TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

Phase 4

Completed

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT01095159
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Primary Completion: 2011-12
• Study Completion: 2013-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-28
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

• Clinical and urodynamic for stress urinary

Exclusion Criteria

• Detrusor overactivity (urodynamic study)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare the efficacy of employing the Gynecare TVT Secur™ with the traditional Gynecare TVT- O™ for treating female stress urinary incontinence.	1 year

Trial Locations

Locations (1)

Federal University of Sao Paulo - Unifesp; 🇧🇷 São Paulo, SP, Brazil