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TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

NCT01095159 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2018-05-30

No results posted yet for this study

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.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

TVT-O

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

DEVICE

TVT-S

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

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Ana Maria HM BIANCHI, FELLOW · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-12-31
Completion
2013-12-31

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01095159 on ClinicalTrials.gov