A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
NCT ID: NCT01371994
Last Updated: 2024-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
640 participants
INTERVENTIONAL
2011-08-02
2013-10-21
Brief Summary
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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.
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Detailed Description
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Participants will complete an electronic daily pad use diary during the study
duration. Participants will also be asked to complete several questionnaires during the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Solifenacin succinate
Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
solifenacin succinate
oral
Placebo
Participants received matching placebo tablets once a day for 12 weeks.
Placebo
oral
Interventions
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solifenacin succinate
oral
Placebo
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Urology Centers of Alabama
Homewood, Alabama, United States
Alaska Clinical Research Center
Anchorage, Alaska, United States
Urological Associates of Southern Arizona
Tucson, Arizona, United States
University of California, San Diego Moores Cancer Center
La Jolla, California, United States
Tower Urology
Los Angeles, California, United States
Radiological Associates of Sacramento Medical Group, Inc.
Sacramento, California, United States
Urology Center of Colorado
Denver, Colorado, United States
Urology Associates
Englewood, Colorado, United States
Advanced Urology
Parker, Colorado, United States
Connecticut Clinical Research Center
Middlebury, Connecticut, United States
Grove Hill Medical Center
New Britain, Connecticut, United States
Urologic Surgeons of Washington
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Urology Research Network
Hialeah, Florida, United States
East Coast Institute for Research
Jacksonville, Florida, United States
Winter Park Urology Associates
Orlando, Florida, United States
Southeastern Research Group
Tallahassee, Florida, United States
Northwestern University
Chicago, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Northeast Indiana Research
Fort Wayne, Indiana, United States
Urology of Indiana
Greenwood, Indiana, United States
The University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
The Iowa Clinic
West Des Moines, Iowa, United States
Tulane University School of Medicine, Department of Urology
New Orleans, Louisiana, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Spectrum Health Medical Group
Grand Rapids, Michigan, United States
Adult and Pediatric Urology Group
Sartell, Minnesota, United States
Five Valley Urology
Missoula, Montana, United States
South Nevada Aids Research
Las Vegas, Nevada, United States
AdvanceMed Research
Lawrenceville, New Jersey, United States
Delaware Valley Urology
Mount Laurel, New Jersey, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Community Care Physicians PC
Albany, New York, United States
Brooklyn Urology Research Group
Brooklyn, New York, United States
University Urology Associates
New York, New York, United States
Hudson Valley Urology, PC
Poughkeepsie, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
AMP Urology
Syracuse, New York, United States
Cary Urology
Cary, North Carolina, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
The Urology Group
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Romius Institute of Northwest Ohio
Toledo, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, United States
Pharma Resources
East Providence, Rhode Island, United States
Academic Urologists
Chattanooga, Tennessee, United States
Volunteer Research Group
Knoxville, Tennessee, United States
Southeast Urology Network
Memphis, Tennessee, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Methodist Hospital Research Institute
Houston, Texas, United States
Methodist Urology Associates
Houston, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Urology Group
Seattle, Washington, United States
CAMC Institute Clinical Trial Center
Charleston, West Virginia, United States
University of Wisconsin Hospital
Madison, Wisconsin, United States
The Prostate Centre, Diamond Health Care Centre
Vancouver, British Columbia, Canada
University Health Network/ Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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Related Links
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Link to results on the Astellas Clinical Study Results website.
Other Identifiers
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905-UC-050
Identifier Type: -
Identifier Source: org_study_id
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