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Stress Urinary IncontinencePhase 4TVTOxTVTSNCT01095159

TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

A Phase 4 study testing TVT-O and TVT-S in people with Stress Urinary Incontinence, run by Federal University of São Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years, women only
Conditions the study is for
Stress Urinary Incontinence
What is being tested?
TVT-O and TVT-S
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteBrazil
Study dates
Feb 2009to Dec 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical and urodynamic for stress urinary

Who cannot join

  • Detrusor overactivity (urodynamic study)
  • Urodynamic changes suggesting reduced vesical capacity
  • Associated neurological diseases
  • Coagulopathies
  • Pregnancy
  • Foreign matter sensitiveness history
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Federal University of Sao Paulo - Unifesp

    São Paulo, São Paulo, 0-4023- 062

Other trials in Brazil

About this study

Official title: 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.

Being tested
TVT-O, TVT-S
Keywords
TVTO, TVTSecur, Mini sling, stress urinary incontinence
Medical subject headings
Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TVT-ODevice

    Also called TVT-O™ (Gynecare™, USA).

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

  • TVT-SDevice

    Also called TVT-Secur™ (Gynecare™, USA).

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

Study groups in NCT01095159
Study groupRoleWhat they receive
TVT-OActive comparatorSubjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
Receives: Device: TVT-O
TVT-SActive comparatorSubjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).
Receives: Device: TVT-S

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2010 (estimated)
  2. Study startFeb 2009
  3. Primary completionDec 2011
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01095159
Sponsor's protocol ID
UNIFESP-TVTOxTVTS
Acronym
TVTOxTVTS
Status last verified
May 2018
First submitted
29 Mar 2010
Last updated
30 May 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37888839

  • 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.

    PubMed 24643378

  • 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.

    PubMed 23208003

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TVT-O and TVT-S in people with Stress Urinary Incontinence, run by Federal University of São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01095159, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.

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