Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence
NCT ID: NCT00534365
Last Updated: 2017-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
281 participants
INTERVENTIONAL
2007-08-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Tension-free vaginal tape procedure (TVT)
tension-free vaginal tape
Retropubic mid-urethral sling
2
TVT-SECUR device
TVT-SECUR device
Mid-urethral mini-sling
Interventions
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tension-free vaginal tape
Retropubic mid-urethral sling
TVT-SECUR device
Mid-urethral mini-sling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Urodynamic stress incontinence confirmed with multichannel urodynamic testing
* Age of at least 21 years
* Desires surgical correction of stress urinary incontinence
Exclusion Criteria
* Detrusor overactivity on preoperative multichannel urodynamic testing
* History of previous synthetic, biologic or fascial sub-urethral sling
* Desires future childbearing
* History of bleeding diathesis or current anti-coagulation therapy
* Current genitourinary fistula or urethral diverticulum
* Reversible cause of incontinence (i.e. drug effect)
* Contraindication to surgery
21 Years
FEMALE
No
Sponsors
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Good Samaritan Hospital, Ohio
OTHER
Greater Baltimore Medical Center
OTHER
Medstar Health Research Institute
OTHER
Duke University
OTHER
Foundation for Female Health Awareness
OTHER
Women and Infants Hospital of Rhode Island
OTHER
Main Line Health
OTHER
The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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Matthew D Barber, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Washington Hospital Center
Washington D.C., District of Columbia, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Duke University Medical Center
Durham, North Carolina, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Main Line Health
Paoli, Pennsylvania, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Countries
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References
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Barber MD, Weidner AC, Sokol AI, Amundsen CL, Jelovsek JE, Karram MM, Ellerkmann M, Rardin CR, Iglesia CB, Toglia M; Foundation for Female Health Awareness Research Network. Single-incision mini-sling compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):328-37. doi: 10.1097/AOG.0b013e318242a849.
Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
Other Identifiers
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FFHA 07-01
Identifier Type: -
Identifier Source: org_study_id
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