Status:
TERMINATED
Over Active Bladder Patients Having Sling Surgery
Lead Sponsor:
Cleveland Clinic Florida
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18-100 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether treatment with anti-muscarinic medications following sub-urethral sling procedures improves overall subjective and objective outcomes in women with mi...
Detailed Description
Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take...
Eligibility Criteria
Inclusion
- Age \>/= 18
- Patient is appropriate for sub-urethral sling procedure
- Mixed urinary incontinence
- No antimuscarinic therapy for previous 30 days
Exclusion
- Uncontrolled narrow angle glaucoma
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00852696
Start Date
February 1 2008
End Date
February 1 2010
Last Update
July 1 2022
Active Locations (1)
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1
Cleveland Clinic Florida
Weston, Florida, United States, 33331