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

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
TVT-O
TVT-S
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring TVTO, TVTSecur, Mini sling, stress urinary incontinence

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Sao Paulo - Unifesp

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TVT-O

TVT-S

Arm Description

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

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

Outcomes

Primary Outcome Measures

Compare the efficacy of employing the Gynecare TVT Secur™ with the traditional Gynecare TVT- O™ for treating female stress urinary incontinence.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2010
Last Updated
May 28, 2018
Sponsor
Federal University of São Paulo
Collaborators
Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT01095159
Brief Title
TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence
Acronym
TVTOxTVTS
Official Title
Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Johnson & Johnson

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
TVTO, TVTSecur, Mini sling, stress urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TVT-O
Arm Type
Active Comparator
Arm Description
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
Arm Title
TVT-S
Arm Type
Active Comparator
Arm Description
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).
Intervention Type
Device
Intervention Name(s)
TVT-O
Other Intervention Name(s)
TVT-O™ (Gynecare™, USA).
Intervention Description
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
Intervention Type
Device
Intervention Name(s)
TVT-S
Other Intervention Name(s)
TVT-Secur™ (Gynecare™, USA).
Intervention Description
Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Maria HM BIANCHI, FELLOW
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo - Unifesp
City
São Paulo
State/Province
SP
ZIP/Postal Code
0-4023- 062
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
24643378
Citation
Bianchi-Ferraro AM, Jarmy-DiBella ZI, de Aquino Castro R, Bortolini MA, Sartori MG, Girao MJ. Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results. Int Urogynecol J. 2014 Oct;25(10):1343-8. doi: 10.1007/s00192-014-2352-7. Epub 2014 Mar 19.
Results Reference
derived
PubMed Identifier
23208003
Citation
Bianchi-Ferraro AM, Jarmy-Di Bella ZI, Castro Rde A, Bortolini MA, Sartori MG, Girao MJ. Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2013 Sep;24(9):1459-65. doi: 10.1007/s00192-012-1998-2. Epub 2012 Dec 4.
Results Reference
derived

Learn more about this trial

TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

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