A Comparative Study Minisling Versus Transobturator (TOT)Sling

Phase 4CompletedNCT01094353

Federal University of São Paulo145 enrolled

Overview

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

eligibility criteria was : female stress urinary incontinence

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

145

Conditions

Female Stress Urinary Incontinence

Interventions

Mini-slingPROCEDURE

The minisling is a new intervention therapeutic option for surgical treatment in women with stress urinary incontinence. It is made of polypropylene monofilament mesh, held between two self-anchoring polypropylene columns in a fishbone design connected to two delivering needles.

TransobturatorPROCEDURE

Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Federal University of São Paulo

São Paulo, Brazil

Outcomes

Primary Outcomes

to assess efficacy between tot with minisling in cure in women with stress urinary incontinence

to assess efficacy and safety of minisling and transobturator sling in treatment of female stress urinary incontinence

Time frame: one year

Data from ClinicalTrials.gov

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