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

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ClinicalTrials.gov Identifier: NCT01095159
Recruitment Status : Unknown
Verified March 2012 by Ana Maria Homem de Mello Bianchi, Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
First Posted : March 30, 2010
Last Update Posted : March 13, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: TVT-O Device: TVT-S Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence
Study Start Date : February 2009
Primary Completion Date : December 2011
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: TVT-Secur™ (Gynecare™, USA).


Outcome Measures

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095159


Locations
Brazil
Federal University of Sao Paulo - Unifesp
São Paulo, SP, Brazil, 0-4023- 062
Sponsors and Collaborators
Federal University of São Paulo
Johnson & Johnson
Investigators
Principal Investigator: Ana Maria HM BIANCHI, FELLOW Federal University of São Paulo
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ana Maria Homem de Mello Bianchi, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01095159     History of Changes
Other Study ID Numbers: UNIFESP-TVTOxTVTS
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by Ana Maria Homem de Mello Bianchi, Federal University of São Paulo:
TVTO
TVTSecur
Mini sling
stress urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders