NCT01095159

TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of TVTO™ and TVTSecur™ as surgical treatment for female urinary stress incontinence.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	TVT-O	Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
DEVICE	TVT-S	Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-12-01
• Completion: 2013-12-01
• First posted: 2010-03-30
• Last updated: 2018-05-30

Locations

1 site across 1 country: Brazil