Overview

This trial is active, not recruiting.

Condition stress urinary incontinence
Treatments tvt-o, tvt-s
Phase phase 4
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
tvt-o TVT-O™ (Gynecare™, USA).
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
(Active Comparator)
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).
tvt-s TVT-Secur™ (Gynecare™, USA).
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).

Primary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

Official title Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence
Principal investigator Ana Maria HM BIANCHI, FELLOW
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.