A Multicenter VESIcare® Efficacy and Safety Study for the Treatment of Urgency Associated With Overactive Bladder (OAB)
VENUS
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5mg and 10mg VESIcare® for the Treatment of Urgency Associated With Overactive Bladder
1 other identifier
interventional
739
1 country
65
Brief Summary
The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2004
Shorter than P25 for phase_3
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 29, 2007
CompletedFirst Posted
Study publicly available on registry
April 2, 2007
CompletedSeptember 18, 2014
September 1, 2014
1.3 years
March 29, 2007
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome
Weeks 1, 4, 8 and 12
Secondary Outcomes (5)
Improvement of urgency
Weeks 1, 4, 8 and 12
Improvement of frequency, incontinence and nocturia
Weeks 1, 4, 8 and 12
Number of patients satisfied with treatment
Weeks 1, 4, 8 and 12
Assessment of the efficacy
End of study
Evaluation of the safety and tolerability
Baseline to end of study
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- At least 1 urinary urgency episode/24h (on average) documented in a 3-day patient diary in the screening phase with or without urge incontinence, and usually with frequency and nocturia, described as OAB
- Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride and are no longer receiving such treatment for a minimum of 14 days immediately preceding entry into the study. These previously treated patients must present at the investigative site on no anticholinergic agents and with the desire to receive treatment for OAB. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.
- Patients having urgency with or without urge incontinence accompanied by frequency of ≥8 episodes per 24 hours, and/or nocturia, for a period of ≥3 months prior to screening.
You may not qualify if:
- Previous treatment with darifenacin
- Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for \<3 months
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
- Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
- Clinically significant outflow obstruction (benign prostatic hyperplasia) as determined by the Investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Unknown Facility
Phoenix, Arizona, 85032, United States
Unknown Facility
Scottsdale, Arizona, 85258, United States
Unknown Facility
Atherton, California, 94027, United States
Unknown Facility
Carmichael, California, 95608, United States
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Escondido, California, 72025, United States
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Fresno, California, 93703, United States
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Los Angeles, California, 90057, United States
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Mission Hills, California, 91345, United States
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Mission Viejo, California, 92691, United States
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Salinas, California, 93901, United States
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Valley Village, California, 91607, United States
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Aurora, Colorado, 80012, United States
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Denver, Colorado, 80205, United States
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New London, Connecticut, 06320, United States
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Norwalk, Connecticut, 06850, United States
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Trumbull, Connecticut, 06611, United States
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Waterbury, Connecticut, 06708, United States
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Washington D.C., District of Columbia, 20017, United States
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Boyton Beach, Florida, 33347, United States
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Clearwater, Florida, 33761, United States
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Clearwater, Florida, 33765, United States
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Gainesville, Florida, 32607, United States
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Pembroke Pines, Florida, 33027, United States
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Plantation, Florida, 33324, United States
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Tallahassee, Florida, 32308, United States
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Alpharetta, Georgia, 30005, United States
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Atlanta, Georgia, 30342, United States
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Blue Ridge, Georgia, 30513, United States
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Marietta, Georgia, 30060, United States
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Boise, Idaho, 83702, United States
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Centralia, Illinois, 62801, United States
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Slidell, Louisiana, 70461, United States
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Bloomfield Hills, Michigan, 48302, United States
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Chesterfield, Missouri, 63017, United States
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St Louis, Missouri, 63117, United States
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St Louis, Missouri, 63128, United States
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Billings, Montana, 59102, United States
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Lawrenceville, New Jersey, 08648, United States
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South Bound Brook, New Jersey, 08880, United States
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Albuquerque, New Mexico, 87108, United States
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Albany, New York, 12205, United States
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East Syracuse, New York, 13057, United States
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Hewlett, New York, 11551, United States
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Lewiston, New York, 14092, United States
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New York, New York, 10021, United States
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Concord, North Carolina, 28025, United States
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Hickory, North Carolina, 28601, United States
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Winston-Salem, North Carolina, 27103, United States
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Bismarck, North Dakota, 58501, United States
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Cincinnati, Ohio, 45220, United States
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Cleveland, Ohio, 44195, United States
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Eugene, Oregon, 97401, United States
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Endwell, Pennsylvania, 13760, United States
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Media, Pennsylvania, 19063, United States
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Monroeville, Pennsylvania, 15146, United States
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Philadelphia, Pennsylvania, 19114, United States
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Uniontown, Pennsylvania, 15401, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Athens, Texas, 75751, United States
Unknown Facility
Ogden, Utah, 84403, United States
Unknown Facility
West Point, Utah, 84015, United States
Unknown Facility
Richmond, Virginia, 23294, United States
Unknown Facility
Spokane, Washington, 99202, United States
Unknown Facility
Vancouver, Washington, 98607, United States
Unknown Facility
Morgantown, West Virginia, 26506, United States
Related Publications (4)
Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8.
PMID: 18995887BACKGROUNDToglia MR, Serels SR, Laramee C, Karram MM, Nandy IM, Andoh M, Seifeldin R, Forero-Schwanhaeuser S. Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial. Postgrad Med. 2009 Sep;121(5):151-8. doi: 10.3810/pgm.2009.09.2062.
PMID: 19820284BACKGROUNDStoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PMID: 37160401DERIVEDSerels SR, Toglia MR, Forero-Schwanhaeuser S, He W. Impact of solifenacin on diary-recorded and patient-reported urgency in patients with severe overactive bladder (OAB) symptoms. Curr Med Res Opin. 2010 Oct;26(10):2277-85. doi: 10.1185/03007995.2010.509582.
PMID: 20707767DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2007
First Posted
April 2, 2007
Study Start
May 1, 2004
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
September 18, 2014
Record last verified: 2014-09