TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence
NCT ID: NCT01095159
Last Updated: 2018-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
124 participants
INTERVENTIONAL
2009-02-28
2013-12-31
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
SINGLE
Study Groups
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TVT-O
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
TVT-O
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
TVT-S
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).
TVT-S
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).
Interventions
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TVT-O
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
TVT-S
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Urodynamic changes suggesting reduced vesical capacity
* Associated neurological diseases
* Coagulopathies
* Pregnancy
* Foreign matter sensitiveness history
* Acute urinary tract infection
* Sequel from high ionizing radiation exposure
* Use of drugs that may result in high surgical risk and/or significant postoperative complication
* Anesthetic procedure contraindication
* Vulvovaginitis: presence of vaginal secretion with infection clinically or lab supported
18 Years
90 Years
FEMALE
No
Sponsors
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Johnson & Johnson
INDUSTRY
Federal University of São Paulo
OTHER
Responsible Party
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Ana Maria Homem de Mello Bianchi
MD
Principal Investigators
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Ana Maria HM BIANCHI, FELLOW
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
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Federal University of Sao Paulo - Unifesp
São Paulo, São Paulo, Brazil
Countries
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References
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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.
Bianchi-Ferraro AM, Jarmy-DiBella ZI, de Aquino Castro R, Bortolini MA, Sartori MG, Girao MJ. Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results. Int Urogynecol J. 2014 Oct;25(10):1343-8. doi: 10.1007/s00192-014-2352-7. Epub 2014 Mar 19.
Bianchi-Ferraro AM, Jarmy-Di Bella ZI, Castro Rde A, Bortolini MA, Sartori MG, Girao MJ. Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2013 Sep;24(9):1459-65. doi: 10.1007/s00192-012-1998-2. Epub 2012 Dec 4.
Other Identifiers
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UNIFESP-TVTOxTVTS
Identifier Type: -
Identifier Source: org_study_id
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