Study Results
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View full resultsBasic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2008-02-29
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Placebo Group
Placebo Orally 9 weeks once daily.
Placebo
Take orally once daily for 9 weeks.
Solifenacin Group
Solifenacin Orally 9 weeks once daily.
Solifenacin
Solifenacin is used to treat overactive bladder. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. Take orally once daily for 9 weeks.
Interventions
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Solifenacin
Solifenacin is used to treat overactive bladder. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. Take orally once daily for 9 weeks.
Placebo
Take orally once daily for 9 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is appropriate for sub-urethral sling procedure
* Mixed urinary incontinence
* No antimuscarinic therapy for previous 30 days
Exclusion Criteria
* Acute cystitis
* Unevaluated hematuria
* Currently using anti-muscarinic therapy
* Unable to complete pre-operative urodynamics
* Contraindication to anti-cholinergic therapy
* Unable or unwilling to complete diaries or quality of life questionaire
* Significant (exteriorized) Pelvic Organ Prolapse
18 Years
100 Years
FEMALE
Yes
Sponsors
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Astellas Pharma US, Inc.
INDUSTRY
Cleveland Clinic Florida
OTHER
Responsible Party
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Eric Hurtado
Investigator
Principal Investigators
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G W Davila, MD
Role: PRINCIPAL_INVESTIGATOR
Cleeland Clinic
Locations
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Cleveland Clinic Florida
Weston, Florida, United States
Countries
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Other Identifiers
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8867
Identifier Type: -
Identifier Source: org_study_id
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