TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

Federal University of São Paulo124 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

124

Conditions

Stress Urinary Incontinence

Interventions

TVT-ODEVICE

Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).

TVT-SDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Federal University of Sao Paulo - Unifesp

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

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

Time frame: 1 year

Data from ClinicalTrials.gov

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