TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence
Phase 4
Completed
- Conditions
- Stress Urinary Incontinence
- Interventions
- Device: TVT-ODevice: TVT-S
- 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
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
- Arm && Interventions
Group Intervention Description TVT-O 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 TVT-S Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Federal University of Sao Paulo - Unifesp
🇧🇷São Paulo, SP, Brazil