
    University of California Davis, Department of Urology
    Sacramento, CA, United States, 95817
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    Withdrawn
    Wake Forest University School of Medicine
    Winston-Salem, North Carolina, United States, 27103
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    Completed
    The Urology Group
    Cincinnati, OH, United States, 45212
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    Completed
    Cleveland Clinic
    Cleveland, Ohio, United States, 44195
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    Completed
    The University of Iowa Hospitals and Clinics
    Iowa City, Iowa, United States, 52242
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    Completed
    Lahey Clinic Medical Center
    Burlington, MA, United States, 01805
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    Completed
    Urology of Indiana
    Greenwood, Indiana, United States, 46143
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    Completed
    Oregon Health and Science University
    Portland, OR, United States, 97239
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    Withdrawn
    Southwest Urology
    Middlesburg Heights, Ohio, United States, 44130
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    Completed
    Romius Institute of Northwest Ohio
    Toledo, Ohio, United States, 43615
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    Completed
    Adult and Pediatric Urology Group
    Sartell, Minnesota, United States, 56377
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    Completed
    Tower Urology
    Los Angeles, CA, United States, 90048
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    Completed
    Spectrum Health Medical Group
    Grand Rapids, Michigan, United States, 49546
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    Completed
    Methodist Urology Associates
    Houston, TX, United States, 77094
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    Completed
    Connecticut Clinical Research Center
    Middlebury, Connecticut, United States, 06762
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    Completed
    CAMC Institute Clinical Trial Center
    Charleston, West Virginia, United States, 25304
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    Completed
    The Prostate Centre, Diamond Health Care Centre
    Vancouver, BC, Canada, V5Z IM9
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    Completed
    Southeast Urology Network
    Memphis, TN, United States, 38119
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    Completed
    Advanced Urology
    Parker, Colorado, United States, 80134
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    Completed
    The Iowa Clinic
    West Des Moines, IA, United States, 50266
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    AMP Urology
    Syracuse, NY, United States, 13210
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    Grove Hill Medical Center
    New Britain, Connecticut, United States, 06052
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    Urological Associates of Southern Arizona
    Tucson, Arizona, United States, 85715
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    Southeastern Research Group
    Tallahassee, Florida, United States, 32308
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    AdvanceMed Research
    Lawrenceville, New Jersey, United States, 08648
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    University of California, San Diego Moores Cancer Center
    La Jolla, CA, United States, 92093
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    Pharma Resources
    East Providence, Rhode Island, United States, 02915
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    Withdrawn
    Peninsula Urology Center
    Redwood City, California, United States, 94062
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    Withdrawn
    UT Southwestern Med. Center
    Dallas, TX, United States, 75390
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    Completed
    Cary Urology
    Cary, North Carolina, United States, 27511
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    Completed
    Urologic Consultants of Southeastern Pennsylvania
    Bala Cynwyd, PA, United States, 19004
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    Withdrawn
    Weill Cornell Medical College Department of Urology
    New York, NY, United States, 10065
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    Completed
    University of Florida
    Gainesville, FL, United States, 32610
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    Withdrawn
    Long Island Jewish Health System, The Arthur Smith Institute for Urology
    New Hyde Park, NY, United States, 11040
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    Withdrawn
    Georgia Urology
    Atlanta, GA, United States, 30342
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    Completed
    Springfield Clinic
    Springfield, Illinois, United States, 62703
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    University of California, Irvine
    Orange, CA, United States, 92868
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    Completed
    Urology Clinics of North Texas
    Dallas, Texas, United States, 75231
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    Methodist Hospital Research Institute
    Houston, TX, United States, 77030
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    Henry Ford Hospital
    Detroit, MI, United States, 48202
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    Volunteer Research Group
    Knoxville, TN, United States, 37920
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    Virginia Mason Medical Center
    Seattle, WA, United States, 98101
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    Completed
    Northeast Indiana Research
    Fort Wayne, Indiana, United States, 46825
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    Completed
    South Nevada Aids Research
    Las Vegas, NV, United States, 89106
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    Withdrawn
    Urology Associates of Norwalk
    Norwalk, CT, United States, 06859
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    Trial info
    Follow Trial
    Age
    18+ years
    Diamond icon
    Condition
  • Urge to Urinate
    • Gender icon
    Sex
    Male
    Calendar icon
    Trial Dates
    Aug 2011 - Oct 2013
    Additional Study Details
    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
    MaximizeExclusion 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.

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