A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
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
1 other identifier
interventional
640
2 countries
60
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2011
Typical duration for phase_4
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2011
CompletedFirst Posted
Study publicly available on registry
June 13, 2011
CompletedStudy Start
First participant enrolled
August 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2013
CompletedResults Posted
Study results publicly available
October 9, 2014
CompletedNovember 21, 2024
October 1, 2024
2.2 years
June 10, 2011
October 6, 2014
November 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time From First Dose to Urinary Continence
Urinary continence is defined as the first of three consecutive 24-hour days in which a participant uses no pads, or a pad for security which remains completely dry, during the 12-week treatment period. Participants recorded their daily pad usage in an electronic diary. Kaplan-Meier curves were used to estimate the distribution of cumulative incidence of urinary continence over the 12-week study treatment period. Participants who did not experience the event during the 12-week treatment period were considered as censored at the End of Treatment (EOT) visit or Week 12, whichever occurs first.
12 weeks
Secondary Outcomes (18)
Percentage of Participants Who Gain Continence During 12-week Treatment Period
Weeks 4, 8, and 12
Average Daily Pad Usage at Baseline
Baseline (7 days prior to Day 1)
Change From Baseline in Average Daily Pad Usage
Baseline and Weeks 4, 8 and 12
American Urology Association Symptom Score (AUASS) at Baseline
Baseline
Change From Baseline in American Urology Association Symptom Score (AUASS)
Baseline and Week 12
- +13 more secondary outcomes
Study Arms (2)
Solifenacin succinate
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants received matching placebo tablets once a day for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Alaska Clinical Research Center
Anchorage, Alaska, 99508, United States
Urological Associates of Southern Arizona
Tucson, Arizona, 85715, United States
University of California, San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Tower Urology
Los Angeles, California, 90048, United States
Radiological Associates of Sacramento Medical Group, Inc.
Sacramento, California, 95815, United States
Urology Center of Colorado
Denver, Colorado, 80211, United States
Urology Associates
Englewood, Colorado, 80113, United States
Advanced Urology
Parker, Colorado, 80134, United States
Connecticut Clinical Research Center
Middlebury, Connecticut, 06762, United States
Grove Hill Medical Center
New Britain, Connecticut, 06052, United States
Urologic Surgeons of Washington
Washington D.C., District of Columbia, 20036, United States
University of Florida
Gainesville, Florida, 32610, United States
Urology Research Network
Hialeah, Florida, 33016, United States
East Coast Institute for Research
Jacksonville, Florida, 32204, United States
Winter Park Urology Associates
Orlando, Florida, 32803, United States
Southeastern Research Group
Tallahassee, Florida, 32308, United States
Northwestern University
Chicago, Illinois, 60611, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Northeast Indiana Research
Fort Wayne, Indiana, 46825, United States
Urology of Indiana
Greenwood, Indiana, 46143, United States
The University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
The Iowa Clinic
West Des Moines, Iowa, 50266, United States
Tulane University School of Medicine, Department of Urology
New Orleans, Louisiana, 70112, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Spectrum Health Medical Group
Grand Rapids, Michigan, 49546, United States
Adult and Pediatric Urology Group
Sartell, Minnesota, 56377, United States
Five Valley Urology
Missoula, Montana, 59808, United States
South Nevada Aids Research
Las Vegas, Nevada, 89106, United States
AdvanceMed Research
Lawrenceville, New Jersey, 08648, United States
Delaware Valley Urology
Mount Laurel, New Jersey, 08043, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Community Care Physicians PC
Albany, New York, 12208, United States
Brooklyn Urology Research Group
Brooklyn, New York, 11215, United States
University Urology Associates
New York, New York, 10016, United States
Hudson Valley Urology, PC
Poughkeepsie, New York, 12601, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
AMP Urology
Syracuse, New York, 13210, United States
Cary Urology
Cary, North Carolina, 27511, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27607, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Romius Institute of Northwest Ohio
Toledo, Ohio, 43615, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004, United States
Pharma Resources
East Providence, Rhode Island, 02915, United States
Academic Urologists
Chattanooga, Tennessee, 37403, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, United States
Southeast Urology Network
Memphis, Tennessee, 38119, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
Methodist Hospital Research Institute
Houston, Texas, 77030, United States
Methodist Urology Associates
Houston, Texas, 77094, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Swedish Urology Group
Seattle, Washington, 98104, United States
CAMC Institute Clinical Trial Center
Charleston, West Virginia, 25304, United States
University of Wisconsin Hospital
Madison, Wisconsin, 53792, United States
The Prostate Centre, Diamond Health Care Centre
Vancouver, British Columbia, V5Z IM9, Canada
University Health Network/ Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Results Point of Contact
- Title
- Medical Director, Urology
- Organization
- Astellas Pharma Global Development, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2011
First Posted
June 13, 2011
Study Start
August 2, 2011
Primary Completion
October 21, 2013
Study Completion
October 21, 2013
Last Updated
November 21, 2024
Results First Posted
October 9, 2014
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.