NCT01095159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

2.8 years

First QC Date

March 29, 2010

Last Update Submit

May 28, 2018

Conditions

Stress Urinary Incontinence

Keywords

TVTOTVTSecurMini slingstress urinary incontinence

Outcome Measures

Primary Outcomes (1)

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

    1 year

Study Arms (2)

TVT-O

ACTIVE COMPARATOR

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

Device: TVT-O

TVT-S

ACTIVE COMPARATOR

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

Interventions

TVT-ODEVICE

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

Also known as: TVT-O™ (Gynecare™, USA).
TVT-O
TVT-SDEVICE

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

Also known as: TVT-Secur™ (Gynecare™, USA).
TVT-S

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical and urodynamic for stress urinary

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo - Unifesp

São Paulo, São Paulo, 0-4023- 062, Brazil

Location

Related Publications (3)

  • Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

    PMID: 37888839DERIVED

  • 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.

    PMID: 24643378DERIVED

  • 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.

    PMID: 23208003DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ana Maria HM BIANCHI, FELLOW

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 29, 2010

First Posted

March 30, 2010

Study Start

February 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2013

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

BR(1)