TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence
This trial is active, not recruiting.
|Condition||stress urinary incontinence|
|Sponsor||Federal University of São Paulo|
|Collaborator||Johnson & Johnson|
|Start date||February 2009|
|End date||December 2011|
|Trial size||124 participants|
|Trial identifier||NCT01095159, UNIFESP-TVTOxTVTS|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
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
Female participants from 18 years up to 90 years old.
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
|Official title||Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence|
|Principal investigator||Ana Maria HM BIANCHI, FELLOW|
Call for more information