A Comparative Study Minisling Versus Transobturator (TOT)Sling

Phase 4

Completed

• Conditions: Female Stress Urinary Incontinence

• Registration Number: NCT01094353
• Lead Sponsor: Federal University of São Paulo

Brief Summary

A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot with minisling.

Detailed Description

eligibility criteria was : female stress urinary incontinence

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Primary Completion: 2011-12
• Study Completion: 2015-07
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 145

Inclusion Criteria

• clinical and urodynamic diagnosis of SUI in patients between 18 and 90 years

Exclusion Criteria

• postvoid residual urine volume more than 100 ml, coagulation disorders, current urinary tract infection, sequelae of previous radiation therapy of the pelvis, anticoagulant therapy, vulvovaginitis, and anesthesia contraindication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
to assess efficacy between tot with minisling in cure in women with stress urinary incontinence	one year	to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil