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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Ana Maria Homem de Mello Bianchi, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01095159
First received: March 29, 2010
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Stress Urinary Incontinence
Device: TVT-O
Device: TVT-S
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 124
Study Start Date: February 2009
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Federal University of São Paulo

Additional 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
Study First Received: March 29, 2010
Last Updated: March 9, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
TVTO
TVTSecur
Mini sling
stress urinary incontinence

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

ClinicalTrials.gov processed this record on October 23, 2014