Stress Urinary Incontinence
Conditions
Keywords
TVTO, TVTSecur, Mini sling, stress urinary incontinence
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.
Interventions
DEVICETVT-O
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
DEVICETVT-S
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).
Sponsors
Johnson & Johnson
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the efficacy of employing the Gynecare TVT Secur™ with the traditional Gynecare TVT- O™ for treating female stress urinary incontinence. | 1 year |
Countries
Brazil
Outcome results
None listed