Clinical Trials Directory

Trials / Completed

CompletedNCT01094353

A Comparative Study Minisling Versus Transobturator (TOT)Sling

Randomised Trial of Ophira™ Minisling System and Unitape™ for the Treatment of Stress Urinary Incontinence in Women

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
145 (actual)
Sponsor
Federal University of São Paulo · Academic / Other
Sex
Female
Age
18 Years – 90 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDUREMini-slingThe 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.
PROCEDURETransobturatorTransobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence

Timeline

Start date
2008-06-01
Primary completion
2011-12-01
Completion
2015-07-01
First posted
2010-03-26
Last updated
2017-06-21

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01094353. Inclusion in this directory is not an endorsement.