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

Federal University of São Paulo

Status and phase: Completed; Phase 4

Conditions: Stress Urinary Incontinence

Treatments: Device: TVT-S; Device: TVT-O

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01095159

UNIFESP-TVTOxTVTS

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 2 patient groups

TVT-O

Active Comparator group

Description:

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

Treatment:

Device: TVT-O

TVT-S

Active Comparator group

Description:

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

Treatment:

Device: TVT-S