Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2008-10-31
2012-10-31
Brief Summary
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This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 3 years.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gynecare TVT-SECUR system
All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence
Gynecare TVT-SECUR system
All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
Interventions
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Gynecare TVT-SECUR system
All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA I or II
* Age 21-89
Exclusion Criteria
* Not completed childbearing
* ASA III or higher
* Need concomitant surgery
* Poor compliance for office based approach
21 Years
89 Years
FEMALE
No
Sponsors
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Ethicon, Inc.
INDUSTRY
Michigan Institution of Women's Health PC
OTHER
Responsible Party
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Salil Khandwala MD
President, Michigan Institution of Women's Health PC
Principal Investigators
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Salil S Khandwala, MD
Role: PRINCIPAL_INVESTIGATOR
Michigan Institute of Women's Health PC
Locations
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Advanced Urogynecology of Michigan PC
Dearborn, Michigan, United States
Countries
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Other Identifiers
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MIWH08-001
Identifier Type: -
Identifier Source: org_study_id
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