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OpenTrials
Completed

NCT Number: NCT01095159

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Federal University of Sao Paulo - Unifesp

São Paulo, 0-4023- 062, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TVT-O

Device

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

Other names: TVT-O™ (Gynecare™, USA).

TVT-S

Device

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

Other names: TVT-Secur™ (Gynecare™, USA).

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

Comparative Study of TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

Acronym: TVTOxTVTS

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Mar 30, 2010
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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