TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence (TVTOxTVTS)

May 28, 2018 updated by: Ana Maria Homem de Mello Bianchi, Federal University of São Paulo

Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 0-4023- 062
        • Federal University of Sao Paulo - Unifesp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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-O
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
Other Names:
  • TVT-O™ (Gynecare™, USA).
Active Comparator: TVT-S
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (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).
Other Names:
  • TVT-Secur™ (Gynecare™, USA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Johnson & Johnson

Investigators

  • Principal Investigator: Ana Maria HM BIANCHI, FELLOW, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (Estimate)

March 30, 2010

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 28, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIFESP-TVTOxTVTS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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